title: Validation of the European Oncology Quality of Life Toolkit. A European Pilot Survey.

summary:
The improvement or preservation of quality of life (QoL) is one of the three pillars of the European Union (EU) Mission on Cancer, which underpins the needs of patients from cancer diagnosis throughout treatment, survivorship, and advanced terminal stages. Clinical studies and real-world data show that the use of Patient Reported Outcome Measures (PROMs) for QoL assessment in routine oncology practice has positive effects on patient wellbeing and healthcare resource utilization. However, full implementation of PROMs is not yet part of standard of care and is not adequately considered in cancer policies and programs.

A comprehensive tool incorporating the perspective of patients at different stages of the disease trajectory and widely applicable across Europe is still lacking.

The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL, developed from preferences and priorities of people with past or current cancer experience. The EUonQoL-Kit includes three electronic questionnaires, specifically designed for different disease phases (patients in active treatment, survivors, and patients in palliative care), available in both static and dynamic (Computer Adaptive Testing, CAT) versions and in several European languages.

This is a multicentre observational study, with the following aims:

The primary aim is to perform the psychometric validation of the EUonQoL-Kit.
Secondary aims are to assess its acceptability, to validate the CAT version, and to provide estimates of QoL across different European countries.

The EUonQoL-Kit will be administered to a sample of cancer patients and survivors from 46 European cancer centres. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C).

Each centre will recruit 100 patients (40 from group A, 30 from group B, 30 from group C), for an overall sample size of 4,600 patients (at least 4,000 patients are assumed to be enrolled, due to an expected lower recruitment rate of 10-15%). Three sub-samples of patients (each corresponding to 10% of the total sample for each centre) will fill in an additional questionnaire:

EORTC QLQ-C30, to test concurrent validity.
Live-CAT version, to test the feasibility of such implementation.
EUonQoL-Kit, 2-7 days after the first completion, to assess test-retest reliability.

time_perspective: Cross-Sectional

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lead_sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

collaborators: Gustave Roussy, Cancer Campus, Grand Paris

collaborators: DEUTSCHES KREBSFORSCHUNGSZENTRUM HEIDELBERG (German Cancer Research Center)

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

collaborators: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

collaborators: STICHTING NEDERLANDS INSTITUUT VOOR ONDERZOEK VAN DE GEZONDHEIDSZORG

collaborators: ORGANISATION OF EUROPEAN CANCER INSTITUTES

collaborators: FEDERAZIONE ITALIANA DELLE ASSOCIAZIONI DI VOLONTARIATO IN ONCOLOGIA

collaborators: SDRUZHENIE ASOTSIATSIA NA PATSIENTITE SONKOLOGICHNI ZABOLYAVANIA I PRIYATELI

collaborators: FEDERATIA ASOCIATIILOR BOLNAVILOR DE CANCER

collaborators: Region Hovedstaden (Bispebjerg Hospital & Rigshospitalet)

location_country:
Finland
Germany
Ireland
Poland
Turkey
Croatia
Czechia
Serbia
France
Slovenia
Lithuania
Portugal
Slovakia
Hungary
Denmark
Latvia
Romania
Belgium
Moldova, Republic of
Estonia
Italy
Cyprus
Albania
Norway
United Kingdom
Netherlands
Austria
Spain
Greece
Bulgaria
Georgia
Sweden

location_facility: General Oncology Hospital of Athens - Saint Savvas

location_facility: lnstitut de Cancérologie de l'Ouest (ICO)

location_facility: The "Prof. Dr. Ion Chiricuta"Institute of Oncology (IOCN)

location_facility: Universitäres Centrum für Tumorerkrankungen (UCT)

location_facility: National Cancer Institute (Národný onkologický ústav)

location_facility: HUS Syöpäkeskus Helsingin Yliopistollinen Sairaala

location_facility: Vall Hebron Institute of Oncology (VHIO)

location_facility: Institutul Oncologic "Al. Trestioreanu" (IOB)

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Istituto Tumori Giovanni Paolo II, IRCCS

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. (IPO-Porto)

location_facility: Klinika za tumore Klinički bolnički centar Sestre milosrdnice

location_facility: Cyprus Association of Cancer Patients and Friends (PASYKAF)

location_facility: Fundación Instituto Valenciano de Oncología (IVO)

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

intervention_type: Other


type: Registry Identifier

title: A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

acronym: LIMBER

summary: This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

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
United Kingdom
Denmark
Australia
Japan
Spain
Canada
France

location_facility: Hopital Maisonneuve-Rosemont, Montreal, Qc

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: Azienda Ospedaliero-Universitaria Careggi (Aouc)

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: A Phase 3, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-Risk Stage II-IV Melanoma

summary: The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid [mRNA]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.

design_allocation: Randomized

lead_sponsor: Merck Sharp & Dohme LLC

sponsor_collaborators:
Merck Sharp & Dohme LLC
ModernaTX, Inc.

location_country:
Germany
Italy
Poland
Portugal
New Zealand
Israel
United Kingdom
Australia
Sweden
Belgium
United States
Spain
Greece
Turkey
Chile
Taiwan
Canada
France

location_facility: Hopital Claude Huriez - CHU de Lille ( Site 1207)

location_facility: Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 1300)

location_facility: Hospital Universitario Ramón y Cajal ( Site 1602)

location_facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1601)

location_facility: Centre Hospitalier de l'Université de Montréal-Unité de Recherche Clinique en Oncologie et Hématolo

location_facility: I.E.U. Medical Point Hastanesi-Oncology ( Site 3005)

location_facility: ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1804)

location_facility: Orlando Health Cancer Institute ( Site 1937)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2908)

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

location_facility: Memorial Ankara Hastanesi-Medical Oncology ( Site 3010)

location_facility: Westmead Hospital-Department of Medical Oncology ( Site 1001)

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust ( Site 1813)

location_facility: Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 3002)

location_facility: Cancer and Hematology Centers of Western Michigan ( Site 1932)

location_facility: Centre intégré de cancérologie du CHU de Québec Université L-Hemato-Oncology ( Site 1101)

location_facility: UCSF Medical Center at Mission Bay ( Site 1929)

location_facility: Universitaetsklinikum des Saarlandes ( Site 1313)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 1309)

location_facility: HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit

location_facility: Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 1301)

location_facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1603)

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3604)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 3008)

location_facility: Bristol Haematology and Oncology Centre ( Site 1811)

location_facility: University College London Hospital ( Site 1807)

location_facility: Metropolitan Hospital-A' Oncology Dpt ( Site 3701)

location_facility: Universitätsmedizin Rostock-Klinik und Poliklinik für Dermatologie und Venerologie ( Site 1310)

location_facility: European Interbalkan Medical Center-Oncology Department ( Site 3702)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 3200)

location_facility: H.R.U Málaga - Hospital General-Oncology ( Site 1605)

location_facility: Bialostockie Centrum Onkologii ( Site 2905)

location_facility: SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1306)

