title: A Phase Ib, Single-Arm, Open-Label Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab in Pediatric Patients Hospitalized With COVID-19

summary: This is a single-arm, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and exploratory efficacy of tocilizumab (TCZ) for the treatment of pediatric patients from birth to less than 18 years old hospitalized with COVID-19 and who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Poland
Spain
Italy
Greece
United States
France

location_facility: Tulane University Health Sciences Center

location_facility: University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital

location_facility: Szpital Kliniczny im Karola Jonschera Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu

location_facility: Hospital Infantil Universitario Niño Jesus; Sección de Neuropediatria

location_facility: Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia

location_facility: ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco

location_facility: Feinstein Institute for Medical Research

location_facility: Central Michigan University College of Medicine

location_facility: UT Physicians - Pediatric Center - Texas Medical Center

location_facility: CHRU Montpellier; SMPEA Peyre Plantade Centre de Ressources Autisme

location_facility: IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN


ipd_sharing: Yes

status: Recruiting

primary_purpose: Treatment

intervention_type: Drug

acronym: ENDYMION 2

title: A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2)

study_completion_date_type: Anticipated

lead_sponsor: Takeda

type: EudraCT Number

type: Registry Identifier

source: euctr

study_start_date_type: Actual

study_type: Interventional

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

enrollment_type: Anticipated

location_country:
Poland
Serbia
Spain
Greece
Italy
Australia
Latvia
Canada
Russian Federation
Ukraine
Hungary
United States
France
China
Belgium
Japan
Netherlands

location_facility: University of California Benioff Children's Hospital

location_facility: ASST di Mantova - Azienda Ospedaliera Carlo Poma

location_facility: Childrens' Hospital of Athens 'P. and A. Kyriakou'

location_facility: Children's Hospital of Chongqing Medical University

location_facility: ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

location_facility: Guangzhou Women And Children's Medical Center

location_facility: Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

location_facility: CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA

location_facility: Kumamoto-Ezuko Medical Center for The Severely Disabled

location_facility: National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Institute of Neurology and Neurosurgery at Saint Barnabas, LLC

location_facility: Cook Children's Medical Center - Jane and John Justin Neurosciences Center

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Medical University of South Carolina Children Hospital - PIN

location_facility: National Center of Neurology and Psychiatry

location_facility: SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr

location_facility: Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy

location_facility: Hopital Universitaire des Enfants Reine Fabiola

location_facility: Russian National Research Medical University n.a. N.I.Pirogov

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: University of Utah - Primary Children's Hospital - PPDS

location_facility: University of Iowa Hospitals & Clinics - (CRS)

location_facility: Clinic for Neurology and Psychiatry for Children and Youth

location_facility: Children and Youth Health Care Institute of Vojvodina

location_facility: Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Communal Non-profit Enterprise Dnipro City Children Clinical Hospital #5 of DCC

location_facility: Clinical Integrative Research Center of Atlanta

location_facility: Xiangya Hospital of Central South University

location_facility: Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC

location_facility: Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: MultiCare Institute for Research & Innovation (Tacoma)

location_facility: Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie

location_facility: National Hospital Organization Nishi-Niigata Chuo National Hospital

location_facility: The Second Affiliated Hospital of Guangzhou Medical Univeristy

location_facility: Beijing Children's Hospital,Capital Medical University

location_facility: Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

location_facility: Stichting Epilepsie Instellingen Nederland

summary:
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS).

Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There will be scheduled visits and follow-up phone calls throughout the study.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Investigate the Effects of Two Doses (Up-titration to a Fixed Dose Regimen) of Oral BI 685509 on Portal Hypertension After 24 Weeks Treatment in Patients With Clinically Significant Portal Hypertension (CSPH) in Compensated Cirrhosis

summary:
This study is open to adults with liver cirrhosis and high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether a medicine called BI 685509 helps people with this condition.

Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 685509 as tablets twice a day. Participants in the placebo group take placebo as tablets twice a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine.

Participants are in the study for about 8 months. During this time, they visit the study site about 14 times. At 3 of the visits, the doctors check the pressure in a liver vein. This is done with a catheter (a long thin tube) and gives information about the pressure in the portal vein. The change in blood pressure is then compared between the groups to see whether the treatment works.

The doctors also regularly check participants' health and take note of any unwanted effects.

design_allocation: Randomized

ipd_sharing_description:
Once the time frame criteria given under number 4 are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

lead_sponsor: Boehringer Ingelheim

location_country:
Denmark
Taiwan
Portugal
Romania
Spain
Italy
Austria
Netherlands
Argentina
Canada
Switzerland
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany

location_facility: Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria

location_facility: National Hospital Organization Yokohama Medical Center

location_facility: Beijing Youan Hospital, Capital Medical University

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: The Affiliated Hospital of Hangzhou Normal University

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: American Research Corporation at the Texas Liver Institute

location_facility: Regional Institute of Gastroenterology Hepatology "Prof. Dr. O. Fodor"


ipd_sharing: No

title: A Phase 3 Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ISIS 721744 in Patients With Hereditary Angioedema (HAE)

lead_sponsor: Ionis Pharmaceuticals, Inc.

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
Canada
United States
France
Israel
Turkey
Belgium
Germany
Bulgaria

summary: The purpose of this study is to evaluate the safety and efficacy of donidalorsen in participants with HAE and effect of donidalorsen on the quality and pattern of HAE attacks and their impact on quality of life (QoL).


acronym: Operetta 2

intervention_type: Other

title: A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis

lead_sponsor: Hoffmann-La Roche

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

location_country:
Poland
Brazil
Serbia
Spain
Greece
Austria
Australia
Italy
Argentina
Canada
Mexico
Ukraine
United Kingdom
Hungary
United States
France
Belgium
Germany
Bulgaria

location_facility: University of Colorado Denver Childrens Hospital Rocky Mountain MS Center

location_facility: Debreceni Egyetem Klinikai Központ; Gyermekklinika

location_facility: NYU Langone Medical Center; Laura and Isaac Perlmutter Cancer Center

location_facility: A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)

location_facility: Vestische Kinder- und Jugendklinik Datteln

location_facility: Hôpital Universitaire des Enfants Reine Fabiola; porte 10, batiment K

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Neurologii Rozwojowej

location_facility: KZ "Dnipropetrovska oblasna dytiacha klinichna likarnia" DOR

location_facility: Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

location_facility: Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY

location_facility: Universita' G. D'Annunzio; Dipartimento di Neuroscienze, Imaging e Scienze Cliniche

location_facility: Pediatric Multiple Sclerosis and Related Disorders Program at Boston Children's Hospital

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

location_facility: Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Neurologia

location_facility: CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie

location_facility: Medizinische Universität Wien; Univ.Klinik fuer Neurologie

location_facility: Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Clinic for neurology, Clinical Center Kragujevac

location_facility: Great Ormond Street Hospital For Children; Neurology

location_facility: Instytut Pomnik Centrum Zdrowia Dziecka; Klinika Neurologii i Epileptologii

location_facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Kinder-und Jugendmedizin_UMG

location_facility: Royal Children's Hospital Melbourne - PIN

location_facility: Hospital Eginition; First Department of Neurology

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia

location_facility: Baylor College of Medicine/Texas Children's Hospital

location_facility: IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

location_facility: Hopital Pierre Wertheimer - Hopital Neurologique; Service de neurologie

location_facility: Centre Hospitalier Universitaire de Bicêtre

location_facility: Cleveland Clinic, Mellen Center for Multiple Sclerosis

location_facility: Hospital Universitario de la Princesa; Servicio de Neurologia

location_facility: Hippokration General Hospital; First Department of Pediatrics

location_facility: Washington University, Pediatric MS and other Demyelinating Disease Center

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: Multiprofile Hospital For Active Treatment In Neurology And Psychiatry (MHATNP) ''St. Naum"

location_facility: Instytut Centrum Zdrowia Matki Polki; Klinika Neurologii

location_facility: Universitätsklinikum Münster; Klinik für Kinder- und Jugendmedizin

summary: This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis aged between 10 and < 18 years over a duration of at least 96 weeks.


title: A Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study With Open-Label Extension to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of LMI070/Branaplam Administered as Weekly Oral Doses in Participants With Early Manifest Huntington's Disease

acronym: VIBRANT-HD

summary: This is the first study of branaplam in adults with Huntington's Disease (HD) to determine the correct dose required to lower mutant huntingtin protein (mHTT) levels in the cerebrospinal fluid (CSF) to a degree expected to be efficacious over longer periods of time.

status: Active, not recruiting

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
Canada
Hungary
United States
France
Belgium
Germany


title: An Open Label, First-in-human Study of BAY 2927088 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring an EGFR and/or HER2 Mutation

summary:
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body.

Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer.

Several EGFR and/or HER2 mutations exist in the cancer cells. Two mutations observed in NSCLC are called EGFR- or HER2exon20ins and EGFR C797X. The study treatment, BAY2927088, works by blocking the mutated EGFR protein and also its ex20ins version which are present in NSCLC. It is also believed to work against HER2 and HER2ex20ins mutations. Researchers think this may help stop the further spread of NSCLC cancer.

This is the first time that researchers will study BAY2927088 in humans. In this study, the researchers want to learn more about using BAY2927088 in participants who have NSCLC with EGFR and/or HER2 mutations including EGFRex20ins and/or HER2ex20ins mutations.

The main aims of this study are to find for BAY2927088

how safe BAY2927088 is
how it affects the body (also referred to as tolerability)
how BAY2927088 moves into, through and out of the body
the maximum amount of BAY2927088 that the participants can take without too many side effects.

The researchers will also study the action of BAY2927088 against the cancer. This study will have three parts. The first part will help find the most appropriate dose that can be given in the third part.

Each participant of the first, so called dose escalation part, will be assigned to one specific dose group for BAY2927088. The amount of BAY2927088 that is given increases stepwise from one group to the next.

The participants of the second, so called Backfill part will be assigned any specific dose that has already been tested during Part 1 and found to be safe.

The participants of the third, so called dose expansion part, will receive the most appropriate dose of BAY2927088 found in the first and second parts.

During the study, the participants will take the study treatment in 3 week periods called "cycles". They will in general take BAY2927088 once daily until their cancer gets worse, until they have medical problems, until they leave the study or until the study is terminated. Participants will have around 5 visits in each cycle.

During the study, the study team will:

take blood and urine samples
take regular CT or MRI scans to check if the participants' cancer has gotten better or worse
check the participants' overall health and heart health
ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

design_allocation: Non-Randomized

ipd_sharing: Undecided

ipd_sharing_description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Taiwan
Hong Kong
Spain
Italy
Korea, Republic of
United States
France
China
Japan
Singapore

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Fundacion Jimenez Diaz (Clinica de la Concepcion)

location_facility: IRCCS Centro di Riferimento Oncologico (CRO)

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: Henry Ford Health System | Brigitte Harris Cancer Pavilion

location_facility: NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G.Pascale

location_facility: Shanghai Chest Hospital, Shanghai Jiaotong University

location_facility: Seoul National University Bundang Hospital


title: A Phase 1/1b/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors

acronym: MTAP

summary:
The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors.

The primary objective of Part 3 of this study is to evaluate the objective response rate (ORR) of AMG 193 in adult participants with metastatic or locally advanced MTAP-null non-small cell lung cancer (NSCLC), after prior treatment with chemotherapy and/or a programmed death-1/ligand 1 (PD-1/L1) inhibitor.

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

lead_sponsor: Amgen

location_country:
Austria
Australia
Switzerland
United States
France
Belgium
Japan
Germany

location_facility: South Texas Accelerated Research Therapeutics

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

location_facility: Nationales Centrum für Tumorerkrankungen Heidelberg

location_facility: University of Pittsburgh Medical Center Cancer Pavillion

location_facility: Istituto Oncologico della Svizzera Italiana

location_facility: American Oncology Partners of Maryland, PA


primary_purpose: Prevention

intervention_type: Biological

title: A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age

lead_sponsor: ModernaTX, Inc.

ReferenceType: derived

ReferenceCitation: Kadambari S, Evans C, Lyall H. Congenital Infections: Priorities and Possibilities for Resource-limited Settings. Pediatr Infect Dis J. 2022 Sep 12. doi: 10.1097/INF.0000000000003710. [Epub ahead of print]

location_country:
Spain
Italy
United Kingdom
Estonia
Australia
Canada
Finland
United States
France
Israel
Belgium
Germany

location_facility: LMC Manna Research - Toronto - HyperCore - PPDS

location_facility: Centre Hospitalier et Universitaire de Limoges

location_facility: University of Minnesota Clinical Research Unit

location_facility: Village Health Partners Frisco Medical Village

location_facility: Meridian Clinical Research-(Rockville Maryland)

location_facility: Meridian Clinical Research (Norfolk-Nebraska)

location_facility: Carolina Institute for Clinical Research - M3 WR - ERN - PPDS

location_facility: LMC Manna Research - Montreal - HyperCore - PPDS

location_facility: Paratus Clinical Research - Western Sydney

location_facility: LMC Manna Research - Burlington - HyperCore - PPDS

location_facility: Baptist Health Center for Clinical Research

location_facility: Premier Family Physicians - Austin - Hunt

location_facility: NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust

location_facility: Groupe Hospitalier Cochin Saint Vincent de Paul

location_facility: Alliance for Multispecialty Research, LLC

location_facility: LMC Manna Research - Quebec - HyperCore - PPDS

location_facility: Meridian Clinical Research-(Omaha Nebraska)

location_facility: Meridian Clinical Research (Grand Island, Nebraska)

location_facility: Mount Vernon Clinical Research, LLC - M3 WR - ERN - PPDS

location_facility: Diex Recherche - Victoriaville - HyperCore

location_facility: Velocity Clinical Research, New Smyrna Beach

location_facility: Health Research of Hampton Roads Inc. - ClinEdge

location_facility: Clinical Trials of Texas, Inc. - HyperCor

location_facility: Medislim GmbH - Zentrum fuer Ambulante Klinische Forschung

location_facility: Clinical Research Institute, Inc - CRN - PPDS

location_facility: Austin Regional Clinic ARC Clinical Research at Kelly Lane

location_facility: Velocity Clinical Research - Chula Vista

location_facility: University of the Sunshine Coast, Health Hub Morayfield

location_facility: Meridian Clinical Research (Endwell-New York) - Platinum - PPDS

location_facility: Paradigm Clinical Research Institute, Inc. - ClinEdge

location_facility: Diex Recherche - Joilette - HyperCore - PPDS

location_facility: Dr. Anil K. Gupta Medicine Professional Corporation

location_facility: David Ramstad Associates Research - IACT - HyperCore - PPDS

location_facility: Meridian Clinical Research (Hastings, Nebraska)

location_facility: LMC Manna Research - Mirabel - HyperCore - PPDS

location_facility: Tampereen Yliopisto Seinajoen Rokotusklinikka

location_facility: University of Texas Medical Branch - Bay Colony, SIVS Clinical Trials Program

location_facility: CTI Clinical Research Center - ClinEdge - PPDS

location_facility: MediSync Clinical Research Hattiesburg Clinic

location_facility: Fondazione MBBM (MONZA E BRIANZA PER IL BAMBINO E LA SUA MAMMA) - c/o Centro Maria Letizia Verga

location_facility: M3 Wake Research, Inc - M3 WR - ERN - PPDS

summary: The main purpose of this study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia

acronym: PATHWAY

summary: The purpose of this study is to evaluate the efficacy and safety of parsaclisib compared with placebo in participants with Primary Warm Autoimmune Hemolytic Anemia (wAIHA),

