title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Single Doses of Cetrelimab (JNJ 63723283), an Anti-PD-1 Monoclonal Antibody, in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

summary: The purpose of the study is to characterize the pharmacokinetic (PK) profile of cetrelimab administered subcutaneous (SC) and optionally intravenous (IV) in chronic hepatitis B (CHB) participants.

primary_purpose: Basic Science

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

lead_sponsor: Janssen Research & Development, LLC

location_country: Germany Poland Belgium Spain France

location_facility: PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.


title: Interventional, Open-label Effectiveness Study of Flexible Doses of Vortioxetine on Depressive Symptoms in Patients With Major Depressive Disorder Comorbid With Generalized Anxiety Disorder

acronym: RECONNECT

summary: This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression coexisting with generalized anxiety disorder.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Christensen MC, Schmidt S, Grande I. Effectiveness of vortioxetine in patients with major depressive disorder comorbid with generalized anxiety disorder: Results of the RECONNECT study. J Psychopharmacol. 2022 May;36(5):566-577. doi: 10.1177/02698811221090627. Epub 2022 May 2.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

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: SAGE Publications

ipd_sharing: Undecided

lead_sponsor: H. Lundbeck A/S

location_country:
Italy
Poland
Korea, Republic of
Spain
Estonia
France

location_facility: Inje University Ilsan Paik Hospital (KR0002)

location_facility: Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Sp.k. (PL0007)

location_facility: Cabinet du Docteur Karim Boutayeb (FR0001)

location_facility: Niepubliczny Zaklad Opieki Psychiatrycznej Mentis (PL0004)

location_facility: Cabinet du Docteur Patrick Bourgoin (FR0002)

location_facility: MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk (PL0009)

location_facility: Chonnam National University Hospital (KR0003)

location_facility: Centrum Medyczne Luxmed Sp.Z O.O. (PL0006)

location_facility: Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0003)

location_facility: NZOZ Dom Sue Ryder - Pallmed Sp. z o.o. (PL0003)

location_facility: Instituto Internacional de Neurociencias Aplicadas (ES0001)

location_facility: Centrum Zdrowia Psychicznego Biomed - Jan Latala (PL0001)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 1/2 Trial of a Novel Therapeutic Vaccine (EO2401) in Combination With Immune Check Point Blockade, for Treatment of Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma

acronym: Spencer

summary: This is a multicenter, Phase 1/2, First-In-Human study to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2401 in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Randomized

ipd_sharing: No

lead_sponsor: Enterome

location_country:
Germany
Italy
Denmark
Sweden
Netherlands
United States
Spain
France

location_facility: Assistance Publique - Hôpitaux de Marseille - Hôpital Nord

intervention_type: Biological

status_simplified: Ongoing


acronym: PACIFIC 6

lead_sponsor: AstraZeneca

summary: This is a Phase II, open-label, multi-centre study to determine the safety of a fixed dose of Durvalumab (MEDI4736) (1500 mg) every 4 weeks [q4w] in participants with unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), who have not progressed following platinum-based sequential chemoradiation therapy (sCRT). This study will be conducted in Europe and North America.

title: A Phase II, Open-Label, Multi-Centre, International Safety Study of Durvalumab Following Sequential Chemotherapy and Radiation Therapy in Patients With Stage III, Unresectable Non-Small Cell Lung Cancer (PACIFIC 6)

type: EudraCT Number

source: euctr

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

design_allocation: Non-Randomized

location_country:
Germany
Italy
United Kingdom
United States
Spain
France

ipd_sharing: Yes


lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study was to support the selection of a safe and tolerable tobramycin inhalation powder (TIP) dose, and regimen that exhibits effective bacterial reduction of P. aeruginosa in non-cystic fibrosis bronchiectasis (BE) patients with P. aeruginosa colonization.

ReferenceCitation: Loebinger MR, Polverino E, Chalmers JD, Tiddens HAWM, Goossens H, Tunney M, Ringshausen FC, Hill AT, Pathan R, Angyalosi G, Blasi F, Elborn SJ, Haworth CS; iBEST-1 Trial Team. Efficacy and safety of TOBI Podhaler in Pseudomonas aeruginosa-infected bronchiectasis patients: iBEST study. Eur Respir J. 2021 Jan 5;57(1):2001451. doi: 10.1183/13993003.01451-2020. Print 2021 Jan.

oa_colors: green other

evidence: open (via free pdf)

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

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

version: submittedVersion

unpaywall_oa_status: bronze

publisher_dissemination: European Respiratory Society

ReferenceCitation: Loebinger MR, Polverino E, Blasi F, Elborn SJ, Chalmers JD, Tiddens HA, Goossens H, Tunney M, Zhou W, Angyalosi G, Hill AT, Haworth CS; iBEST-1 Trial Team. Efficacy and safety of tobramycin inhalation powder in bronchiectasis patients with P. aeruginosa infection: Design of a dose-finding study (iBEST-1). Pulm Pharmacol Ther. 2019 Oct;58:101834. doi: 10.1016/j.pupt.2019.101834. Epub 2019 Aug 18.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

sponsor_collaborators: Fundacion Clinic per a la Recerca Biomedica

title: A Randomized, Blinded, Parallel Group, Multi-center Dose-finding Study, to Assess the Efficacy, Safety and Tolerability of Different Doses of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection

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

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

location_country:
Germany
Italy
United Kingdom
Belgium
Spain
France


title: A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF or Other Tenofovir DF-containing Regimens (Ritonavir-boosted Atazanavir Plus Emtricitabine/Tenofovir DF or Efavirenz/Emtricitabine/Tenofovir DF) Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naïve HIV-1 Infected Adults With eGFR ≥70 mL/Min

summary: The primary objective of this study is to assess glomerular function before and during administration of stribild (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) or a regimen containing TDF without cobicistat (COBI) as ritonavir (RTV)-boosted atazanavir (ATV/r) plus truvada (TVD; FTC/TDF) or atripla (ATR; efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)) compared to a regimen containing neither TDF nor COBI as ATV/r plus abacavir/lamivudine (ABC/3TC) via determination of actual glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma clearance and estimated (calculated) glomerular filtration rate (eGFR).

lead_sponsor: Gilead Sciences

location_country:
Ireland
United Kingdom
Belgium
Spain
France


title: A Phase Ib Dose-finding Study of BYL719 Plus Everolimus and BYL719 Plus Everolimus Plus Exemestane in Patients With Advanced Solid Tumors, With Dose-expansion Cohorts in Renal Cell Cancer (RCC), Pancreatic Neuroendocrine Tumors (pNETs), and Advanced Breast Cancer (BC) Patients.

summary:
Dose escalation part: to determine the highest dose of alpelisib administered on a daily basis when given in combination with daily everolimus or in combination with daily everolimus and exemestane.

Dose expansion part: To describe safety and tolerability of the alpelisib and everolimus or alpelisib, everolimus and exemestane combinations.

ReferenceCitation: Fankhauser M, Bechmann N, Lauseker M, Goncalves J, Favier J, Klink B, William D, Gieldon L, Maurer J, Spottl G, Rank P, Knosel T, Orth M, Ziegler CG, Aristizabal Prada ET, Rubinstein G, Fassnacht M, Spitzweg C, Grossman AB, Pacak K, Beuschlein F, Bornstein SR, Eisenhofer G, Auernhammer CJ, Reincke M, Nolting S. Synergistic Highly Potent Targeted Drug Combinations in Different Pheochromocytoma Models Including Human Tumor Cultures. Endocrinology. 2019 Nov 1;160(11):2600-2617. doi: 10.1210/en.2019-00410.

evidence: open (via free article)

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

repositories_concat: PubMed Central;www.zora.uzh.ch

publisher_dissemination: The Endocrine Society

location_country:
Germany
Italy
Hungary
Hong Kong
United Kingdom
Netherlands
United States
Spain
France

location_facility: Memorial Sloan Kettering Cancer Center SC - BYL719Z2102


title: A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema

acronym: TRANSFORM

summary: To compare the clinical outcomes of Endoscopic Lung Volume Reduction (ELVR) using Pulmonx Zephyr Valves vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema subjects in a controlled trial design setting.

