type: U.S. NIH Grant/Contract

title: A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled, Two-part Adaptive Design, Platform Trial of Investigational Treatments for Primary Prevention of Disease Progression in Dominantly Inherited Alzheimer's Disease

acronym: DIAN-TU

summary: The purpose is to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer's disease (AD)-causing mutation. Part 1 will determine if treatment with the study drug prevents or slows the rate of amyloid beta (Aβ) pathological disease accumulation demonstrated by Aβ positron emission tomography (PET) imaging. Part 2 will evaluate the effect of early Aβ plaque reduction/prevention on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, p-tau, NfL) compared to an external control group from the DIAN-OBS natural history study and the DIAN-TU-001 placebo-treated participants.

status: Suspended

ReferenceCitation: Bateman RJ, Xiong C, Benzinger TL, Fagan AM, Goate A, Fox NC, Marcus DS, Cairns NJ, Xie X, Blazey TM, Holtzman DM, Santacruz A, Buckles V, Oliver A, Moulder K, Aisen PS, Ghetti B, Klunk WE, McDade E, Martins RN, Masters CL, Mayeux R, Ringman JM, Rossor MN, Schofield PR, Sperling RA, Salloway S, Morris JC; Dominantly Inherited Alzheimer Network. Clinical and biomarker changes in dominantly inherited Alzheimer's disease. N Engl J Med. 2012 Aug 30;367(9):795-804. doi: 10.1056/NEJMoa1202753. Epub 2012 Jul 11. Erratum In: N Engl J Med. 2012 Aug 23;367(8):780.

ReferenceCitation: Mills SM, Mallmann J, Santacruz AM, Fuqua A, Carril M, Aisen PS, Althage MC, Belyew S, Benzinger TL, Brooks WS, Buckles VD, Cairns NJ, Clifford D, Danek A, Fagan AM, Farlow M, Fox N, Ghetti B, Goate AM, Heinrichs D, Hornbeck R, Jack C, Jucker M, Klunk WE, Marcus DS, Martins RN, Masters CM, Mayeux R, McDade E, Morris JC, Oliver A, Ringman JM, Rossor MN, Salloway S, Schofield PR, Snider J, Snyder P, Sperling RA, Stewart C, Thomas RG, Xiong C, Bateman RJ. Preclinical trials in autosomal dominant AD: implementation of the DIAN-TU trial. Rev Neurol (Paris). 2013 Oct;169(10):737-43. doi: 10.1016/j.neurol.2013.07.017. Epub 2013 Sep 6.

ReferenceCitation: Wang G, Berry S, Xiong C, Hassenstab J, Quintana M, McDade EM, Delmar P, Vestrucci M, Sethuraman G, Bateman RJ; Dominantly Inherited Alzheimer Network Trials Unit. A novel cognitive disease progression model for clinical trials in autosomal-dominant Alzheimer's disease. Stat Med. 2018 Sep 20;37(21):3047-3055. doi: 10.1002/sim.7811. Epub 2018 May 14.

ReferenceCitation: Weninger S, Carrillo MC, Dunn B, Aisen PS, Bateman RJ, Kotz JD, Langbaum JB, Mills SL, Reiman EM, Sperling R, Santacruz AM, Tariot PN, Welsh-Bohmer KA. Collaboration for Alzheimer's Prevention: Principles to guide data and sample sharing in preclinical Alzheimer's disease trials. Alzheimers Dement. 2016 May;12(5):631-2. doi: 10.1016/j.jalz.2016.04.001. No abstract available.

ReferenceCitation: Grill JD, Bateman RJ, Buckles V, Oliver A, Morris JC, Masters CL, Klunk WE, Ringman JM; Dominantly Inherited Alzheimer's Network. A survey of attitudes toward clinical trials and genetic disclosure in autosomal dominant Alzheimer's disease. Alzheimers Res Ther. 2015 Jul 22;7(1):50. doi: 10.1186/s13195-015-0135-0. eCollection 2015.

ReferenceCitation: McDade E, Bateman RJ. Stop Alzheimer's before it starts. Nature. 2017 Jul 12;547(7662):153-155. doi: 10.1038/547153a. No abstract available.

ReferenceCitation: McDade E, Wang G, Gordon BA, Hassenstab J, Benzinger TLS, Buckles V, Fagan AM, Holtzman DM, Cairns NJ, Goate AM, Marcus DS, Morris JC, Paumier K, Xiong C, Allegri R, Berman SB, Klunk W, Noble J, Ringman J, Ghetti B, Farlow M, Sperling RA, Chhatwal J, Salloway S, Graff-Radford NR, Schofield PR, Masters C, Rossor MN, Fox NC, Levin J, Jucker M, Bateman RJ; Dominantly Inherited Alzheimer Network. Longitudinal cognitive and biomarker changes in dominantly inherited Alzheimer disease. Neurology. 2018 Oct 2;91(14):e1295-e1306. doi: 10.1212/WNL.0000000000006277. Epub 2018 Sep 14.

ReferenceCitation: Ryman DC, Acosta-Baena N, Aisen PS, Bird T, Danek A, Fox NC, Goate A, Frommelt P, Ghetti B, Langbaum JB, Lopera F, Martins R, Masters CL, Mayeux RP, McDade E, Moreno S, Reiman EM, Ringman JM, Salloway S, Schofield PR, Sperling R, Tariot PN, Xiong C, Morris JC, Bateman RJ; Dominantly Inherited Alzheimer Network. Symptom onset in autosomal dominant Alzheimer disease: a systematic review and meta-analysis. Neurology. 2014 Jul 15;83(3):253-60. doi: 10.1212/WNL.0000000000000596. Epub 2014 Jun 13.

ReferenceCitation: Weng H, Bateman R, Morris JC, Xiong C. Validity and power of minimization algorithm in longitudinal analysis of clinical trials. Biostat Epidemiol. 2017;1(1):59-77. doi: 10.1080/24709360.2017.1331822. Epub 2017 Jun 13.

ipd_sharing_description: Access to DIAN-TU trial data will follow the DIAN-TU data access policy, which complies with the guidelines established by the Collaboration for Alzheimer's Prevention [CAP REF].

lead_sponsor: Washington University School of Medicine

collaborators:
Hoffmann-La Roche
Alzheimer's Association
National Institute on Aging (NIA)
Genentech, Inc.

location_country:
Germany
Ireland
Italy
Colombia
United Kingdom
Argentina
Australia
Netherlands
Mexico
United States
Spain
Canada
Puerto Rico
France

location_facility: Grupo de Neurociencias Sede de la Universidad de Antioquia

location_facility: University of California San Diego Medical Center

location_facility: Instituto de Investigaciones Neurologicas Raul Carrea, FLENI

location_facility: CHU de Quebec - Hôpital de l' Enfant Jésus

location_facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli

location_facility: Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

location_facility: University of Puerto Rico, School of Medicine

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Hospital Clínic I Provincial de Barcelona


title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder

summary: 6-week, randomized, double-blind, fixed-dose, placebo-controlled, parallel group study in children and adolescents (aged 5 to17 years) with autism spectrum disorder (ASD) with irritability, agitation, or self-injurious behaviors to study the efficacy and safety of pimavanserin

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: ACADIA Pharmaceuticals Inc.