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950)

location_facility: Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1005)

location_facility: Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 2402)

location_facility: Istituto Europeo di Oncologia IRCCS ( Site 1404)

location_facility: HOSPITAL CLINICO DE VALENCIA ( Site 1604)

location_facility: Centro Hospitalar de Lisboa Ocidental - Hospital De Sao Francisco Xavier ( Site 3602)

location_facility: Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 1402)

location_facility: National Cheng Kung University Hospital-Clinical Trial Center ( Site 4004)

location_facility: Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 3603)

location_facility: Melanoma Institute Australia-Clinical Trials Unit ( Site 1000)

location_facility: General Hospital of Athens "Laiko"-First Department of Internal Medicine ( Site 3700)

location_facility: The Alfred Hospital-Medical Oncology Alfred Cancer Trials ( Site 1004)

location_facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2903)

location_facility: Princess Alexandra Hospital ( Site 1003)

location_facility: Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 1302)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi

location_facility: Centre Georges François Leclerc ( Site 1210)

location_facility: Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3402)

location_facility: Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 1102)

location_facility: Hacettepe Universite Hastaneleri ( Site 3006)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3003)

location_facility: Bioclinic Thessalonikis Private Clinic Single Member S.A.-Oncology ( Site 3703)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 1944)

location_facility: Skånes Universitetssjukhus Lund ( Site 3201)


title: A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of the Central Nervous System (CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

acronym: Quanti CNS

summary:
Researchers are looking for a better way to help people with known or suspected brain or spinal cord-related problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).

MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a "contrast-enhanced" MRI (CE-MRI). Such CE-MRI may help identify certain health problems or improve the evaluation.

The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.

The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect brain and spinal cord-related problems in gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.

The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.

Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.

At the start or during the study, the doctors and their study team will:

take blood and urine samples
do physical examinations
check blood pressure and heart rate
review the MRI scans obtained in the study and decide on the diagnosis
ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

primary_purpose: Diagnostic

ipd_sharing: No

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

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

lead_sponsor: Bayer

location_country:
Germany
Italy
Hungary
Argentina
United Kingdom
Japan
Sweden
United States
China
Korea, Republic of
Turkey
Czechia
Bulgaria
Canada
France

location_facility: Uniklinik Kiel /Radiologie und Neuroradiologie

location_facility: University of California Irvine Medical Center

location_facility: Uppsala University Hospital, Neuroradiology Department

location_facility: Clinica Universitaria Reina Fabiola | Consultorios Externos

location_facility: London Health Sciences Centre (LHSC) - University Hospital

location_facility: Sanatorio Allende | Departamento de Investigación Clínica

location_facility: Karolinska University Hospital, Solna Neuroradiology

location_facility: Karolinska University Hospital, Huddinge Neuroradiology

location_facility: Instituto Alexander Fleming | Sede Central - Departamento de Diagnostico por Imagenes

location_facility: University of Texas Southwestern Medical Center

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.

location_facility: Debreceni Egyetem Klinikai Kozpont, Idegsebeszeti Klinika

location_facility: Hospital of the University of Occupational and Environmental Health, Japan

location_facility: University of Missouri Hospital and Clinic - Neuroradiology

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: The First Affiliated Hospital of Jinan University

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: National Hospital Organization Kanmon Medical Center

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz, Kozponti Diagnosztikai Centrum

location_facility: Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan

location_facility: Princess Margaret Hospital-University Health Network

location_facility: Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

location_facility: Beijing Tiantan Hospital, Captial Medical University

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Huai'an First People's Hospital, Nanjing Medical University

location_facility: Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

location_facility: Koc Universitesi Tip Fakultesi - Radyoloji

location_facility: Lokman Hekim Universitesi Tip Fakultesi - Radyoloji

location_facility: Beijing Chaoyang Hospital, Capital Medical University

location_facility: Acibadem City Clinic Multiprofile Hospital for Active Treatm

location_facility: Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department

location_facility: Japan Organization of Occupational Health and Safety Kagawa Rosai Hospital

location_facility: Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Imaging Diagnostic Department


title: A Phase 2, Multicenter, Double-blind, Two-arm Study of Subcutaneous RVT-3101 for the Treatment of Subjects With Moderate to Severe Active Crohn's Disease

summary: This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of RVT-3101 in adult participants with moderate to severe active Crohn's disease.

ipd_sharing: Undecided

lead_sponsor: Telavant, Inc.

location_country:
Germany
Poland
Slovakia
Hungary
Belgium
United States
Spain
Bulgaria
Canada
France

location_facility:
Telavant Site
Televant Site


title: A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

summary: The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.

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
New Zealand
Argentina
Australia
Czechia
Canada
France
Denmark
United States
Romania
Belgium
United Kingdom
Sweden
Netherlands
Korea, Republic of
Spain
South Africa
Bulgaria
Israel

location_facility: Centro Integral de Medicina Respiratoria (CIMER)

location_facility: MEDICAL CENTER HERA EOOD; Office of Pulmonology and Phtisiatrics

location_facility: University of Cape Town Lung Institute; Lung Clinical Research

location_facility: Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako

location_facility: Pulmonary Specialists of the Palm Beaches

location_facility: Neomed Out-Patient Treatment and Diagnosis Medical Center SRL

location_facility: Sf. Ioan cel Nou Emergency County Hospital

location_facility: Centro de Investigaciones Clínicas Belgrano

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: St Francis Medical Institute ClinEdge PPDS

location_facility: Sherman Clinical Research - ClinEdge - PPDS

location_facility: Clinique de pneumologie et du sommeil de Lanaudiere

location_facility: Florida Institute for Clinical Research, LLC

location_facility: South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS

location_facility: EMED Centrum Uslug Medycznych Ewa Smialek

location_facility: SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS

location_facility: Sierra Clinical Research - ClinEdge - PPDS

location_facility: PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

location_facility: Centrum Medyczne Bydgoszcz- PRATIA - PPDS

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska lek.

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Medical Center New rehabilitation center EOOD

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.

location_facility: Leon Daniello Pneumophthisiology Clinical Hospital

location_facility: Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik; Krzysztof Cudzik

location_facility: Private Practice Dr Jean Benoit Martinot

location_facility: CARE - Centro de Alergia y Enfermedades Respiratorias


title: SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE

acronym: SELECT-SLE

summary:
Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed.

Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 3 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib based on their disease activity and their original treatment assignment in Study 1 or 2. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world.

Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3.

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
Poland
New Zealand
Australia
Brazil
Japan
Croatia
France
Lithuania
Portugal
Slovakia
Hungary
Switzerland
United States
Latvia
Estonia
Puerto Rico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Israel

location_facility: Newport Huntington Medical Group /ID# 252827

location_facility: IRIS Research and Development, LLC /ID# 253618

location_facility: University of Yamanashi Hospital /ID# 253264

location_facility: Hokkaido University Hospital /ID# 253306

location_facility: Trinity Universal Research Associates, Inc /ID# 253013

location_facility: Tel Aviv Sourasky Medical Center /ID# 252858

location_facility: AA Medical Research Center - Grand Blanc /ID# 253028

location_facility: CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 253346

location_facility: University of Miyazaki Hospital /ID# 253416

location_facility: Providence Medical Foundation /ID# 252822

location_facility: Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 253020

location_facility: Inselspital, Universitätsspital Bern /ID# 252909

location_facility: SoonChunHyang University CheonAn Hospital /ID# 254777

location_facility: Bay Area Arthritis and Osteo /ID# 253597

location_facility: Northshore University Health System Dermatology Clinical Trials Unit /ID# 254568

