title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

summary: The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (AD).

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Dermira, Inc.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Mexico
United States
Spain
Taiwan
Czechia
Canada
France

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: Chang Gung Memorial Hospital at Kaohsiung

location_facility: Hospital Universitario de Gran Canaria Doctor Negrín

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Respiratory Medicine Research Institute of Michigan, PLC

location_facility: CHOP-Centro De Especialidades De Mollabao

location_facility: PanAmerican Clinical Research - Cuernavaca

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: The University of Texas Health Science Center at Houston

location_facility: Integrative Skin Science and Research - Location 2

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: University Hospital,Kyoto Prefectural University of Medicine

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: The Pennsylvania Centre for Dermatology, LLC

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: National Hospital Organization Sagamihara National Hospital

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: National Taiwan University Hospital - Hsinchu branch

location_facility: Instituto de Neumonología Y Dermatología

location_facility: IBPClin - Instituto Brasil de Pesquisa Clínica

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Okayama City General Medical Center Okayama City Hospital

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.


title: A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents With Irritability Associated With Autism Spectrum Disorder (ASD)

summary:
52-week, open-label extension study of double-blind study ACP-103-069 to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with ASD in children and adolescents (aged 5 to 17 years).

ACP-103-069 is a 6-week, randomized, double-blind, fixed-dose, placebo controlled, parallel group study of pimavanserin in children and adolescents with irritability associated with autism spectrum disorder (ASD).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: ACADIA Pharmaceuticals Inc.

location_country:
Italy
Poland
Hungary
United States
Spain
France

location_facility: Magyarországi Református Egyház Bethesda Gyermekkórháza

location_facility: Eastside Therapeutic Resource, Inc. dba Core Clinical Research

location_facility: L'Assistance Publique - Hôpitaux de Paris, labélisé Institut Carnot

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Quest Therapeutics of Avon Lake dba Haidar Almhana Nieding LLC

location_facility: Southwest Autism Research and Resource Center

location_facility: The EHS Medical Practice, PA, D/B/A Sarkis Clinical Trials

location_facility: Fondazione Istituto Neurologico Nazionale Casimiro Mondino - IRCCS

location_facility: Centrum Neuropsychiatrii Neuromed SP ZOZ

location_facility: Policlinico Riuniti - Azienda Ospedaliero Universitaria

location_facility: ERG Clinical Research - New York, PLLC DBA Richmond Behavioral Associates

location_facility: Centrum Badań Klinicznych PI-House Sp. z o.o.

location_facility: Clinical Research of Southern Nevada, LLC

location_facility: 1st Allergy and Clinical Research Group, d/b/a IMUNOe Research Centers

location_facility: La Nostra Famiglia - Scientifica IRCCS Eugenio Medea

location_facility: MedicMental Indywidualna Specjalistyczna Praktyka Lekarska Monika Szewczuk-Boguslawska

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia

summary: The purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

design_allocation: Randomized

lead_sponsor: Ionis Pharmaceuticals, Inc.

location_country:
Poland
Argentina
Brazil
Czechia
Canada
France
Lithuania
Portugal
Slovakia
Hungary
United States
Romania
Belgium
Malaysia
Italy
Netherlands
Mexico
Spain
Taiwan
Bulgaria
Sweden

location_facility: Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD

location_facility: Interna a diabetologicka ambulancia - IN-DIA s.r.o.

location_facility: CIPREC - Centro de Investigación y Prevención Cardiovascular

location_facility: Diabetes and Endocrinology Consultants, P.C.

location_facility: Specialized Hospital for Active Treatment of Cardiology

location_facility: Alabama Clinical Therapeutics, LLC Alabaster

location_facility: Joanne F. Liutkus Medicine Professional Corporation

location_facility: Medical University of South Carolina (MUSC)

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Ambulancia diabetologicka a poruch latkovej premeny a vyzivy

location_facility: Clinical Best Solutions Sp. Z.o.o Spolka Komandytowa

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

location_facility: Diabetes & Glandular Disease Clinic, P.A.

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Diabetologická a endokrinologická ambulance Milan Kvapil

location_facility: Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

location_facility: University Multiprofile Hospital for Active Treatment Pulmed OOD

location_facility: Centro de Investigación Cardiométabolica de Aguascalientes S.A. de C.V.

location_facility: Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed S.R.L

location_facility: Centro Hospitalar de Entre Douro e Vouga


title: A Multicenter, Open-label Phase 1/2 Study of TYRA300 in Advanced Urothelial Carcinoma and Other Solid Tumors With Activating FGFR3 Gene Alterations (SURF301)

summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations, including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid tumors.

design_allocation: Non-Randomized

lead_sponsor: Tyra Biosciences, Inc

location_country:
United States
Spain
Australia
France

location_facility: Florida Cancer Affiliates - Ocala - Main (Ocala Oncology - Ocala)

location_facility: NEXT Barcelona - Hospital Quironsalud Barcelona

location_facility: Duke Cancer Institute (DCI) - Duke Cancer Center

location_facility: Gustave Roussy (Institut de Cancerologie Gustave-Roussy)

location_facility: Memorial Sloan Kettering Cancer Center (MSKCC)

location_facility: Institut de Cancerologie de L'Ouest (ICO)

location_facility: NEXT Madrid - Hospital Universitario Quironsalud Madrid

location_facility: Vall d'Hebron Institut d'Oncologia (VHIO)

location_facility: Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville

location_facility: Seattle Cancer Care Alliance (SCCA) - South Lake Union


title: A Multi-Center, Randomized, Double-Masked Phase 2 Study to Assess Safety and Efficacy of ADVM-022 (AAV.7m8-aflibercept) in Anti-VEGF Treatment-Experienced Patients With Neovascular (Wet) Age-related Macular Degeneration (nAMD) [LUNA]

summary: Neovascular or wet age-related macular degeneration (nAMD) is a degenerative ocular disease associated with the infiltration of abnormal blood vessels in the retina from the underlying choroid layer and is a leading cause of blindness in patients over 65 years of age. The abnormal angiogenic process in nAMD is stimulated and modulated by vascular endothelial growth factor (VEGF). Treatment of nAMD requires frequent intravitreal (IVT) injections of VEGF inhibitors (anti-VEGF) administered every 4-16 weeks. ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product being developed for the treatment of nAMD and offers the potential for sustained intraocular expression of aflibercept following a single IVT injection. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.

ipd_sharing: Undecided

lead_sponsor: Adverum Biotechnologies, Inc.

sponsor_collaborators:
Adverum Biotechnologies, Inc.
Parexel

location_country:
United States
United Kingdom
France

location_facility:
Adverum Clinical Site 100
Adverum Clinical Site 176
Adverum Clinical Site 601
Adverum Clinical Site 116
Adverum Clinical Site 167
Adverum Clinical Site 151
Adverum Clinical Site 107
Adverum Clinical Site 159
Adverum Clinical Site 152
Adverum Clinical Site 174
Adverum Clinical Site 171
Adverum Clinical Site 108
Adverum Clinical Site 154
Adverum Clinical Site 124
Adverum Clinical Site 144
Adverum Clinical Site 178
Adverum Clinical Site 175
Adverum Clinical Site 162
Adverum Clinical Site 126
Adverum Clinical Site 122
Adverum Clinical Site 161
Adverum Clinical Site 500
Adverum Clinical Site 149
Adverum Clinical Site 501
Adverum Clinical Site 165
Adverum Clinical Site 172
Adverum Clinical Site 177
Adverum Clinical Site 119
Adverum Clinical Site 123
Adverum Clinical Site 168
Adverum Clinical Site 502
Adverum Clinical Site 600
Adverum Clinical Site 170
Adverum Clinical Site 169
Adverum Clinical Site 164
Adverum Clinical Site 166
Adverum Clinical Site 146
Adverum Clinical Site 101
Adverum Clinical Site 163

intervention_type: Genetic


title: A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous TAK-341 in Subjects With Multiple System Atrophy

summary:
The main aim is to see how TAK-341 works after 52 weeks in participants with multiple system atrophy as measured by the Unified Multiple System Atrophy Rating Scale Part I (UMSARS).