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
United States
France
Israel
Belgium
Japan
Germany

location_facility:
Investigative Site US007
Investigative Site ES006
Investigative Site IT001
Investigative Site AT001
Investigative Site GB005
Investigative Site JP005
Investigative Site ES004
Investigative Site ES005
Investigative Site JP010
Investigative Site US004
Investigative Site FR001
Investigative Site IT003
Investigative Site PL005
Investigative Site BE002
Investigative Site CA001
Investigative Site PL001
Investigative Site JP003
Investigative Site IL002
Investigative Site DE002
Investigative Site US002
Investigative Site US006
Investigative Site IT002
Investigative Site ES001
Investigative Site GB003
Investigative Site JP009
Investigative Site JP001
Investigative Site JP002
Investigative Site FR002
Investigative Site DE001
Investigative Site BE001
Investigative Site US005
Investigative Site PL004
Investigative Site IT005
Investigative Site PL006
Investigative Site JP006
Investigative Site PL002
Investigative Site IT004
Investigative Site GB004
Investigative Site 007
Investigative Site US003
Investigative Site FR003
Investigative Site GB002
Investigative Site ES003
Investigative Site US001
Investigative Site AT002
Investigative Site JP008
Investigative Site JP004
Investigative Site IT006
Investigative Site US012
Investigative Site ES002
Investigative Site IL001
Investigative Site NL001
Investigative Site PL003


type: Other Identifier

title: A Phase 2a, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

acronym: AFFINITY

summary: The purpose of this study is to evaluate the efficacy of guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) to prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapies by assessing clinical response compared with guselkumab monotherapy.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Denmark
Poland
Spain
Italy
Russian Federation
Ukraine
Hungary
United States
France
Sweden

location_facility: GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: State Institution Institute of therapy named after L.T.Malaya AMS Ukraine

location_facility: FGBU Research Institute of Rheumatology named V.A.Nasonova

location_facility: Clinical-Diagnostic Center Euromedservice, JSC

location_facility: Arizona Arthritis and Rheumatology Research, PLLC

location_facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: WroMedica I.Bielicka, A.Strzałkowska s.c.

location_facility: Tula Regional Clinical Dermatovenerological Dispensary

location_facility: Trinity Universal Research Associates, LLC

location_facility: Azienda Ospedaliero-Universitaria di Cagliari

location_facility: Ryazan Regional Clinical Dermatovenerological Dispensary

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud

location_facility: Municipal Institution Regional hospital-center of emergency care and disasters medicine

location_facility: Republican Clinical Hospital - G.G. Kuvatov

location_facility: IRCCS Policlinico San Matteo, Università degli studi di Pavi

location_facility: Smolensk regional hospital on Smolensk railway station

location_facility: Vital Medical Center Orvosi es Fogaszati Kozpont

location_facility: NYU Langone Ambulatory Care Brooklyn Heights

location_facility: Rostov Regional Clinical Dermatovenerological Dispensary

location_facility: Clinical Emergency Hospital n.a. N.V. Solovyev

location_facility: Akademiskt Specialistcentrum centrum för reumatologi

location_facility: Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital'

location_facility: Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

location_facility: Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

location_facility: SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

location_facility: ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil

location_facility: Unity Health-White County Medical Center

location_facility: Krasnodar Clinical Dermatovenerologic Dispensary

location_facility: MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council

location_facility: Twoja Przychodnia - Centrum Medyczne Nowa Sol


acronym: cosMOG

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3, Pivotal Study With an Open-Label Extension Period to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-Associated Disease (MOG-AD)

lead_sponsor: UCB Biopharma SRL

ReferenceCitation: Mader S, Kümpfel T, Meinl E. Pathomechanisms in demyelination and astrocytopathy: autoantibodies to AQP4, MOG, GFAP, GRP78 and beyond. Curr Opin Neurol. 2022 Jun 1;35(3):427-435. doi: 10.1097/WCO.0000000000001052. Review.

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Spain
Italy
Australia
Mexico
Switzerland
Sweden
Korea, Republic of
United States
France
Turkey
Belgium
Japan
Germany
Czechia

summary: The purpose of the study is to evalute the efficacy, safety and tolerability of rozanolixizumab for treatment of adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD).


title: A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION)

acronym: MOTION

summary:
This is a multicenter Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option.

The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Participants assigned to placebo in Part 1 will have the option to receive vimseltinib for Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label vimseltinib.

lead_sponsor: Deciphera Pharmaceuticals LLC

location_country:
Poland
Hong Kong
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Switzerland
United States
France
Norway
Germany

location_facility: University Hospital Essen (Universitätsklinikum Essen)

location_facility: Cancer & Haematology Centre, The Churchill Hospital - Oxford University Hospitals NHS Foundation Trust

location_facility: Universitäts-Kinderspital beider Basel (UKBB)

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori


title: A Phase III Prospective, Multicenter, Randomized, Open-Label Trial of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

acronym: MAJIC

summary: A study of acalabrutinib plus venetoclax (AV) versus venetoclax plus obinutuzumab (VO) in previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

ReferenceCitation: Ryan CE, Davids MS, Hermann R, Shahkarami M, Biondo J, Abhyankar S, Alhasani H, Sharman JP, Mato AR, Roeker LE. MAJIC: a phase III trial of acalabrutinib + venetoclax versus venetoclax + obinutuzumab in previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Future Oncol. 2022 Sep 14:0. doi: 10.2217/fon-2022-0456. [Epub ahead of print] Review.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Poland
Spain
Australia
Hungary
United States
France
Czechia


acronym: POSTERITY

title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis

location_country:
Poland
Brazil
Spain
United Kingdom
Russian Federation
Canada
Peru
United States
France
South Africa

location_facility: Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica

location_facility: Indiana University Health University Hospital

location_facility: Great Ormond Street Hospital for Children

location_facility: CHU de Toulouse - Hôpital des Enfants; Nephro - Rhumato - Medecine Interne - Hypertension

location_facility: Hospital Sant Joan De Deu; Servicio de Reumatologia Pediatrica

location_facility: Red Cross War Memorial Children's Hospital; Nephrology Unit

location_facility: Hospital de La Paz; Unidad de Reumatologia Pediatrica

location_facility: Children's Hospital Colorado, Anchutz Medical Campus

location_facility: Hospital Ramon y Cajal ; Servicio de Reumatologia

location_facility: Universidade Federal de Sao Paulo - UNIFES

location_facility: Saint-Petersburg State; Pediatrics Medical Academy

location_facility: Cohen Children's Medical Center of New York; Pediatrics

location_facility: Hôpital Robert Debré; Nephrologie pediatrique

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy

location_facility: Ser Servicos Especializados Em Reumatologia

location_facility: Szpital Specjalistyczny dla Dzieci i Doroslych; Oddzial Kliniczny Pediatrii i Nefrologii

summary: This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics of obinutuzumab in adolescent participants aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN).


title: A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis

summary:
This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial to evaluate the efficacy, safety and tolerability of HZN-825 in subjects with IPF. Subjects will be screened within 8 weeks prior to the Baseline (Day 1) Visit. Approximately 360 subjects who meet the trial eligibility criteria will be randomly assigned in a 1:1:1 ratio on Day 1 to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks using the following 2 stratification factors:

Prior use of approved IPF therapy (i.e., nintedanib or pirfenidone): yes or no
FVC % predicted at Baseline: ≥70% or <70%

lead_sponsor: Horizon Therapeutics Ireland DAC

location_country:
Taiwan
Spain
Greece
Italy
Australia
Argentina
Canada
Korea, Republic of
United States
Chile
France
South Africa
Mexico
Netherlands

location_facility: Oaxaca Site management Organization (OSMO)

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Centro Respiratorio Integral LTDA. (CENRESIN)

location_facility: Clinical Trials Center of Middle Tennessee

location_facility: Seoul National University Bundang Hospital

location_facility: University of Cape Town Lung Institute (UCTLI)

location_facility: Unidad de Investigación Clínica En Medicina SC

location_facility: Instituto De Enfermedades Respiratorias E Investigacion Medica

location_facility: Hospital Universitario Dr. Jose Eleuterio González

location_facility: Metroplex Pulmonary and Sleep Medicine Center

location_facility: University General Hospital of Heraklion

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Kaohsiung Medical University - Chung-Ho Memorial Hospital


title: A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of MK-7684A (MK-7684 [Vibostolimab] With MK-3475 [Pembrolizumab] Coformulation) in Participants With Relapsed or Refractory Hematological Malignancies

summary: The purpose of the study is to determine the safety and tolerability of pembrolizumab/vibostolimab (MK-7684A) in hematological malignancies. This study will also evaluate the overall response rate (ORR), the duration of response (DOR), and disease control rate (DCR) following administration of pembrolizumab/vibostolimab. In addition, this study will characterize pharmacokinetic (PK) profile of vibostolimab (MK-7684).

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Denmark
Poland
Taiwan
Brazil
Spain
Italy
Russian Federation
Canada
Ukraine
Hungary
United States
Chile
France
Israel
Turkey
Germany

location_facility: Országos Onkológiai Intézet-HEMATOLÓGIA ÉS LYMPHOMA OSZTÁLY KEMOTERÁPIA A ( Site 0405)

location_facility: Pitie Salpetriere University Hospital-Clinical haematology ( Site 0304)

location_facility: Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0424)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0427)

location_facility: Chang Gung Medical Foundation-Linkou Branch ( Site 0262)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 0400)

location_facility: University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0021

location_facility: Instituto Nacional del Cancer ( Site 0626)

location_facility: Universitätsklinikum Leipzig ( Site 0328)

location_facility: Almazov National Medical Research Centre-Intensive care unit No. 10 for oncohematological patients (

location_facility: Ankara University Hospital Cebeci ( Site 0561)

location_facility: Pécsi Tudományegyetem Klinikai Központ-I.sz. Belgyógyászati Klinika Hematológia ( Site 0401)

location_facility: Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 0325)

location_facility: GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0548)

location_facility: Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 0562)

location_facility: Dokuz Eylül Üniversitesi-Hematology ( Site 0563)

location_facility: Soroka Medical Center-Hematology Department ( Site 0523)

location_facility: Clinica Universidad de Navarra ( Site 0444)

location_facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 0442)

location_facility: University of Chicago Medical Center ( Site 0005)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0023)

location_facility: Universitätsklinikum Marburg ( Site 0333)

location_facility: McGill University Health Centre ( Site 0037)

location_facility: Universitaetsklinikum Hamburg-Eppendorf-II. medical clinic ( Site 0332)

location_facility: University of Texas MD Anderson Cancer Center ( Site 0014)

location_facility: Chang Gung Memorial Hospital at Kaohsiung ( Site 0263)

location_facility: Sheba Medical Center-Hemato Oncology ( Site 0524)

location_facility: Ege University Medicine of Faculty ( Site 0565)

location_facility: City of Hope Comprehensive Cancer Center-Hematology ( Site 0024)

location_facility: centre hospitalier lyon sud-Service Hématologie ( Site 0300)

location_facility: Rigshospitalet-Hematology - CTU ( Site 0361)

location_facility: Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site

location_facility: Universitaetsklinikum Essen ( Site 0327)

location_facility: MEDICAL COLLEGE OF WISCONSIN ( Site 0016)

location_facility: Semmelweis University-Belgyógyászati és Hematológiai Klinika ( Site 0403)

location_facility: Ospedale San Raffaele-Unità Linfomi ( Site 0382)

location_facility: Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S

location_facility: Russian Scientific Research Institute of Hematology and Blood Transfusion-Hematology ( Site 0542)

location_facility: Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0362)

location_facility: Hospital Universitario de Salamanca-Hematology ( Site 0441)

location_facility: Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0031)

location_facility: Instituto do Câncer e Transplante de Curitiba ( Site 0611)

location_facility: National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine (

location_facility: Policlinico S. Orsola- Malpighi-Istituto di Ematologia "L. e A. Seragnoli" ( Site 0381)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 0383)

location_facility: Institute of Transfusion Medicine and Blood of the National Academy of Medical Sciences of Ukraine (

location_facility: Moscow City Clinical Hospital S.P. Botkin ( Site 0547)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)

location_facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0601)

location_facility: Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 0446)

location_facility: Medical Oncology Associates, PS ( Site 0001)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 0593)


title: A Phase 3b/4, Double-masked, Randomized, International, Parallel-assignment, Multicenter Trial in Patients With Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab

summary: This is a double-masked, randomized, parallel-assignment, multicenter trial examining the safety and tolerability of teprotumumab in the treatment of Thyroid Eye Disease (TED) in adult participants. This international, Phase 3b/4 trial is being conducted to fulfill an FDA post-marketing requirement for a descriptive trial to evaluate the safety, efficacy and need for re-treatment of 3 different teprotumumab treatment durations for TED. In addition, serum samples from participants with a Baseline Clinical Activity Score (CAS) ≥3 will be evaluated for biomarkers of disease.

lead_sponsor: Horizon Therapeutics USA, Inc.

location_country:
Spain
Italy
United Kingdom
United States
France
Germany

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Centre Hospitalier National D'ophtalmologie Des Quinze Vingts


title: CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting

acronym: MANTRA

summary:
MANTRA is a prospective, multiple-arm, multi-center, global, post-market clinical follow-up study. The main objective is to monitor ongoing safety and performance of the CORCYM devices and accessories used for aortic, mitral and tricuspid valvular diseases in a real-world setting.

Corcym S.r.l., is a medical device manufacturer with a broad product portfolio for cardiac surgeons, offering solutions for the treatment of aortic, mitral and tricuspid valve disease.

The MANTRA Master Plan (Master Protocol) is intended as an overarching Umbrella Protocol that allows multiple sub-studies to be added, as needed. The Umbrella Master Protocol concept offers an excellent solution to provide post-marketing clinical follow-up information on the entire cardiac surgery heart valve portfolio of the sponsor in a common database, including corelab assessment of hemodynamic and structural performance, annular motion and Dynamics for one of the products.