ReferenceCitation: Kemp SV, Slebos DJ, Kirk A, Kornaszewska M, Carron K, Ek L, Broman G, Hillerdal G, Mal H, Pison C, Briault A, Downer N, Darwiche K, Rao J, Hubner RH, Ruwwe-Glosenkamp C, Trosini-Desert V, Eberhardt R, Herth FJ, Derom E, Malfait T, Shah PL, Garner JL, Ten Hacken NH, Fallouh H, Leroy S, Marquette CH; TRANSFORM Study Team *. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM). Am J Respir Crit Care Med. 2017 Dec 15;196(12):1535-1543. doi: 10.1164/rccm.201707-1327OC.

oa_host_type: repository

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

unpaywall_oa_status: green

publisher_dissemination: American Thoracic Society

lead_sponsor: Pulmonx Corporation

location_country:
Germany
France
United Kingdom
Netherlands
Belgium
Sweden

location_facility: Thoraxklinik am Universitäts Klinikum Heidelberg

location_facility: The Royal Brompton Hospital & Harefield NHS Foundation Trust

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: West of Scotland Regional Heart & Lung Centre - Golden Jubilee National Hospital

intervention_type: Device


title: Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve

summary: The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

ReferenceType: result

ReferenceCitation: Vahanian A, Urena M, Walther T, Treede H, Wendler O, Lefevre T, Spence MS, Redwood S, Kahlert P, Rodes-Cabau J, Leipsic J, Webb J. Thirty-day outcomes in patients at intermediate risk for surgery from the SAPIEN 3 European approval trial. EuroIntervention. 2016 Jun 12;12(2):e235-43. doi: 10.4244/EIJV12I2A37.

publisher_dissemination: Europa Digital & Publishing

ReferenceCitation: Webb J, Gerosa G, Lefevre T, Leipsic J, Spence M, Thomas M, Thielmann M, Treede H, Wendler O, Walther T. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014 Dec 2;64(21):2235-43. doi: 10.1016/j.jacc.2014.09.026. Epub 2014 Nov 24.

oa_host_type: publisher

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

lead_sponsor: Edwards Lifesciences

location_country:
Germany
Italy
United Kingdom
Canada
France

location_facility: Laval, Institut universitaire de cardiologie et de pneumologie de Quebec


title: Assessment of the Safety and Efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the Treatment of Single de Novo Bifurcation Lesions in Native Coronary Arteries

acronym: BIPAX

summary: The purpose of this trial is to assess the safety and efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the treatment of single de novo bifurcation lesions in native coronary arteries with a main branch reference vessel diameter of 2.5-3.5 mm and side branch reference vessel diameter of 2.0-3.0 mm.

lead_sponsor: MINVASYS

location_country: Italy Poland Brazil Netherlands Spain Bulgaria France

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Karol Marcinkowski University of Medical Sciences


title: Prospective Open-Label Investigation Of The Non-surgical Treatment With Collagenase Clostridium Histolyticum (Xiapex)

acronym: POINT X

summary: This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the affected fingers and the patient and physician reported treatment satisfaction and disease severity and their relation to ROM. Recovery to normal activities, recovery time (How long overall, time to use hand, time to return to work or daily activities, amount of work or daily activity time missed or reduced and affects on productivity and daily activities) will be assessed via patient diary. Use of concomitant analgesic medications will be recorded and total healthcare resource utilization (HCRU).

ReferenceCitation: Warwick D, Arner M, Pajardi G, Reichert B, Szabo Z, Masmejean EH, Fores J, Chapman DS, Gerber RA, Huard F, Seghouani A, Szczypa PP; POINT X Investigators. Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes. J Hand Surg Eur Vol. 2015 Feb;40(2):124-32. doi: 10.1177/1753193413519926. Epub 2014 Jan 26.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repositories_concat: PubMed Central;air.unimi.it

lead_sponsor: Pfizer

location_country:
Germany
Italy
Hungary
United Kingdom
Denmark
Sweden
Spain
France


title: Multicentre Paediatric Disease Registry in Essential Thrombocythaemia

summary: The aim of this study is to evaluate the progression of ET in children (aged 6-17years inclusive) over a period of 5 years maximum. The study will also assess how children are diagnosed, treatment options for those children with symptoms and events related to their ET and the outcomes of those treatments.

study_type: Observational

time_perspective: Cross-Sectional

lead_sponsor: Shire

location_country:
Germany
Italy
United Kingdom
Switzerland
Spain
Greece
Czechia
France

location_facility: Hospital Universitario Virgen de la Arrixac

location_facility: Sección de Hematología Pediátrica. Hospital de la Santa Creu i Sant Pau

location_facility: Hospital Universitario Mutua de Terrassa

location_facility: Clinic of Paediatric haematology and oncology University Hospital Motol

location_facility: Department of Cellular Biotechnologies and Hematology. Sapienza University

location_facility: Centre Hospitalier Lyon Sud - service Hématologie

location_facility: Dipartimento di Biomedicina dell'Eta Evolutiva. University of Bari

location_facility: Zentrum für Kinder- und Jugendmedizin Klinik II / III

location_facility: Leitender Arzt, Pädiatrische Hämatologie/Onkologie Kinderspital

location_facility: Department of Oncology, Pausilipon Hospital, AORN Santobono

location_facility: Children's Clinic, Royal Berkshire Hospital

location_facility: Paediatric Oncology Unit, Hopital Cote De Nacre

location_facility: Servicio de Hematología Clínica, Hospital Sant Joan de Déu Barcelona

location_facility: Paediatric Clinic University Hospital Olomouc

location_facility: Jefe de Servicio Oncología Y Hematología Pediátricas

location_facility: Hamatology Unit. Paediatric Department. University of Torino

location_facility: Department Haematology, Hospital Ramon y Caja

location_facility: Chairmen of Pediatric Hamatooncology Outpatient Clinic. Hospital San Gerardo

location_facility: Klinikum Chemnitz GmbH, Klinik für Kinder-und Jugendmedizin

location_facility: Servicio de Transfusión, Hospital Universitario Niño Jesús

location_facility: Practicen Hospitalier , Institute d'Hematologie et Oncologie Pediatrique

location_facility: Complexo Hospitalario Universitario, Santiago

location_facility: Pediatric Hamatology Unit. Department of Hematology and Oncology. G Gaslini Children's hospital. Largo


summary: The objective of this study is to explore the efficacy, safety and cognitive properties of Lu AE58054 as augmentation therapy to risperidone in patients with schizophrenia.

title: A Randomised, Double-blind, Parallel-Group, Fixed Dose Study Exploring the Efficacy and Safety of Lu AE58054 as Augmentation Therapy to Risperidone in Patients With Schizophrenia

location_country:
Germany
Italy
Poland
Hong Kong
Belgium
Thailand
Taiwan
France


title: Phase II Study of GW786034 in Patients With Relapsed or Refractory Soft Tissue Sarcoma

summary: The purpose of this study is to evaluate the activity and tolerability of pazopanib in subjects with advanced and/or metastatic soft tissue sarcoma who have relapsed following standard therapies or for whom no standard therapy exists and to characterize the pharmacokinetics of pazopanib in this subject population.

ReferenceType: background

ReferenceCitation: Sleijfer S, Ray-Coquard I, Papai Z, Le Cesne A, Scurr M, Schoffski P, Collin F, Pandite L, Marreaud S, De Brauwer A, van Glabbeke M, Verweij J, Blay JY. Pazopanib, a multikinase angiogenesis inhibitor, in patients with relapsed or refractory advanced soft tissue sarcoma: a phase II study from the European organisation for research and treatment of cancer-soft tissue and bone sarcoma group (EORTC study 62043). J Clin Oncol. 2009 Jul 1;27(19):3126-32. doi: 10.1200/JCO.2008.21.3223. Epub 2009 May 18.

ReferenceCitation: Sleijfer S, Gorlia T, Lamers C, Burger H, Blay JY, Le Cesne A, Scurr M, Collin F, Pandite L, Marreaud S, Hohenberger P. Cytokine and angiogenic factors associated with efficacy and toxicity of pazopanib in advanced soft-tissue sarcoma: an EORTC-STBSG study. Br J Cancer. 2012 Aug 7;107(4):639-45. doi: 10.1038/bjc.2012.328. Epub 2012 Jul 17.

ReferenceCitation: Kasper B, Sleijfer S, Litiere S, Marreaud S, Verweij J, Hodge RA, Bauer S, Kerst JM, van der Graaf WTA. Long-term responders and survivors on pazopanib for advanced soft tissue sarcomas: subanalysis of two European Organisation for Research and Treatment of Cancer (EORTC) clinical trials 62043 and 62072. Ann Oncol. 2014 Mar;25(3):719-724. doi: 10.1093/annonc/mdt586. Epub 2014 Feb 6.

lead_sponsor: GlaxoSmithKline

location_country:
Hungary
United Kingdom
Netherlands
Belgium
France


title: Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas

summary:
RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and slow the growth of the tumor.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have gliomas.