The study will enroll approximately 138 patients. Participants will receive a total of 13 intravenous infusions every 4 weeks approximately, these may be either of TAK-341 or placebo, after each infusion some blood samplings will be taken and other assessments completed.

This trial will be conducted in North America, Europe and Asia.

ipd_sharing: Yes

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.

lead_sponsor: Takeda

sponsor_collaborators: Takeda AstraZeneca

location_country:
Germany
Italy
Portugal
United Kingdom
Denmark
Japan
Austria
United States
Spain
France

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Universitatsklinikum Giesen und Marburg GmbH

location_facility: National Center of Neurology and Psychiatry

location_facility: Fondazione Istituto Neurologico Mondino IRCCS

location_facility: Hospital de Santa Maria-Avenida Prof. Egas Moniz

location_facility: Beth Israel Deaconess Medical Center - 330 Brookline Ave

location_facility: Medical Hospital of Tokyo Medical and Dental University

location_facility: Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi dAragona

location_facility: Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Deutsches Zentrum fur Neurodegenerative Erkrankung

location_facility: University of Texas Southwestern Medical Center

location_facility: Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) - St. Josef-Hospital

location_facility: Quest Research Institute - Alcanza - HyperCore


title: A Randomized, Multi-centric, Placebo-controlled, Participant and Investigator-blinded Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Adult Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.

summary: This is a randomized, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac surgery.

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

lead_sponsor: Novartis Pharmaceuticals

location_country: Germany Lithuania Hungary Argentina Singapore Brazil Belgium Spain Taiwan Czechia Estonia France


title: A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy

acronym: ALKIVIA

summary: This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome [ASyS]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/.

lead_sponsor: argenx

location_country:
Germany
Ireland
Poland
Argentina
Australia
Thailand
Turkey
Canada
Serbia
France
Lithuania
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
Italy
Cyprus
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Georgia
Sweden

location_facility:
Investigator site US0010163
Investigator site DE0490043
Investigator Site US0010161
Investigator site IT0390002
Investigator site CY3570001
Investigator site TH0660011
Investigator site GR0300015
Investigator site GE9950022
Investigator site TH0660014
Investigator site TH0660015
Investigator site UK0440029
Investigator site AR0540010
Investigator site NL0310012
Investigator site ES0340048
Investigator site US0010127
Investigator site TW8860009
Investigator site TR0900028
Investigator site AR0540005
Investigator site IT0390054
Investigator site GR0300012
Investigator Site US0010170
Investigator site DE0490049
Investigator site IT0390051
Investigator site FR0330043
Investigator site MX0520009
Investigator site GR0300013
Investigator site DK0450007
Investigator site IT0390050
Investigator site AT0430011
Investigator site US0010165
Investigator site FR0330031
Investigator site UK0440025
Investigator site KR0820010
Investigator site FR0330036
Investigator site US0010071
Sabine Coppieters
Investigator site BE0320026
Investigator site UK0440032
Investigator site US0010016
Investigator site CH0410005
Investigator site GR0300014
Investigator site PL0480044
Investigator site US0010026
Investigator site LT370002
Investigator site UK0440038
Investigator site US0010092
Investigator site TR0900029
Investigator site US0010128
Investigator site CA0019008
Investigator site AU0610014
Investigator site US0010180
Investigator site ES0340047
Investigator site US0010006
Investigator site US0010122
Investigator site GE9950027
Investigator site HU0360021
Investigator site ES0340049
Investigator site US0010162
Investigator site BE0320023
Investigator site US0010194
Investigator site UK0440040
Investigator site ES0340039
Investigator site NL0310010
Investigator site KO0820011
Investigator site US0010139
Investigator site PT3510008
Investigator site IT0390049
Investigator site AR0540006
Investigator site US0010004
Investigator site HU0360013
Investigator site US0010020
Investigator site BE0320001
Investigator site IT0390064
Investigator site US0010167
Investigator site GR0300011
Investigator site TH0660012
Investigator site US0010013
Investigator site GE9950023
Investigator site US0010185
Investigator site IE3530005
Investigator site ES0340046
Investigator site BE0320009
Investigator site US0010195
Investigator site BG3590019
Investigator site LT3700001
Investigator site DE0490038
Investigator site TW8860005
Investigator site GE9950026
Investigator site AR0540009
Investigator site UK0440023
Investigator site IE3530006
Investigator site ES0340060
Investigator site US0010164
Investigator site KO0820013
Investigator site PL0480042
Investigator site US0010198
Investigator site TH0660016
Investigator site GE9950025
Investigator site US0010203
Investigator site AR0540008
Investigator site SE0460002
Investigator site ES0340042
Investigator site KR0820009
Investigator site GE9950024
Investigator site BG3590021
Investigator site KO0820012
Investigator site CA0019010
Investigator site RS3810016
Investigator site AU0610015
Investigator site KR0820014
Investigator site TH0660013
Investigator site TR0900027

intervention_type: Other


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease

summary:
This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease.

The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

lead_sponsor: Karuna Therapeutics

location_country:
Germany
Italy
Slovakia
United States
Spain
Czechia
Bulgaria
Serbia
France


title: A 14 Week Phase 2b, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Efficacy, Safety and Tolerability of TEV-48574 in Adult Patients With Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD)

acronym: RELIEVE UCCD

summary:
The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14.

Secondary objectives:

To evaluate the efficacy and dose response of the 2 different dose regimens as assessed by multiple standard measures
To evaluate the safety and tolerability of the 2 different dose regimens
To evaluate the immunogenicity of the 2 different dose regimens

The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit www.clinicalstudydatarequest.com to make your request

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Germany
Italy
Poland
Slovakia
Hungary
Norway
Japan
Belgium
United States
Spain
Czechia
Bulgaria
France

location_facility:
Teva Investigational Site 15364
Teva Investigational Site 35280
Teva Investigational Site 84116
Teva Investigational Site 62071
Teva Investigational Site 35277
Teva Investigational Site 59198
Teva Investigational Site 62072
Teva Investigational Site 59196
Teva Investigational Site 32793
Teva Investigational Site 54221
Teva Investigational Site 15358
Teva Investigational Site 30284
Teva Investigational Site 31292
Teva Investigational Site 15366
Teva Investigational Site 53516
Teva Investigational Site 53514
Teva Investigational Site 84118
Teva Investigational Site 15360
Teva Investigational Site 15374
Teva Investigational Site 15559
Teva Investigational Site 15361
Teva Investigational Site 53508
Teva Investigational Site 15372
Teva Investigational Site 15359
Teva Investigational Site 84114
Teva Investigational Site 53519
Teva Investigational Site 51333
Teva Investigational Site 53517
Teva Investigational Site 31318
Teva Investigational Site 84110
Teva Investigational Site 51336
Teva Investigational Site 15371
Teva Investigational Site 84111
Teva Investigational Site 15556
Teva Investigational Site 41015
Teva Investigational Site 62074
Teva Investigational Site 31291
Teva Investigational Site 15362
Teva Investigational Site 15375
Teva Investigational Site 15367
Teva Investigational Site 51338
Teva Investigational Site 84113
Teva Investigational Site 59199
Teva Investigational Site 35279
Teva Investigational Site 53509
Teva Investigational Site 84117
Teva Investigational Site 51335
Teva Investigational Site 51334
Teva Investigational Site 15369
Teva Investigational Site 53512
Teva Investigational Site 53513
Teva Investigational Site 32796
Teva Investigational Site 15373
Teva Investigational Site 41014
Teva Investigational Site 15357
Teva Investigational Site 37133
Teva Investigational Site 54220
Teva Investigational Site 15368
Teva Investigational Site 53511
Teva Investigational Site 84112
Teva Investigational Site 53515
Teva Investigational Site 31293
Teva Investigational Site 37134
Teva Investigational Site 62076
Teva Investigational Site 53518
Teva Investigational Site 15365
Teva Investigational Site 15370
Teva Investigational Site 15363
Teva Investigational Site 62073
Teva Investigational Site 53510
Teva Investigational Site 59197
Teva Investigational Site 15558