Currently, three sub-studies are planned:

MANTRA - Aortic Sub-Study
MANTRA - Mitral/Tricuspid Sub-Study (Excluding Memo 4D)
MANTRA - Memo 4D Sub-Study

study_type: Observational

time_perspective: Prospective

lead_sponsor: Corcym S.r.l

location_country:
Portugal
United Kingdom
Italy
Austria
Netherlands
Canada
Switzerland
Korea, Republic of
United States
France
Belgium
Germany

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: CHU Toulouse_Rangueil University Hospital

location_facility: Pusan National University Yangsan Hospital

location_facility: Az. Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Molinette

location_facility: Azienda ospedaliera dei Colli - Ospedale Monaldi


title: A Phase 2a Study of TPN-101 in Patients With Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) Associated With Hexanucleotide Repeat Expansion in the C9orf72 Gene (C9ORF72 ALS/FTD)

summary: This is a Phase 2a study to assess the the safety and tolerability of TPN-101 in patients with Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) Associated with Hexanucleotide Repeat Expansion in the C9orf72 gene (C9ORF72 ALS/FTD).

lead_sponsor: Transposon Therapeutics, Inc.

location_country:
Spain
United States
France
Belgium
Germany

location_facility: The University of North Carolina at Chapel Hill, Department of Neurology

location_facility: Columbia University Medical Center - The Neurological Institute of New York

location_facility: VIB-KU Leuven Center for Brain & Disease Research

location_facility: Groupe Hospitalier Pitie-Salpetriere - La Federation de Maladies du Systeme Nerveux

location_facility: Universitaetsklinikum Ulm - Klinik fuer Neurologie

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS)

location_facility: Hospital Universitari I Politècnic La Fe

location_facility: University of California Irvine - ALS & Neuromuscular Center

location_facility: Massachusetts General Hospital (MGH) - Amyotrophic Lateral Sclerosis (ALS) Multidisciplinary Clinic

location_facility: University of California at San Francisco/UCSF


title: BONAPH1DE, A Prospective Observational Study of Patients With Primary Hyperoxaluria Type 1 (PH1)

summary: The purpose of this study is to describe the natural history and progression of patients diagnosed with PH1, and to characterize the long-term real-world safety and effectiveness of lumasiran.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
United States
France
Israel
Belgium


title: An Open-label, Multi-center, ph II Platform Study Evaluating the Efficacy and Safety of NIS793 and Other New Investigational Drug Combinations With SOC Anti-cancer Therapy for the 2L Treatment of Metastatic Colorectal Cancer (mCRC)

summary:
The purpose of this study is to evaluate the preliminary efficacy and safety of NIS793 and other novel investigational combinations with standard of care (SOC) anti-cancer therapy vs SOC anti-cancer therapy for the second line treatment of mCRC.

This study aims to explore whether different mechanisms of action may reverse resistance and improve responsiveness to the currently considered SOC anti-cancer therapy in the second line metastatic colorectal cancer (mCRC) setting.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Taiwan
Spain
Italy
Australia
Canada
Korea, Republic of
United States
France
Israel
Singapore
Japan
Germany
Czechia

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Washington University School of Medicine


title: A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma

summary: Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

lead_sponsor: Inhibrx, Inc.

location_country:
Spain
Italy
Ireland
Netherlands
United Kingdom
United States
France
Germany

location_facility: Fondazione del Piemonte per I'Oncologia - Istituto di Candiolo IRCC

location_facility: University College London (UCL) - Medical School

location_facility: Saint Vincent's University Hospital part of Irish Sarcoma Group

location_facility: Washington University School of Medicine - St. Louis

location_facility: University of California, San Francisco (UCSF)

location_facility: Hospital de la Santa Creu i Sant Pau Barcelona

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Policlinico Universitario Campus Biomedico

location_facility: Oregon Health & Science University (OHSU) Knight Cancer Institute

location_facility: Oklahoma State University (OSU) - Stephenson Cancer Center


title: A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab- Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease

location_country:
Spain
Italy
United Kingdom
United States
South Africa
Japan
Czechia
Australia
Puerto Rico
Turkey
Mexico
Norway
Malaysia
Singapore
Canada
Hungary
Germany
Taiwan
Greece
New Zealand
Finland
Thailand
France
Chile
Colombia

location_facility: Maebashi Red Cross Hospital ( Site 0451)

location_facility: Hospital Tunku Azizah-Paediatric ( Site 0481)

location_facility: DHR Health Institute for Research and Development ( Site 0029)

location_facility: NYU Langone Hospital - Long Island-Pediatrics ( Site 0028)

location_facility: Sabah Women and Children Hospital ( Site 0478)

location_facility: FVR, Kokkolan rokotetutkimusklinikka ( Site 0304)

location_facility: Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527)

location_facility: Mackay Memorial Hospital-Pediatrics ( Site 0753)

location_facility: Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361)

location_facility: The University of North Carolina at Chapel Hill ( Site 0035)

location_facility: Tulane University School of Medicine ( Site 0010)

location_facility: National Taiwan University Hospital ( Site 0751)

location_facility: Hospital Raja Perempuan Zainab II-Department of Pediatric ( Site 0477)

location_facility: Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 07

location_facility: Ankara University Hospital Cebeci ( Site 0801)

location_facility: FVR, Oulun rokotetutkimusklinikka ( Site 0303)

location_facility: FVR, Turun rokotetutkimusklinikka ( Site 0302)

location_facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0378)

location_facility: The Children's Hospital of San Antonio ( Site 0038)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426)

location_facility: Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M

location_facility: Songklanagarind hospital-Department of Pediatrics ( Site 0776)

location_facility: Southampton General Hospital ( Site 0826)

location_facility: Semmelweis University-Szülészeti és Nőgyógyászati Klinika PIC ( Site 0381)

location_facility: Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366)

location_facility: Children's Hospital Colorado ( Site 0011)

location_facility: Universitaetsklinikum Freiburg ( Site 0365)

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432)

location_facility: Morales Vargas Centro de Investigacion ( Site 0509)

location_facility: Centro de Investigación Médico Biológica y Terapia Avanzada ( Site 0502)

location_facility: UPR Medical Sciences Campus-Pediatrics ( Site 0626)

location_facility: Instituto de investigaciones Centro Medico Imbanaco ( Site 0229)

location_facility: University Hospital-Pediatrics ( Site 0019)

location_facility: Fukuoka Children's Hospital ( Site 0452)

location_facility: University of South Florida-Department of Pediatrics ( Site 0045)

location_facility: Canadian Center for Vaccinology ( Site 0179)

location_facility: MeVac - Meilahti Vaccine Research Center ( Site 0306)

location_facility: Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359)

location_facility: Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet-PIC ( Site 0384)

location_facility: Hospital Germans Trias i Pujol ( Site 0738)

location_facility: Instituto Nacional de Pediatria ( Site 0506)

location_facility: FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305)

location_facility: Evelina London Children's Hospital ( Site 0829)

location_facility: Oaxaca Site Management Organization ( Site 0504)

location_facility: Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331)

location_facility: University of Kentucky HealthCare - Turfland ( Site 0044)

location_facility: Driscoll Children's Hospital ( Site 0025)

location_facility: Ibaraki Children's Hospital ( Site 0458)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin

location_facility: University of Rochester Medical Center ( Site 0017)

location_facility: Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0201)

location_facility: Our Lady of the Lake Children's Hospital ( Site 0031)

location_facility: Hospital Roberto del Río-Infectología Pediátrica ( Site 0205)

location_facility: Telethon Kids Institute-Vaccine Trials Group ( Site 0101)

location_facility: Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030)

location_facility: Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0230)

location_facility: Nihon University Itabashi Hospital ( Site 0453)

location_facility: FVR, Tampereen rokotetutkimusklinikka ( Site 0301)

location_facility: Fundación Hospitalaria San Vicente de Paúl ( Site 0233)

location_facility: Shizuoka Saiseikai General Hospital ( Site 0456)

location_facility: Clínica Universitaria Bolivariana ( Site 0227)

location_facility: ATTIKON GENERAL UNIVERSITY HOSPITAL-3rd Department of Pediatrics ( Site 0855)

location_facility: MultiCare Health System-Baker Center ( Site 0036)

location_facility: Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843)

location_facility: Morehouse School Of Medicine ( Site 0049)