location_country:
Italy
Poland
Hungary
Australia
United States
Spain
France

location_facility: Magyarországi Református Egyház Bethesda Gyermekkórháza

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

location_facility: Fondazione PTV - Policlinico Tor Vergata

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

location_facility: Centre Hospitalier Universitaire (C.H.U) de Rouen

location_facility: Centrum Neuropsychiatrii NEUROMED SP ZOZ

location_facility: The Childhood and Adolescence Neuropsychiatry Clinic - University of Cagliari and Pediatric Hospital "A. Cao" - ASL 8 of Cagliari

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Complejo Asistencial Universitario de Burgos

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

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

location_facility: Fondazione Istituto Neurologico Nazionale Casimiro Mondino - IRCCS

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona (AOUI)

location_facility: Centre de Ressources Autisme Rhône-Alpes - Center Hospitalier le Vinatier

location_facility: Children's Health Queensland Hospital and Health Service

location_facility: Institut Global d´Atenció Integral del Neurodesenvolupament (IGAIN)

location_facility: Southwest Autism Research & Resource Center

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: Hospital Infantil Universitario Niño Jesús

location_facility: Azienda Ospedaliero Universitaria (AOU) Consorziale Policlinico

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

location_facility: Azienda Ospedaliera Universitaria "Federico II"

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

type: Registry Identifier

title: Brightline-2: A Phase IIa/IIb, Open-label, Single-arm, Multi-centre Trial of Brigimadlin (BI 907828) for Treatment of Patients With Locally Advanced / Metastatic, MDM2 Amplified, TP53 Wild-type Biliary Tract Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, or Other Selected Solid Tumours

summary:
This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists.

The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828 as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check the size of the tumour and whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

ipd_sharing: Yes

ipd_sharing_description:
Once the criteria in section "Time Frame" 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
Singapore
Australia
Japan
Switzerland
Austria
Belgium
United States
Korea, Republic of
Spain
Thailand
Taiwan
France

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital

location_facility: University Hospital Bern/Inselspital Bern

location_facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

location_facility: National Taiwan University Cancer Center

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island


type: Other Identifier

title: A Phase 4, Randomized, Double-blind Placebo-Controlled, Efficacy and Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use.

summary: This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).

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.

lead_sponsor: Pfizer

location_country:
Finland
Germany
Italy
Poland
United Kingdom
Denmark
Australia
Sweden
Mexico
Belgium
United States
Spain
Canada
France

location_facility: Ki Health Partners LLC, dba New England Institute for Clinical Research

location_facility: Centrum Leczenia Bolu dr n med Lukasz Kmieciak

location_facility: Twoja Przychodnia Nowosolskie Centrum Medyczne

location_facility: Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit

location_facility: Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit

location_facility: MICS Centrum Medyczne Damiana Walbrzyska

location_facility: Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k.

location_facility: DiGiovanna Institute for Medical Education And Research

location_facility: University of Calgary South Health Campus

location_facility: Unidad de Investigación En Salud de Chihuahua Sc

location_facility: CHU Clermont Ferrand - Hopital Gabriel Montpied

location_facility: Fondazione Mondino - Istituto Neurologico Nazionale IRCCS

location_facility: University Hospital Marqués de Valdecilla

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Centro de Investigación Médica de Aguascalientes (CIMA)


title: Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System

acronym: FARADISE

summary:
The goal of any novel design or therapeutic strategy to treat atrial fibrillation is to restore normal sinus rhythm and to reduce or eliminate the symptoms due to rapid atrial response.

Boston Scientific has developed the FARAPULSE™ Pulsed Field Ablation therapy that uses irreversible electroporation to induce cell death.

This Registry is intended to obtain purely observational and prospective real world data and to provide continued evidence on the safety and effectiveness when the FARAPULSE™ pulsed field ablation System is used per hospitals' standard of care.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Ireland
Italy
Poland
Israel
Hong Kong
United Kingdom
Australia
Netherlands
Austria
Belgium
Spain
Greece
Malaysia
Czechia
France

location_facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

location_facility: Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse

location_facility: Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH

location_facility: Hospital Clinico Universitario Lozano Blesa

intervention_type: Device


title: Phase 1b/3 Global, Randomized, Controlled, Open-label Trial Comparing Treatment With RYZ101 to Standard of Care Therapy in Subjects With Inoperable, Advanced, SSTR+, Well-differentiated GEP-NETs That Have Progressed Following Prior 177Lu-SSA Therapy

summary: This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity [HA]-DOTATATE.

lead_sponsor: RayzeBio, Inc.

location_country:
Brazil
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: Winship Cancer Institute, Emory University Hospital Midtown

location_facility: University Hospitals Cleveland Medical Center

location_facility: Fundacao Antonio Prudente - A.C. Camargo Cancer Center

location_facility: University Health Network - Princess Margaret Cancer Centre

location_facility: Profound Research LLC/MHP Radiation Oncology Institute

location_facility: Huntsman Cancer Hospital University of Utah

location_facility: Sociedade Beneficente De Senhoras Hospital - Sírio-Libanês Brasilia

location_facility: CHU Beaujon, APHP.Nord - Université Paris Cité

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio-Libanes


title: An Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura

acronym: MAYARI

summary:
This is a single group, treatment, Phase 3, open-label, single-arm study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy (IST) without firstline therapeutic plasma exchange (TPE) with primary endpoint of remission in male and female participants aged 18 to 80 years with immune-mediated thrombotic thrombocytopenic purpura (iTTP).

The anticipated study duration per participant without a recurrence while on therapy is maximum 24 weeks (ie, approximately 1 day for screening + maximum 12 weeks of treatment for the presenting episode + 12 weeks of follow-up). Participants will have daily assessments during hospitalization and weekly visits for assessments during ongoing treatment with caplacizumab and IST. There will be 3 outpatient visits for assessments during the follow-up period. There will be two additional follow-up visits for participants who do not have ADAMTS13 activity levels of ≥50% at the time of caplacizumab discontinuation.

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

lead_sponsor: Sanofi

location_country:
Germany
Italy
United Kingdom
Japan
Netherlands
Austria
Belgium
United States
Spain
Greece
Czechia
Canada
France

location_facility: Beth Israel Deaconess Medical Center Site Number : 8400005

location_facility: University of Alabama Site Number : 8400011

location_facility: The Ohio State University Comprehensive Cancer Center Site Number : 8400001

location_facility: Duke University Medical Center Site Number : 8400022

location_facility: University Of Southern California Site Number : 8400020

location_facility: Perelman Center for Advanced Medicine Site Number : 8400003

location_facility: University of Minnesota Site Number : 8400013

location_facility: Montefiore Medical Center Site Number : 8400019

location_facility: Johns Hopkins University Site Number : 8400007

location_facility: University of Utah Site Number : 8400009


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122/DNL151 in Participants With Parkinson's Disease and Pathogenic LRRK2 Variants

acronym: LIGHTHOUSE

summary:
In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). The study will focus on participants with a specific genetic variant in their LRRK2 gene.

The main question researchers are trying to answer is if taking BIIB122 slows the worsening of PD more than placebo in the early stages of PD.

To help answer this question, researchers will use a questionnaire called the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, also known as the MDS-UPDRS.