location_facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825

location_facility: University General Hospital Attikon /ID# 253209

location_facility: HCL - Hopital de la Croix-Rousse /ID# 254147

location_facility: Clinical Research Puerto Rico /ID# 256352

location_facility: Military Medical Academy Multiprofile Hospital /ID# 252644

location_facility: Pauls Stradins Clinical University Hospital /ID# 253750

location_facility: Arthiritis and Rheumatology Specialists PA /ID# 255950

location_facility: Clinical Research of West Florida, Inc /ID# 253899

location_facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 252831

location_facility: MICS Centrum Medyczne Bydgoszcz /ID# 253281

location_facility: China Medical University Hospital /ID# 252936

location_facility: National Taiwan University Hospital /ID# 252937

location_facility: Caribbean Medical Research Center /ID# 254882

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 252958

location_facility: David S. Hallegua MD, A Professional Corporation /ID# 253902

location_facility: Kansas City Physician Partners /ID# 254786

location_facility: Clinical Trials of Texas, Inc /ID# 254949

location_facility: Hospital Garcia de Orta, EPE /ID# 252903

location_facility: CHU Toulouse - Hopital Rangueil /ID# 254148

location_facility: Paramount Medical Research Con /ID# 253016

location_facility: Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828

location_facility: Arthritis Clinical Research Trials /ID# 253349

location_facility: Clinical Research Source, Inc. /ID# 253027

location_facility: MICS Centrum Medyczne Warszawa /ID# 253273

location_facility: Arthritis and Rheumatology Research Institute, PLLC /ID# 253014

location_facility: Hospital of the University of Occupational and Environmental Health, Japan /ID# 253269

location_facility: Hanyang University Seoul Hospital /ID# 252955

location_facility: International Medical Research /ID# 253617

location_facility: AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767

location_facility: Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253623

location_facility: The Chaim Sheba Medical Center /ID# 252857

location_facility: Atlanta Research Center for Rheumatology /ID# 253610

location_facility: Diagnostic consultative center Focus-5 /ID# 252642

location_facility: Greater Chicago Specialty Physicians /ID# 253021

location_facility: Hospital Universitario Virgen de Valme /ID# 253121

location_facility: R & H Clinical Research - 777 Katy /ID# 254126

location_facility: Crowley CORE, LLC - Hinsdale Orthopaedics /ID# 253018

location_facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820

location_facility: Holdsworth House Medical Practice /ID# 253542

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 253123

location_facility: Jacksonville Center for Clinical Research /ID# 257272

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 254552

location_facility: Clinical Research of Philadelphia, LLC /ID# 254156

location_facility: West Tennessee Research Institute /ID# 252807

location_facility: ETYKA-Osrodek Badan Klinicznych /ID# 252967

location_facility: Deerbrook Medical Associates /ID# 253029

location_facility: Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824

location_facility: Wallace Rheumatic Studies Center, LLC /ID# 252806

location_facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 253233

location_facility: DM Clinical Research - Tomball /ID# 255134

location_facility: National Hospital Organization Chibahigashi National Hospital /ID# 253268

location_facility: Diagnostic consultative center Focus-5 /ID# 252643

location_facility: Advanced Quality Medical Research /ID# 254983

location_facility: Arthritis & Rheumatic Disease Specialties /ID# 253624

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 253755

location_facility: Winelands Medical Research - Somerset West /ID# 254614

location_facility: Clinical Research of West Florida - Tampa /ID# 253602

location_facility: The Lady Davis Carmel Medical Center /ID# 253303

location_facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 252902

location_facility: Chonnam National University Bitgoeul Hospital /Id# 254675

location_facility: Hadassah Medical Center-Hebrew University /ID# 252654


title: A Phase 1, Open-Label, Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

summary: To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.

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

location_country:
Italy
United Kingdom
Denmark
Switzerland
United States
Spain
France

location_facility: The Angeles Clinic and Research Institute

location_facility: Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust

location_facility: Centre Hospitalier Universitaire Vaudois (Chuv)

location_facility: University of Texas Md Anderson Cancer Center

location_facility: Cancer and Hematology Centers of Western Michigan-Start Midwest

location_facility: Istituto Oncologico Della Svizzera Italiana

location_facility: Fondazione Irccs Istituto Nazionale Del Tumori Di Milano

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Centro Ricerche Cliniche Di Verona (Crc)

location_facility: South Texas Accelerated Research Therapeutics

location_facility: Cambridge University Hospitals Nhs Foundation Trust

location_facility: Rigshospitalet Uni of Hospital of Copenhagen

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital


title: A Retrospective Cohort Study to Characterize Propionic Acidemia Patients

summary: This is a non-interventional, global, multicenter, retrospective cohort study describing participant characteristics, clinical outcomes, and event rates in participants with propionic acidemia (PA).

study_type: Observational

time_perspective: Retrospective

lead_sponsor: ModernaTX, Inc.

location_country:
Italy
United Kingdom
Australia
United States
Spain
Canada
France

location_facility: ASST di Monza - Azienda Ospedaliera San Gerardo

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Stollery Children's Hospital University of Alberta


title: An Open-Label, Phase 2, Safety, and Efficacy Study of Ruxolitinib Cream in Participants With Genital Vitiligo

summary: An open-label study in which participants with non-segmental vitiligo with genital involvement will apply ruxolitinib 1.5% cream twice a day (BID) to all depigmented areas (up to 10% BSA) for up to 48 weeks. Participants should continue to treat depigmented areas identified for treatment at baseline regardless of whether the area begins to improve or fully repigment.

location_country:
United States
Canada
France

location_facility: Vitiligo & Pigmentation Institute of Southern California

location_facility: Austin Institute For Clinical Research Aicr Pflugerville

location_facility: Innovative Dermatology: Legacy Medical Village

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Hopital Henri Mondor Service de Dermatologie

location_facility: Center For Dermatology Clinical Research, Inc


title: A Randomized, Double-Blind, Parallel-Group, Active Controlled Trial With Open-Label Safety Extension to Evaluate the Tolerability, Safety, and Efficacy of Atogepant Versus Topiramate in Subjects Requiring Preventive Treatment of Migraine (TEMPLE)

acronym: TEMPLE

summary:
A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment) and safety of atogepant compared to topiramate in participants with migraine.

Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world.

Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. After 24 weeks, all eligible participants will receive atogepant for 52 weeks in Period 2. Participants are monitored for safety for 4 weeks after their last study treatment.