title: A Phase II, Multicentre, Open-Label Study to Assess the Efficacy and Safety of Olaparib Monotherapy and Olaparib Plus Durvalumab Combination as Neoadjuvant Therapy in Patients With BRCA Mutations and Early Stage HER2-Negative Breast Cancer

acronym: OlympiaN

summary:
This study to learn more about olaparib and olaparib plus durvalumab combination therapy and also to better understand the studied disease, breast cancer, and associated health problems.

Olaparib is a type of drug called a PARP (poly [adenosine diphosphate-ribose] polymerase) inhibitor. PARP inhibitors can destroy cancer cells that are not good at repairing DNA damage. Olaparib is also approved by US Food and Drug Administration (FDA), European Medicines Agency (EMA) and in other countries for treating women with BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

Durvalumab is a type of anticancer drug called immunotherapy that targets cancer cells by blocking the signal that prevents the immune system from seeing the cancer cell. Your immune system can then attack and kill the cancer cells. Durvalumab is approved by the FDA and the EMA for the treatment of patients with locally advanced non-small cell lung cancer after receiving chemoradiation therapy and extensive-stage small cell lung cancer in combination with chemotherapy.

Some parts of this study are experimental, which means that durvalumab and the combination of olaparib and durvalumab are still in the development stage for the treatment of breast cancer, and they are not approved for treatment of breast cancer, except for use in research studies like this.

lead_sponsor: AstraZeneca

location_country:
Germany
Italy
Israel
United Kingdom
Australia
Austria
Belgium
United States
Spain
France


type: Registry Identifier

title: A Phase 3B/4, Multicenter, Randomized, Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Moderate-to-severe Scalp Psoriasis (PSORIATYK SCALP)

summary: The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.

status: Active, not recruiting

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Poland
United Kingdom
United States
France

location_facility:
Local Institution - 0017
Local Institution - 0031
Local Institution - 0003
Local Institution - 0011
Local Institution - 0041
Local Institution - 0044
Local Institution - 0015
Local Institution - 0007
Local Institution - 0002
Local Institution - 0040
Local Institution - 0039
Local Institution - 0038
Local Institution - 0005
Local Institution - 0014
Local Institution - 0012
Local Institution - 0033
Local Institution - 0001
Local Institution - 0022
Local Institution - 0008
Local Institution - 0047
Local Institution - 0013
Local Institution - 0049
Local Institution - 0045
Local Institution - 0004
Local Institution - 0026
Local Institution - 0048
Local Institution - 0051
Local Institution - 0019
Local Institution - 0006


title: A Multicenter, Open-Label, First-In-Human, Multiple Expansion Cohort, Phase 1/2 Study to Evaluate the Safety and Efficacy of DR-01 in Adult Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas

summary: This is a multicenter, first-in-human, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas

lead_sponsor: Dren Bio

sponsor_collaborators:
Dren Bio
Novotech


type: Other Identifier

title: A Phase 1b Study of JNJ-75276617 in Combination With AML-Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations

summary: The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of JNJ-75276617 in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of JNJ-75276617 in combination with AML directed therapies at the RP2D(s) (dose expansion).

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:
Germany
Italy
United Kingdom
Australia
United States
Spain
France

location_facility: Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: University College London Hospitals NHSFT

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Institut Universitaire du Cancer Toulouse Oncopole


title: A Long-term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy

acronym: ARDA+

summary: This trial is an extension of the antecedent trial ARGX-117-2002. It is a multicenter trial that has been designed to evaluate the long-term safety and tolerability, efficacy, immunogenicity, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ARGX-117 Intravenously (IV) in adults with Multifocal Motor Neuropathy (MMN). The trial will include a double-blinded rollover treatment period (DTP), an open-label treatment period (OTP), and a safety follow-up period.

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

location_facility:
Investigator site DE00490045
Investigator site US0010143
Investigator site PL00480045
Investigator Site IT00390058
Investigator site US0010066
Investigator site US0010126
Investigator site IT00390057
Investigator site NL00310013
Investigator site PL00480043
Investigator site FR00330039
Investigator site AT00430012
Investigator site US0010121
Investigator site FR00330038
Investigator site IT00390056
Investigator site BE00320027
Investigator site UK00440034
Investigator site US0010013
Investigator site ES00340056
Investigator site FR00330042
Investigator site US0010019
Investigator site ES00340043
Investigator site ES00340044


title: A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Mipasetamab Uzoptirine (ADCT-601) Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With Selected Advanced Solid Tumors

summary: The primary objective of this study is to identify the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine.

lead_sponsor: ADC Therapeutics S.A.

location_country:
United States
Spain
United Kingdom
France

location_facility: Sarah Cannon at University of Oklahoma Health Sciences Center

location_facility: Washington University School of Medicine

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Stanford Cancer Center, Stanford Medicine at Stanford University

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Vanderbilt University Medical Center (VUMC) - Ingram Cancer Center


title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

acronym: SPIREA

summary: The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Japan
Mexico
United States
Korea, Republic of
Spain
Czechia
Canada
France

location_facility: A.O. Universitaria Ospedali Riuniti di Ancona

location_facility: Arizona Arthritis and Rheumatology Research, PLLC

location_facility: University of California Irvine Medical Center

location_facility: Centro de Estudios de Investigacion Basica y Clinica, S.C.

location_facility: Országos Mozgásszervi Intézet ORFI telephely

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

location_facility: University of Pennsylvania - Perelman School of Medicine

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: University of Texas at Houston Medical School

location_facility: ACME Research Arthritis and Osteoporosis Center

location_facility: National Hospital Organization Osaka Minami Medical Center

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher

location_facility: Wexner Medical Center at the Ohio State University

location_facility: Integral Rheumatology & Immunology Specialists

location_facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

location_facility: Attune Health Autoimmune and Inflamation Care and Research

location_facility: Centro Integral en Reumatología S.A de C.V.

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: Lawson Health Research / London Health Sciences Center Research


title: A Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Mucopolysaccharidosis Type II

acronym: COMPASS

summary:
This is a Phase 2/3, multiregional, two-arm, double-blind, randomized, active (standard-of-care)-controlled study of the efficacy and safety of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme-replacement therapy (ERT) for mucopolysaccharidosis type II (MPS II).