The MDS-UPDRS measures impairment and disability in people living with PD. It was created in the 1980s and is one of the most used rating scales for PD symptoms.
The MDS-UPDRS has 4 parts, and a higher score means more severe PD symptoms.
Part I assesses non-motor experiences of daily living, including but not limited to memory loss, problems sleeping, pain, depression, and anxiety.
Part II measures motor experiences of daily living.
Part III is the results of a motor symptoms exam by a medical professional.
Part IV records PD complications caused by motor symptoms.

Researchers will also learn more about the safety of BIIB122.

A description of how the study will be done is given below.

Participants will take BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but contains no real medicine.
Participants will be in the study for 103 weeks to 187 weeks. This includes the screening and follow-up periods.
Participants will take BIIB122 or placebo 1 time a day for 96 to 180 weeks.
Participants can continue to take certain medications for PD. Participants must be on the same dose of medication for at least 90 days before the study begins.
Participants will visit the clinic less often as the study continues, ranging every 4 weeks to every 24 weeks.

status: Terminated

study_completion_date_type: Actual

enrollment_type: Actual

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

lead_sponsor: Biogen

sponsor_collaborators:
Biogen
Denali Therapeutics Inc.

location_country:
Germany
Italy
United Kingdom
United States
Spain
France

location_facility: University of California San Francisco (UCSF)

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Weill Medical College of Cornell University

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer

location_facility: Parkinson's Disease and Movement Disorders Center

location_facility: Rocky Mountain Movement Disorders Center, PC

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

status_simplified: Unknown


title: A Randomized, Double-blind, Placebo-controlled, Two Parallel Groups, International Multicenter Trial to Evaluate the Effect of Plerixafor in Acute Respiratory Failure Related to COVID-19.

acronym: LEONARDO

summary:
This phase IIb study, LEONARDO is a multicenter, randomized, double-blind, placebo- controlled, parallel group study, to assess the therapeutic efficacy and safety of Plerixafor in patients over 18 years of age,

with acute respiratory failure related to COVID-19 and
Recently admitted in ICU or equivalent structure (within 48 hours) for COVID-19 related respiratory failure
without invasive mechanical ventilation and
requiring oxygen support ≥ 5L/min to obtain a transcutaneous O2 saturation > 94% A total of 150 participants, will be randomized in a 2:1 ratio to receive either Plerixafor (n=100) or placebo (n=50) as a continuous IV infusion for 7 days (from D1 to D8) in addition to standard of care (e.g. glucocorticoids...).

Safety data will be reviewed by an independent Data and Safety Monitoring Board (DSMB) during the study.

study_start_date_type: Anticipated

status: Withdrawn

ipd_sharing: Undecided

lead_sponsor: 4Living Biotech

location_country: Bulgaria France

location_facility: Military Medical Academy Multiprofile Hospital for Active Treatment Sofia

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: University First Multiprofile Hospital for Active Treatment Sofia St John the Baptist

location_facility: University Hospital for Active Treatment and Emergency Medicine NI Pirogov EAD

location_facility: Multiprofile Hospital for Active Treatment Dr Ivan SeliminskiSliven AD

location_facility: Centre Hospitalier Départemental de Vendée - Les Oudairies

location_facility: Multiprofile Hospital for Active Treatment AD Haskovo

location_facility: Multiprofile Hospital For Active Treatment Pazardzhik AD

location_facility: University Multiprofile Hospital for Active Treatment Prof Dr Stoyan Kirkovich AD


title: A Phase 1/2 Study of BMS-986408 Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

summary: The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.

design_allocation: Non-Randomized

lead_sponsor: Bristol-Myers Squibb

location_country:
Switzerland
United States
Spain
Canada
France

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone-CEPCM

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest


lead_sponsor: ACELYRIN Inc.

summary: Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin-17A, to which it binds with high affinity. This study investigates izokibep in subjects with active non-infectious, intermediate-, posterior- or pan-uveitis requiring high-dose steroids.

location_facility:
Clinical Research Site
Clinical Research Site (4008)
Clinical Research Site (4007)

title: A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Non-infectious, Intermediate-, Posterior- or Pan-uveitis

source: euctr

location_country:
Germany
Italy
Austria
United States
Spain
Czechia
France


title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase IIIb Study Evaluating the Effect of Inclisiran on Atherosclerotic Plaque Progression Assessed by Coronary Computed Tomography Angiography (CCTA) in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events (VICTORION-PLAQUE)

acronym: V-PLAQUE

summary: CKJX839D12303 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's vessels as measured by coronary computed tomography angiography (CCTA) from baseline to month 24. This study is being conducted in eligible participants with a diagnosis of non-obstructive coronary artery disease (NOCAD), where the coronary arteries are blocked less than 50%, and with no previous cardiovascular events.

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:
Ireland
Italy
India
Hungary
Argentina
United Kingdom
Australia
Brazil
Japan
Switzerland
Belgium
United States
China
Korea, Republic of
Spain
Chile
Canada
France


title: A Phase 3, Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults With Tuberous Sclerosis Complex (TSC)-Related Epilepsy (TrustTSC)

summary: This is a Phase 3, global, double-blind, randomized, placebo-controlled study of adjunctive GNX treatment in children and adults with TSC-related epilepsy. The study consists of a 4-week prospective Baseline phase, defined as the first 28 days following screening, followed by a double-blind phase consisting of a 4-week titration period (Day 1 to Day 28) and a 12-week maintenance period (Day 29 to Week 16).

lead_sponsor: Marinus Pharmaceuticals

location_country:
Germany
France
Italy
United Kingdom
United States
Spain
Canada
Israel

location_facility: NHS acute tertiary referral centre, John Radcliffe Hospital

location_facility: Children's Hospital of Michigan Central Michigan University

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

location_facility: McGovern Medical School at the University of Texas Health Science Center

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of Utah Health Care-Pediatric Neurology

location_facility: Barrow Neurological Institute at Phoenix Children's Hospital

location_facility: Child Neurology Consultants of Austin (CNCA)

location_facility: Institute of Neurology and Neurosurgery at Saint Barnabas

location_facility: Royal Aberdeen Children's Hospital, NHS Grampian

location_facility: Pediatric Neurology and Muscular Diseases Unit - University of Genoa

location_facility: Boston Children's Hospital, Harvard Medical School

location_facility: Department of Neurology and Sense Organs, AOU Policlinico di Bari

location_facility: Nemours Children's Hospital - Delaware Valley

location_facility: UCLA Mattel Children's Hospital, TSC Center

location_facility: ZNN - Epilepsiezentrum Frankfurt am Main

location_facility: TSC Clinic at Northeast Regional Epilepsy Group

location_facility: Hospital Regional Universitario de Málaga

location_facility: Epilepsie-Zentrum Bethel - Krankenhaus Mara

location_facility: Atrium Health/Levine Children's Hospital

location_facility: University of North Carolina at Chapel Hill

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: University of Texas Southwestern Medical Center


title: A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation

summary: The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Loxo Oncology, Inc.

location_country:
Germany
Singapore
Australia
Japan
Belgium
United States
China
Korea, Republic of
Spain
Canada
France

location_facility: Hospital Clinic y Provincial de Barcelona

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: South Texas Accelerated Research Therapeutics (START)

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Clinico Universitario de Valencia


title: Study of EOS884448 Alone, and in Combination With Iberdomide With or Without Dexamethasone, in Participants With Relapsed or Refractory Multiple Myeloma

summary: This is a multicenter, open-label, phase I/II clinical study, to assess the safety, tolerability, antitumor activity, pharmacokinetics and pharmacodynamics of EOS884448 (also known as EOS-448 or GSK4428859A), alone or in combination with iberdomide with and without dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM).

lead_sponsor: iTeos Belgium SA

sponsor_collaborators:
iTeos Belgium SA
Bristol-Myers Squibb
GlaxoSmithKline
iTeos Therapeutics

location_country:
United States
Spain
Belgium
France

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Eastern Connecticut Hematology & Oncology


title: A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination With INCAGN02385 (Anti-LAG-3) and INCAGN02390 (Anti-TIM-3) as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

summary: The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).

ipd_sharing_description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Biosciences International Sàrl

location_country:
Germany
Italy
Poland
Portugal
Netherlands
Belgium
United States
Korea, Republic of
Spain
Greece
Taiwan
Canada
Georgia
France

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E.