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 safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

location_country: Germany Italy Poland Portugal Hungary Israel Austria Belgium Czechia Canada France

location_facility: CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 247561

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 247575

location_facility: Unidade Local de Saúde de Matosinhos, EPE /ID# 247169

location_facility: Klinische Forschung Schwerin GmbH /ID# 248074

location_facility: Instytut Zdrowia Dr Boczarska-Jedynak Sp. Z O.O. Sp.K. /Id# 247315

location_facility: Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 247323

location_facility: Gesundheitszentrum Hoppegarten /ID# 249242

location_facility: Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 246029

location_facility: Klinische Forschung Hamburg GmbH /ID# 248620

location_facility: AP-HP - Hopital Lariboisière /ID# 249244

location_facility: Debreceni Egyetem Klinikai Központ /ID# 247549

location_facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 247167

location_facility: Universitaetsklinikum Tuebingen /ID# 246043

location_facility: Fakultni Thomayerova nemocnice /ID# 249016

location_facility: Medizinische Universitaet Innsbruck /ID# 247213

location_facility: Universitaetsmedizin Greifswald /ID# 248574

location_facility: Neurologisches Facharztzentrum Berlin /ID# 248064

location_facility: Praxis fuer Neurologie, Psychiatrie und Psychotherapie /ID# 248427

location_facility: Hospital Garcia de Orta, EPE /ID# 247163

location_facility: 2CA-Braga, Hospital de Braga /ID# 247165

location_facility: Medizinische Universitaet Wien /ID# 247119

location_facility: Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 246030

location_facility: Hospital Prof. Doutor Fernando Fonseca, EPE /ID# 247172

location_facility: Studienzentrum fuer Neurologie und Psychiatrie /ID# 249236

location_facility: Aggarwal and Associates Limited /ID# 247727

location_facility: Vitamed Galaj i Cichomski Sp.j. /ID# 247314

location_facility: Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247298

location_facility: Krankenhaus der Barmherzigen Brueder Trier /ID# 248564

location_facility: Vancouver Island Health Authority /ID# 247733

location_facility: Konventhospital Barm. Brueder /ID# 247217


title: A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer

summary: This study is to assess the pharmacokinetics (PK) and safety of SC MK-3475A vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are MK-3475A subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.

status: Active, not recruiting

location_country:
Poland
Guatemala
Hungary
Argentina
Romania
Japan
Brazil
United States
China
Spain
Thailand
South Africa
Turkey
Chile
Taiwan
France

location_facility: Franciscan Health Lafayette East ( Site 0020)

location_facility: Hospital Italiano de Córdoba ( Site 1000)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 4410)

location_facility: Fudan University Shanghai Cancer Center-Oncology ( Site 4512)

location_facility: Chang Gung Memorial Hospital at Kaohsiung ( Site 4200)

location_facility: Kanagawa Cardiovascular and Respiratory Center ( Site 4404)

location_facility: Nippon Medical School Hospital ( Site 4403)

location_facility: Osaka International Cancer Institute ( Site 4407)

location_facility: Beijing Chest Hospital,Capital Medical University ( Site 4511)

location_facility: A. C. Camargo Cancer Center ( Site 1106)

location_facility: Mid Florida Hematology and Oncology Center ( Site 0010)

location_facility: Chongqing Three Gorges Central Hospital ( Site 4516)

location_facility: Saitama Prefectural Cancer Center ( Site 4402)

location_facility: Division of Medical Oncology, Siriraj H ( Site 4303)

location_facility: Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2100)

location_facility: Steve Biko Academic Hospital-Medical Oncology ( Site 2904)

location_facility: Clinica Adventista Belgrano-Oncology ( Site 1004)

location_facility: Institutul Oncologic-Oncologie Medicala ( Site 2302)

location_facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 2602)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 4411)

location_facility: Centre Hospitalier de Cornouaille Quimper - Concarneau ( Site 2600)

location_facility: Hospital de Câncer de Recife ( Site 1107)

location_facility: Instituto Nacional del Cancer-CR Investigación ( Site 1211)

location_facility: Wuhan Union Hospital Cancer Center-Cancer center ( Site 4502)

location_facility: Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1404)

location_facility: Beijing Cancer hospital-intrathoratic deparmtment II ( Site 4510)

location_facility: Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2301)

location_facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2401)

location_facility: Medical Oncology Centre of Rosebank ( Site 2907)

location_facility: Gunma Prefectural Cancer Center ( Site 4416)

location_facility: Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (

location_facility: Centro Regional de Sub Especialidades Médicas SA ( Site 1401)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 4414)

location_facility: Instituto Joinvilense de Hematologia e Oncologia ( Site 1101)

location_facility: CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1102)

location_facility: Taizhou Hospital of Zhejiang Province-Respiratory ( Site 4508)

location_facility: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1100)

location_facility: Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 1005)

location_facility: İnönü Üniversitesi Turgut Özal Tıp Merkezi-medical oncology depertmant ( Site 2503)

location_facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2801)

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

location_facility: University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022)

location_facility: Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2900)

location_facility: The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 4515)

location_facility: Maharaj Nakorn Chiang Mai Hospital ( Site 4300)

location_facility: Hattiesburg Clinic Hematology/Oncology ( Site 0008)

location_facility: National Taiwan University Cancer Center (NTUCC) ( Site 4205)

location_facility: Törökbálinti Tüdőgyógyintézet ( Site 2105)

location_facility: St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023)

location_facility: Instituto Alexander Fleming ( Site 1008)

location_facility: National Hospital Organization Hokkaido Cancer Center ( Site 4415)

location_facility: Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1210)

location_facility: Mercy Health-Paducah Medical Oncology and Hematology ( Site 0006)

location_facility: CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2903)

location_facility: CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2404)

location_facility: Changhua Christian Hospital ( Site 4203)

location_facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 1400)

location_facility: Semmelweis Egyetem-Pulmonológiai Klinika ( Site 2104)

location_facility: SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2303)

location_facility: Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2402)

location_facility: Gulhane Egitim Arastirma Hastanesi-Oncology ( Site 2504)

location_facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 2603)

location_facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 2506)

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2103)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2102)

location_facility: Juntendo University Hospital ( Site 4413)

location_facility: National Taiwan University Hospital-Oncology ( Site 4204)

location_facility: The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 4514)

location_facility: Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002)

location_facility: Orchard Healthcare Research Inc. ( Site 0011)

location_facility: Kansai Medical University Hospital ( Site 4408)

location_facility: Central Care Cancer Center - Bolivar ( Site 0017)

location_facility: I.E.U. Medical Point Hastanesi-Oncology ( Site 2507)

location_facility: Beijing Peking Union Medical College Hospital-pneumology department ( Site 4501)

location_facility: Ankara City Hospital-Medical Oncology ( Site 2501)

location_facility: Hospital Universitari Vall d'Hebron-Oncology ( Site 2400)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 4207)

location_facility: Fujian Provincial Cancer Hospital ( Site 4517)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)

location_facility: Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University ( Site 4520)

location_facility: National Cheng Kung University Hospital ( Site 4202)

location_facility: Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 4503)


acronym: RSV MAT-015

lead_sponsor: GlaxoSmithKline

summary:
The purpose of this follow-up study is to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study.

The study participants enrolled in this follow-up study received RSVPreF3 maternal vaccination (any dose) or controls during the following prior RSV MAT studies: RSV MAT-001 (NCT03674177), RSV MAT-004 (NCT04126213), RSV MAT-010 (NCT05045144), RSV MAT-011 (NCT04138056), RSV MAT-009 (NCT04605159), RSV MAT-012 (NCT04980391) and RSV MAT-039 (NCT05169905).