Participants may also qualify to enter an open-label treatment phase with DNL310 or idursulfase based on pre-specified criteria.

lead_sponsor: Denali Therapeutics Inc.

location_country:
Germany
Italy
United Kingdom
Argentina
Sweden
Netherlands
Belgium
United States
Spain
Turkey
Czechia
Canada
France

location_facility: UCSF Benioff Children's Hospital Oakland

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Hospital Clínico Universitario de Santiago

location_facility: Great Ormond Street Hospital for Children

location_facility: University of Alberta - Faculty of Medicine & Dentistry

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: The University of Texas Medical School at Houston

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Drottning Silvias Barn Och Ungdomssjukhus

location_facility: Erasmus Medical Center - Sophia Children's Hospital

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: Ann and Robert H Lurie Children's Hospital of Chicago


title: A Phase 2b Multicenter, Long-Term Extension, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

acronym: FRONTIER 2

summary: The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

location_country:
Germany
Poland
United Kingdom
Japan
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: University of Pittsburgh Department of Dermatology

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: ISA - Interdisciplinary Study Association GmbH

location_facility: DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.

location_facility: Seoul National University Bundang Hospital

location_facility: CRS Clinical Research Services Berlin GmbH

location_facility: Universitatsklinikum Schleswig-Holstein - Kiel

status_simplified: Completed


title: A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer

summary: This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.

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:
Germany
Italy
Israel
Denmark
Australia
Japan
Netherlands
Switzerland
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: Swedish Cancer Institute Medical Oncology

location_facility: Azienda Ospedaliera Universitaria Renato Dulbecco

location_facility: Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol

location_facility: Fondazione IRCCS San Gerardo dei Tintori

location_facility: West Virginia University Health Sciences Center

location_facility: New York University Langone Medical Center

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec

location_facility: University of Southern California, Norris Comprehensive Cancer Center

location_facility: The University of North Carolina at Chapel Hill

location_facility: Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano


title: A Phase 2A, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of PTC518 in Subjects With Huntington's Disease

summary: The primary goal of this study is to evaluate the safety and pharmacodynamic effects of PTC518 compared with placebo in participants with HD.

lead_sponsor: PTC Therapeutics

location_country:
Germany
Italy
New Zealand
United Kingdom
Australia
Netherlands
Austria
United States
Spain
Canada
France

location_facility: IRCCS Carlo Besta Neurological Institutte

location_facility: University of Otago, New Zealand Brain Research Institute

location_facility: The Barbery National Centre for Mental Health

location_facility: University of Washington Department of Neurology

location_facility: Manchester University NHS Foundation Trust

location_facility: Cardiff University Schools of Medicine and Biosciences

location_facility: The Leeds Teaching Hospitals NHS Trust, Chapel Allerton Hospital

location_facility: Hôpital Universitaire de Marseille Hôpital de la Timone

location_facility: The University of Texas Health Science Center at Houston; McGovern Medical School

location_facility: Centre hospitalier de l'université de Montréal (CHUM)

location_facility: Irccs Istituto Delle Scienze Neurologiche Di Bologna Uoc Clinica Neurologica

location_facility: The Ottawa Hospital, Parkinson's and Movement Disorders Clinic

location_facility: IRCCS Casa Sollievo della Sofferenza Research Hospital

location_facility: Rocky Mountain Movement Disorders Center

location_facility: UCL Queen Square Institute of Neurology National Hospital for Neurology and Neurosurgery

location_facility: Columbia University, G.H. Sergievsky Center

location_facility: Centre Hospitalier Universitaire d'Angers


title: Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

summary: The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.

location_country:
Poland
Japan
United States
China
Korea, Republic of
Taiwan
Czechia
France

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Fujian Medical University Union Hospital

location_facility: National Center of Neurology and Psychiatry

location_facility: South Shore Neurologic Associates - Patchogue

location_facility: The Third Xiangya Hospital of Central Sourth University

location_facility: Xuanwu Hospital ,Capital Medical University

location_facility: Advocate Health - Aurora St. Luke's Medical Center

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Qianfoshan hospital of Shandong Province

location_facility: Tokyo Women's Medical University Hospital

location_facility: Kobe City Medical Center General Hospital


title: A Randomized, Double-blind, Placebo-Controlled Phase 2 Study With Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects With Chronic Pulmonary Sarcoidosis

acronym: RESOLVE-Lung

summary: This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE).

lead_sponsor: Kinevant Sciences GmbH

location_country:
Germany
United Kingdom
Netherlands
Belgium
United States
Turkey
France


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab As Monotherapy Or In Addition To Baseline Therapy In Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

acronym: Meteoroid

summary: The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period

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).

lead_sponsor: Hoffmann-La Roche

sponsor_collaborators:
Hoffmann-La Roche
Chugai Pharmaceutical

location_country:
Germany
Italy
Israel
Australia
Brazil
Japan
United States
China
Korea, Republic of
Canada
France

location_facility: Huashan Hospital Affiliated to Fudan University

location_facility: The Third Affiliated Hospital of Sun Yat-Sen University

location_facility: Massachusetts General Hospital; Neurology

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

location_facility: Tianjin Medical University General Hospital

location_facility: Klinikum Großhadern, LMU; Institut für klinische Neuroimmunologie

location_facility: University of Florida College of Medicine Gainesville; Neurology

location_facility: Beijing Tiantan Hospital,Capital Medical University

location_facility: Washington University School of Medicine in St. Louis

location_facility: Beijing Children's Hospital, Capital Medical University

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II

location_facility: Universitätsklinikum Düsseldorf; Klinik für Neurologie

location_facility: Fondazione Istituto Neurologico Mondino IRCCS

location_facility: Hadassah University Hospital Ein Kerem; Neurology Department

location_facility: Box Hill Hospital; Department of Neurology

location_facility: The First Affiliated Hospital, Chongqing Medical University

location_facility: Vestische Kinder- und Jugendklinik Datteln

location_facility: MUCH - Montreal Neurological Institute & Hospital

location_facility: Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

location_facility: Xiangya Hospital Central South University

location_facility: The First Hospital of Shanxi Medical University

location_facility: University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)

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

location_facility: Instituto do Cerebro do Rio Grande do Sul

location_facility: Azienda Ospedaliera Universitaria Integrata Verona; Neurologia B

location_facility: West China Hospital - Sichuan University

location_facility: University of Cincinnati; Department of Neurology

location_facility: Unity Health Toronto - St. Michael's Hospital

location_facility: Universitätsklinikum Mannheim; Neurologische Klinik

location_facility: Tohoku Medical and Pharmaceutical University Hospital

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Duke University Medical Center; Dept. of Neurology

location_facility: Royal Melbourne Hospital; Department of Neurology

location_facility: NeuroCure Clinical Research Center (NCRC); Clinical Neuroimmunology; Charitè Campus Mitte

location_facility: Royal North Shore Hospital; Department of Neurology


title: A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7240/PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)

acronym: ATHENA-SSc-ILD

summary: The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.

lead_sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

location_country:
Germany
Italy
Poland
Hungary
Israel
Norway
Australia
United Kingdom
Netherlands
Switzerland
Belgium
United States
Spain
Canada
France

location_facility: Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 4253)

location_facility: Massachusetts General Hospital ( Site 4003)

