title: A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (KEYFORM-007)

summary:
The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil).

The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Germany
Australia
Japan
Turkey
Chile
Czechia
Canada
France
United States
Ukraine
China
Malaysia
Italy
Norway
United Kingdom
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel

location_facility: Xiangya Hospital Central South University ( Site 1171)

location_facility: University Malaya Medical Centre ( Site 1301)

location_facility: Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169)

location_facility: The Second Affiliated Hospital of Anhui Medical University ( Site 1179)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 1654)

location_facility: Centro Investigacion Cancer James Lind ( Site 0204)

location_facility: Japanese Foundation for Cancer Research ( Site 0602)

location_facility: Hospital Universitari Vall d Hebron ( Site 0900)

location_facility: SRBHI of Kirov Region Center of Oncology and medical radiology ( Site 0854)

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1657)

location_facility: National Cancer Center Hospital East ( Site 0600)

location_facility: Hospital Clinico San Carlos ( Site 0902)

location_facility: UT Southwestern Medical Center ( Site 1709)

location_facility: IRCCS Casa Sollievo della Sofferenza ( Site 0554)

location_facility: Institut du Cancer Avignon-Provence ( Site 0306)

location_facility: Odessa Regional Clinical Hospital ( Site 1664)

location_facility: Fakultni Thomayerova nemocnice ( Site 1205)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 0956)

location_facility: Wuhan Union Hospital Cancer Center ( Site 1162)

location_facility: LMU Klinikum Grosshadern der Universitaet Muenchen ( Site 1253)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0952)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1064)

location_facility: Helse Bergen HF - Haukeland univeritetssykehus ( Site 1353)

location_facility: Fakultni nemocnice Na Bulovce ( Site 1202)

location_facility: Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0870)

location_facility: Fujian Province Cancer Hospital ( Site 1178)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 1506)

location_facility: Western Health-Sunshine & Footscray Hospitals ( Site 0052)

location_facility: Leeds Teaching Hospitals NHS Trust ( Site 1050)

location_facility: Georgetown University Hospital ( Site 1148)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 1501)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 1504)

location_facility: Cancercare Rondebosch Oncology ( Site 1509)

location_facility: Hospital Sant Pau i la Santa Creu ( Site 0905)

location_facility: Fudan University Shanghai Cancer Center ( Site 1176)

location_facility: Southern Medical University Nanfang Hospital ( Site 1154)

location_facility: Antalya Egitim ve Arastirma Hastanesi ( Site 1010)

location_facility: Hospital Universitario Virgen Macarena ( Site 0906)

location_facility: Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 1185)

location_facility: Akershus universitetssykehus ( Site 1352)

location_facility: SHBI "Leningrad Regional Clinical Oncology Dispensary n.a. L.D. Roman"-Clinical Trials Department (

location_facility: Ukrainian Center of Tomotherapy ( Site 1658)

location_facility: National Cheng Kung University Hospital ( Site 0955)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0500)

location_facility: Pantai Hospital Kuala Lumpur ( Site 1303)

location_facility: Oregon Health & Science University ( Site 1141)

location_facility: Johanniter Krankenhaus Bonn ( Site 1254)

location_facility: Seattle Cancer Care Alliance ( Site 1107)

location_facility: FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 0851)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0208)

location_facility: The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159)

location_facility: Clinical Research Center of specialized types medical care-Oncology ( Site 0860)

location_facility: University College London Hospitals NHS Foundation Trust ( Site 1056)

location_facility: Shanghai Tenth People's Hospital ( Site 1170)

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1118)

location_facility: Fakultni nemocnice Hradec Kralove ( Site 1207)

location_facility: Intermountain Medical Center ( Site 1707)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 0609)

location_facility: Fakultni nemocnice v Motole ( Site 1201)

location_facility: VCU Health Adult Outpatient Pavillion ( Site 1712)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 1006)

location_facility: Gulhane Egitim ve Arastirma Hastanesi ( Site 1009)

location_facility: Inova Schar Cancer Institute ( Site 1130)

location_facility: Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0872)

location_facility: Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173)

location_facility: Seoul National University Hospital ( Site 0653)

location_facility: Saitama Prefectural Cancer Center ( Site 0603)