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház-Újszülött Intenzív Osztály ( Si

location_facility: Universitätsklinikum Leipzig-Neonatology ( Site 0354)

location_facility: Tribe Clinical Research, LLC ( Site 0002)

location_facility: Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C. ( Site 0508)

location_facility: Hospital Universitario Central de Asturias ( Site 0740)

location_facility: Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380)

location_facility: Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383)

location_facility: Rutgers University-Pediatric Clinical Research Center ( Site 0007)

location_facility: Oslo Universitetssykehus Ullevål ( Site 0551)

location_facility: Taichung Veterans General Hospital ( Site 0754)

location_facility: Chris Hani Baragwanath Academic Hospital ( Site 0701)

location_facility: Chang Gung Medical Foundation-Linkou Branch ( Site 0752)

location_facility: Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844)

location_facility: Erciyes University Medical Faculty-pediatric infection ( Site 0804)

location_facility: Clínica Alemana de Santiago-Neonatology department ( Site 0207)

location_facility: Children's National Medical Center ( Site 0020)

location_facility: Alberta Children's Hospital-Department of Pediatrics ( Site 0180)

location_facility: Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332)

location_facility: Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252)

location_facility: Szabolcs-Szatmar-Bereg Megyei Kórházak és Egyetemi Otatókórház-Gyermekosztály ( Site 0376)

location_facility: National Center for Child Health and Development ( Site 0455)

location_facility: Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004)

location_facility: CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731)

location_facility: The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827)

location_facility: Hospital Universitary General de Catalunya-Pediatrics ( Site 0737)

location_facility: University Malaya Medical Centre-Department of Paediatrics ( Site 0480)

location_facility: Hippokration University Hopsital-3rd Pediatric Department ( Site 0851)

location_facility: Institute for the Care of Mother and Child ( Site 0251)

location_facility: Dr. von Haunersches Kinderspital ( Site 0358)

location_facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739)

location_facility: Japan Community Healthcare Organization Kyushu Hospital ( Site 0454)

location_facility: Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854)

location_facility: KK Women's and Children's Hospital-Department of Neonatology ( Site 0877)

location_facility: Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0778)

location_facility: Hospital Universitario La Paz ( Site 0726)

location_facility: Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703)

summary: This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

lead_sponsor: Global Blood Therapeutics

location_country:
Kenya
Brazil
Saudi Arabia
Italy
Nigeria
Lebanon
Oman
United Kingdom
Tanzania
France
United States
Turkey
Colombia
Germany

location_facility: University of South Alabama Children's and Women's Hospital

location_facility: Sociedad de Oncología y hematología del Cesar Ltda

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

location_facility: Fundação Faculdade Regional de Medicina de São José Do Rio Preto

location_facility: KEMRI CRDR Clinical Research Clinic Nairobi

location_facility: Hacettepe University Ihsan Dogramaci Children's Hospital

location_facility: KEMRI/CRDR Siaya Clinical Research Annex

location_facility: Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP

location_facility: Children's Healthcare of Atlanta at Scottish Rite Hospital

location_facility: Azienda Ospedaliera Universitaria (AOU) dell'Università degli Studi della Campania Luigi Vanvitelli

location_facility: Organizacion Clinica Bonnadona Prevenir S.A.S.

location_facility: American University of Beirut Medical Center

location_facility: Lagos University Teaching Hospital Haematology

location_facility: Baskent University Medical Faculty Adana Dr. Turgut Noyan Practice and Research Center

summary: This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.


title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Proof-of-concept, Phase IIA Study of MP1032 Plus Standard of Care vs Standard of Care in the Treatment of Hospitalized Participants With Moderate to Severe COVID-19

summary: The purpose of this study is to evaluate the efficacy and safety of MP1032 with standard of care (SoC) verses placebo with SoC in hospitalized adults participants with moderate to severe coronavirus disease 2019 (COVID-19).

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: MetrioPharm AG

location_country:
Spain
Italy
Hungary
United States
France
Romania
Bulgaria

location_facility: Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes"

location_facility: Hospital Universitario Marqués de Valdecilla/IDIVAL

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Hospital Clinic de Barcelona Hospital Clinic i Provincial

location_facility: Hospital Ramon y Cajal, Edificio Central

location_facility: Spitalul Clinic de Boli Infectioase "Sfanta Parascheva"

status_simplified: Completed


title: A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label Extension

acronym: NEOS

summary: Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest

lead_sponsor: Novartis Pharmaceuticals

location_country:
Croatia
Spain
Italy
United States
Belgium
Poland
Portugal
Austria
Australia
Russian Federation
India
Israel
Turkey
Mexico
Slovakia
Brazil
Canada
Guatemala
Germany
Taiwan
Latvia
Estonia
France
Chile


title: SAFFRON-301: A Randomized Phase 3 Study of Tislelizumab in Combination With Sitravatinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Progressed on or After Platinum-Based Chemotherapy and Anti-PD-(L)1 Antibody

summary: The purpose of this study is to evaluate the efficacy and safety of tislelizumab in combination with sitravatinib compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have disease progression following platinum-based chemotherapy and anti-programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) antibody, with the anti-PD-(L)1 antibody administered in combination with or sequentially before or after the platinum-based chemotherapy.

lead_sponsor: BeiGene

location_country:
Spain
Italy
Australia
Netherlands
United States
France
China
Germany

location_facility: First Affiliated Hospital of Xiamen University

location_facility: Cairns and Hinterland Hospital and Health Service

location_facility: San Antonio Military Medical Center (SAMMC)

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Tianjin Medical University General Hospital

location_facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

location_facility: Affiliated Zhongshan Hospital of Fudan University

location_facility: The University of Texas Health Science Center at Tyler

location_facility: Atlantic Health System/Morristown Medical Center

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Xinqiao Hospital Affiliated to The Army Medical University

location_facility: Harbin Medical University Cancer Hospital

location_facility: Thomas Jefferson University Hospital - Central

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Cancer Center of Guangzhou Medical University

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Cancer Hospital of Shantou University Medical College - Oncology

location_facility: General Hospital of Ningxia Medical University

location_facility: Huashan hospital affiliated to Fudan University

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Tongji Hospital of Tongji Medical College Huazhong University of Science Technology

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine

location_facility: Tianjin Medical University Cancer institute & Hospital

location_facility: Affiliated Tumor Hospital of Guangxi Medical University

location_facility: Helen F Graham Cancer Center-Christiana Care

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Nanfang Hospital of Southern Medical University

location_facility: Anhui Cancer Hospital aka West Branch of Anhui Province Hospital

location_facility: The People's Hospital of Guangxi Zhuang Autonomous Region

location_facility: The Second Xiangya Hospital central South University

location_facility: Gallipoli Medical Research Foundation (Greenslopes Private Hospital)

location_facility: University of Mississippi Medical Center

location_facility: Fort Belvoir Community Hospital (Geneva Foundation)

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology

location_facility: Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.

location_facility: Cancer Hospital Chinese Academy of Medical Science

location_facility: The First Hospital of Dalian Medical University

location_facility: Daping Hospital, Third Military Medical University

location_facility: The Second Hospital, University of South China

location_facility: Hospital Universitario Arnau de Vilanova

location_facility: Hospital Regional Universitario de Malaga

location_facility: Affiliated Cancer Hospital of Xinjiang Medical University

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: The First affiliated hospital of Nanchang University

location_facility: Affiliated hospital of Qingdao University

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Centre Hospitalier Universitaire Limoges CHU de Limoges

location_facility: Peking Union Medical College Hospital - Oncology

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Azienda Ospedaliera Universitaria Integrata Di Verona

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Universitätsklinikum Münster Hämatologie und Onkologie