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Sklodowskiej-Curie 24A ( Site 4451)

location_facility: CHU de Bordeaux. Hopital Pellegrin ( Site 4202)

location_facility: Szpital Specjalistyczny nr 1 w Bytomiu ( Site 4453)

location_facility: Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site

location_facility: Hospital Universitario Doctor Peset ( Site 4103)

location_facility: A.O.U. Citta della Salute e della Scienza di Torino ( Site 4304)

location_facility: Universitaetsklinikum Freiburg ( Site 4152)

location_facility: University of Pittsburgh Medical Center ( Site 4016)

location_facility: Medical University of South Carolina - PPDS ( Site 4004)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 4251)

location_facility: Centrum Medyczne Reuma Park NZOZ ( Site 4450)

location_facility: HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)

location_facility: Hospital Clinico Universitario Lozano Blesa ( Site 4100)

location_facility: Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 4503)

location_facility: Tel Aviv Sourasky Medical Center ( Site 4606)

location_facility: Hospital Santa Creu i Sant Pau ( Site 4102)

location_facility: Hospital Universitario 12 de Octubre ( Site 4106)

location_facility: Universitaetsklinikum Koeln ( Site 4151)

location_facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy ( Site 4454)

location_facility: St. Joseph's Health Care London ( Site 4701)

location_facility: Universitaetsspital Zuerich ( Site 4500)

location_facility: Pacific Arthritis Care Center ( Site 4008)

location_facility: Fondazione IRCCS Policlinico San Matteo ( Site 4303)

location_facility: Boston University School of Medicine ( Site 4021)

location_facility: University Of Alberta Hospital ( Site 4702)

location_facility: Radboud University Medical Center ( Site 4650)

location_facility: Cedars Sinai Medical Center ( Site 4010)

location_facility: Hospital Universitario Vall d'Hebron - PPDS ( Site 4107)

location_facility: Rutgers Robert Wood Johnson Medical School ( Site 4013)

location_facility: Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)

location_facility: Azienda Policlinico Umberto I ( Site 4302)

location_facility: University of Toledo Medical Center ( Site 4002)

location_facility: Hospital For Special Surgery ( Site 4020)

location_facility: National Jewish Health Medical Center ( Site 4015)

location_facility: St Vincents Hospital Melbourne ( Site 4051)

location_facility: Mount Sinai Hospital [Toronto, Canada] ( Site 4700)

location_facility: Hospital Universitario Ramon y Cajal ( Site 4101)

location_facility: Hospital Regional Universitario de Malaga ( Site 4104)

location_facility: Arcispedale Santa Maria Nuova ( Site 4300)

location_facility: Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452)

location_facility: Ospedale Policlinico San Martino ( Site 4305)

location_facility: MedStar Georgetown University Hospital ( Site 4005)

location_facility: Rheumazentrum am Krankenhaus Bad Doberan ( Site 4150)

location_facility: Azienda Ospedaliera Universitaria Careggi ( Site 4301)

location_facility: University of Michigan Hospital ( Site 4001)

location_facility: Froedtert and Medical College of Wisconsin ( Site 4012)

location_facility: Kerckhoff-Klinik-Forschungs-GmbH ( Site 4153)

location_facility: Cleveland Clinic Foundation ( Site 4019)


title: A Phase 1/2, Multicenter, Randomized, Placebo-Controlled, Double Blind Single Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia Followed by an Open-Label Extension

summary:
This is a Phase 1/2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL593 in two parts followed by an optional open-label extension (OLE) period.

Part A will evaluate the safety, tolerability, PK, and PD of single doses of DNL593 in healthy male and healthy female participants of nonchildbearing potential. Part B will evaluate the safety, tolerability, PK, and PD of multiple doses of DNL593 in participants with frontotemporal dementia (FTD) over 25 weeks. Part B will be followed by Part C, an optional 18-month OLE period available for all participants who complete Part B.

sponsor_collaborators:
Denali Therapeutics Inc.
Takeda

location_country:
Italy
Colombia
Portugal
United Kingdom
Brazil
Netherlands
Belgium
Spain
Turkey
Czechia
Serbia
France

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

location_facility: Faculdade de Medicina Da Universidade de São Paulo

location_facility: L2IP - Instituto de Pesquisas Clinicas LTDA

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Istanbul University Istanbul Medical Faculty


title: A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Efficacy of Nebulized PC945 When Added to Systemic Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)

summary: To assess the efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA

lead_sponsor: Pulmocide Ltd

location_country:
Germany
Italy
Israel
Argentina
United Kingdom
Brazil
Austria
Belgium
United States
Korea, Republic of
Spain
Greece
Chile
Taiwan
Canada
France

location_facility:
Clinical Research Site
Clinical Research SIte
Clinical R Site


title: A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination With Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination With Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer

summary: This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Japan
Turkey
Canada
France
Lithuania
Portugal
Hungary
United States
Romania
China
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Israel

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 3012)

location_facility: Hattiesburg Clinic Hematology/Oncology ( Site 0003)

location_facility: Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907)

location_facility: I.E.U. Medical Point Hastanesi-Oncology ( Site 2408)

location_facility: Niigata Cancer Center Hospital ( Site 3005)

location_facility: Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)

location_facility: National Cancer Center Hospital East ( Site 3002)

location_facility: Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201)

location_facility: VA West Los Angeles Medical Center ( Site 0004)

location_facility: Medizinische Hochschule Hannover-Department of Pneumology ( Site 0901)

location_facility: Kanagawa cancer center-Department of Thoracic Oncology ( Site 3004)

location_facility: Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402)

location_facility: Heartlands Hospital-Oncology Research ( Site 2604)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105)

location_facility: Jeroen Bosch Hospital-Pulmonology ( Site 1605)

location_facility: SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900)

location_facility: Aichi Cancer Center Hospital ( Site 3016)

location_facility: The First Hospital of Jilin University ( Site 2914)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2401)

location_facility: Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2912)

location_facility: Ankara Bilkent City Hospital ( Site 2403)

location_facility: Okayama University Hospital ( Site 3011)

location_facility: Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901)

location_facility: Sheba Medical Center-ONCOLOGY ( Site 1302)

location_facility: Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800)

location_facility: Klaipeda University Hospital-Oncology chemotherapy ( Site 1502)

location_facility: Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707)

location_facility: Jilin Cancer Hospital-GCP office ( Site 2909)

location_facility: Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106)

location_facility: MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 1905)

location_facility: Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002)

location_facility: Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505)

location_facility: Medipol University Medical Faculty-oncology ( Site 2400)

location_facility: University of Virginia Cancer Center ( Site 0019)

location_facility: Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102)

location_facility: Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104)

location_facility: Hospital Provincial del Centenario ( Site 0205)

location_facility: Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203)

location_facility: Centro Hospitalar do Porto - Hospital de Santo António ( Site 1813)

location_facility: Harbin Medical University Cancer Hospital-oncology of department ( Site 2920)

location_facility: Klinik Penzing-2. Lungenabteilung ( Site 0502)

location_facility: Fort Wayne Medical Oncology and Hematology ( Site 0013)

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500)

location_facility: Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1703)

location_facility: Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701)

location_facility: Medische Centrum Leeuwarden ( Site 1619)

location_facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)

location_facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709)

location_facility: LungenClinic Grosshansdorf-Onkologie ( Site 0903)

location_facility: Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1403)

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2407)

location_facility: Medizinische Universität Graz ( Site 0504)

location_facility: Beijing Peking Union Medical College Hospital ( Site 2921)

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910)

location_facility: University General Hospital of Heraklion ( Site 1004)

location_facility: Kanazawa University Hospital ( Site 3006)

location_facility: Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 1901)

location_facility: The First Affiliated Hospital of Soochow University ( Site 2913)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 3013)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

location_facility: Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501)

location_facility: Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403)

location_facility: National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501)

location_facility: Memorial Ankara Hastanesi-Medical Oncology ( Site 2406)

location_facility: Zhejiang Cancer Hospital-Oncology ( Site 2919)

location_facility: H.R.U Málaga - Hospital General-Oncology ( Site 2104)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)

location_facility: Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2102)

location_facility: National Hospital Organization Hokkaido Cancer Center ( Site 3015)

location_facility: Shaare Zedek Medical Center-Oncology ( Site 1300)

location_facility: Fudan University Shanghai Cancer Center ( Site 2908)

location_facility: iCan Oncology Center Centro Medico AVE ( Site 0406)

location_facility: Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906)

location_facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané

location_facility: Korea University Guro Hospital-Internal Medicine ( Site 2803)