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of Virginia - Emily Couric Clinical Cancer Center

location_facility: Ico Girona Hospital Universitari de Girona Dr Josep Trueta

location_facility: Fondazione Del Piemonte Per L Oncologia Ircc Candiolo

location_facility: Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli

location_facility: McGill University Jewish General Hospital

location_facility: Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

location_facility: Przychodnia Lekarska Komed Roman Karaszewski

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade L

location_facility: University Hospital of West Attica - Attikon

location_facility: Icans - Institut de Cancerologie Strasbourg Europe

location_facility: Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria

location_facility: Hospital General Universitario de Valencia

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Institutional Review Board Taipei Veterans General Hospital

location_facility: Huntsman Cancer Institute At University of Utah

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch

location_facility: McGill University Health Centre/Glen Site/Cedars Cancer Centre

location_facility: Pusan National University Yangsan Hospital

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: University of California San Francisco Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Fondazione Irccs Istituto Nazionale Del Tumori Di Milano

location_facility: Catalans Institute of Oncology Barcelona

location_facility: Chonnam National University Hwasun Hospital

location_facility: Centrum Onkologii Im. Prof. Franciszka Lukaszczyka

location_facility: University of California San Diego Medical Center, Moores Cancer Center

location_facility: University of Maryland-Greenebaum Cancer Center

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)


title: A Phase 2, Multicenter, Randomized, Open-label Study of DS-7300a, a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC)

summary: This study intends to define the recommended Phase 2 dose of ifinatamab deruxtecan (I-DXd) based on the efficacy, safety, and pharmacokinetics (PK) results observed in participants with Extensive-stage Small Cell Lung Cancer (ES-SCLC) who received at least 1 prior line of platinum-based chemotherapy and a maximum 3 prior lines of therapy and to investigate I-DXd anti-tumor activity in this population.

status: Active, not recruiting

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

sponsor_collaborators:
Daiichi Sankyo, Inc.
Merck Sharp & Dohme LLC

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

location_facility: Hospital Regional Universitario de Malaga

location_facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve

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

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

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: West China Hospital of Sichuan University

location_facility: Seoul National University Bundang Hospital

location_facility: Millennium Research & Clinical Development

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Centre hospitalier Intercommunal de Créteil


type: Other Grant/Funding Number

title: A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker, Cognitive, and Clinical Endpoints in Dominantly Inherited Alzheimer's Disease

summary: To assess the safety, tolerability, biomarker, cognitive, and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug improves disease-related biomarkers and slows the rate of progression of cognitive or clinical impairment.

ReferenceType: background

ReferenceCitation: Jack CR Jr, Knopman DS, Jagust WJ, Petersen RC, Weiner MW, Aisen PS, Shaw LM, Vemuri P, Wiste HJ, Weigand SD, Lesnick TG, Pankratz VS, Donohue MC, Trojanowski JQ. Tracking pathophysiological processes in Alzheimer's disease: an updated hypothetical model of dynamic biomarkers. Lancet Neurol. 2013 Feb;12(2):207-16. doi: 10.1016/S1474-4422(12)70291-0.

ReferenceCitation: Fitzpatrick AWP, Falcon B, He S, Murzin AG, Murshudov G, Garringer HJ, Crowther RA, Ghetti B, Goedert M, Scheres SHW. Cryo-EM structures of tau filaments from Alzheimer's disease. Nature. 2017 Jul 13;547(7662):185-190. doi: 10.1038/nature23002. Epub 2017 Jul 5.

ReferenceCitation: Falcon B, Zhang W, Murzin AG, Murshudov G, Garringer HJ, Vidal R, Crowther RA, Ghetti B, Scheres SHW, Goedert M. Structures of filaments from Pick's disease reveal a novel tau protein fold. Nature. 2018 Sep;561(7721):137-140. doi: 10.1038/s41586-018-0454-y. Epub 2018 Aug 29.

ReferenceCitation: Kopeikina KJ, Hyman BT, Spires-Jones TL. Soluble forms of tau are toxic in Alzheimer's disease. Transl Neurosci. 2012 Sep;3(3):223-233. doi: 10.2478/s13380-012-0032-y.

ReferenceCitation: Braak H, Braak E. Neuropathological stageing of Alzheimer-related changes. Acta Neuropathol. 1991;82(4):239-59. doi: 10.1007/BF00308809.

ReferenceCitation: Goedert M, Spillantini MG. Propagation of Tau aggregates. Mol Brain. 2017 May 30;10(1):18. doi: 10.1186/s13041-017-0298-7.

ReferenceCitation: Falcon B, Cavallini A, Angers R, Glover S, Murray TK, Barnham L, Jackson S, O'Neill MJ, Isaacs AM, Hutton ML, Szekeres PG, Goedert M, Bose S. Conformation determines the seeding potencies of native and recombinant Tau aggregates. J Biol Chem. 2015 Jan 9;290(2):1049-65. doi: 10.1074/jbc.M114.589309. Epub 2014 Nov 18.

ReferenceCitation: Barghorn S, Zheng-Fischhofer Q, Ackmann M, Biernat J, von Bergen M, Mandelkow EM, Mandelkow E. Structure, microtubule interactions, and paired helical filament aggregation by tau mutants of frontotemporal dementias. Biochemistry. 2000 Sep 26;39(38):11714-21. doi: 10.1021/bi000850r.

ReferenceCitation: von Bergen M, Friedhoff P, Biernat J, Heberle J, Mandelkow EM, Mandelkow E. Assembly of tau protein into Alzheimer paired helical filaments depends on a local sequence motif ((306)VQIVYK(311)) forming beta structure. Proc Natl Acad Sci U S A. 2000 May 9;97(10):5129-34. doi: 10.1073/pnas.97.10.5129.

ReferenceCitation: von Bergen M, Barghorn S, Li L, Marx A, Biernat J, Mandelkow EM, Mandelkow E. Mutations of tau protein in frontotemporal dementia promote aggregation of paired helical filaments by enhancing local beta-structure. J Biol Chem. 2001 Dec 21;276(51):48165-74. doi: 10.1074/jbc.M105196200. Epub 2001 Oct 17.