No intervention will be administered in this study. The exposure was the intervention (either RSVPreF3 vaccine or control) received by the study participants in the above-mentioned prior RSV MAT studies.

title: A Phase 3b, Non-randomized, Open Label, Multi-country, Cohort Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies (RSV MAT-001, RSV MAT-004, RSV MAT-010, RSV MAT-011, RSV MAT-009, RSV MAT-012 and RSV MAT-039) During Any Pregnancy Conceived Post Vaccination/Control

primary_purpose: Other

type: EudraCT Number

source: euctr

ipd_sharing_description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

location_country:
Finland
Germany
New Zealand
Argentina
Australia
Brazil
Thailand
Canada
France
Colombia
United States
Honduras
Dominican Republic
India
Belgium
Philippines
Italy
Mexico
Korea, Republic of
Spain
Bangladesh
Panama
South Africa
Taiwan


title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered GLPG3667 Once Daily for 24 Weeks in Adult Subjects With Dermatomyositis

acronym: GALARISSO

summary: The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered GLPG3667 once daily for 24 weeks in adult participants with dermatomyositis (DM).

lead_sponsor: Galapagos NV

location_country:
Italy
Poland
United Kingdom
Argentina
Romania
Belgium
United States
Spain
Croatia
Chile
Czechia
Bulgaria
France

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Inland Rheumatology Clinical Trials, Inc.

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Altoona Center for Clinical Research, P.C.

location_facility: Azienda Ospedaliero Universitaria Pisana


lead_sponsor: Takeda

summary:
The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT).

The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.

location_facility: Stanford Center for Sleep Sciences and Medicine

location_facility: St. Lukes Sleep Medicine and Research Center

location_facility: IRCCS Istituto delle Scienze Neurologiche di Bologna

location_facility: National Center of Neurology and Psychiatry

location_facility: Medical University of South Carolina - PPDS

location_facility: Comprehensive Sleep Medicine Associates - Sugar Land

location_facility: Istituto Neurologico Mediterraneo Neuromed

location_facility: Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH

location_facility: Hospital General Universitari de Castello

location_facility: Tricoastal Narcolepsy and Sleep Disorders Center, PLLC

location_facility: RESM respiratory and sleep medical-care clinic

location_facility: Oslo Universitetssykehus HF Rikshospitalet

title: A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy Without Cataplexy (Narcolepsy Type 2)

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

location_country:
Germany
Finland
Italy
Norway
Australia
Japan
Netherlands
Sweden
Switzerland
United States
Spain
France


title: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis

summary:
The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo.

Participants will either receive fazirsiran or placebo. Liver biopsies, a way of collecting a small tissue sample from the liver, will be taken twice during this study.

collaborators: Takeda Development Center Americas, Inc.

location_country:
Germany
Italy
Poland
Portugal
Australia
Switzerland
Austria
Belgium
United States
Spain
Canada
France

location_facility: University Hospitals Cleveland Medical Center

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Indiana University School of Medicine - Indianapolis

location_facility: Medizinische Universität Wien (Medical University of Vienna)

location_facility: University of California Benioff Children's Hospital

location_facility: Morgan Stanley Childrens Hospital of New York Presbyterian (CHONY) - PIN

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of Arizona Thomas D. Boyer Liver Institute

location_facility: University of California San Diego, Altman Clinical and Translational Institute

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Columbia University Irving Medical Center

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Hospital Universitario Vall d'Hebron - PPDS


title: Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors

summary: The goal of this Phase 3 clinical trial is study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.

ReferenceType: background

ReferenceCitation: Zhang Y, Du X, Liu M, Tang F, Zhang P, Ai C, Fields JK, Sundberg EJ, Latinovic OS, Devenport M, Zheng P, Liu Y. Hijacking antibody-induced CTLA-4 lysosomal degradation for safer and more effective cancer immunotherapy. Cell Res. 2019 Aug;29(8):609-627. doi: 10.1038/s41422-019-0184-1. Epub 2019 Jul 2.

ReferenceCitation: Liu Y, Zheng P. Preserving the CTLA-4 Checkpoint for Safer and More Effective Cancer Immunotherapy. Trends Pharmacol Sci. 2020 Jan;41(1):4-12. doi: 10.1016/j.tips.2019.11.003. Epub 2019 Dec 10.

lead_sponsor: OncoC4, Inc.

sponsor_collaborators:
OncoC4, Inc.
BioNTech SE

location_country:
Germany
Italy
United Kingdom
Australia
Netherlands
Belgium
United States
China
Korea, Republic of
Spain
Turkey
Canada
France

location_facility: Barts Health NHS Trust (St. Bartholomew's Hospital) - 2802

location_facility: Affiliated Hospital of Hebei University - 3214

location_facility: Genesis Cancer and Blood Institute - 1123

location_facility: Tianjin Medical University Cancer Institute and Hospital - 3208

location_facility: The First Affiliated Hospital of Anhui Medical University - 3221

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - 2310

location_facility: The Christie NHS Foundation Trust - 2803

location_facility: Fujian Medical University Union Hospital - 3225

location_facility: Chongqing University Cancer Hospital - 3213

location_facility: The Oncology Institute (TOI) Clinical Research - 1109

location_facility: Texas Oncology - Fort Worth Cancer Center - 1141

location_facility: Zhujiang Hospital of Southern Medical University - 3203

location_facility: Deaconess Chancellor Center for Oncology - 1131

location_facility: The Catholic University of Korea, St Vincent's Hospital - 3105

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - 3219

location_facility: Hospital Universitario Lucus Augusti - 2405

location_facility: Hospital General Universitario de Valencia - 2406

location_facility: NHO-Revive Research Institute, LLC - 1152

location_facility: Keimyung University Dongsan Hospital - 3102

location_facility: IRCCS Istituto Tumori Giovanni Paolo II - 2306

location_facility: Asklepios Fachkliniken Muenchen-Gauting - 2203

location_facility: Hematology Oncology Clinics - Baton Rouge - 1142

location_facility: Guangdong Provincial People's Hospital - 3201

location_facility: AOU Policlinico Giaccone, Università di Palermo - 2309

location_facility: Izmir Ekonomi Universitesi Medical Point Hastanesi - 2607

location_facility: XCancer/Dothan Hematology & Oncology - 1114

location_facility: The First Affiliated Hospital of Guangdong Pharmaceutical University - 3215

location_facility: Göztepe Prof Dr. Suleyman Yalcin City Hospital - 2605

location_facility: Orchard Healthcare Research, Inc. - 1116

location_facility: Alliance for Multispecialty Research, LLC - 1144

location_facility: Akdeniz University Medical Hospital - 2606

location_facility: Texas Oncology - Northeast Texas - Tyler - 1134

location_facility: University of Kentucky - Markey Cancer Center - 1112

location_facility: Centre Hospitalier Intercommunal de Créteil - 2502

location_facility: Florida Cancer Specialists -North - 1125

location_facility: Pennsylvania Cancer Specialists Research Institute - 1101

location_facility: Severance Hospital, Yonsei University Health System - 3104

location_facility: CHU Limoges - Hospital du Cluzeau - 2503

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine - 3220

location_facility: Medipol University Medical Faculty Hospital - 2603

location_facility: Cancer Care Associates of York, Inc. - 1113

location_facility: Florida Cancer Specialists -South - 1126

location_facility: The Second Affiliated Hospital of Nanchang University - 3224

location_facility: Hospital Regional Universitario de Malaga - 2403

location_facility: Tongji University - Shanghai Oriental Hospital (Shanghai East Hospital) - 3240