ReferenceCitation: Raymond E, Brandes AA, Dittrich C, Fumoleau P, Coudert B, Clement PM, Frenay M, Rampling R, Stupp R, Kros JM, Heinrich MC, Gorlia T, Lacombe D, van den Bent MJ; European Organisation for Research and Treatment of Cancer Brain Tumor Group Study. Phase II study of imatinib in patients with recurrent gliomas of various histologies: a European Organisation for Research and Treatment of Cancer Brain Tumor Group Study. J Clin Oncol. 2008 Oct 1;26(28):4659-65. doi: 10.1200/JCO.2008.16.9235.

ReferenceCitation: Raymond E, Brandes A, Van Oosterom A, et al.: Multicentre phase II study of imatinib mesylate in patients with recurrent glioblastoma: an EORTC: NDDG/BTG Intergroup study. [Abstract] J Clin Oncol 22 (Suppl 14): A-1501, 2004.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Italy
United Kingdom
Netherlands
Austria
Belgium
Switzerland
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center


title: An Open-Label, Non-Comparative Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

summary: The purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of patients with confirmed candidemia or invasive candidiasis.

lead_sponsor: Astellas Pharma Inc

location_country:
Germany
Italy
Poland
United Kingdom
Sweden
Austria
Spain
France

location_facility: Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie

location_facility: Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie

location_facility: Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology

location_facility: Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera

location_facility: Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle

location_facility: Klinikum der Stadt, Medizinische Klinik A

location_facility: Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas

location_facility: LMU Munchen, Hamatopoetische Zell - Transplantation

location_facility: Hospital Clinic I Provencial, Servicio Enfermadades Infecciosas

location_facility: Hospital Doce de Octubre, Servicio de Microbiologia Y Enfermadades Infecciosas

location_facility: Royal Free Hospital, Dept. of Haematological Oncology

location_facility: Institute of Haematology and Blood Transfusion

location_facility: Hopital Henri Mondor, Dervice d'Hematologie Clinique

location_facility: Johann Wolfgang Goethe Universitat, Medizinische Klinik III

location_facility: Hopital Necker Enfants Malades, Service d"Hematologie

location_facility: Uniklinik Mainz, III. Medizinische Klinik


type: Other Identifier

title: An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis

summary: The purpose of the study is to evaluate the safety and efficacy of FK463 in patients with proven or probable invasive infections due to Aspergillus species.

ReferenceCitation: Denning DW, Marr KA, Lau WM, Facklam DP, Ratanatharathorn V, Becker C, Ullmann AJ, Seibel NL, Flynn PM, van Burik JA, Buell DN, Patterson TF. Micafungin (FK463), alone or in combination with other systemic antifungal agents, for the treatment of acute invasive aspergillosis. J Infect. 2006 Nov;53(5):337-49. doi: 10.1016/j.jinf.2006.03.003. Epub 2006 May 6.

ReferenceCitation: Kontoyiannis DP, Ratanatharathorn V, Young JA, Raymond J, Laverdiere M, Denning DW, Patterson TF, Facklam D, Kovanda L, Arnold L, Lau W, Buell D, Marr KA. Micafungin alone or in combination with other systemic antifungal therapies in hematopoietic stem cell transplant recipients with invasive aspergillosis. Transpl Infect Dis. 2009 Feb;11(1):89-93. doi: 10.1111/j.1399-3062.2008.00349.x. Epub 2008 Oct 8.

location_facility: Hopital Necker Enfants Malades, Service d'Hematologie

location_facility: Hospital Doce de Octubre, Servicio de Microbiologia y Enfermadades Infecciosas

location_facility: Hopital Henri Mondor, Service d'Hematologie Clinique

location_facility: Hospital Clinic I provencial, Servicio Enfermadades Infecciosas


title: Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Semaglutide 2.4 mg, Cagrilintide 2.4 mg and Placebo in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity

summary: This study will look if CagriSema can lower kidney damage in people with chronic kidney disease (CKD), type 2 diabetes (T2D) and overweight or obesity. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors. The study will compare CagriSema to the 2 medicines semaglutide and cagrilintide, when they are taken alone. It will also compare CagriSema to a "dummy" medicine (also called placebo) without any active ingredient. Participant will either get CagriSema 2.4 mg, semaglutide 2.4 mg, cagrilintide 2.4 mg or placebo. Which treatment participant will get is decided by chance (like flipping a coin). Study doctor will not know which of the study medicines participant will get. For each participant, the study will last for about 35 weeks.

study_start_date_type: Anticipated

status: Not yet recruiting

enrollment_type: Anticipated

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

lead_sponsor: Novo Nordisk A/S

location_country:
Poland
India
Slovakia
Hungary
Argentina
Japan
Brazil
United States
Spain
Thailand
Greece
Canada
France


title: ARTEMIS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Patients With Acute Myocardial Infarction

acronym: ARTEMIS

summary: The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.

sponsor_collaborators:
Novo Nordisk A/S
Duke Clinical Research Institute

location_country:
Germany
Italy
Poland
India
Israel
Argentina
Netherlands
Korea, Republic of
Spain
Greece
Malaysia
Bulgaria
France


type: Registry Identifier

title: A Phase 3, Randomized, Double-Blind, 52-Week, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Nonsegmental Vitiligo

summary: This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.

status: Recruiting

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

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

lead_sponsor: Incyte Corporation

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
United States
Bulgaria
Canada
France

location_facility: Vitiligo & Pigmentation Institute of Southern California

location_facility: Nottingham University Hospitals - Treatment Center

location_facility: Provita Sp.Zo.O. Centrum Medyczne Angelius

location_facility: Callender Dermatology and Cosmetic Center

location_facility: Clinexpert Egeszsegugyi Szolgaltato Es Kereskedelmi Kft.

location_facility: Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust

location_facility: Barts Health Nhs Trust - Whipps Cross University Hospital

location_facility: Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (Ccm)

location_facility: Centre Hospitalier Universitaire de Nice,Hopital L Archet

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak

location_facility: Ambulatory For Specialized Medical Care - Individual Practice For Specialized Medical Care - Skin An

location_facility: Azienda Ospedaliera Spedali Civili Di Brescia-Universita Degli Studi Di Brescia

location_facility: Center For Dermatology Clinical Research, Inc

location_facility: Austin Institute For Clinical Research Aicr Pflugerville

location_facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu

location_facility: Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele Ospedale Gaspare Rodolico Di Catania

location_facility: Heights Dermatology and Aesthetic Center

location_facility: Florida Academic Centers Research and Education Llc

location_facility: Synexus Polska Sp. Z O.O. Oddzial W Gdansku

location_facility: Dermatology Treatment and Research Center

location_facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z O.O.

location_facility: Hospices Civils de Lyon (Hcl) - Hopital Edouard Herriot (Heh)

location_facility: Indiana University School of Medicine Iusm Indianapolis

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Dermed Centrum Medyczne Sp. Z O.O.

location_facility: British Columbia'S Centre For Dermatologic Science - the Skin Care Centre

location_facility: Futuremeds Targowek Centrum Medyczne Amed Warszawa Targowek

location_facility: Fondazione Policlinico Universitario Agostino Gemelli Irccs

location_facility: Prywatny Gabinet Dermatologiczny Elzbieta Klujszo

location_facility: University Hospitals of Leicester-Leicester Royal Infirmary (Lri)

location_facility: University of Alabama At Birmingham Hospital-Whitaker Clinic

location_facility: Manor Hospital (Walsall) - Walsall Healthcare Nhs Trust

location_facility: Obudai Egeszsegugyi Centrum - Dunaujvaros

location_facility: Centre de Recherche Dermatologique de Quebec


title: A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301

summary: This is a phase 3, randomized, controlled study of IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.