ReferenceCitation: Salloway S, Farlow M, McDade E, Clifford DB, Wang G, Llibre-Guerra JJ, Hitchcock JM, Mills SL, Santacruz AM, Aschenbrenner AJ, Hassenstab J, Benzinger TLS, Gordon BA, Fagan AM, Coalier KA, Cruchaga C, Goate AA, Perrin RJ, Xiong C, Li Y, Morris JC, Snider BJ, Mummery C, Surti GM, Hannequin D, Wallon D, Berman SB, Lah JJ, Jimenez-Velazquez IZ, Roberson ED, van Dyck CH, Honig LS, Sanchez-Valle R, Brooks WS, Gauthier S, Galasko DR, Masters CL, Brosch JR, Hsiung GR, Jayadev S, Formaglio M, Masellis M, Clarnette R, Pariente J, Dubois B, Pasquier F, Jack CR Jr, Koeppe R, Snyder PJ, Aisen PS, Thomas RG, Berry SM, Wendelberger BA, Andersen SW, Holdridge KC, Mintun MA, Yaari R, Sims JR, Baudler M, Delmar P, Doody RS, Fontoura P, Giacobino C, Kerchner GA, Bateman RJ; Dominantly Inherited Alzheimer Network-Trials Unit. A trial of gantenerumab or solanezumab in dominantly inherited Alzheimer's disease. Nat Med. 2021 Jul;27(7):1187-1196. doi: 10.1038/s41591-021-01369-8. Epub 2021 Jun 21.

ReferenceCitation: Sandusky-Beltran LA, Sigurdsson EM. Tau immunotherapies: Lessons learned, current status and future considerations. Neuropharmacology. 2020 Sep 15;175:108104. doi: 10.1016/j.neuropharm.2020.108104. Epub 2020 Apr 28.

lead_sponsor: Washington University School of Medicine

collaborators: Accelerating Medicines Partnership (AMP)

location_country:
Germany
Ireland
Italy
Colombia
United Kingdom
Argentina
Australia
Brazil
Japan
Mexico
Netherlands
United States
Spain
Canada
Puerto Rico
France

location_facility: Grupo de Neurociencias Sede de la Universidad de Antioquia

location_facility: University of California San Diego Medical Center

location_facility: Instituto de Investigaciones Neurologicas Raul Carrea, FLENI

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP

location_facility: CHU de Quebec - Hôpital de l' Enfant Jésus

location_facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli

location_facility: Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

location_facility: Niigata University Medical & Dental Hospital

location_facility: University of Puerto Rico, School of Medicine

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Hospital Clínic I Provincial de Barcelona

location_facility: Osaka City University Hospital Clinical Research Center of Dementia

lead_sponsor_type: academique


title: A Randomized, Double-Blind, Placebo-Controlled Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma

acronym: ASPIRE

summary: The study is a randomized, double-blind, placebo-controlled, multicenter study of standard treatment with nab-paclitaxel and gemcitabine with or without SBP-101 in subjects previously untreated for metastatic pancreatic ductal adenocarcinoma (PDA), including subjects who have received prior neoadjuvant or adjuvant treatment.

lead_sponsor: Panbela Therapeutics, Inc.

location_country:
Germany
Italy
United Kingdom
Australia
Austria
Belgium
United States
Korea, Republic of
Spain
France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Genesis Cancer and Blood Institute (SCRI)

location_facility: MultiCare Regional Cancer Center - Tacoma

location_facility: Ospedale Casa Sollievo Della Sofferenza IRCCS

location_facility: A.ö. Krankenhaus der Barmherzigen Brüder

location_facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

location_facility: MD Anderson Cancer Center Madrid - España

location_facility: Chonnam National University Hwasun Hospital

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Azienda Ospedaliera Universitaria Integrata Di Verona

location_facility: Azienda Unita Sanita Locale di Reggio Emilia IRCCS

location_facility: Ospedale Santa Maria Della Misericordia Di Perugia

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: Froedtert Hospital & the Medical College of Wisconsin

location_facility: Azienda Ospedaliero Universitaria Pisana


title: A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of Multiple Dose Levels of Atuliflapon Given Orally Once Daily for Twelve Weeks in Adults With Moderate to Severe Uncontrolled Asthma

acronym: FLASH

summary: This is a randomised, placebo-controlled, double-blind study to assess the efficacy and safety of Atuliflapon administered at multiple dose levels over a 12-week treatment period to adult participants with moderate to severe uncontrolled asthma.

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

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

lead_sponsor: AstraZeneca

location_country:
Germany
Poland
Argentina
Australia
Japan
Turkey
Croatia
Chile
Serbia
France
Slovenia
Slovakia
Hungary
United States
Ukraine
Romania
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria


title: A Multi-centre, Single Arm, Open-label Extension Study to Evaluate the Long-term Safety of GSK3511294 (Depemokimab) in Adult and Adolescent Participants With Severe Asthma With an Eosinophilic Phenotype From Studies 206713 or 213744

acronym: AGILE

summary: The purpose of this open-label 12-month extension study is to continue to characterize the long-term safety, efficacy and immunogenic profile of GSK3511294 (Depemokimab) in participants with severe asthma with an eosinophilic phenotype following completion of clinical studies 206713 or 213744.

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

lead_sponsor: GlaxoSmithKline

sponsor_collaborators:
GlaxoSmithKline
Iqvia Pty Ltd

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Australia
Japan
United States
China
Spain
Taiwan
Czechia
Canada
France

intervention_type: Biological


title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Profile of BI 764198 Administered Orally Once Daily for 12 Weeks in Patients With Focal Segmental Glomerulosclerosis

summary:
This study is open to adults with a type of kidney disease called primary focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 improves the health of the kidneys in people with FSGS. Three different doses of BI 764198 are tested in this study.

Participants are put into 4 groups randomly, which means by chance. Three of the groups receive different doses of BI 764198 and one group receives placebo. Participants are in the study for about 4 months. For about 3 months, they take BI 764198 or placebo as capsules once a day.

Placebo capsules look like BI 764198 capsules but do not contain any medicine. Participants visit the study site about 10 times. You can participate in this study from your home. In this case a research nurse will visit you for the study visits.

Kidney health is assessed based on the analysis of urine samples, which participants collect at home. At the end of the study, the results are compared between the different groups. During the study, the doctors also regularly check the general health of the participants.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Ireland
Italy
New Zealand
United Kingdom
Australia
Belgium
United States
China
Spain
France

location_facility: Tongren hospital, Shanghai Jiaotong University School of Medicine

location_facility: The First Afiliated Hospital, Sun Yet-sen University

location_facility: New Zealand Clinical Research (ChristChurch)

location_facility: Dallas Nephrology Associates Medical Clinic

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: The Ohio State University Wexner Medical Center

location_facility: Texas Tech University Health Sciences Center

location_facility: Shanghai Fifth People's Hospital affiliated to Fudan University

location_facility: The University of North Carolina at Chapel Hill


title: An Open Label, Single Arm, Extension Trial to Examine Long-term Safety of Iclepertin Once Daily in Patients With Schizophrenia Who Have Completed Previous Iclepertin Phase III Trials (CONNEX-X)

summary:
This study is open to adults with schizophrenia who took part in a previous CONNEX study (study 1346-0011, 1346-0012, or 1346-0013). The purpose of this study is to find out how well people with schizophrenia can tolerate a medicine called Iclepertin in the long term.