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

summary: The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Taiwan
Brazil
Romania
Spain
Ireland
Italy
Australia
Mexico
Argentina
Finland
Russian Federation
United Kingdom
Hungary
United States
Chile
China
France
Colombia
Czechia

location_facility: Clinical Research of West Florida, Inc. (Clearwater)

location_facility: Amarillo Center for Clinical Research-Research

location_facility: Greater Chicago Specialty Physicians - Orland Park

location_facility: University Hospitals Cleveland Medical Center-Dermatology

location_facility: Arthritis and Rheumatism Associates (ARA) - Jonesboro

location_facility: St. Luke's Intermountain Research Center-St. Luke's Clinic - Rheumatology

location_facility: Paramount Medical Research & Consulting, Llc

location_facility: Great Lakes Clinical Trials - West Wilson Avenue

location_facility: Arthritis & Rheumatology Research Institute

location_facility: Arthritis, Rheumatic & Bone Disease Associates, Affiliate of Trabecular Medical Group, LLC

location_facility: Arizona Arthritis & Rheumatology Associates

location_facility: Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière-RHEUMATOLOG

location_facility: Arthritis Center of Lexington-Bluegrass Community Research, Inc.

location_facility: CHU Montpellier Lapeyronie Hospital-Rhumatologie


title: APPROACH-IS II: Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II

acronym: APPROACH-IS II

summary: This is an international, cross-sectional and descriptive study that aims to investigate differences in patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) and that aims to explore the profile and healthcare needs of adults with congenital heart diseases.

time_perspective: Cross-Sectional

ReferenceCitation: Moons P, Goossens E, Luyckx K, Kovacs AH, Andresen B, Moon JR, Van De Bruaene A, Rassart J, Van Bulck L; APPROACH-IS II consortium and ISACHD. The COVID-19 pandemic as experienced by adults with congenital heart disease from Belgium, Norway, and South Korea: impact on life domains, patient-reported outcomes, and experiences with care. Eur J Cardiovasc Nurs. 2022 Aug 29;21(6):620-629. doi: 10.1093/eurjcn/zvab120.

ipd_sharing_description: Well-argued and reasonable requests can be directed to the Principal Investigator (Prof. Philip Moons) of the study.

lead_sponsor: KU Leuven

location_country:
United Kingdom
Italy
United States
Belgium
Japan
Portugal
Austria
Australia
Argentina
Ethiopia
India
Malta
Turkey
Norway
Malaysia
Sweden
Cameroon
Brazil
Canada
Switzerland
Bulgaria
Denmark
Taiwan
Greece
Botswana
Korea, Republic of
France
Chile
Colombia
Netherlands
Pakistan
Senegal

location_facility: Paediatric & Congenital Heart Centre, IJN (National Heart Institute)

location_facility: Royal Brompton Hospital, Royal Brompton & Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust

location_facility: Montreal Heart Institute, Université de Montréal

location_facility: Lucile Packard Children's Hospital and Stanford Health Care

location_facility: University of Southwestern Medical Center

location_facility: Ege University Health Application and Research Center, Cardiology Department

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto

location_facility: Reference Center of Congenital Heart Disease , University Hospital Center of São João

location_facility: Oslo University Hospital, Rikshospitalet

location_facility: College of Health sciences, Addis Ababa University

location_facility: Centre Hospitalier universitaire vaudois

location_facility: Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Chiba Cerebral and Cardiovascular Center

location_facility: Taussig Heart Center of Johns Hopkins Hospital


title: Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination With ExPEC9V in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years

summary: The purpose of this study is to demonstrate the efficacy of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) compared to placebo in the prevention of the first invasive extraintestinal pathogenic Escherichia coli disease (IED) event caused by ExPEC9V O-serotypes.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Denmark
Taiwan
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
New Zealand
Thailand
Sweden
Korea, Republic of
United States
France
Israel
Colombia
Japan
Germany
Czechia

location_facility: Family Practice Center of Wadsworth dba New Venture Medical Research

location_facility: Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital

location_facility: South Tees Hospitals NHS Foundation Trust

location_facility: Japan Community Health Care Organization Osaka Hospital

location_facility: Southern California Permanente Medical Group

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA

location_facility: Programa de Estudio y Control de Enfermedades Tropicales

location_facility: Southern Clinical Trials Totara Clinical Research

location_facility: Consorci D'Atenció Primària de Salut Barcelona Esquerra

location_facility: North Texas Infectious Diseases Consultants

location_facility: IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.

location_facility: University Hospitals Of Leicester Nhs Trust

location_facility: Baptist Health Center for Clinical Research

location_facility: Hallym University Chuncehon Medical Center

location_facility: The Julius Center - Utrecht Science Park - Stratenum

location_facility: Clinical Alliance for Research and Education

location_facility: Soonchunhyang University Bucheon Hospital

location_facility: Veterans Affairs Greater Los Angeles HCS

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Multicare Institute For Research & Innovation - Rockwood Clinic - Cheney

location_facility: Carolina Institute for Clinical Research

location_facility: Barwon Health - University Hospital Geelong

location_facility: Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz

location_facility: Centro de Atencion e Investigacion Medica S.A. - CAIMED

location_facility: Vancouver ID Research and Care Centre Society

location_facility: National Hospital Organization Yokohama Medical Center

location_facility: West Roxbury Veterans Affairs Medical Center

location_facility: NIHR Collaborations for Leadership in Applied Health Research and Care Oxford

location_facility: Corporación Clínica Universidad Cooperativa De Colombia Clínica Ucc

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: California Adult Circumcision - Alvarado La Mesa Urology Center

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Multi-Specialty Research Associates, Inc.

location_facility: Innovative Research of West Florida, Incorporated

location_facility: Fundacion Centro de Investigaciones Clinicas IPS Cardiomet

location_facility: Tropical Medicine Hospital, Mahidol University

location_facility: Aesculap Ambulance sro - Zdravotni Stredisko Centrum Zdravi

location_facility: Midlands Partnership NHS Foundation Trust

location_facility: Asociacion IPS Medicos Internistas de Caldas

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Mishawaka Osteopathic Clinic/MOC Research

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: San Diego Sports Medicine & Family Health Center

location_facility: Medical Corporation Toyoshikai Kano Hospital

location_facility: Floating Hospital For Children at Tufts Medical Center

location_facility: Ascension Medical Group - St. John Clinic Infectious Disease

location_facility: The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit

location_facility: Charlottesville Medical Research Center, LLC

location_facility: ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti

location_facility: Seoul National University Bundang Hospital

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Infectious Disease Associates of Central Virginia

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Red-Institut für medizinische Forschung und Fortbildung

location_facility: Royal Devon & Exeter NHS Foundation Trust

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Japan Community Health care Organization Kyushu Hospital

location_facility: The Catholic university of Korea, St. Vincent's Hospital

location_facility: Interspond-Clinical Research Institute of AZ

location_facility: Samson Assuta Ashdod University Hospital

location_facility: Dr. Anil K Gupta Medicine Professional Corporation

location_facility: Japan Community Health Care Organization Kyusyu Hospital


title: A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Mechanism of Action of Ruxolitinib Cream for Vitiligo

summary: The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.

lead_sponsor: Incyte Corporation

location_country:
United States
Canada
France

location_facility: Simcoderm Medical and Surgical Dermatology Center

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: George Washington Medical Faculty Associates


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care

lead_sponsor: Biogen

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

location_country:
Poland
Taiwan
Spain
Greece
Australia
Korea, Republic of
United States
Chile
France
Mexico
Sweden
Bulgaria

summary:
The primary objective of this study is to demonstrate efficacy of BIIB059 compared with placebo in participants with active systemic lupus erythematosus (SLE), who are receiving background lupus standard of care (SOC) therapy in reducing disease activity.