lead_sponsor: Immunocore Ltd

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Romania
Australia
Brazil
Switzerland
Austria
Belgium
Mexico
United States
Spain
Canada
France

location_facility: Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Klinik fuer Dermatologie Venerologie und Allergologie - Hauttumorcentrum Charite (HTCC)

location_facility: Universitaetsklinikum Heidelberg (UKHD) - Hautklinik

location_facility: Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus

location_facility: Assistance Publique-Hôpitaux de Paris (AP-HP)

location_facility: Hospital General Universitario Gregorio Marañon (HGUGM)

location_facility: Cliniques Universitaires Saint-Luc, Medical Oncology

location_facility: Sf Nectarie Oncology Center, Oncology Department

location_facility: Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux - Hospitalier Saint-Andre

location_facility: University of Sydney - Melanoma Institute Australia (MIA) - The Poche Centre

location_facility: University of Colorado Hospital (UCH) - Medical Campus

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH) - Oncology Centre

location_facility: The University of Queensland (UQ) - Princess Alexandra Hospital (PAH)

location_facility: University Medical Center Hamburg-Eppendorf (UKE)

location_facility: UCLA Department of Medicine- Hematology/Oncology

location_facility: Instituto Américas - Instituto de Educação Pesquisa e Gestão em Saúde Oncosite

location_facility: Institut Claudius Regaud - Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)

location_facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - London

location_facility: Institut Català d'Oncologia (ICO) - Hospital Duran i Reynals

location_facility: Instituto Nacional de Cancer (INCA) (Brazilian National Cancer Institute)

location_facility: The Christie NHS Foundation Trust - The Christie Clinic

location_facility: University of California San Diego (UCSD) - Moores Cancer Center

location_facility: Columbia University - Herbert Irving Comprehensive Cancer Center

location_facility: Georgetown University Medical Center (GUMC)

location_facility: UHN - Princess Margaret Cancer Centre, University Health Network

location_facility: Assistance Publique - Hôpitaux de Paris - Hôpital Saint-Louis - Centre d'Onco-Dermatologie

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: University of Alberta - Cross Cancer Institute

location_facility: Institutul Oncologic " Prof. Dr. Ion Chiricuta" Str. (IOCN)

location_facility: Hospital Civil (Hospital Regional Universitario de Malaga)

location_facility: Azienda Ospedaliera Universitaria Senese - Istituto Toscano Tumori (ITT) - Siena

location_facility: Instituto Oncologico Dr. Rosell (IOR) Hospital Universitario Dexeus

location_facility: Universitaetsklinikum Essen - Klinik und Poliklinik fuer Dermatologie, Venerologie und Allergologie

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

location_facility: East and North Hertfordshire NHS Trust - Mount Vernon Hospital - Mount Vernon Cancer Centre (MVCC)

location_facility: Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano

location_facility: The Angeles Clinic and Research Institute - West Los Angeles - The Melanoma Center

location_facility: Hospital Clinico Universitario de Valencia

location_facility: UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center

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

location_facility: UniversitaetsSpital Zuerich - Dermatologische Klinik

location_facility: Universitaire Ziekenhuizen (UZ) Leuven - General Medical Oncology

location_facility: The Clatterbridge Cancer Centre (CCC) NHS Foundation Trust (Clatterbridge Centre for Oncology NHS Foundation Trust) - Clatterbridge Cancer Centre - Aintree


title: A Phase 1b/2 Open-label Study of Samuraciclib in Combination With Elacestrant in Participants With Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer

acronym: SUMIT-ELA

summary: This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.

lead_sponsor: Carrick Therapeutics Limited

sponsor_collaborators:
Carrick Therapeutics Limited
Berlin-Chemie AG Menarini Group

location_country:
United States
Spain
United Kingdom
France

location_facility: Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University

location_facility: Site 64 - Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

location_facility: Site 63 - South Texas Accelerated Research Therapeutics, CIOCC, Hospital Madrid Norte-Sanchinarro

location_facility: Site 81 - Bergonie unicancer, Nouvelle-Aquitaine, L'Institut Bergonie

location_facility: Site 69 - Universidad de Navarra - Clinica Universidad de Navarra (CUN)

location_facility: Site 65 - Complexo Hospitalario Universitario A Coruña

location_facility: Site 67 - Universidad de Sevilla, Hospital Universitario Virgen Macarena

location_facility: Site 84 - UNICANCER, Centre Leon-Berard (CLB)

location_facility: Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus

location_facility: Site 34 -The University of Texas, MD Anderson Cancer Center, Nellie B. Connally Breast Center

location_facility: Site 35 - Cleveland Clinic, Taussig Cancer Institute

location_facility: Site 68 -Hospital Universitario Vall d'Hebron

location_facility: Site 42 - Dana-Farber Cancer Institute, EDDC

location_facility: Site 43 - Mid Florida Hematology and Oncology Center

location_facility: Site 82 - Institut de Cancerologie de Ouest (ICO)

location_facility: Site 61 - Institut Catala d'Oncologia (ICO), Hospital Duran i Reynals Location

location_facility: Site 41 - The START Center for Cancer Care, South Texas Oncology and Hematology

location_facility: Site 60 - NEXT Oncology EU Hospital Universitario Quiron Salud Madrid

location_facility: Site 40 - Massachusetts General Hospital

location_facility: Site 83 - Institut Paoli Calmettes (IPC)

location_facility: Site 4 - The Christie NHS Foundation Trust

location_facility: Site 2 - Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: Site 62 - Universidad de Navarra, Clinica Universidad de Navarra (CUN)

location_facility: Site 80 - Centre Jean Bernard, Clinique Victor Hugo


title: A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD): The "ELEMENT-MDS" Trial

acronym: ELEMENT-MDS

summary: The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).

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 Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
Poland
Colombia
India
Hungary
Argentina
Australia
Brazil
Mexico
United States
China
Spain
Greece
Czechia
Canada
Puerto Rico
France

location_facility: Ventura County Hematology Oncology Specialists

location_facility: John Muir Medical Center - Concord Campus

location_facility: Metro-Minnesota Community Clinical Oncology

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: American Oncology Partners of Maryland, PA

location_facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: General Hospital of Athens "G. Gennimatas"

location_facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

location_facility: Fred Hutchinson Cancer Center at University of Washington Medical Center - Northwest

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

location_facility: Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház

location_facility: Veteran Affairs Central California Health Care


title: A Phase 2, Randomized, Open-Label, Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer

summary:
The purpose of this study is to determine whether the amount of time before disease progression can be prolonged in participants with metastatic castration-resistant prostate cancer (MCRPC) who receive lorigerlimab in addition to the standard of care (SOC) of docetaxel and prednisone. About 150 participants with mCRPC will be enrolled. Participants will be randomized in a 2:1 ratio to receive lorigerlimab with docetaxel and prednisone (experimental arm) or docetaxel and prednisone alone (standard-of-care arm).

Lorigerlimab+docetaxel or docetaxel will be administered intravenously (IV) in clinic on Day 1 of each 3-week cycle. Prednisone will be administered orally twice daily. Lorigerlimab will be administered for up to 35 cycles. Docetaxel and prednisone will be administered up to 10 cycles until treatment discontinuation criteria are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI) and prostate-specific antigen (PSA) blood tests. Participants will be asked to complete questionnaires about their health and well-being. Routine examinations and blood tests will be performed and evaluated by the study doctor.

Participants who have disease progression standard-of-care arm have the option of continuing on the study to receive lorigerlimab monotherapy.

lead_sponsor: MacroGenics

location_country:
Poland
Belgium
United States
Spain
Bulgaria
Georgia
Puerto Rico
France

location_facility: University of Virginia Health System Cancer Center

location_facility: Pan American Center for Oncology Trials, LLC


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in Subjects With Parkinson's Disease With a Pathogenic Variant in the Glucocerebrosidase (GBA1) Gene

acronym: ACTIVATE

summary: The purpose of this randomized, double-blind, placebo-controlled study is to assess the efficacy of BIA 28-6156 over placebo in delaying clinical meaningful motor progression over 78 weeks in subjects with Parkinson's disease who have a pathogenic variant in the glucocerebrosidase 1 (GBA1) gene (GBA-PD).

lead_sponsor: Bial R&D Investments, S.A.

location_country:
Germany
Italy
Poland
Portugal
United Kingdom
Sweden
Netherlands
United States
Spain
Canada
France

location_facility: Azienda Ospedaliera Universitaria, "Luigi Vanvitelli"

location_facility: University Hospitals Cleveland Medical Center

location_facility: Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou - Centre d'Investigation Clinique (CIC) - Inserm 1414

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore

location_facility: King's College London - David Goldberg Centre

location_facility: Karolinska Universitetssjukhuset - Solna - Neurologiska kliniken (Neurology Clinic)

location_facility: Krakowska Akademia Neurologii Sp. z o.o.