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1810)

location_facility: European Interbalkan Medical Center ( Site 1000)

location_facility: Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 1101)

location_facility: Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1706)

location_facility: Centrul de Oncologie Oncolab-Medical Oncology ( Site 1904)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 2409)

location_facility: Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700)

location_facility: Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005)

location_facility: Japanese Foundation for Cancer Research ( Site 3003)

location_facility: Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1400)

location_facility: Frankston Hospital-Oncology and Haematology ( Site 2702)

location_facility: Maastricht UMC+-Pulmonary disease ( Site 1602)

location_facility: Chungnam national university hospital-Department of Internal Medicine ( Site 2802)

location_facility: Ege University Medicine of Faculty-Chest Diseases Department ( Site 2402)

location_facility: Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905)

location_facility: Centro de Investigacion Clinica de Oaxaca ( Site 0410)

location_facility: Dana-Farber Cancer Institute ( Site 0018)

location_facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2100)

location_facility: Rambam Health Care Campus-Oncology ( Site 1301)

location_facility: Kepler Universitätsklinikum ( Site 0507)

location_facility: Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407)

location_facility: Kansai Medical University Hospital ( Site 3009)

location_facility: Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2103)

location_facility: Shanghai Chest Hospital-Oncology department ( Site 2900)

location_facility: CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800)

location_facility: Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701)

location_facility: Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702)

location_facility: Fujian Provincial Cancer Hospital-oncology department ( Site 2904)

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805)

location_facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200)

location_facility: Los Angeles Hematology Oncology Medical Group ( Site 0006)

location_facility: Sotiria Thoracic Diseases Hospital of Athens ( Site 1003)

location_facility: Cancer and Hematology Centers of Western Michigan ( Site 0001)

location_facility: Isala, locatie Zwolle-Poli Longziekten ( Site 1612)

location_facility: West China Hospital Sichuan University ( Site 2903)

location_facility: The Christie-Clinical Research Facility ( Site 2607)


title: A Phase 2b Multicenter, Randomized, Placebo Controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

acronym: FRONTIER 1

summary: Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.

location_facility: University of Pittsburgh Department of Dermatology

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: ISA - Interdisciplinary Study Association GmbH

location_facility: Atlanta Dermatology, Vein & Research Center

location_facility: DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.

location_facility: Seoul National University Bundang Hospital

location_facility: Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Universitatsklinikum Schleswig Holstein Kiel

location_facility: Charite - Universitaetsmedizin Berlin (CCM)


title: A Phase 1b Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-110 in Combination With Abiraterone in Patients With Metastatic Prostate Cancer

summary: Phase 1b study to assess the combination of ARV-110 and abiraterone in patients with metastatic prostate cancer with rising PSA values on abiraterone.

lead_sponsor: Arvinas Androgen Receptor, Inc.

location_country:
United States
United Kingdom
Canada
France


title: A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

summary: This is a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly. The study participants are adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt).

lead_sponsor: Ascendis Pharma Endocrinology Division A/S

location_country:
Germany
Poland
Australia
Japan
Armenia
Turkey
Canada
Serbia
France
Slovakia
United States
Ukraine
Romania
Malaysia
Italy
United Kingdom
Korea, Republic of
Spain
Greece
Georgia
Israel


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:
Italy
Poland
United Kingdom
Brazil
United States
Spain
Greece
Croatia
South Africa
France

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

location_facility: Hospital Infantil Universitario Niño Jesus; Sección de Neuropediatria

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

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

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

location_facility: Feinstein Institute for Medical Research

location_facility: Central Michigan University College of Medicine

location_facility: University Hospital for Infection Diseases "Dr. Fran Mihaljevic" - PPDS

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

location_facility: Tulane University Health Sciences Center

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

location_facility: UT Physicians - Pediatric Center - Texas Medical Center


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.

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

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

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: Beijing Youan Hospital, Capital Medical University

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Northwell Health Center for Liver Disease

location_facility: American Research Corporation at the Texas Liver Institute

location_facility: Azienda Ospedaliera Policlinico di Modena

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

location_facility: National Hospital Organization Yokohama Medical Center

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

location_facility: The Affiliated Hospital of Hangzhou Normal University

location_facility: Leids Universitair Medisch Centrum (LUMC)


lead_sponsor: Pfizer

summary: The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years with episodic migraine.

location_facility: University of Missouri Health Care - Pathology Department

location_facility: Unita di Neurologia, Azienda Ospedaliera San Giuseppe Moscati

location_facility: Midwest Children's Health Research Institute, LLC

location_facility: Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej

location_facility: UOSVD Centro Epilessia ed EEG dellEta Evolutiva

location_facility: Colorado Springs Neurological Associates

location_facility: University of Missouri Health Care - Clinical Research Center

location_facility: DM Clinical Research (Administrative Office Only)

location_facility: Dent Neurosciences Research Center, Inc.

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie

location_facility: Texas Institute for Neurological Disorders

location_facility: Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

location_facility: DCT-Stone Oak, LLC dba Discovery Clinical Trials

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: University of Missouri Health Care - Investigation Pharmacy (IP to be shipped here)

location_facility: Monroe Carell Jr Children's Hospital at Vanderbilt

location_facility: DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials

location_facility: South Ogden Family Medicine Ogden Clinic/CCT Research

location_facility: Carolina Institute for Clinical Research, LLC

location_facility: Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic

location_facility: Avera McKennan Hospital & University Health Center

location_facility: Fondazione Mondino - Istituto Neurologico Nazionale IRCCS

location_facility: University of Missouri School of Medicine

location_facility: Hospital Clinico Universitario de Valladolid (HCUV)

location_facility: U.O. di Neurologia- ASST Spedali Civili di Brescia

location_facility: North Texas Center for Clinical Research

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

location_facility: Alina Clinical Trials, LLC Barbara Baxter, Sole MBR

location_facility: U.O. Neuropsichiatria Infantile, IRCCS Fondazione Mondino

location_facility: Avera Medical Group Pediatric Specialists

title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age

primary_purpose: Prevention

source: euctr

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Italy
Poland
United States
Spain
Canada
France


title: Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients With Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy

acronym: SAPPHIRE

summary: This Phase 3 trial (Study SRK-015-003) is being conducted in patients ≥2 years old at Screening, who were previously diagnosed with later-onset spinal muscular atrophy (SMA) (i.e., Type 2 and Type 3 SMA) and are receiving an approved survival motor neuron (SMN) upregulator therapy (i.e., either nusinersen or risdiplam), to confirm the efficacy and safety of apitegromab as an adjunctive therapy to nusinersen and evaluate the efficacy and safety of apitegromab as an adjunctive therapy to risdiplam.

lead_sponsor: Scholar Rock, Inc.

location_country:
Germany
Italy
Poland
United Kingdom
Netherlands
Belgium
United States
Spain
France

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Washington University School of Medicine in St. Louis

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Gillette Children's Specialty Healthcare

location_facility: Children's Hospital of The King's Daughters

location_facility: Centro Clinico Nemo Pediatrico Policlinico A. Gemelli-Università Cattolica Sacro Cuore

location_facility: Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka: CZD Warszawa

location_facility: University of Wisconsin School of Medicine and Public Health

location_facility: Uniwersyteckie Centrum Kliniczne w Gdańsku

location_facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

location_facility: Columbia University, SMA Clinical Research Center

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Foundation I.R.C.C.S. Carlo Besta Neurological Institute

location_facility: Great Ormond Street Hospital for Children NHS Foundation Trust


title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects With Moderately to Severely Active Ulcerative Colitis

summary:
This is a study to understand if taking VTX002 daily as a tablet orally is safe and effective in participants diagnosed with moderate to severe ulcerative colitis (UC). Approximately 189 participants will take VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily.