location_facility: University of Tennessee Medical Center - 1146

location_facility: HealthPartners Institute, Cancer Research Center - 1143

location_facility: Anhui Medical University - The Second Hospital - 3222

location_facility: The Ohio State University James Cancer Center - 1104

location_facility: The First Affliated Hospital of Zhengzhou University - 3207

location_facility: Klinikverbund Allgaü - Klinikum Kempten - 2205

location_facility: Chengdu Seventh People's Hospital - 3229

location_facility: Xiangya Hospital, Central South University - 3223

location_facility: Royal Devon University Healthcare NHS - 2808

location_facility: Azienda Ospedaliera Universitaria "Federico II" - 2304

location_facility: MultiCare Institute for Research and Innovation - Tacoma - 1148

location_facility: Cotton O'Neil Clinical Research Center - 1151

location_facility: UC Davis Comprehensive Cancer Center - 1103

location_facility: Saskatchewan Cancer Agency - Saskatoon Cancer Centre - 1202

location_facility: Istanbul Üniversitesi Onkoloji Enstitüsü - 2613

location_facility: Saskatchewan Cancer Agency - Regina - 1201

location_facility: West China Hospital, Sichuan University - 3238

location_facility: Universita Campus Bio-medico Di Roma (UCBM) - Policlinico Universitario - 2303

location_facility: Jessa Ziekenhuis (Jessa Hospital) - Campus Salvator - 2102

location_facility: University Hospital Birmingham (UHB) / Queen Elizabeth Hospital Birmingham - 2801

location_facility: Chungbuk National University Hospital - 3101

location_facility: Union Hospital Tongji Medical College - 3212

location_facility: Xuzhou Medical University - The Affiliated Hospital - 3234

location_facility: Fundacion Instituto Valenciano De Oncologia (IVO) - 2402

location_facility: The Second Affiliated Hospital of Soochow University - 3217

location_facility: Renmin Hospital of Wuhan University - 3216

location_facility: The First Affiliated Hospital of Xiamen University - 3210

location_facility: The Affiliated Tumor Hospital of Harbin Medical University - 3232

location_facility: Sarah Cannon Research Institute - Tennessee Oncology at Nashville - 1119

location_facility: Hospital General Universitario de Elche - 2401

location_facility: Hospital General Universitario Gregorio Marañon - 2404

location_facility: Trakya University Faculty of Medicine Edirne - 2608

location_facility: The People's Hospital of Guangxi Zhuang Autonomous Region - 3228

location_facility: University of Cincinnati Cancer Center - 1107

location_facility: Cancer Hospital, Chinese Academy of Medical Sciences - 3211

location_facility: Oklahoma Cancer Specialists and Research Institute Tulsa, OK (OCSRI) (QCCA) - 1154

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University - 3218

location_facility: Nanjing Medical University (NMU) - Nanjing First Hospital - 3239

location_facility: Fondazione IRCCS Instituto Tumori Di Milano - 2305

location_facility: Clinica Oncologica Ospedali Riuniti Ancona - 2311

location_facility: Springfield Clinic - The Cancer Center - 1110

location_facility: Universita degli Studi di Perugia - Ospedale Santa Maria della Misericordia - 2308


title: A 44-Week Phase 2b Long-Term Extension, RandomizEd, Double-BLind, Study to Determine the Long-Term PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Completed the Main Phase of the Dose-Ranging Study (RELIEVE UCCD LTE)

summary:
The primary objective of the study is to evaluate the efficacy and dose response of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult participants with inflammatory bowel disease (IBD).

Secondary objectives of the study are to:

evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
evaluate the safety and tolerability of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
evaluate the immunogenicity of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD

The total duration of participant participation in the study is planned to be up to 66 weeks for each individual participant. The study duration is approximately 37 months.

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

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

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

location_facility:
Teva Investigational Site 15364
Teva Investigational Site 35280
Teva Investigational Site 84116
Teva Investigational Site 62071
Teva Investigational Site 35277
Teva Investigational Site 59198
Teva Investigational Site 62072
Teva Investigational Site 59196
Teva Investigational Site 54221
Teva Investigational Site 30284
Teva Investigational Site 31292
Teva Investigational Site 15366
Teva Investigational Site 53516
Teva Investigational Site 53514
Teva Investigational Site 15374
Teva Investigational Site 15361
Teva Investigational Site 53508
Teva Investigational Site 15372
Teva Investigational Site 15359
Teva Investigational Site 31302
Teva Investigational Site 84114
Teva Investigational Site 53519
Teva Investigational Site 53517
Teva Investigational Site 31318
Teva Investigational Site 84110
Teva Investigational Site 51336
Teva Investigational Site 62074
Teva Investigational Site 84111
Teva Investigational Site 31291
Teva Investigational Site 15375
Teva Investigational Site 51338
Teva Investigational Site 84113
Teva Investigational Site 59199
Teva Investigational Site 35279
Teva Investigational Site 53509
Teva Investigational Site 51334
Teva Investigational Site 15369
Teva Investigational Site 53512
Teva Investigational Site 15357
Teva Investigational Site 53511
Teva Investigational Site 54220
Teva Investigational Site 31293
Teva Investigational Site 53515
Teva Investigational Site 62076
Teva Investigational Site 53518
Teva Investigational Site 15370
Teva Investigational Site 15363
Teva Investigational Site 62073
Teva Investigational Site 53510
Teva Investigational Site 59197
Teva Investigational Site 53513


title: Study to Evaluate the Effect of Dose and Duration of Treatment of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) on Safety, Tolerability, and Potential Outcomes in Adult Patients With ABPA

summary:
The goal of this clinical trial is to learn about PUR1900 as an inhaled, antifungal therapeutic for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. The main questions it aims to answer are:

Is PUR1900 safe and well tolerated in adults with asthma and ABPA?
Is there an effect of daily administration of PUR1900 on potential outcome measures in adults with asthma and ABPA?
Is there fungal resistance to A. fumigatus?

This study includes a 28-day screening period, a 112-day (16-week) treatment period, and a 56-day (8 week) observation period.

Participants will take either 40mg of PUR1900, 20 mg of PUR1900 or Placebo for 112 days and complete an eDairy, answer questions about their asthma and complete peak respiratory flow measurements at home. They will come to the clinic approximate once a month during the treatment period and complete study assessments. At the end of the observation period participants will complete one more clinic visit. Participants who complete this study may be given the opportunity to continue on study drug in an open label extension study.

lead_sponsor: Pulmatrix Inc.

location_country:
United States
United Kingdom
Australia
France

location_facility: University of Alabama Medical Center at Birmingham

location_facility: University Hospital of South Manchester - Wythenshawe Hospital,

location_facility: University of Kansas Medical Center Research Institute

location_facility: Mater Hospital Brisbane, Respiratory Research Group

location_facility: Southern Illinois University Center for Clinical Research

location_facility: University Hospitals Birmingham - Heartlands Hospital


title: A Phase 3, Single-arm, Multicenter, Multinational, Open-label, One-way Crossover Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged ≥ 12 Years With Severe Hemophilia A or B With or Without Inhibitory Antibodies to Factor VIII or IX

acronym: ATLAS-NEO

summary:
This is a multicenter, multinational, open-label, one-way cross-over, Phase 3, single-arm study for treatment of hemophilia.

The purpose of this study is to measure the frequency of treated bleeding episodes with fitusiran in male adult and adolescent (≥12 years old) participants with hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX who have switched from their prior standard of care treatment.