location_facility: University of Dundee - Ninewells Hospital and Medical School

location_facility: St. Antonius Ziekenhuis (St. Antonius Hospital) - Utrecht

location_facility: Paracelsus-Kliniken Deutschland GmbH & Co. KGaA - Paracelsus-Elena-Klinik - Zentrum fuer Parkinson-Syndrome und Bewegungsstoerungen (Centre of Parkinsonism and Movement Disorders)

location_facility: NeuroKlinika Gabinet Lekarski prof. Andrzej Bogucki

location_facility: Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum)

location_facility: Park Nicollet Struther's Parkinson's Center (Struthers Parkinsons Center at HealthPartners)

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: Gertrudis Clinic Biskirchen, Parkinson-Center

location_facility: Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau

location_facility: Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Neurologica

location_facility: Clinique Neuro-Outaouais (Neuro-Outaouais Clinic)

location_facility: Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Pitie-Salpetriere - Centres d'Investigation Clinique (CIC) Paris-Est

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Centro Hospitalar do Porto (CHP) - Hospital Geral de Santo Antonio (HGSA)

location_facility: Klinikum der Universität München, Campus Grosshadern, Neurologische Klinik und Poliklinik

location_facility: Plymouth Hospitals NHS Trust - Derriford Hospital

location_facility: University of Texas Health Science Center - San Antonio

location_facility: Neurologisches Fachkrankenhaus für, Bewegungsstörungen / Parkinson

location_facility: Skanes Universitetssjukhus - Lund (Universitetssjukhuset i Lund)

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio e Ruggi d'Aragona

location_facility: Rutgers Robert Wood Johnson Medical School

location_facility: Parkinson's Disease and Movement Disorders Cente at University of Pennyslvania

location_facility: Fondazione IRCCS Istituto Neurologico "Carlo Besta"

location_facility: Philipps-Universitaet Marburg; Philipps-Universitaet Marburg - Klinik fuer Neurologie

location_facility: Centro Hospitalar S. João, E.P.E Serviço de Neurologia


title: A Phase 3b/4 Randomized, Double-Blind, Double Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and Who Had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)

acronym: SELECT- SWITCH

summary:
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed.

Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world.

Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Germany
Portugal
Hungary
United Kingdom
Japan
Belgium
United States
Korea, Republic of
Spain
Greece
Croatia
Chile
South Africa
Bulgaria
Canada
Puerto Rico
France

location_facility: Rheumatology Center of San Diego /ID# 255038

location_facility: Purushotham & Akther Kotha MD, Inc /ID# 252704

location_facility: Rheumatology Associates PA - Portland /ID# 255014

location_facility: Queen Mary University of London /ID# 252671

location_facility: Chonnam National University Bitgoeul Hospital /Id# 254802

location_facility: Bluegrass Community Research /ID# 254653

location_facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 253432

location_facility: West Tennessee Research Institute /ID# 254620

location_facility: The Royal Free London NHS Foundation Trust /ID# 252297

location_facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 252492

location_facility: Diagnostic consultative center 17 Sofia /ID# 252341

location_facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 252489

location_facility: Providence Medical Foundation /ID# 252690

location_facility: Aurora Rheumatology and Immunotherapy Center /ID# 254049

location_facility: Centre Rhumatologie de l'Est /ID# 254932

location_facility: Qualmedica Research - Evansville /ID# 254005

location_facility: Clinical Research of West Florida, Inc /ID# 254649

location_facility: Centre de Recherche Musculo-Squelettique /ID# 256273

location_facility: MAV Korhaz ess Rendelointezet /ID# 252628

location_facility: Sagawa Akira Rheumatology Clin /ID# 252773

location_facility: Complejo Asistencial Dr. Sotero del Rio /ID# 252559

location_facility: Arizona Arthritis & Rheumatology Associates - Tucson /ID# 255017

location_facility: Greater Chicago Specialty Physicians /ID# 254000

location_facility: Arthritis and Rheumatology Research Institute, PLLC /ID# 254045

location_facility: Portsmouth Hospitals University NHS Trust /ID# 252772

location_facility: Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 252836

location_facility: Crowley CORE, LLC - Hinsdale Orthopaedics /ID# 254712

location_facility: Trinity Health Med Arts Clinic /ID# 254010

location_facility: Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253733

location_facility: Comprehensive Rheumatology Center /ID# 252688

location_facility: Groupe de Recherche en Maladies Osseuses Inc /ID# 253409

location_facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 255021

location_facility: Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 255018

location_facility: Kumamoto Orthopaedic Hospital /ID# 253167

location_facility: Diagnostic consultative center Focus-5 /ID# 252354

location_facility: Hanyang University Seoul Hospital /ID# 252161

location_facility: CHU Amiens-Picardie Site Sud /ID# 252384

location_facility: Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 255266

location_facility: Trinity Universal Research Associates - Carrollton /ID# 254648

location_facility: CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 252400

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 254144

location_facility: Diagnostic consultative center Focus-5 /ID# 252555

location_facility: Hospital Garcia de Orta, EPE /ID# 252491

location_facility: The Arthritis & Diabetes Clinic, Inc. /ID# 254014

location_facility: Rheumatology Associates of Oklahoma /ID# 253994

location_facility: Centro Internacional de Estudios Clinicos /ID# 252561

location_facility: The Queen Elizabeth Hospital, Kings Lynn NHS Foundation Trust /ID# 252301

location_facility: R & H Clinical Research - 777 Katy /ID# 255024

location_facility: Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 253057

location_facility: Valerius Medical Group & Research Center of Greater Long Beach, Inc /ID# 252692

location_facility: NYU Langone Ambulatory Care Brooklyn Heights /ID# 254621

location_facility: West Texas Clinical Research /ID# 253736

location_facility: Military Medical Academy Multiprofile Hospital /ID# 252355

location_facility: Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 253999

location_facility: Corporacion de Beneficiencia Osorno /ID# 252556

location_facility: Kansas City Physician Partners /ID# 255035

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 252430

location_facility: AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 253431

location_facility: Bay Side Misato Medical Center /ID# 252661

location_facility: Clinical Research of Philadelphia, LLC /ID# 255025

location_facility: Arthritis Clinical Research Trials /ID# 252370

location_facility: Atlanta Research Center for Rheumatology /ID# 254623

location_facility: Seoul National University Hospital /ID# 252160

location_facility: Winelands Medical Research Centre /ID# 252369

location_facility: Medical Corporation Keiai Kai Clinic /ID# 252750

location_facility: Sugimoto Rheumatology and Internal Medicine Clinic /ID# 252774

location_facility: Hospital Universitario y Politecnico La Fe /ID# 254143

location_facility: Bay Area Arthritis and Osteo /ID# 254046

location_facility: Paramount Medical Research Con /ID# 254048

location_facility: Rheumatologische-Immunologische Praxis Templin /ID# 252863

location_facility: DM Clinical Research - Tomball /ID# 254001

location_facility: CHR Orleans - Hopital de la Source /ID# 252385

location_facility: Rheumatic Disease Center, LLP /ID# 254015

location_facility: Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 253311

location_facility: Katayama Orthopedic Rheumatology Clinic /ID# 252746

location_facility: Matsubara Mayflower Hospital /ID# 252834

location_facility: Dr Naik-Medical Professional Corporation-Alliance Health /ID# 254018

location_facility: Deerbrook Medical Associates /ID# 254008

location_facility: Newport Huntington Medical Group /ID# 252687

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 252425

location_facility: Arthritis and Rheumatism Associates /ID# 254013

location_facility: University of Colorado Hospital /ID# 254617

location_facility: Specijalna bolnica za medicinsku rehabilitaciju Krapinske Toplice /ID# 252455

location_facility: The Lundquist Institute at Harbor-UCLA Medical Center /ID# 252691

location_facility: Physician Research Collaboration, LLC /ID# 254012

location_facility: Clinical Research of West Florida - Tampa /ID# 255264

location_facility: CHU Toulouse - Hopital Purpan /ID# 252402

location_facility: Advanced Rheumatology of Houston /ID# 254003

location_facility: International Medical Research /ID# 254651

location_facility: University General Hospital Attikon /ID# 254751

location_facility: Rheumatology Clinic of Houston /ID# 254002

location_facility: St.Luke's International Hospital /ID# 253131

location_facility: AA Medical Research Center - Grand Blanc /ID# 254007

location_facility: CHU Montpellier - Hôpital Lapeyronie /ID# 252386

location_facility: Winelands Medical Research - Somerset West /ID# 252745

location_facility: Trinity Universal Research Associates, Inc /ID# 253995

location_facility: Sun Valley Arthritis Center Ltd. /ID# 254654

location_facility: SoonChunHyang University CheonAn Hospital /ID# 254942

location_facility: Chungnam National University Hospital /ID# 252159

location_facility: Dartmouth-Hitchcock Medical Center /ID# 253798


title: A Randomized Open Label Phase II Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (also known as RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT) and axitinib, as compared to pembrolizumab and axitinib in participants with previously untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma (ccRCC).