Participants take Iclepertin as tablets once a day for 1 year. In addition, all participants take their normal medication for schizophrenia.

Participants are in the study for a little more than 1 year. During this time, they visit the study site about 13 times and get about 9 phone calls from the study team.

The doctors collect information on any health problems of the participants. Doctors also regularly check the participants' symptoms of schizophrenia.

location_country:
Finland
Germany
Poland
Argentina
Japan
Brazil
Croatia
Chile
Czechia
Canada
Serbia
France
Lithuania
Colombia
Slovakia
Denmark
United States
Belgium
China
Malaysia
Italy
Norway
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Sweden

location_facility: The Affiliated Brain Hospital of Guangzhou Medical University

location_facility: Central Teaching Hospital of the Medical University of Lodz

location_facility: Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)

location_facility: Hospital Provincial. Complejo Asistencial de Zamora

location_facility: Institute of Psychiatry and Neurology in Warsaw

location_facility: Brain Hospital Affiliated to Nanjing Med University

location_facility: National Hospital Organization Shimofusa Psychiatric Medical Center

location_facility: National Hospital Organization Hizen Psychiatric Medical Center

location_facility: Centro de Investigación y Proyectos en neurociencia CIPNA

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center

location_facility: The Second Affiliated Hospital of Xinxiang Medical Univ.

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Zentrum für klinische Forschung Dr. med. I. Schöll

location_facility: First Affiliated Hospital of Xi'an JiaoTong University

location_facility: Artemis Institute for Clinical Research, LLC

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: The Second Xiangya Hospital Of Central South University

location_facility: Centro de Investigación Clinica Acelerada, S.C.

location_facility: Collaborative Neuroscience Network, LLC (CNS)

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: ASCLEPES Research Centers, P.C. dba Alliance Research

location_facility: Clinica Privada de Salud Mental Santa Teresa de Avila

location_facility: Trial Tech- Tecnologia em pesquisa com medicamentos

location_facility: CPN - Centro de Estudos em Neurociências

location_facility: J A Serviços Médicos Ltda/ Instituto Goiano de Neuropisquiatria

location_facility: The sixth People's Hospital of Hebei Province

location_facility: Clínica Viver - Centro de Desospitalização Humana

location_facility: Instituto de Informacion e Investigacion en Salud Mental A.C. (INFOSAME).

location_facility: Instituto Médico de la Fundación Estudios Clínicos

location_facility: Clinical Hospital Center Dr. Dragisa Misovic

location_facility: "Attikon" University General Hospital of Attica

location_facility: The Affiliated Hospital of Guizhou Medical University

location_facility: Instituto Colombiano del Sistema Nervioso- Clínica Montserrat

location_facility: Fundación FunDaMos para la asistencia e investigación en psiquiatría

location_facility: The First Affilliated Hospital Of Kunming of Medical College

location_facility: Medical Corporation Yamadakai Yatsushiro Welfare Hospital

location_facility: Pusan National University Yangsan Hospital

location_facility: Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

location_facility: CENYDET-Centro Neurobiológico y de Estres Traumático (Biopsychomedical Research Group S.R.L.)

location_facility: Hospital de Base - Fac Med de Sao Jose do Rio Preto

location_facility: Seoul National University Bundang Hospital

location_facility: General Oncology Hospital "Agioi Anargyri"

location_facility: Universitair Psychiatrisch Centrum Duffel (UPC Duffel)

location_facility: Studienzentrum für Neurologie und Psychiatrie

location_facility: Niigata University Medical and Dental Hospital

location_facility: Psychiatricka Ambulancia Psycholine s.r.o.

location_facility: National Center of Neurology and Psychiatry

location_facility: Resolution Psychopharmacology Research Institute

location_facility: Centro de Investigaciones del Sistema Nervioso SAS- Grupo Cisne SAS

location_facility: Individual Specialist Medical Practice Filip Rybakowski

location_facility: The First Hospital of Hebei Medical University

location_facility: Podlassian Center of Psychogeriatry, Bialystok

location_facility: 3rd Affiliated Hosp of Sun yet-sen University

location_facility: CEN (Centro Especializado Neurociencias)

location_facility: Okehazama Hospital Fujita Kokoro Care Center

location_facility: National Center for Global Health and Medicine Kohnodai Hospital

location_facility: Osaka City Hospital Organization Osaka City General Hospital

location_facility: Instituto Nacional de Neurologia y Neurocirugia

location_facility: Azienda Sanitaria Ospedale S. Luigi Gonzaga


title: A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Non-pharmacologically Treated Acromegaly (PATHFNDR-2)

summary: A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with non-pharmacologically treated acromegaly.

lead_sponsor: Crinetics Pharmaceuticals Inc.

location_country:
Germany
Italy
Poland
India
Hungary
Argentina
Israel
United Kingdom
Brazil
United States
China
Spain
Greece
Bulgaria
France

location_facility:
Crinetics Study Site (b)
Crinetics Study Site (a)
Crinetics Study Site


title: Retrospective, Observational Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps Treated by FASENRA®

acronym: RANS

summary: The purpose of this observational study is to describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.

status: Completed

time_perspective: Retrospective

location_country:
Germany
Italy
Japan
United States
Spain
France

intervention_type: Other

status_simplified: Completed


title: A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO)

acronym: MARIO

summary: This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis included candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.

lead_sponsor: Scynexis, Inc.

location_country:
Germany
Italy
Israel
Belgium
United States
Korea, Republic of
Spain
Greece
South Africa
Bulgaria
Canada
France

location_facility: University of Pretoria and Steve Biko Academic Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Big Metropolitan Hospital Niguarda Regional Health Authority

location_facility: University Health Network- Toronto General Hospital

location_facility: Keimyung University - Dongsan Medical Center

location_facility: General Hospital of Athens "Evangelismos", 1st Department of Critical Care

location_facility: University of Alabama at Birmingham School of Medicine

location_facility: University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv", Plovdiv, Department of Surgery

location_facility: University of Pennsylvania School of Medicine

location_facility: General University Hospital Gregorio Maranon

location_facility: University Clinical Hospital of Valencia

location_facility: General Hospital of Thessaloniki "Ippokratio"

location_facility: University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich"

location_facility: Paris University Hospitals Center- Cochin Hospital

location_facility: Lady Davis Carmel Medical Center, Infectious Diseases Unit

location_facility: University and Polytechnic Hospital La Fe

location_facility: Municipal Hospital Munich GMbH/Hospital Neuperlach

location_facility: Central Friuli University Healthcare Company

location_facility: Washington University School of Medicine

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Victor Dupouy Hospital Center Argenteuil

location_facility: University Hospitals Leuven, Campus Gasthuisberg

location_facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Clinic of Purulent-Septic Surgery

location_facility: University of Texas Health Science Center at Houston

location_facility: Rambam Health Care Campus, Institute of Infectious Diseases

location_facility: IRCCS- University Hospital San Martino-IST

location_facility: Hospital del Mar Medical Research Institute (IMIM)

location_facility: University Hospital Puerta de Hierro Majadahonda

location_facility: University Polyclinic Hospital of Modena


title: A Multicenter, Open-label, Phase 1 Study Evaluating the Safety and Tolerability of HMPL-760 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Other Non-Hodgkin Lymphoma (NHL)

summary: An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-760 in patients with previously treated CLL/SLL or NHL

lead_sponsor: Hutchmed

location_country:
France
Italy
Poland
Australia
United States
Spain
Israel

location_facility: New York University Langone Med Center. Lab

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Wojewodzki Szpital Specjalistyczny w Legnicy