location_facility: China Medical University Hospital ( Site 0953)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0871)

location_facility: Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0155)

location_facility: Hadassa Ein Karem Medical Center ( Site 0504)

location_facility: Hacettepe Universitesi Tip Fakultesi ( Site 1003)

location_facility: Goztepe Prof.Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1002)

location_facility: Hospital Universitario 12 de Octubre ( Site 0901)

location_facility: London Regional Cancer Program - London HSC ( Site 0154)

location_facility: MUSC Hollings Cancer Center ( Site 1715)

location_facility: Institut Kanser Negara - National Cancer Institute ( Site 1302)

location_facility: A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0553)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 1105)

location_facility: Tianjin Medical University Cancer Institute and Hospital ( Site 1161)

location_facility: The West Clinic, PLLC dba West Cancer Center ( Site 1149)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 1703)

location_facility: The Third Xiangya Hospital of Central South University ( Site 1175)

location_facility: Royal Brisbane and Women s Hospital ( Site 0058)

location_facility: Changzhou Cancer Hospital-Department of Oncology ( Site 1183)

location_facility: Taipei Veterans General Hospital ( Site 0951)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0850)

location_facility: National Taiwan University Hospital ( Site 0950)

location_facility: Fakultni nemocnice Kralovske Vinohrady ( Site 1208)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0206)

location_facility: Istituto Clinico Humanitas - Cancer Center ( Site 0555)

location_facility: Philipps-Universitaet Marburg. ( Site 1252)

location_facility: National Cancer Center Hospital ( Site 0601)

location_facility: West China Hospital Sichuan University ( Site 1172)

location_facility: Hopital Europeen Georges Pompidou ( Site 0300)

location_facility: Universitetssykehuset i Nord Norge. ( Site 1355)

location_facility: Oslo Universitetssykehus HF. Ulleval ( Site 1351)

location_facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)

location_facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 0550)

location_facility: Katholisches Marienkrankenhaus gGmbH ( Site 1257)

location_facility: Universita degli Studi della Campania Luigi Vanvitelli-UOC Oncoematologia ( Site 0556)

location_facility: University Hospital Coventry & Warwickshire ( Site 1062)

location_facility: Sun Yat-Sen University Cancer Center ( Site 1150)

location_facility: Baskent Universitesi Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1007)

location_facility: St John of God Subiaco Hospital ( Site 0051)

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 1052)

location_facility: Policlinico Gemelli di Roma ( Site 0552)

location_facility: Masarykuv onkologicky ustav ( Site 1203)


title: A Phase 3 Randomized, Active-Controlled, Double-Masked Study to Evaluate the Safety and Efficacy of TRS01 Eye Drops in the Treatment of Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma

summary: The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Tarsier Pharma

location_country:
United States
Germany
France

location_facility:
Palisades Park
Plano
Los Angeles 2
Tübingen
Paris
San Antonio 2
Waltham
München
Jacksonville
Norfolk
Winter Haven
Austin
Lyon
Munster
Winston-Salem
Washington, MO
Aurora
Marietta
San Antonio
Nashville
Düsseldorf
Dijon
Lakewood
La Jolla
Nantes
Boston
Los Angeles
Bonn
Freiburg

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients With Pulmonary Arterial Hypertension (PAH)

acronym: IMPAHCT

summary: IMPAHCT: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial is a Phase 2b/Phase 3 study to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with Pulmonary Arterial Hypertension (PAH). The Phase 2b part of the study will assess three doses to establish an optimal dose for the Phase 3 part of the study. The Phase 2b primary endpoint will be the placebo corrected change in pulmonary vascular resistance (PVR). The Phase 3 primary endpoint will be the placebo corrected change in 6-minute walk distance (6MWD) after 24 weeks of treatment.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Aerovate Therapeutics

location_country:
Germany
Poland
Argentina
Australia
Chile
Czechia
Canada
France
Portugal
United States
Latvia
Belgium
China
Puerto Rico
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Israel