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

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Poland
United Kingdom
Australia
United States
China
Korea, Republic of
Spain
France

location_facility: Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

location_facility: Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street

location_facility: Institut Gustave Roussy; Oncologie Medicale

location_facility: Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii

location_facility: Chonnam National University Hwasun Hospital

location_facility: Sunshine Coast University Hospital; The Adem Crosby Centre

location_facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Universitätsklinikum Ulm; Klinik für Urologie

location_facility: Hospital Universitari i Politecnic La Fe; Oncologia

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Hospital Universitario Ramon y Cajal;Oncology Dept.

location_facility: Institut Sainte Catherine;Recherche Clinique

location_facility: Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii

location_facility: Vanderbilt University Medical Center; Vanderbilt University


title: A Phase 2, Open-label, Multicenter Study Investigating RP3 Oncolytic Immunotherapy in Combination With First- or Second-line Therapy in Patients With Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma

summary: This is a Phase 2, open-label, 2-cohort clinical study evaluating RP3 in combination with atezolizumab plus bevacizumab as First- or Second-line Systemic Therapy in patients with locoregionally advanced and/or metastatic Hepatocellular Carcinoma not amenable to surgical resection or standard locoregionally directed therapies.

lead_sponsor: Replimune Inc.

sponsor_collaborators:
Replimune Inc.
Roche Pharma AG

location_country:
Germany
United Kingdom
United States
Greece
France

location_facility: University General Hospital of Herakleion

location_facility: University of Washington Fred Hutchinson Cancer Center

location_facility: University Hospital Leipzig Clinic and Polyclinic for Oncology, Gastroenterology, Hepatology, Pneumatology, Infectiology

location_facility: Leeds Teaching Hospital NHS Trust / St James's University Hospital

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Clatterbridge Cancer Center NHS Foundation Trust

location_facility: Universitätsklinikum Mainz Hautklinik und Poliklinik

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Service d'Ocologie Digestive et Medicale Hopital Paul Brousse

location_facility: University of Iowa Hospitals and Clinics

location_facility: Uniklinikum Heidelberg National Center for Tumors Heidelberg (NCT)

location_facility: University of California San Diego, UCSD

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: "Hippocration" General Hospital of Athens, B' Department of Internal Medicine, Hepatogastroenterology Unit

location_facility: Université Claude Bernard Lyon 1, Centre Hospitalier Lyon Sud


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of Baricitinib in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata

acronym: BRAVE-AA-PEDS

summary:
The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata (hair loss) in children from 6 years to less than 18 years of age.

The study is divided into 4 periods, a 5-week Screening period, a 36-week Double-Blind Treatment Period, an approximately 2-year Long-term Extension Period, and a 4-week Post-treatment Follow-up period.

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

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Poland
Hungary
Australia
Japan
United States
Korea, Republic of
Spain
Taiwan
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Institute for Skin, Health, and Immunity

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Dermatology and Skin Cancer Specialists, LLC

location_facility: Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

location_facility: NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL

location_facility: University Hospitals Cleveland Medical Center

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

location_facility: Florida Academic Centers Research and Education, LLC

location_facility: Laser Clinic Dermatologia Laserowa Medycyna Estetyczna

location_facility: The South Bend Clinic Center for Research

location_facility: Hospital Universitario Quiron Salud Madrid

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology

location_facility: Niigata University Medical & Dental Hospital

location_facility: Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii

location_facility: California Dermatology & Clinical Research Institute

location_facility: Kyunghee University Hospital at Gangdong

location_facility: Specjalistyczny Gabinet Dermatologiczny s.c.

location_facility: Dermatologische Gemeinschaftspraxis Dres. Quist

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt

location_facility: Dermatology Treatment and Research Center

location_facility: Hospital General Universitario de Alicante

location_facility: Universitätsklinik und Poliklinik für Dermatologie und Venerologie

location_facility: The Pennsylvania Centre for Dermatology, LLC

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak

location_facility: Vital Prospects Clinical Research Institute, PC

location_facility: Total Skin and Beauty Dermatology Center, PC

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

location_facility: Klinikum Rechts der Isar der TU Muenchen

location_facility: Medicover Integrated Clinical Services (MICS) Centrum Medyczne Bydgoszcz

location_facility: Hospital Universitari Germans Trias i Pujol (HUGTP)

location_facility: Catholic Children's Hospital Wilhelmstift

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


title: A Randomized, Parallel-group, 24 Week, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy and Safety of Secukinumab Compared to Placebo in Adult Patients With Active Rotator Cuff Tendinopathy

summary: The purpose of the present study is to assess the efficacy of secukinumab 300 mg s.c. (subcutaneous) compared to placebo, each in combination with standard of care, in improving signs, symptoms and physical function in participants with moderate to severe rotator cuff tendinopathy (RCT), using a randomized, double-blind, placebo controlled, parallel group design to minimize bias.

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Portugal
Slovakia
Argentina
Denmark
United States
Malaysia
Turkey
Czechia
Bulgaria
Canada
France


title: A Phase 2/3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)

summary: This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16. The primary hypothesis is Vericiguat is superior to placebo in reducing NT-proBNP at Week 16.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Finland
Germany
Ireland
New Zealand
Thailand
Turkey
France
Colombia
Portugal
Hungary
Denmark
United States
Malaysia
Italy
Singapore
Netherlands
Korea, Republic of
Spain
Sweden

location_facility: Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 2402)

location_facility: Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 10

location_facility: Rigshospitalet-BørneUngeAfdelingen ( Site 0800)

location_facility: Le Bonheur Children's Hospital ( Site 0007)

location_facility: Seoul National University Hospital ( Site 2803)

location_facility: Hacettepe Universite Hastaneleri ( Site 3304)

location_facility: CHU Lille - Institut Coeur Poumon ( Site 1005)

location_facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2904)

location_facility: National University Hospital-Paediatrics ( Site 2600)

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1003)

location_facility: Faculty of Medicine - Khon Kaen University ( Site 3202)

location_facility: The Children's Hospital at Montefiore ( Site 0030)

location_facility: Johns Hopkins All Children's Hospital ( Site 0029)

location_facility: Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)

location_facility: S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303)

location_facility: Ankara Bilkent Şehir Hastanesi. ( Site 3300)

location_facility: Hôpital Universitaire Necker Enfants Malades ( Site 1001)

location_facility: Children's Health Ireland (CHI) at Crumlin ( Site 1400)

location_facility: Pusan National University Yangsan Hospital ( Site 2802)

location_facility: Children's Hospital of Philadelphia (CHOP) ( Site 0004)

location_facility: Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900)

location_facility: Children's Hospital Colorado ( Site 0012)

location_facility: Columbia University Medical Center-Pediatric Cardiology ( Site 0016)

location_facility: Skånes Universitetssjukhus Lund ( Site 3000)

location_facility: Children's Healthcare of Atlanta - Egleston Hospital ( Site 0001)

location_facility: The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)

location_facility: Universitaetsklinikum Heidelberg ( Site 1100)

location_facility: University Medical Center Groningen ( Site 1901)

location_facility: Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401)

location_facility: Loma Linda University Health System ( Site 0008)

location_facility: Centro Hospitalar de Sao Joao - Hospital de Sao Joao ( Site 2403)

location_facility: Universitaetsklinikum Freiburg ( Site 1102)

location_facility: Universitair Medisch Centrum Utrecht ( Site 1902)

location_facility: Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 3200)

location_facility: University Malaya Medical Centre ( Site 1701)

location_facility: KK Women's and Children's Hospital ( Site 2601)

location_facility: Kinderklinik des Uni-Klinikums Erlangen ( Site 1104)

location_facility: Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita

location_facility: Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)

location_facility: Children's Hospital of Pittsburgh ( Site 0010)

location_facility: Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019)


title: A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1)

summary: The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 G/L in adult participants with primary ITP.