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS


title: A Phase 1, Open-label, Dose Finding Study of CC-95251 Alone and in Combination With Antineoplastic Agents in Subjects With Acute Myeloid Leukemia and Myelodysplastic Syndromes

summary: The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 alone and in combination with antineoplastic agents in participants with relapsed or refractory acute myeloid leukemia and relapsed or refractory and treatment-naive higher risk melodysplastic syndromes.

location_country:
Italy
Norway
United Kingdom
Australia
Sweden
United States
Spain
Canada
France

location_facility: University of Miami Hospital and Clinics, Sylvester Cancer Center

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

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

location_facility: Humanitas-U.O di Oncologia medica ed Ematologia

location_facility: The University Of Texas MD Anderson Cancer Center

location_facility: UT Southwestern-Harold C. Simmons Cancer Center

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)


acronym: ENDYMION 2

lead_sponsor: Takeda

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

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

location_facility: ASST di Mantova - Azienda Ospedaliera Carlo Poma

location_facility: The Second Affiliated Hospital of Guangzhou Medical Univeristy

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

location_facility: Medical University of South Carolina Children Hospital - PIN

location_facility: Clinical Integrative Research Center of Atlanta

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

location_facility: Guangzhou Women And Children's Medical Center

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

location_facility: Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel

location_facility: Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Stichting Epilepsie Instellingen Nederland

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

location_facility: Children and Youth Health Care Institute of Vojvodina

location_facility: Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center

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

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

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

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

location_facility: MultiCare Institute for Research & Innovation (Tacoma)

location_facility: Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh

location_facility: Hopital Universitaire des Enfants Reine Fabiola

location_facility: Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC

location_facility: Klinikum der Johann-Wolfgang Goethe-Universitat

location_facility: Boston Children's Health Physicians (BCHP)

location_facility: National Hospital Organization Nagasaki Medical Center

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

location_facility: University of California Benioff Children's Hospital

location_facility: Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

location_facility: Hospital Regional Universitario de Malaga Hospital General

location_facility: Xiangya Hospital of Central South University

location_facility: Northwell Health Physician Partners - Neurology at Lenox Hill

location_facility: Beijing Children's Hospital,Capital Medical University

location_facility: Children's Hospital of Chongqing Medical University

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

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

location_facility: National Center of Neurology and Psychiatry

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Instituto de Neurologia de Curitiba (INC)

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

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

location_facility: Kumamoto-Ezuko Medical Center for The Severely Disabled

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

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

location_facility: Clinic for Neurology and Psychiatry for Children and Youth

location_facility: National Hospital Organization Nishi-Niigata Chuo National Hospital

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN

location_facility: Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak

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

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

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.

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


title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of NBI-921352 as Adjunctive Therapy in Adult Subjects With Focal Onset Seizures (FOS)

summary: This study will evaluate the safety, pharmacokinetics, and efficacy of three different doses of NBI-921352 versus placebo in adults with focal onset seizures

lead_sponsor: Neurocrine Biosciences

location_country:
Italy
Hungary
United Kingdom
Australia
Belgium
Spain
Czechia
France


title: A Multi-cohort, Randomized, Phase 2, Open-label Study to Assess the Preliminary Efficacy, Safety, and Pharmacokinetics of BIVV020 for Prevention and Treatment of Antibody-mediated Rejection in Adult Kidney Transplant Recipients.

summary:
Primary Objectives:

Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR
Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR

Secondary Objectives:

To assess the overall efficacy of BIVV020 in prevention or treatment of AMR
To characterize the safety and tolerability of BIVV020 in kidney transplant participants
To characterize the pharmacokinetic (PK) profile of BIVV020 in kidney transplant participants
To evaluate the immunogenicity of BIVV020

ReferenceType: derived

ReferenceCitation: Karpman D, Bekassy Z, Grunenwald A, Roumenina LT. A role for complement blockade in kidney transplantation. Cell Mol Immunol. 2022 Jul;19(7):755-757. doi: 10.1038/s41423-022-00854-5. Epub 2022 Mar 24. No abstract available.

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 pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

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

lead_sponsor: Sanofi

location_country:
Germany
Italy
Australia
Sweden
United States
Spain
Canada
France

location_facility: University of California Los Angeles (UCLA) - Ronald Reagan UCLA Medical Center Site Number : 8400103

location_facility: University Of Wisconsin Hospital And Clinics Site Number : 8400003

location_facility: University of California San Francisco Site Number : 8400001

location_facility: Massachusetts General Hospital Site Number : 8400007

location_facility: NYU Langone Medical Center Site Number : 8400102

location_facility: Brigham & Women's Hospital Site Number : 8400004


title: A Modular Phase II, Open-label, Multicentre Study to Assess AZD4573 Efficacy and Safety as Monotherapy or in Combination With Anti-cancer Agents in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma or Classical Hodgkin Lymphoma

summary: This is a modular dose confirmation and expansion study. The core study design is to assess the efficacy of AZD4573, administered as monotherapy or combination therapy, to participants with either r/r PTCL or r/r cHL and to confirm the safety profiles and PK in these populations. Module 1 of this study will evaluate the efficacy, safety, and tolerability of AZD4573 monotherapy in participants with r/r PTCL or r/r cHL. If AZD4573 monotherapy is found to have promising anti-tumour efficacy in Module 1, an AZD4573 monotherapy Phase II expansion may be added via a substantial protocol amendment.

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

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

location_country:
Italy
United Kingdom
Singapore
Australia
Sweden
United States
Korea, Republic of
Taiwan
France


lead_sponsor: Amzell

summary: The main purpose of this study is to evaluate the efficacy of AMZ002 compared to Vigabatrin in participants with newly diagnosed infantile spasms (IS).

location_facility: Staten Island University Hospital, North

location_facility: Bharati Vidyapeeth Deemed University - Bharati Hospital

location_facility: Tecnologico De Monterrey - Hospital Zambrano Hellion - Instituto de Neurologia y Neurocirugia

location_facility: Universita degli Studi di Napoli Federico II

location_facility: Provincial Specialist Children's Hospital st. Ludwika

location_facility: Azienda Ospedaliera Universitaria Integrata

location_facility: Paediatric Hospital Dr. Juan P. Garrahan

location_facility: Wake Forest Baptist Medical Center - PPDS

location_facility: Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia

location_facility: AOU Anna Meyer - Clinica di Neurologia Pediatrica

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

title: A Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of AMZ002, Compared to Vigabatrin, in the Treatment of Infantile Spasms

location_country:
Italy
Poland
India
Argentina
Mexico
United States
Spain
France


summary:
The study is a phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants aged 18 years and older with advanced and metastatic gastrointestinal cancer. This study is structured as a master protocol for the investigation of SAR444245 with other anticancer therapies.

Sub study 01 - Cohort A aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC).

Sub study 02 - Cohort B1, B2 and B3 would focus on non MSI-H tumors with a large unmet need to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma (GC/GEJ), especially with low PD-L1 expression or after progression on prior PD1/PD-L1-based regimens.