The study consists of a 28-day Screening Period (to see if a participant qualifies for the study), a 13-week double-blind period (a participant receives either active Dose A, Dose B or Placebo), a Long-Term Extension (LTE) Treatment Period of up to 39 weeks, an Open-Label Extension (OLE) Treatment Period of up to 143 weeks, and a 2-week Follow-Up Period. The maximal duration of treatment including the Induction Period, LTE and OLE will be 36 months.

lead_sponsor: Oppilan Pharma Ltd

location_country:
Germany
Italy
Lithuania
Poland
India
Slovakia
Hungary
United States
Korea, Republic of
Czechia
Bulgaria
Georgia
Serbia
France

location_facility:
Local Site # 380002
Local Site # 840007
Local Site # 250001
Local Site # 616012
Local Site # 276009
Local Site # 356003
Local Site # 616011
Local Site # 276003
Local Site # 840045
Local Site # 276005
Local Site # 250003
Local Site # 348002
Local Site # 276008
Local Site # 840026
Local Site # 250004
Local Site # 616015
Local Site # 616002
Local Site # 348001
Local Site # 840018
Local Site # 840043
Local Site # 268006
Local Site # 616001
Local Site # 203002
Local Site # 203001
Local Site # 203004
Local Site # 703002
Local Site # 703001
Local Site # 616013
Local Site # 688003
Local Site # 410004
Local Site # 616014
Local Site # 840013
Local Site # 703003
Local Site # 8400039
Local Site # 380004
Local Site # 616003
Local Site # 688002
Local Site # 440002
Local Site # 348003
Local Site # 616009
Local Site # 616004
Local Site # 840010
Local Site # 616006
Local Site # 100005
Local Site # 268001
Local Site # 688004
Local Site # 688001
Local Site # 410002
Local Site # 276007
Local Site # 616010
Local Site # 616007
Local Site # 840046
Local Site # 840001
Local Site # 840042
Local Site # 840006
Local Site # 840040
Local Site # 840016
Local Site # 268004
Local Site # 380009
Local Site # 356005
Local Site # 616008
Local Site # 268002
Local Site # 616017
Local Site # 840028
Local Site # 840049
Local Site # 268005
Local Site # 410003
Local Site # 440001
Local Site # 100002
Local Site # 348004
Local Site # 840033
Local Site # 840030
Local Site # 268003
Local Site # 840044
Local Site # 356001
Local Site # 380008
Local Site # 380001


lead_sponsor: Bristol-Myers Squibb

summary: Trial to Evaluate the Efficacy and Safety of Abatacept subcutaneous (SC) in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy

location_facility: Johns Hopkins University -Johns Hopkins Bayview Medical Center

title: A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC With Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy (IIM)

location_country:
Germany
Italy
Australia
Brazil
Japan
Mexico
Sweden
United States
Korea, Republic of
Czechia
France


title: A Randomized, Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of GSK2330672 Administration for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis (GLIMMER: GSK2330672 triaL of IBAT Inhibition With Multidose Measurement for Evaluation of Response)

summary: This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC). Participants will receive either placebo or one of the 4 dose regimens of GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice daily). Participants on GSK2330672 will also receive placebo tablets to maintain blinding. The study has a prospectively defined adaptive design that will utilize interim data to further inform and potentially optimize the doses under investigation. Hence, additional dose regimen may be added during study. The total duration of a participant in the study will be up to 45 days of screening and 24 weeks of study including follow-up.

ReferenceType: derived

ReferenceCitation: Levy C, Kendrick S, Bowlus CL, Tanaka A, Jones D, Kremer AE, Mayo MJ, Haque N, von Maltzahn R, Allinder M, Swift B, McLaughlin MM, Hirschfield GM; GLIMMER Study Group. GLIMMER: A Randomized Phase 2b Dose-Ranging Trial of Linerixibat in Primary Biliary Cholangitis Patients With Pruritus. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1902-1912.e13. doi: 10.1016/j.cgh.2022.10.032. Epub 2022 Nov 4.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Japan
United States
Spain
Canada
France


title: An Open-label, Multi-center Long-term Safety Roll-over Study in Patients With Tuberous Sclerosis Complex (TSC) and Refractory Seizures Who Are Judged by the Investigator to Benefit From Continued Treatment With Everolimus After Completion of Study CRAD001M2304.

summary: The purpose of this study is to evaluate the long-term safety in patients with TSC and refractory seizures who are currently receiving everolimus treatment in the Novartis-sponsored EXIST-3 study and who are determined to be benefiting from continued treatment as judged by the investigator at the completion of EXIST-3

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Poland
Colombia
Hungary
United Kingdom
Australia
Japan
Mexico
Belgium
United States
Korea, Republic of
Spain
Thailand
Turkey
Taiwan
Canada
Russian Federation
France

location_facility: Texas Scottish Rite Hospital for Children SC

location_facility: University of Colorado School of Medicine


title: A Phase II Single Arm Clinical Trial of a Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma

acronym: TITAN-RCC

summary: TITAN RCC (0216-ASG) is a Phase 2, open-label study of nivolumab monotherapy with additional nivolumab/ipilimumab "boost" cycles in previously untreated and pretreated (2nd line), advanced or metastatic renal cell carcinoma (mRCC) subjects with intermediate and high risk disease according to IMDC.

lead_sponsor: AIO-Studien-gGmbH

sponsor_collaborators:
AIO-Studien-gGmbH
Bristol-Myers Squibb

location_country:
Germany
Italy
United Kingdom
Austria
Belgium
Spain
Czechia
France

location_facility: Ordensklinikum Linz Barmherzige Schwestern

location_facility: Universität des Saarlandes Medizinische Fakultät

location_facility: AKH Wien Universitätsklinik für Innere Medizin I

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hôpitaux Universitaires de Strasbourg Hôpital Civil

location_facility: Azienda USL8 Arezzo U.O.C. Oncologia Medica

location_facility: Hospital Universitario Central de Asturias

location_facility: Universitätsklinikum Jena und Poliklinik für Urologie

location_facility: Azienda Ospedaliera San Camillo Forlanini

intervention_type: Biological


lead_sponsor: Merus N.V.

summary: This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion (eNRGy)

location_facility: Vall D'Hebron Institute of Oncology (VHIO)

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Seoul National University College of Medicine

location_facility: START Hospital Universitario Madrid Sanchinarro

location_facility: Severance Hospital- Yonsei Cancer Center

location_facility: Hematology-Oncology Specialist of Fredericksburg

location_facility: Virginia Mason Hospital & Seattle Medical Center

location_facility: National Cancer Centre of Singapore PTE LTD

location_facility: The University of Texas MD Anderson Cancer Center

title: A Phase I/II Study of MCLA-128, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients With Solid Tumors (eNRGy)

location_country:
Germany
Italy
Israel
Norway
Singapore
Japan
Sweden
Netherlands
Austria
Belgium
United Kingdom
United States
Korea, Republic of
Spain
Taiwan
Canada
France


acronym: SUNFISH

summary: Multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of Risdiplam in adult and pediatric participants with Type 2 and Type 3 SMA. The study consists of two parts, an exploratory dose finding part (Part 1) of Risdiplam for 12 weeks and a confirmatory part (Part 2) of Risdiplam for 24 months.