location_country:
Germany
Australia
Japan
Thailand
Turkey
Czechia
France
Hungary
Hong Kong
United States
Romania
Belgium
China
Malaysia
Italy
Norway
Singapore
United Kingdom
Austria
Mexico
Spain
Bulgaria

location_facility: Hematology Oncology Association of Rockland

location_facility: INTEGRIS Cancer Institute of Oklahoma Integris South West Med Center


summary: This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with Non-radiographic axial spondyloarthritis, (nr-axSpA) who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response (ASDAS-CRP < 1.3). Maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120.

title: A Multicenter Study of Secukinumab, With a Randomized Double-blind, Placebo-controlled Withdrawal-retreatment Period, to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

location_country: Germany Italy Poland Colombia Hungary Israel Romania Brazil Netherlands Mexico Belgium Thailand Malaysia Turkey Czechia Philippines France


title: A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Furmonertinib Compared to Platinum-Based Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

summary: Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of furmonertinib at 2 dose levels (160 mg once daily [QD] and 240 mg QD) compared to platinum-based chemotherapy in previously untreated patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations. A target of approximately 375 patients will be randomized in a 1:1:1 ratio to treatment with furmonertinib 240 mg QD, furmonertinib 160 mg QD, or platinum-based chemotherapy.

lead_sponsor: ArriVent BioPharma, Inc.

sponsor_collaborators:
ArriVent BioPharma, Inc.
Allist Pharmaceuticals, Inc.

location_country:
Italy
Singapore
Australia
Brazil
Japan
Netherlands
United States
China
Korea, Republic of
Spain
Malaysia
Thailand
Taiwan
Philippines
France

location_facility:
ArriVent Investigative Site
Arrivent Investigative site
Allist
Allist Investigative Site
Arrivent Investigative Site


acronym: Level Up

summary:
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.

Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment period 1 and a 16-week treatment period 2. During period 1, participants are randomly assigned in 1 of 2 groups, called treatment arms to receive upadacitinib Dose A or dupilumab. In Period 2, participants will receive upadacitinib Dose A or Dose B. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide.

Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label for 32 weeks and followed for 30 days.

There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 249548

location_facility: Linkou Chang Gung Memorial Hospital /ID# 249257

location_facility: D&H National Research Centers /ID# 250734

location_facility: Dermatology Research Institute Inc. /ID# 251642

location_facility: Queen's Square Medical Center, Dermatology and Allergology /ID# 252551

location_facility: Centrum Medyczne ALL-MED Badania Kliniczne /ID# 249630

location_facility: Uludag University Medical Faculty /ID# 249864

location_facility: Florida International Rsrch cr /ID# 249667

location_facility: Clinical Research Institute SC /ID# 249647

location_facility: The First Hospital of China Medical University /ID# 249638

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 250123

location_facility: Tianjin Medical University General Hospital /ID# 250246

location_facility: Herlev and Gentofte Hospital /ID# 248900

location_facility: Clinical Trials Research Institute /ID# 250213

location_facility: Dermatology and Ophthalmology Kume Clinic /ID# 254570

location_facility: Universitaetsklinikum Tuebingen /ID# 249552

location_facility: The Second Xiangya Hospital of Central South University /ID# 249657

location_facility: Hospital Universitario y Politecnico La Fe /ID# 251524

location_facility: Treasure Valley Medical Research /ID# 250727

location_facility: IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 250558

location_facility: Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 249195

location_facility: Klinicki bolnicki centar Rijeka /ID# 249593

location_facility: Seoul National University Hospital /ID# 251492

location_facility: Oregon Dermatology and Research Center /ID# 250726

location_facility: Universitair Ziekenhuis Leuven /ID# 251399

location_facility: Arke SMO, S.A. de C.V. / Veracruz /ID# 250147

location_facility: Universitaetsklinikum Freiburg /ID# 249555

location_facility: Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 249746

location_facility: Yale Center for Clinical Investigation /ID# 254791

location_facility: Centre de Recherche dermatologique du Quebec Metropolitain /ID# 250427

location_facility: Zhejiang Provincial People's Hospital /ID# 249653

location_facility: Guangzhou First People's Hospital /ID# 249695

location_facility: Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 250124

location_facility: CCA Braga - Hospital de Braga /ID# 250480

location_facility: Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 249819

location_facility: Dermatology Research Associates /ID# 249829

location_facility: Vital Prospects Clinical Research Institute, PC /ID# 249840

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 249549

location_facility: Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 252554

location_facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 250306

location_facility: Korea University Ansan Hospital /ID# 249814

location_facility: Virginia Clinical Research, Inc. /ID# 249908

location_facility: University of Virginia - Dermatology /ID# 254166

location_facility: Alliance Dermatology and MOHs Center, PC /ID# 249671

location_facility: Osaka Habikino Medical Center /ID# 252550

location_facility: Clinical Trials Institute at Northwest Arkansas /ID# 249838

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 251347

location_facility: CHU Toulouse - Hopital Larrey /ID# 251344

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249196

location_facility: Diagnostic consultative center Aleksandrovska /ID# 251137

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 251523

location_facility: The University of Hong Kong- Shenzhen Hospital /ID# 249436

location_facility: National Hospital Organization Sagamihara National Hospital /ID# 254518

location_facility: DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 249591

location_facility: National Taiwan University Hospital /ID# 249258

location_facility: 401 GSNA - 401 Army General Hospital /ID# 251843

location_facility: ASMC-IPSMC-Skin and Venereal Diseases /ID# 251272

location_facility: Klinika za djecje bolesti Zagreb /ID# 249590

location_facility: Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 251438

location_facility: Hospital Universitario Basurto /ID# 249784

location_facility: International Clinical Research - Tennessee LLC /ID# 250724

location_facility: Centro Hospitalar de Leiria, EPE /ID# 249194

location_facility: Klinika Ambroziak Sp. z o.o. /ID# 249406

location_facility: Military Medical Academy Multiprofile Hospital /ID# 251187

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 249655

location_facility: Skin Care Research - Boca Raton /ID# 250458

location_facility: University of Utah Mid Valley Dermatology /ID# 250042

location_facility: Kyungpook National University Hospital /ID# 249855

location_facility: Wiseman Dermatology Research /ID# 250219

location_facility: Antelope Valley Clinical Trials /ID# 249946

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 249260

location_facility: Universitaetsklinik Heidelberg /ID# 251458

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 251844

location_facility: Michigan Center for Research Company /ID# 250225

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249560

location_facility: Unidade Local de Saúde de Matosinhos, EPE /ID# 249197

location_facility: Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 249191

location_facility: Oregon Medical Res Center PC /ID# 249666

location_facility: Randall Dermatology of West Lafayette /ID# 250234

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 249547

location_facility: Shanghai Skin Disease Hospital /ID# 249392

location_facility: Hadassah Medical Center-Hebrew University /ID# 251576

location_facility: Universitaetsklinikum Leipzig /ID# 249562

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 250125

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 250419

location_facility: Physician Research Collaboration, LLC /ID# 251099

location_facility: Taichung Veterans General Hospital /ID# 249261

location_facility: Bispebjerg and Frederiksberg Hospital /ID# 248902

location_facility: Wright State Physicians - Fairborn /ID# 254167

location_facility: Beacon Clinical Research, LLC /ID# 251412

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 251431

location_facility: Advanced Clinical Research Institute /ID# 250460

location_facility: Hospital General Universitario de Alicante Doctor Balmis /ID# 251517

location_facility: Inselspital, Universitätsspital Bern /ID# 250577

location_facility: Taipei Municipal Wan Fang Hospital /ID# 251500

location_facility: Taipei Veterans General Hosp /ID# 249263

location_facility: Hangzhou First People's Hospital /ID# 249437

location_facility: Bellaire Dermatology Associates /ID# 250739

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 249818

location_facility: Akdeniz Universitesi Tip Fakul /ID# 249866

location_facility: KonKuk University Medical Center /ID# 249811

location_facility: Dr. Chih-ho Hong Medical Inc. /ID# 251643

location_facility: Huashan Hospital, Fudan University /ID# 250025

location_facility: Karolinska University Hospital /ID# 250328

location_facility: Chung-Ang University Hostipal /ID# 251490

location_facility: Brunswick Dermatology Center /ID# 250220

location_facility: Sjællands Universitetshospital /ID# 248901

location_facility: Hospital Universitario Virgen de las Nieves /ID# 249785

location_facility: National Taiwan University Hospital - Hsinchu branch /ID# 249265

location_facility: Modern Research Associates, PLLC /ID# 250688

location_facility: Texas Dermatology and Laser Specialists /ID# 250367

location_facility: Klinicki bolnicki centar Zagreb /ID# 249596

location_facility: Montefiore Medical Center - Moses Campus /ID# 251214

location_facility: Erciyes University Medical Fac /ID# 249863

location_facility: Universitaetsklinikum Muenster /ID# 249404

location_facility: Soonchunhyang University Hospital Bucheon /ID# 249812

location_facility: Pusan National University Hospital /ID# 249852

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 250128

location_facility: Clinical Research Puerto Rico /ID# 250394

location_facility: Gaziantep University Şahinbey Research and Practice Hospital /ID# 249868

location_facility: Royalderm Agnieszka Nawrocka /ID# 251432

location_facility: Hospital Universitario Virgen Macarena /ID# 249603

location_facility: The Second Affiliated Hospital of Guangzhou Medical University /ID# 249694