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Tianjin Medical University General Hospital

location_facility: Szpital Kliniczny Przemienienia Pańskiego UM im. Marcinkowskiego

location_facility: UCLA/David Geffen School of Medicine-Pulmonary and Criticial Care

location_facility: University of Arizona, Department of Medicine

location_facility: Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

location_facility: Centro de Investigaciones Clinicas de la Universidad Catolica

location_facility: The Ohio State University Wexner Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Universidad Autonoma de Nuevo Leon, Hospital Universitario

location_facility: Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

location_facility: New York-Presbyterian Brooklyn Methodist Hospital

location_facility: Central South University - The Second Xiangya Hospital

location_facility: Sentara Medical Group - Sentara Pulmonary & Critical Care Specialists

location_facility: Hosp. Universitario Marques de Valdecilla

location_facility: Chongqing Medical University - The First Affiliated Hospital

location_facility: Hopital Erasme - Cliniques Universitaires de Bruxelles

location_facility: Dept of Veterans Affairs Greater Los Angeles Healthcare System

location_facility: The Governors of the University of Calgary

location_facility: Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

location_facility: Azienda Socio Sanitaria Territoriale di Monza

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: Washington University School of Medicine

location_facility: Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Southeast University (SEU) - Zhongda Hospital

location_facility: Ospedale San Giuseppe - Fatebenefratelli

location_facility: The Unviersity of New Mexico - UNM Hospitals

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti - Foggia

location_facility: Unidad de Investigacion Clinica en Medicina S.C.

location_facility: George Washington University Medical Faculty Associates, Inc.

location_facility: Cedars-Sinai Medical Center, Pulmonary & Critical Care

location_facility: The Lindner Center for Research and Education

location_facility: Bieganski Provincial Specialist Hospital

location_facility: Hospital of the University of Pennsylvania

location_facility: University of Nebraska Medical Center- Hematology/Oncology Section

location_facility: Hosp. Universitario Gran Canaria Doctor Negrin

location_facility: Louisiana State University health Sciences Center

location_facility: Duke University Medical Center - Duke South Clinic

status_simplified: Ongoing


type: Other Identifier

type: EudraCT Number

title: Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1)

acronym: OASIS 1

summary:
This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight.

This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation.

Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes.

Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning

In addition to taking the medicine, participants will have talks with study staff about:

healthy food choices
how to be more physically active
what participants can do to lose weight The study will last for about 1½ year.Participants will have 14 clinic visits and 7 phone calls with the study doctor. Blood samples will be taken at 10 visits.

Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.

ipd_sharing: Yes

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

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Germany
Poland
Denmark
Japan
United States
Canada
Russian Federation
France


title: An Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

acronym: STARS extend

summary: The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.

lead_sponsor: VectivBio AG

location_country:
Germany
Italy
Poland
Hungary
Argentina
Israel
Japan
Norway
Sweden
United Kingdom
Belgium
United States
Korea, Republic of
Spain
Taiwan
Czechia
France

location_facility: University Polyclinic Foundation "Agostino Gemelli" - IRCCS

location_facility: M. Pirogow Provincial Specialized Hospital

location_facility: COPERNICUS Limited Liability Company, Nutrition Outpatient Clinic for Adults

location_facility: University Hospital Virgen del Rocio (HUVR)

location_facility: Northern Care Alliance NHS Foundation Trust

location_facility: Nice University Hospital Center - Archet 1 Hospital

location_facility: Rambam Health Care Campus, Institute of Gastroenterology

location_facility: Nantes University Hospital Center - Hotel Dieu Hospital

location_facility: Sahlgrenska University Hospital, Sahlgrenska Intestinal Failure and Transplant Centre

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

location_facility: More og Romsdal Hospital Trust - Alesund Hospital

location_facility: University General Hospital Gregorio Maranon

location_facility: Central Hospital of Northern Pest - Military Hospital

location_facility: Stadmedica, Non-Public Healthcare Facility


type: Registry Identifier

title: A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3

summary:
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart in people with type 2 diabetes.The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries.

Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study.

Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

location_country:
Germany
Italy
Poland
Slovenia
India
Hungary
Japan
United States
Thailand
Malaysia
South Africa
Turkey
Czechia
France


title: Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11)

summary: The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) monotherapy, followed by chemotherapy, followed by pembrolizumab consolidation. The primary hypothesis of the study is that the complete response (CR) rate at the end of study intervention according to Lugano 2014 response criteria is higher than conventional chemotherapy.

status: Active, not recruiting

ReferenceType: derived

ReferenceCitation: Allen PB, Lu X, Chen Q, O'Shea K, Chmiel JS, Slonim LB, Sukhanova M, Savas H, Evens AM, Advani R, Pro B, Karmali R, Palmer B, Bayer RA, Eisner RM, Mou E, Dillehay G, Gordon LI, Winter JN. Sequential pembrolizumab and AVD are highly effective at any PD-L1 expression level in untreated Hodgkin lymphoma. Blood Adv. 2023 Jun 27;7(12):2670-2676. doi: 10.1182/bloodadvances.2022008116.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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: gold

publisher_dissemination: American Society of Hematology

location_country:
Italy
Poland
Israel
Australia
United States
Spain
Turkey
Chile
Canada
Russian Federation
France

location_facility: McGill University Health Centre ( Site 0209)

location_facility: Princess Alexandra Hospital-Division of Cancer Services Trials Unit ( Site 0907)

location_facility: St Joseph Heritage Healthcare-Oncology ( Site 0004)

location_facility: Ankara University Hospital Cebeci-hematology ( Site 5000)

location_facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 1031)

location_facility: Bnai Zion Medical Center-Hematology ( Site 1909)

location_facility: Mater Misericordiae Limited ( Site 0904)

location_facility: Centro Investigación del Cáncer James Lind ( Site 1200)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 1804)

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

location_facility: Almazov National Medical Research Centre ( Site 0704)

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1504)

location_facility: Peter MacCallum Cancer Centre ( Site 0905)

location_facility: Policlinico S. Orsola- Malpighi-Istituto di Ematologia L. e A. Seragnoli ( Site 1800)

location_facility: Szpital Wojewódzki w Opolu-Hematology Department ( Site 0401)

location_facility: Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0205)

location_facility: University of Tennessee Medical Center-Cancer Institute ( Site 0006)

location_facility: centre hospitalier lyon sud-Service Hématologie ( Site 1501)

location_facility: Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen-Service d'Hématologie ( Si

location_facility: Clínica Alemana de Santiago ( Site 1206)

location_facility: Instituto Nacional del Cancer ( Site 1205)

location_facility: Hopital du Sacre-Coeur de Montreal ( Site 0206)

location_facility: Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1204)

location_facility: Klinika Hematologii - Instytut Hematologii i Transfuzjologii-Klinika Hematologii ( Site 0402)

location_facility: Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0403)

location_facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 1803)

location_facility: Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 5001)

location_facility: Monash Health-Haematology Research ( Site 0908)

location_facility: OptumCare Cancer Care-Research Department ( Site 0005)

location_facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou-haematology ( Site 1502)

location_facility: Sheba Medical Center-Hemato Oncology ( Site 1904)

location_facility: Northwestern Memorial Hospital ( Site 0002)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 1801)

location_facility: First Pavlov State Medical University of Saint Petersburg-Raisa Gorbacheva Memorial Institut for Pe

location_facility: Hospital Universitario 12 de Octubre ( Site 1032)

location_facility: Moscow City Clinical Hospital S.P. Botkin ( Site 0702)

location_facility: Liverpool Hospital-Haematology ( Site 0906)


title: A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis

acronym: ADAPT NXT

summary:
The purpose of this open-label study is to investigate the efficacy, safety, and tolerability of a continuous regimen of efgartigimod compared with a cyclic regimen in participants with Generalized Myasthenia Gravis (gMG).

Study details include:

The study duration will be up to 138 weeks (including screening and a safety follow-up of up to 9 weeks)

Part A (regimen comparison period) - 21 weeks
Part B (extension period) - up to 105 weeks

The visit frequency, including virtual visits, will be weekly through Week 21 and every 5 weeks for the remainder of the study.