The total study duration will be up to approximately 50 months (200 weeks, 1 study month is equivalent to 4 weeks) and will include:

A screening period up to approximately 60 days,
A standard of care (SOC) period of approximately 6 study months (24 weeks),
A fitusiran treatment period of approximately 36 study months (144 weeks),
An antithrombin (AT) follow-up period of approximately 6 study months (24 weeks) but may be shorter or longer depending on individual participants AT recovery.

The frequency for telephone visits will be approximately every 2 weeks. For site visits the frequency will be approximately every 8 weeks during the SOC period and approximately every 4 weeks during the fitusiran treatment period. If applicable and if allowed by local regulation, home and/or remote visits may be conducted during the study

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

lead_sponsor: Sanofi

location_country:
Germany
Italy
India
Japan
Mexico
United States
China
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Canada
France

location_facility: University of California San Diego-Site Number:8400011

location_facility: University of Minnesota-Site Number:8400016

location_facility: University Hospitals of Cleveland-Site Number:8400001

location_facility: Center for Inherited Blood Disorders (CIBD)-Site Number:8400012

location_facility: Northwell Health Hemostasis and Thrombosis Center-Site Number:8400015

location_facility: Medical College of Wisconsin-Site Number:8400007

location_facility: University Of Utah Health Sciences Center-Site Number:8400006

location_facility: The Gulf States Hemophilia and Thrombophilia Center-Site Number:8400002

location_facility: Children's Medical Center of Dallas-Site Number:8400018


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With IgG4-Related Disease (INDIGO)

acronym: INDIGO

summary: This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)

lead_sponsor: Zenas BioPharma (USA), LLC

location_country:
Germany
Italy
Poland
Hungary
Argentina
Hong Kong
Japan
Sweden
Netherlands
Mexico
United Kingdom
United States
Korea, Republic of
Spain
Turkey
Taiwan
France

location_facility: Hôpitaux Universitaires de Marseille Timone

location_facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

location_facility: Niigata University Medical and Dental Hospital

location_facility: Hospital of University of Occupational and Environmental Health

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: GI PROS Research - Dedicated Research Facility

location_facility: Consultora Integral de Salud Centro Médico Privado

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC

location_facility: Haut-Lévèque Hospital Usn Building South Hospital Group

location_facility: Allergy & Asthma Clinical Research- Dedicated Research Facility

location_facility: Hacettepe University Faculty of Medicine

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher


acronym: Damask

summary:
Researchers are looking for a better way to treat atopic dermatitis (AD), an often long-lasting inflammation of the skin. Atopic dermatitis, also called eczema, is causing patches of skin to become swollen, red, cracked, and itchy.

The immune system helps protect the body from diseases. But sometimes the immune system can be too sensitive and overreact. This may then lead to allergies but also to skin conditions like atopic dermatitis.

The study treatment zabedosertib (BAY1834845) is currently under development for the treatment of atopic dermatitis and other inflammatory diseases. It works by reducing the activity of a protein called IRAK4. IRAK4 promotes the production and activation of a series of proteins that trigger inflammation reactions in the immune cells. By reducing the activity of IRAK4, the inflammation reactions are expected to be reduced.

The main purpose of the study is to learn how well zabedosertib works compared to placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. How well it works means to find out the efficacy of zabedosertib. To answer this, the researchers will compare how many participants had 75% EASI score reduction after 12 weeks treatment between participants treated with zabedosertib and those treated with placebo. EASI represents Eczema Area and Severity Index (EASI). It is a tool for measuring the amount and severity of atopic dermatitis that a patient has on his or her body. The score ranges from 0-72, with 0 meaning clear skin and 72 meaning severe atopic dermatitis. In addition, the itch of the study participants and other tools for measuring the severity of atopic dermatitis will be assessed.

The secondary purpose of the study is to learn how safe it is compared to placebo. To know this, study team will compare how many participants having adverse events after taking study treatment between participants treated with zabedosertib and those treated with placebo.

In the study, participants will be randomly (by chance) assigned to receive zabedosertib or placebo. The participants from both treatment groups will take zabedosertib or placebo for up to 12 weeks.

The study consists of an up to 28-day screening period (Visits 1 and 2), a 12-week treatment period consisting of 5 visits (Visits 3 to 7), and a 4-week follow-up visits (Visits 8). Thus, the total study duration per participant will be 17 to 20 weeks (approximately 140 days).

During the study, the study team will:

take blood and urine samples
take skin samples (not obligatory for all patients)
check the participants' disease area for assessment
provide participants device to record their disease status and to take pictures on their disease areas
have participants complete self-reported questionnaires
do physical examinations
examine heart health using ECG
check vital signs
ask the participants questions about how they are feeling and what events they are having.

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

At 28 days after the participants take their last treatment, the study team will check if participants have any events that might be related to the study treatment. This will be the last visit for the study.

location_facility: Hautarztpraxis Prof. Dr. med. Christian Termeer

location_facility: University of Cincinnati College of Medicine - Dermatology

location_facility: NorthShore University HealthSystem Clinical Trials Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

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

location_facility: Harvard Medical School -Beth Israel Deaconess Medical Center

location_facility: Centrum Nowoczesnych Terapii Dobry Lekarz

location_facility: Dermal NZOZ Sp Osrodek Dermatologiczny Bialystok-Podlasie

title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter Phase 2a Study to Investigate Efficacy and Safety of Zabedosertib (BAY 1834845) for the Treatment of Adult Patients With Moderate-to-severe Atopic Dermatitis

location_country:
Germany
Italy
Poland
United Kingdom
United States
Czechia
France


title: A Phase 1/2, Observer-blind, Randomized, Placebo-controlled Multi-country Study to Assess Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age

summary: The aim of this first time in human proof of concept (FTiH-PoC) study is to evaluate safety and reactogenicity, to demonstrate efficacy and to explore immunogenicity of GlaxoSmithKline's (GSK) Neisseria gonorrhoeae generalized modules for membrane antigens (GMMA) (NgG) investigational vaccine compared to placebo (saline).

primary_purpose: Prevention

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

location_country:
Germany
United Kingdom
Brazil
United States
Spain
South Africa
Philippines
France

intervention_type: Biological


title: A Multicenter, Single Arm, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily Iptacopan in Adult PNH Patients Who Have Hb≥10 g/dL in Response to Anti-C5 Antibody and Switch to Iptacopan

acronym: APPULSE

summary: The purpose of the study is to find out if iptacopan is effective and safe in adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who switch from their current standard of care treatment (eculizumab or ravulizumab) to study treatment, iptacopan/LNP023.

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
United Kingdom
United States
Spain
Korea, Republic of
Turkey
France


lead_sponsor: Pfizer

summary:
Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Lenalidomide and Dexamethasone in people with multiple myeloma.

There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab when administered in combination with daratumumab and lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the minimal residual disease (MRD) negativity rate and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, lenalidomide, and dexamethasone in participants with newly diagnosed transplant-ineligible multiple myeloma.