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 251485

location_facility: Dermatology Hospital of Southern Medical University /ID# 250121

location_facility: ASST Spedali civili di Brescia /ID# 250129

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 249849

location_facility: Taipei Medical University Shuang Ho Hospital /ID# 249256

location_facility: The First Affiliated Hospital of Fujian Medical University /ID# 249674

location_facility: Hospital Garcia de Orta, EPE /ID# 251455

location_facility: Skin Care Research - Hollywood /ID# 250459

location_facility: Oregon Medical Research Center /ID# 250712

location_facility: Beth Israel Deaconess Medical Center /ID# 251212

location_facility: Arkansas Research Trials, LLC /ID# 250722

location_facility: Cryptex Investigación Clínica S.A de C.V /ID# 249994

location_facility: Ondokuz Mayis Universitesi Tip /ID# 249865

location_facility: Alma M. Cruz Santana, MD-Private practice /ID# 250393

location_facility: Papageorgiou General Hospital Thessaloniki /ID# 251840

location_facility: Medical Dermatology Specialist /ID# 250212

location_facility: Dermed Centrum Medyczne Sp. z o.o /ID# 251429

location_facility: Universitaetsklinikum Frankfurt /ID# 249544

location_facility: Azienda Ospedaliera di Perugia /ID# 251572

location_facility: CAST - Center for Advanced Studies and Technology /ID# 251495

location_facility: Centro de Dermatologia de Monterrey /ID# 249126

location_facility: Lidia Rajzer - Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny /ID# 252082

location_facility: UMHAT Dr Georgi Stranski EAD /ID# 251268

location_facility: Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 251437

location_facility: Arlington Research Center, Inc /ID# 250468

location_facility: Norrlands University hospital /ID# 250329

location_facility: Presidio Ospedaliero San Salvatore /ID# 250127

location_facility: Medical Corporation Kojinkai Sapporo Skin Clinic /ID# 252549

location_facility: Diagnostic consultative center Focus-5 /ID# 251269

location_facility: Fondazione Policlinico Universitario Agostino Gemelli /ID# 251494

location_facility: Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 251392

location_facility: Derma Study Center Friedrichshafen GmbH /ID# 251460

location_facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 249848

location_facility: General Hospital Andreas Syggros /ID# 251842

location_facility: First OC Dermatology Research /ID# 250686

location_facility: Klinicki bolnicki centar Split /ID# 249879

location_facility: Cabinet Medical de Dermatovenerologie Dr. Remus Orasan /ID# 249625

location_facility: Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o /ID# 249598

location_facility: INTER CLINIC Piotr Adrian Klimiuk /ID# 251430

location_facility: Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 251566

location_facility: Hospital Universitario La Paz /ID# 251518

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 249192

location_facility: Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 249850

location_facility: Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 250616

title: A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects With Moderate to Severe Atopic Dermatitis (Level-Up)

location_country:
Germany
Poland
Australia
Japan
Turkey
Croatia
Canada
France
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Romania
Belgium
China
Puerto Rico
Italy
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Israel


title: A Phase 1/2 Study of ANV419 as Monotherapy or in Combination With Anti-PD-1 or Anti-CTLA-4 Antibody Following Anti-PD-1/Anti-PD-L1 Antibody Treatment in Patients With Unresectable or Metastatic Cutaneous Melanoma (OMNIA-1)

summary: The purpose of this study is to evaluate the efficacy and safety of ANV419 monotherapy or the combination of ANV419 with anti-PD1 antibody or with anti-CTLA4 antibody in adult participants with advanced (unresectable or metastatic) cutaneous melanoma.

lead_sponsor: Anaveon AG

location_country:
Germany
Italy
United States
Spain
France

location_facility: Centro Oncológico MD Anderson International España

location_facility: Azienda Ospedaliero Universitaria Senese

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Universitätsmedizin der Johannes Gutenberg, Universität Mainz

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"


title: A Phase 1, Open-Label, Multicenter Study of INCA32459 in Participants With Select Advanced Malignancies

summary: This is a multicenter, open-label, single-arm study to investigate the safety, tolerability, PK, pharmacodynamics and preliminary activity of INCA32459 in participants with selected advanced malignancies. Part 1 (dose escalation) will determine the recommended dose of INCA 32459 for expansion (RDE) and the maximum tolerated dose (MTD). Part 2 (dose expansion) will further evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of INCA 32459 at the recommended dose(s) for expansion in 2 tumor-specific cohorts.

location_country:
Italy
Belgium
United States
Spain
France

location_facility: The Angeles Clinic and Research Institute

location_facility: University of Texas Md Anderson Cancer Center

location_facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

location_facility: Hospital Universitario Virgen de La Victoria

location_facility: Hospital of the University of Pennsylvania

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Chu Ucl Namur University Hospital Mont-Godinne

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

location_facility: Hospital General Universitario de Valencia


title: A Phase II, Randomised, Placebo-controlled, Double-blind, Parallel Group, Efficacy and Safety Study of at Least 48 Weeks of Oral BI 685509 Treatment in Adults With Progressive Systemic Sclerosis

acronym: VITALISScE™

summary:
This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma.

The purpose of this study is to find out whether a medicine called BI 685509 helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems.

Participants are put into 2 groups by chance. One group takes BI 685509 tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months.

During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects.

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:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Chile
Czechia
Canada
France
Denmark
Switzerland
United States
India
Romania
Belgium
China
Malaysia
Philippines
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Israel

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T

location_facility: Tianjin Medical University General Hospital

location_facility: Hospital of the University of Occupational and Environmental Health

location_facility: The Second Affiliated Hospital Zhejiang University School of Medicine

location_facility: Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks

location_facility: Centro Integral en Reumatologia, SA. de CV.

location_facility: Medical Plus s.r.o., Rheumatology Outpatient Clinic

location_facility: The First Affiliated Hospital of Soochow University

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: The First Affiliated Hospital Of Bengbu Medical College

location_facility: Università degli Studi Campus Bio-Medico

location_facility: Military Medical Institute- National Research Institute

location_facility: Psoriahue Medicina Interdisciplinaria S.R.L

location_facility: Japan Community Healthcare Organization Chukyo Hospital

location_facility: The Chaim Sheba Medical Center Tel HaShomer

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: Investigacion y Biomedicina de Chihuahua S.C.

location_facility: The First Affiliated Hospital of Ningbo University

location_facility: The University of Texas Health Science Center at Houston

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

location_facility: Grant Medical Foundation, Ruby Hall Clinic

location_facility: Medical University of Graz State Hospital - University Hospital Graz

location_facility: Centro de Investigaciones Médicas Mar del Plata

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Clinical Rheumatology Research Center Sahlgrenska

location_facility: Centro Internacional de Estudios Clínicos (CIEC)

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

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: The First Affiliated Hospital of Wenzhou Med College

location_facility: Oaxaca Site Management Organization, S.C.


title: BURAN: Effects of Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging Parameters

acronym: BURAN

summary: This study will assess the effects of benralizumab on airway dynamics in severe eosinophilic asthma in terms of quantitative computed tomography (CT)-derived measurements of pulmonary structure and function using the Functional Respiratory Imaging (FRI) platform.

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

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

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

lead_sponsor: AstraZeneca

location_country:
Portugal
United Kingdom
Australia
Belgium
United States
Spain
France

intervention_type: Combination Product


lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).

location_facility: Barwon Health - University Hospital Geelong

location_facility: Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

location_facility: Karolinska University Hospital, Huddinge

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

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

title: A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Sweden
Netherlands
Switzerland
Belgium
Korea, Republic of
Spain
Turkey
Czechia
France