ReferenceCitation: Mercuri E, Deconinck N, Mazzone ES, Nascimento A, Oskoui M, Saito K, Vuillerot C, Baranello G, Boespflug-Tanguy O, Goemans N, Kirschner J, Kostera-Pruszczyk A, Servais L, Gerber M, Gorni K, Khwaja O, Kletzl H, Scalco RS, Staunton H, Yeung WY, Martin C, Fontoura P, Day JW; SUNFISH Study Group. Safety and efficacy of once-daily risdiplam in type 2 and non-ambulant type 3 spinal muscular atrophy (SUNFISH part 2): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2022 Jan;21(1):42-52. doi: 10.1016/S1474-4422(21)00367-7. Erratum In: Lancet Neurol. 2022 Feb;21(2):e2. Lancet Neurol. 2022 Mar;21(3):e3. Lancet Neurol. 2022 May;21(5):e5.

oa_host_type: closed

repositories_concat: closed

location_facility: University of Oxford; Department of Paediatrics

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu; Od. Kliniczny Neurologii Dzieci i M?odziezy

location_facility: McGill University Health Centre - Glen Site

location_facility: Hospital Yeditepe University Kozyatagi; Pediatry

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Reumatologia

location_facility: Hopital Femme Mere Enfant; Medecine Physique et Readaptation Pediatrique ? L?ESCALE

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

location_facility: Policlinico Agostino Gemelli; Dipartimento di Neuropsichiatria Infantile

location_facility: Instituto de Puericultura E Pediatria Martagão Gesteira

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

location_facility: Hacettepe University, School of Medicine; Pediatrics Department; Pediatrics Child Neurology Unit

location_facility: Alberta Children's Hospital Division of Pediatric Neurology

location_facility: Clinic for Neurology and Psychiatry for Children and Youth

location_facility: Russian Children Neuromuscular Center of Veltischev

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

location_facility: National Center Of Neurology And Psychiatry Hospital

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; Unità Operativa Complessa di Neurologia

location_facility: IRCCS Ospedale Pediatrico Bambino Gesù; U.O. Malattie Neuromuscolari e Neurodegenerative

location_facility: Universitätsklinikum Freiburg; Klinik für Neuropädiatrie und Muskelerkrankungen

location_facility: London Health Sciences Centre; Children's Hospital; Pediatrics

location_facility: Szpital Gdanskiego Uniwersytetu Medycznego; Clinic of developmental neurology

location_facility: Clinical Medical Center Zagreb; University Hospital Rebro Department of Paediatrics

location_facility: IRCCS Istituto Giannina Gaslini; U.O.S.D. Centro di Miologia e Patologie Neurodegenerative

location_facility: Hôpital Necker-Enfants Malades; Service de neuropédiatrie

location_facility: Fondazione IRCCS Istituto Neurologico ?Carlo Besta?; UO di Neurologia dello Sviluppo

title: A Two Part Seamless, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy Patients

location_country:
Germany
Italy
Poland
United Kingdom
Japan
Brazil
Belgium
United States
China
Spain
Turkey
Croatia
Canada
Serbia
Russian Federation
France


acronym: PSO-LONG

lead_sponsor: LEO Pharma

summary:
A phase 3 trial comparing the efficacy and safety of LEO 90100 aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance therapy in subjects with psoriasis vulgaris.

A 12-month, international, multi-centre, randomised, vehicle controlled, double-blind, 2-arm, parallel group trial.

ReferenceCitation: Guenther L, Takhar A, Megna M, Sebastian M, Nyholm N, Thoning H, Levin LA. Impact of fixed-dose combination Cal/BD foam on the work productivity of patients with psoriasis: results from the 52-week randomized, double-blind, PSO-LONG trial. J Eur Acad Dermatol Venereol. 2022 Jul;36(7):1054-1063. doi: 10.1111/jdv.18053. Epub 2022 Mar 28.

publisher_dissemination: Wiley

ReferenceCitation: Lebwohl MG, Papp KA, Morch MH, Bernasconi MYJ, Warren RB. Long-Term Proactive Treatment of Plaque Psoriasis with Calcipotriene/Betamethasone Dipropionate Foam Prolongs Remission and Reduces Relapses Irrespective of Patient Baseline Characteristics. Dermatol Ther (Heidelb). 2021 Oct;11(5):1657-1665. doi: 10.1007/s13555-021-00585-x. Epub 2021 Aug 2.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Stein Gold L, Alonso-Llamazares J, Lacour JP, Warren RB, Tyring SK, Kircik L, Yamauchi P, Lebwohl M; PSO-LONG Trial Investigators. PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis. Adv Ther. 2020 Nov;37(11):4730-4753. doi: 10.1007/s12325-020-01497-6. Epub 2020 Sep 23.

location_facility: Psoriasis Treatment Center of Central NJ

location_facility: Kliniczny Szpital Wojewódzki, Klinika Dermatologii

location_facility: C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie

location_facility: Rivergate Dermatology Clinical Research Center

location_facility: C.H.U. de Saint-Etienne Service de Dermatologie

location_facility: Center for Dermatology Clinical Research

location_facility: The Guenther Dermatology Research Centre

location_facility: Henry Ford Medical Center - New Center One

location_facility: Universitätsklinikum Essen (AöR), Klinik für Dermatologie

title: LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

location_country:
Germany
Poland
United Kingdom
United States
Canada
France


lead_sponsor: Sanofi

summary: The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic thrombocytopenic purpura (aTTP).

location_facility:
Investigator Site 1
Investigator site
Investigator Site
Investyigator Site 1
Investigator site 2
Investigator Site 2
Investigator site 1

title: Prospective Follow-up Study for Patients Who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES)

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country:
Italy
Hungary
Israel
United Kingdom
Switzerland
Austria
Belgium
United States
Spain
Turkey
Czechia
Canada
France


lead_sponsor: Jazz Pharmaceuticals

summary: This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant who are at high risk or very high risk of developing VOD.

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Akdeniz University Medical Faculty Department of Pediatrics

location_facility: Medical Hospital Tokyo Medical and Dental University

location_facility: 11. Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G M Lancisi G Salesi

location_facility: Medical University of South Carolina - PPDS

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Schneider Children Medical Center of Israel

location_facility: Centre Hospitalier Universitaire du Sart Tilman

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hospital Regional Universitario de Malaga Hospital General

location_facility: The Catholic University of Korea Seoul St. Mary's Hospital

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopôle

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Japanese Red Cross Nagoya Daiichi Hospital

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Acibadem Universitesi Tip Fakultesi Atakent Hastanesi

location_facility: Severance Hospital at Yonsei University Health System

title: A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant

location_country:
Germany
Italy
New Zealand
Israel
United Kingdom
Australia
Japan
Belgium
United States
Korea, Republic of
Spain
Turkey
Canada
France


title: A Prospective, Non-interventional Study Measuring Quality of Life, Treatment Preference and Treatment Satisfaction of Autosomal Dominant Polycystic Kidney Disease Patients in Europe

acronym: ACQUIRE

summary: This is a prospective, non-interventional study (NIS) measuring health-related quality of life (HRQoL), treatment satisfaction, and other patient-reported outcomes (PROs) of ADPKD patients in Europe.

status: Unknown status

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Joly D, Quinn J, Mokiou S, O'Reilly K, Sanchez-Covisa J, Wang-Silvanto J, Doll H. Rationale and study protocol of ACQUIRE, a prospective, observational study measuring quality of life, treatment preference and treatment satisfaction of autosomal dominant polycystic kidney disease (ADPKD) patients in Europe. BMC Nephrol. 2020 Jul 24;21(1):298. doi: 10.1186/s12882-020-01927-1.

lead_sponsor: Otsuka Pharmaceutical Europe Ltd

location_country:
Germany
United Kingdom
Switzerland
Austria
Belgium
Spain
France

location_facility: University Medical Center Schleswig-Holstein

location_facility: CHU Liège - Domaine Universitaire du Sart Tilman

status_simplified: Unknown