Secondary objectives of this study are to demonstrate early onset of efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing disease activity; to demonstrate organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing joint disease activity; to demonstrate effect of BIIB059 compared with placebo in reducing oral corticosteroid (OCS) use; to demonstrate organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing skin disease activity; to demonstrate efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing occurrence of flare up to Week 52; to evaluate additional efficacy of BIIB059 compared with placebo in reducing disease activity with additional disease activity measures; to evaluate the effect of BIIB059 compared with placebo in reducing OCS use; to assess the difference between BIIB059 and placebo on participant-reported health-related quality of life (HRQoL), symptoms, and impacts of SLE; to evaluate the safety and tolerability of BIIB059 in participants with active SLE; and to evaluate immunogenicity of BIIB059 in participants with active SLE.


status: Terminated

acronym: MORNINGSKY

title: A Multicenter, Phase III Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Evaluate the Efficacy, Safety, Antiviral Activity of RO7496998 (AT-527) in Patients With Mild or Moderate COVID-19

lead_sponsor: Hoffmann-La Roche

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

location_country:
Denmark
Brazil
Belgium
Portugal
Italy
Romania
Mexico
Argentina
Switzerland
Ukraine
France
South Africa
Turkey
Colombia
Japan
Germany

location_facility: Prof. Dr. Matei Bals Institute of Infectious Diseases

location_facility: Private Enterprise Private Manufacture Company "Acinus", diagnostic and treatment center

location_facility: Hospital Senhora da Oliveira - Guimaraes, E.P.E

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital; Tesvikiye Caddesi No:20

location_facility: Municipal Non-profit enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council

location_facility: Dr. Victor Babes Clinical Hospital of Pneumophthisiology and Infectious Diseases

location_facility: Karadeniz Technical University Faculty of Medicine

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Ankara University Medical Faculty - PPDS

location_facility: Fujita Health University Banbuntane Hotokukai Hospital

location_facility: Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council

location_facility: Public Non-Profit Enterprise "City Outpatient Clinic #9" of Kharkiv City Council

location_facility: Institute of Infectious Diseases Emilio Ribas

location_facility: Panamerican Clinical Research S.A de C.V.

location_facility: National Hospital Organization Kasumigaura Medical Center

location_facility: PanAmerican Clinical Research, Querétaro

location_facility: Rigshospitalet Copenhagen University Hospital

location_facility: CNE Kyiv City Clinical Hospital#1 of Exec. Body

location_facility: L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco

location_facility: Comprensorio Amedeo Di Savoia Birago Di Vische

location_facility: Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1

location_facility: Hospital E Maternidade Celso Pierro PUCCAMP

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Private Practice Dr Jean Benoit Martinot

location_facility: Polyclinic of Center of Medical Service and Rehabilitation of State JSHC Artem

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council

location_facility: CNPE Ivano-Frankivsk Regional Centre of Phthisiology and Pulmonology of IFRC

location_facility: Sibiu Emergency Clinical County Hospital

location_facility: Sanatorio Medico de Diagnostico Y Tratamiento

location_facility: Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail

summary: This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting.

status_simplified: Unknown


title: ELEVATE, a Global Observational Longitudinal Prospective Registry of Patients With Acute Hepatic Porphyria (AHP)

acronym: ELEVATE

summary: This global patient registry is being conducted to characterize the natural history and real-world clinical management of patients with AHP, and to further characterize the real-world safety and effectiveness of givosiran and other approved AHP therapies.

location_country:
United Kingdom
Italy
United States
France
Germany


title: An Open-label, Long-term Extension Trial of Spesolimab Treatment in Adult Patients With Hidradenitis Suppurativa (HS)

lead_sponsor: Boehringer Ingelheim

ipd_sharing_description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

location_country:
Poland
Spain
Italy
Australia
Netherlands
Canada
United States
France
Norway
Germany
Czechia

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Cityclinic Medical and Psychological Clinic Matusiak Partnership

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Dr. S. K. Siddha Medicine Professional Corporation

summary:
This study is open to adults with hidradenitis suppurativa who took part in a previous clinical study of a medicine called spesolimab. Participants who completed treatment can join this study.

The purpose of this study is to find out how safe spesolimab is and whether it helps people with hidradenitis suppurativa in the long-term. Participants are in this study for about 2 years and 4 months. For 2 years, participants visit the study site every 2 weeks to get spesolimab injections under the skin. At study visits, doctors check the severity of participants' hidradenitis suppurativa and collect information on any health problems of the participants.


title: A Modular Phase I/II, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies

summary: The purpose of the study is to the evaluate safety, tolerability, pharmacokinetics (PK), and efficacy of AZD0466 as monotherapy in partciapants with advanced haematological malignancies and also to assess drug-drug interaction (DDI) potential between AZD0466 and the azole antifungal voriconazole.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Italy
Australia
Korea, Republic of
United States
France
Germany


title: A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma

summary:
The purpose of this Phase 1 study is to evaluate the safety and tolerability of CC-96673 in adult participants with Relapsed or Refractory Non-Hodgkin's Lymphoma (R/R NHL).

The study will be conducted in 2 parts: Part A, monotherapy dose escalation and Part B, monotherapy dose expansion.

Parts A and B will consist of 3 periods: Screening, Treatment, and Follow-up.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
United States
Spain
Canada
France

location_facility: The University of Texas - MD Anderson Cancer Center


title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

summary: The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if deucravacitinib is biologically active and potentially effective in the treatment of participants with moderate to severe DLE/SCLE with or without systemic lupus erythematosus (SLE) that is not well controlled with standard of care therapy.

location_country:
Poland
Taiwan
Russian Federation
Australia
Argentina
United States
France
Mexico
Germany

location_facility: Oklahoma Medical Research Foundation-ORRC

location_facility: Clinical Research Center of the Carolinas

location_facility: Washington University School Of Medicine

location_facility: Ohio State University Wexner Medical Centre-Dermatology West


title: A Prospective, Non-interventional, Long-term, Multinational Cohort Safety Study of Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy (hATTR-PN)

summary: This is a prospective, non-interventional, Long-term, multinational cohort safety study of patients with Hereditary Transthyretin Amyloidosis with Polyneuropathy (hATTR-PN). The overarching goal of this study is to further characterize the long-term safety of TEGSEDI (inotersen) in patients with hATTR-PN under real-world conditions.

lead_sponsor: Akcea Therapeutics

location_country:
Spain
Italy
Greece
United States
France

location_facility:
Study Centre
Study Center


title: A Phase I/II, Open-Label, Multicenter, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Denmark
Spain
Italy
United Kingdom
Australia
Canada
Korea, Republic of
United States
France

location_facility: Hôpital de la Timone, Oncologie Pédiatrique

location_facility: Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita

location_facility: Rigshospitalet; Ny Medicin til Børn med Kræft

location_facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris; Service d Oncologie Pediatrique

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Centre Léon Bérard, Institut d'Hémato-Oncologie Pédiatrique

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica

location_facility: Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS

summary: This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in children and adolescents with ALK fusion-positive solid or CNS tumors for whom prior treatment has proven to be ineffective or for whom there is no satisfactory standard treatment available.


title: A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

location_country:
Poland
Spain
United Kingdom
Australia
Canada
France

location_facility:
Local Institution - 0003
Hopital Robert Debre
The Skin Hospital
Local Institution - 0019
Local Institution - 0009
Local Institution - 0008
Local Institution - 0006
Local Institution - 0005
Local Institution - 0029
Local Institution
Sinclair Dermatology

summary: The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric participants aged 4 to <18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to <18 years) and Cohort 2 (age 4 to <12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in pediatric participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in pediatric participants with psoriasis who have completed Parts A or B of the study.