ipd_sharing: Undecided

lead_sponsor: argenx

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

location_facility:
Investigator Site 7 - US0010001
Investigator Site 21 - IT0390002
Investigator Site 22 - IT0390001
Investigator Site 6 - US0010008
Investigator Site 2 - GEO9950002
Investigator Site 11 - US0010011
Investigator Site 14 - US0010010
Investigator site 39 - IT0390006
Investigator Site 34 - DE0490005
Investigator Site 26 - AT0430002
Investigator Site 5 - PL0480002
Investigator site 37 - CA0019002
Investigator Site 15 - US0010014
Investigator Site 18 - ES0340002
Investigator Site 16 - US0010009
Investigator Site 35 - NL0310001
Investigator Site 4 - PL0480001
Investigator Site 3 - GEO9950003
Investigator Site 23 - FR0330005
Investigator Site 24 - FR0330004
Investigator Site 31 - IT0390005
Investigator Site 29 - CA0019003
Investigator Site 8 - US0010003
Investigator Site 12 - US0010004
Investigator Site 17 - US0010012
Investigator Site 28 - BE0320001
Investigator site 38 - FR0330002
Investigator Site 13 - US0010013
Investigator Site 9 - 0010006
Investigator Site 19 - ES0340001
Investigator Site 30 - IT0390004
Investigator Site 10 - US0010007
Investigator Site 25 - FR0330003
Investigator Site 27 - AT0430001
Investigator Site 33 - DE0490004
Investigator Site 36 - DE0490002
Investigator Site 1 - GEO9950001
Investigator Site 20 - FR0330001
Investigator Site 32 - DE0490001

intervention_type: Biological


title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

summary: The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren's syndrome (pSS) versus placebo.

primary_purpose: Other

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Italy
Poland
Portugal
Japan
Netherlands
United States
Spain
Taiwan
France

location_facility: Malopolskie Badania Kliniczne Sp. z o.o.

location_facility: University of Florida Health Jacksonville

location_facility: Arizona Arthritis and Rheumatology Research, PLLC

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

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: CHU de Grenoble - Hopital Albert Michallon

location_facility: REUMED Zespol Poradni Specjalistycznych Filia nr 2

location_facility: ULSAM, EPE - Hospital Conde de Bertiandos

location_facility: Inland Rheumatology Clinical Trials, Inc.

location_facility: Rheumatology Associates Of South Florida

location_facility: University of Iowa Hospitals and Clinics

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

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

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: Centre for Rheumatology, Immunology and Arthritis

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

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'


title: A Phase 1a/1b Study of LY3537982 in Patients With KRAS G12C-Mutant Advanced Solid Tumors

summary: The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.

design_allocation: Non-Randomized

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Loxo Oncology, Inc.
Merck Sharp & Dohme LLC

location_country:
Australia
Japan
United States
Korea, Republic of
Canada
France

location_facility: Indiana Univ Melvin & Bren Simon Cancer Center

location_facility: Vanderbilt Univeristy School of Medicine

location_facility: Institut du Cancer de Montpellier - Val d'aurelle

location_facility: Chonnam National University Hwasun Hospital

location_facility: South Texas Accelerated Research Therapeutics (START)

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

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

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


title: A Phase 3b, Multi-center, Open-label, Treatment Optimization Study of Oral Asciminib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Previously Treated With 2 or More Tyrosine Kinase Inhibitors.

summary:
The purpose of the study is to optimize the treatment of asciminib in patients with chronic myelogenous leukemia in chronic phase (CML-CP) previously treated with 2 or more Tyrosine Kinase Inhibitors (TKIs). Patients for this study will be identified based on warning criteria and resistance definition following European Leukemia Network (ELN) 2020 recommendations.

In addition, the study will investigate the use of two different posologies. For this, patients will receive asciminib 40 mg (twice-daily) BID or of 80 mg (once daily) once daily (QD).

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
Italy
Poland
United Kingdom
Argentina
Singapore
Brazil
Austria
Korea, Republic of
Spain
Vietnam
Greece
Malaysia
Oman
Canada
France


lead_sponsor: Takeda

summary:
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of convulsive seizures in children and young adults with DS.

Participants will receive their standard antiseizure therapy, plus either a tablet of soticlestat or placebo for 16 weeks. A placebo looks just like soticlestat but will not have any medicine in it.