Sub study 03 - Cohort C aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in participants with advanced unresectable or metastatic HCC who relapsed on prior PD1/PD-L1-based regimens.

Sub study 04 - Cohort D1 and D2 aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with either the anti-PD1 antibody pembrolizumab or with the anti-EGFR IgG1 antibody cetuximab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic colorectal cancer (mCRC).

sponsor_collaborators:
Sanofi
Merck Sharp & Dohme LLC

location_facility: AdventHealth Orlando Site Number : 8400005

location_facility: Seattle Cancer Care Alliance Site Number : 8400009

title: A Phase 2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR-707) Combined With Other Anticancer Therapies for the Treatment of Participants With Advanced and Metastatic Gastrointestinal Cancer

location_country:
Italy
Netherlands
Belgium
United States
China
Korea, Republic of
Spain
Chile
France


title: A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

acronym: MAHOGANY

summary: The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron emission tomography and computed tomography (PET/CT), and to compare the efficacy of zanubrutinib plus rituximab versus R^2 in participants with R/R marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria.

lead_sponsor: BeiGene

location_country:
Ireland
Italy
Australia
Brazil
United States
China
Korea, Republic of
Spain
Czechia
Puerto Rico
France

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

location_facility: Hattiesburg Hematology and Oncology Clinic

location_facility: Sunshine Coast Hospital and Health Service

location_facility: Complejo Asistencial Universitario de Leon

location_facility: Hospital Clinico Universitario Virgen de La Arrixaca

location_facility: Northwest Georgia Oncology Centers Marietta

location_facility: Arcispedale S Maria Nuova Ausl Reggio Emilia Hematology Unit

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Soon Chun Hyang University Hospital Seoul

location_facility: Hopital Prive Dantony, Departement Dhemathologie

location_facility: Centre Hospitalier Universitaire de Nancy Hopital de Brabois

location_facility: Severance Hospital Yonsei University Health System

location_facility: Kyungpook National University Chilgok Hospital

location_facility: The Catholic University of Korea, Seoul St Marys Hospital


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

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

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

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

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

The main aims of this study are to find for BAY2927088

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

The researchers will also study the action of BAY2927088 against the cancer. The study will have three parts: Dose Escalation, Backfill, and Dose Expansion. Each participant of the first, so called dose escalation part, will be assigned to one of specific sequential dose groups for BAY2927088. The amount of BAY2927088 that is given increases stepwise from one group to the next.

The second may be initiated at any dose that has already been tested during the first part and found to be safe and to have either reached a predicted efficacious exposure range or to have induced an objective response. The first part and second part will run concurrently.

The participants of the third, so called dose expansion part, will receive the most appropriate dose of BAY2927088 found in the first and second parts. The third part may be initiated in parallel with the first and second part based on emerging data.

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

During the study, the study team will:

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

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

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

lead_sponsor: Bayer

location_country:
Italy
Poland
Portugal
Israel
Hong Kong
Singapore
Japan
Brazil
Netherlands
Belgium
United States
China
Korea, Republic of
Spain
Taiwan
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)

location_facility: Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department

location_facility: The Center for Cancer and Blood Disorders

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: START Lisbon, CHULN - Centro Hospitalar Universitário de Lisboa Norte

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G.Pascale

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

location_facility: IRCCS Centro di Riferimento Oncologico (CRO)

location_facility: Hospital de Base | Integrated Research Center

location_facility: SP ZOZ USK im. WAM UM w Lodzi - Centralny Szpital Weteranow

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

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Med

location_facility: Fundacion Jimenez Diaz (Clinica de la Concepcion)

location_facility: Henry Ford Health System | Brigitte Harris Cancer Pavilion

location_facility: Institut Gustave Roussy - Département de Médecine Oncologique

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Shanghai Chest Hospital, Shanghai Jiaotong University

location_facility: Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

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

location_facility: Harbin Medical University Cancer Hospital

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: University of Texas MD Anderson Cancer Center

location_facility: AZ Delta | Clinical Trial Center - Pneumology

location_facility: CHULN - H. Sta.Maria (Centro de Investigacao Clinica)

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

location_facility: Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial: Multiple Independent Sub-studies of Setmelanotide in Patients With POMC/PCSK1, LEPR, NCOA1(SRC1), or SH2B1 Gene Variants in the Melanocortin-4 Receptor Pathway

summary:
The protocol describes a randomized, double-blind, placebo-controlled trial with independent sub-studies of setmelanotide in patients with obesity and at least one of the specific gene variants in the Melanocortin-4 Receptor pathway:

POMC or PCSK1 (Sub-study 035a)
LEPR (Sub-study 035b)
SRC1 (Sub-study 035c)
SH2B1 (Sub-study 035d)

The objectives and endpoints are identical for these sub-studies.

lead_sponsor: Rhythm Pharmaceuticals, Inc.

location_country:
Germany
Israel
United Kingdom
Netherlands
United States
Spain
Greece
Canada
Puerto Rico
France

location_facility: Ten's Medical Center - Pediatric Endocrinology Clinic

location_facility: London Medical - The London Diabetes Centre

location_facility: University of Alberta - Alberta Diabetes Institute (ADI)

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Marshfield Clinic Research Foundation, a Division of Marshfield Clinic, Inc

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Chaim Sheba MC, Safra Children's Hospital

location_facility: Hospital Universitario Virgen de la Victoria de Málaga

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Endocrine Associates of Dallas and Plano

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux

location_facility: Vanderbilt University School of Medicine


title: A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy

summary: The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

ipd_sharing_description:
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Poland
Israel
United Kingdom
Australia
Japan
Belgium
United States
Spain
Canada
Russian Federation
France

location_facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant

location_facility: University of North Carolina Medical Center

location_facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

location_facility: Hôpital Universitaire Necker Enfants Malades

location_facility: Atrium Health - Carolinas Medical Center


lead_sponsor: Novo Nordisk A/S

summary:
This study will look at participants body weight from the start to the end of the study. It will also look at how much pain participants have in participants knee from the start to the end of the study and how this affects participants daily life. This is to compare the effect on body weight and pain in the knee in people taking semaglutide with people taking "dummy" medicine. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance.

Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. During the study, participants will have talks with study staff about how to eat healthy food and how to be more physically active. The study will last for about 1 ½ years. Participants will have 14 clinic visits with the study staff. At the first clinic visit participants will have a blood sample taken. Participants will have an X-ray of participants knee taken at the first visit. If participants have had an X-ray recently, this may not be needed.

At 6 of the clinic visits participants cannot take pain medications for 3 days before the visit. Participants cannot take part if participants have had a joint replacement surgery in participants knee. Participants cannot take part if participants have or have had diabetes. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

title: Effect of Subcutaneous Semaglutide 2.4 mg Once-weekly Compared to Placebo in Subjects With Obesity and Knee Osteoarthritis

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

location_country:
Colombia
Norway
Denmark
Sweden
United States
Saudi Arabia
Spain
South Africa
Canada
Russian Federation
France


title: A Phase 2, Randomized, Parallel, Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-agent Belantamab Mafodotin (GSK2857916) in Participants With Relapsed or Refractory Multiple Myeloma (DREAMM-14)

acronym: DREAMM 14

summary: This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Thailand
Canada
France
Switzerland
United States
India
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
Taiwan