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

location_facility: Institut Català d'Oncologia (ICO) - Badalona

location_facility: Fondazione IRCCS San Gerardo dei Tintori

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

location_facility: Institut Català d'Oncologia - L'Hospitalet

location_facility: Institut Català d'Oncologia (ICO) - Girona

location_facility: ASL PESCARA-Presidio Ospedaliero Pescara

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric

location_facility: Chang Gung Medical Foundation-Linkou Branch

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

location_facility: Centre Hospitalier Universitaire de Poitiers

title: MAGNETISMM-6: AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY-DIAGNOSED MULTIPLE MYELOMA

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

location_country:
Germany
Italy
Poland
Israel
Australia
Japan
Korea, Republic of
Spain
Greece
Taiwan
Czechia
Canada
France


title: A Phase 2a Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease

summary:
The purpose of this study is to evaluate the safety and efficacy of once daily oral inhalation dose of MK-5475 380 µg in participants 40 to 85 years (inclusive) with Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease (PH-COPD).

The primary hypothesis of the study is MK-5475, a soluble Guanylate Cyclase (sGC) stimulator is superior to placebo in increasing 6 Minute Walking Distance (6MWD) from baseline at Week 24.

location_country:
Germany
Italy
Colombia
Israel
Argentina
United Kingdom
Australia
Switzerland
Austria
Belgium
Mexico
United States
Korea, Republic of
Spain
Turkey
France

location_facility: Seoul National University Hospital ( Site 1103)

location_facility: University of Virginia Health System-Division of Pulmonary and Critical Care Medicine ( Site 0111)

location_facility: Université Libre de Bruxelles - Hôpital Erasme ( Site 1302)

location_facility: Ospedale San Gerardo-ASST Monza-Cardio Vasolare- Clinica pneumologica ( Site 1802)

location_facility: Medizinische Universitaet Innsbruck ( Site 1202)

location_facility: HOSPITAL CLÍNIC DE BARCELONA ( Site 2001)

location_facility: Gachon University Gil Medical Center ( Site 1101)

location_facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2005)

location_facility: University of Kansas Medical Center-IM-Pulmonary and Critical Care Medicine ( Site 0102)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1601)

location_facility: Lexington VA Medical Center - Cooper Division ( Site 0137)

location_facility: Intermountain Medical Center-Division of Pulmonary & Critical Care Medicine ( Site 0140)

location_facility: Centro Cardiovascular Colombiano Clínica Santa María ( Site 0504)

location_facility: ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ( Site 1804)

location_facility: Creighton University Clinical Research Office ( Site 0123)

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1501)

location_facility: Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 1603)

location_facility: Cantonal Hospital St.Gallen ( Site 2203)

location_facility: Westmead Hospital-Department of Respiratory and Sleep Medicine ( Site 0902)

location_facility: Hospital Privado Universitario de Córdoba-Clinical Cardiology Department ( Site 0302)

location_facility: Mayo Clinic in Rochester, Minnesota ( Site 0131)

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez ( Site 0701)

location_facility: The University of Texas Health Science Center at Houston ( Site 0105)

location_facility: Hammersmith Hospital-Department of Cardiology ( Site 2401)

location_facility: University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular

location_facility: Hospital Universitario Marqués de Valdecilla-Pneumology ( Site 2003)

location_facility: UT Southwestern Medical Center ( Site 0114)

location_facility: Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1201)

location_facility: Alexian Brothers Medical Center-Pulmonary ( Site 0109)

location_facility: Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1605)

location_facility: Mater Misericordiae Limited ( Site 0905)

location_facility: Eskisehir Osmangazi University-Cardiology ( Site 2304)

location_facility: Centro de Investigaciones Clinicas SAS ( Site 0505)

location_facility: Instituto de Cardiologia de Tucuman-Area de Investigacion Clinica ( Site 0303)

location_facility: Hospital Universitari Vall d'Hebron ( Site 2002)

location_facility: Medizinische Hochschule Hannover ( Site 1602)

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust-Clinical Research Facility ( Site 2405)

location_facility: Hacettepe Universite Hastaneleri ( Site 2301)

location_facility: The Prince Charles Hospital ( Site 0904)

location_facility: Centre Hospitalier Universitaire de Poitiers ( Site 1505)


title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Investigate the Efficacy and Safety of Daxdilimab Subcutaneous Injection in Reducing Disease Activity in Adult Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus

summary: A Phase 2, double-blind, randomized, placebo-controlled parallel-group study to evaluate the efficacy and safety of daxdilimab in participants with moderate-to-severe active primary Discoid Lupus Erythematosus (DLE) refractory to standard of care.

lead_sponsor: Horizon Therapeutics Ireland DAC

location_country:
Poland
Argentina
Denmark
Brazil
United States
Greece
Czechia
Bulgaria
Canada
France

location_facility: Service de dermatologie, hôpital Archet 2, CHU NICE

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto, CIP - Centro Integrado de Pesquisa

location_facility: Ambulatory for specialized medical care - individual practice for specialized medical care - skin and venereal diseases

location_facility: IMC - Instituto de Moléstias Cardiovasculares Tatuí

location_facility: Hospital Christovão da Gama - Centro de Estudos

location_facility: Autoimmune Skin Diseases Unit, Dept. of Dermatology

location_facility: Hospital Universitário Evangélico Mackenzie

location_facility: Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde da Universidade de Caxias do Sul

location_facility: Bispebjerg Hospital, Dermato-Venerologisk Afdeling Og Videncenter for Sårheling, D/S.

location_facility: Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.

location_facility: Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Pawel Brzewski Spolka Cywilna

location_facility: HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

location_facility: LASER CLINIC S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki

location_facility: Centro Multidisciplinar de Estudos Clinicos

location_facility: The Center for Dermatology Clinical Research


title: A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care

acronym: MOONBEAM

summary: The primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to <18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is no formal hypothesis.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Germany
Poland
Colombia
Israel
United Kingdom
Australia
Netherlands
United States
Spain
Turkey
France

location_facility: The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 1606)

location_facility: Hacettepe Universite Hastaneleri ( Site 1400)

location_facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1301)

location_facility: University Medical Center Groningen ( Site 0900)

location_facility: Hôpital Universitaire Necker Enfants Malades ( Site 0300)

location_facility: Gazi University Health Research and Application Center Gazi -Çocuk Sağlığı ve Hastalıkları Anabilim

location_facility: Seattle Children's Hospital ( Site 1605)

location_facility: CHU de Toulouse - Hôpital des Enfants ( Site 0302)

location_facility: Universitaetsklinikum Heidelberg ( Site 0401)

location_facility: Ankara Bilkent Şehir Hastanesi. ( Site 1403)

location_facility: Children's Hospital Colorado ( Site 1609)

location_facility: Schneider Children's Medical Center ( Site 0603)

location_facility: Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 1102)

location_facility: The Children's Hospital at Westmead ( Site 0001)

location_facility: Children's National Medical Center ( Site 1600)

location_facility: Hospital Universitari Vall d'Hebron ( Site 1302)

location_facility: Cincinnati Children's Hospital Medical Center ( Site 1602)

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 1500)

location_facility: Centrum Zdrowia Dziecka w Warszawie-Klinika Kardiologii ( Site 1103)

location_facility: Medizinische Hochschule Hannover ( Site 0405)

location_facility: Hospital Universitario Ramón y Cajal ( Site 1300)

location_facility: Mehmet Akif Ersoy Research and Training Hospital ( Site 1404)

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 0303)

location_facility: Hospital Universitari i Politecnic La Fe ( Site 1303)