Participants may continue treatment in an extension study, based on the extension study's entry criteria. Those that want to stop treatment will have a gradual dose reduction during 1 week and then be followed up for 2 weeks.

location_facility: Multicare Health System - Mary Bridge Pediatrics

location_facility: The Second Affiliated Hospital of Guangzhou Medical University

location_facility: Communal Non-profit Enterprise City Childrens Clinical Hospital #6 of DCC

location_facility: Xiangya Hospital Central South University

location_facility: Clinical Integrative Research Center of Atlanta

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

location_facility: Guangzhou Women And Children's Medical Center

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

location_facility: Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel

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

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Stichting Epilepsie Instellingen Nederland

location_facility: Children and Youth Health Care Institute of Vojvodina

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

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

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

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

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

location_facility: Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh

location_facility: Hopital Universitaire des Enfants Reine Fabiola

location_facility: Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC

location_facility: Klinikum der Johann-Wolfgang Goethe-Universitat

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: University of California Benioff Children's Hospital

location_facility: Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

location_facility: Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet

location_facility: Hospital Regional Universitario de Malaga Hospital General

location_facility: Beijing Children's Hospital,Capital Medical University

location_facility: Children's Hospital of Chongqing Medical University

location_facility: National Center of Neurology and Psychiatry

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Instituto de Neurologia de Curitiba (INC)

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

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

location_facility: Kumamoto-Ezuko Medical Center for The Severely Disabled

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

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

location_facility: Clinic for Neurology and Psychiatry for Children and Youth

location_facility: National Hospital Organization Nishi-Niigata Chuo National Hospital

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN

location_facility: Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak

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

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet Syndrome (DS)

source: euctr

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

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


summary:
The aims of the study are:

to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome.
to assess the safety profile of soticlestat when given in combination with other therapies.

Participants will receive their standard antiseizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.

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

location_facility: The Second Affiliated Hospital of Guangzhou Medical University

location_facility: Medical University of South Carolina Children Hospital - PIN

location_facility: Communal Non-profit Enterprise City Childrens Clinical Hospital #6 of DCC

location_facility: Xiangya Hospital Central South University

location_facility: Clinical Integrative Research Center of Atlanta

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

location_facility: Guangzhou Women And Children's Medical Center

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

location_facility: Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Stichting Epilepsie Instellingen Nederland

location_facility: Children and Youth Health Care Institute of Vojvodina

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

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

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

location_facility: MultiCare Institute for Research & Innovation (Tacoma)

location_facility: Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh

location_facility: Hopital Universitaire des Enfants Reine Fabiola

location_facility: Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC

location_facility: Klinikum der Johann-Wolfgang Goethe-Universitat

location_facility: National Hospital Organization Nagasaki Medical Center

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

location_facility: University of California Benioff Children's Hospital

location_facility: Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

location_facility: Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet

location_facility: Northwell Health Physician Partners - Neurology at Lenox Hill

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

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS)

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


lead_sponsor: AbbVie

summary:
Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo. Adverse effects and change in disease activity will be assessed.

Upadacitinib is being evaluated for the treatment of non-segmental vitiligo. The study will enroll approximately 160 participants aged 18-65 with non-segmental vitiligo in 5 treatment arms across 35 sites worldwide.

Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24 weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the first 24 weeks will switch to study drug. Participants who received study drug during the first 24 weeks, will continue to receive study drug.

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: University of Texas Health Science Center at Houston /ID# 229399

location_facility: Yamagata University Hospital /ID# 230362

location_facility: Virginia Clinical Research, Inc. /ID# 228050

location_facility: HCL - Hopital Edouard Herriot /ID# 228194

location_facility: Medical University of South Carolina /ID# 228067

location_facility: CHU Toulouse - Hopital Larrey /ID# 228196

location_facility: Bellaire Dermatology Associates /ID# 228004

location_facility: Michigan Center for Research Company /ID# 228054

location_facility: Tokyo Medical University Hospital /ID# 230288

location_facility: International Clinical Research - Tennessee LLC /ID# 228059

location_facility: Wiseman Dermatology Research /ID# 228410

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 228192

location_facility: Nagoya City University Hospital /ID# 228725

location_facility: University of California Irvine /ID# 229390

location_facility: Dr. Chih-ho Hong Medical Inc. /ID# 228403

location_facility: Nippon Medical School Hospital /ID# 230361

location_facility: Oregon Medical Res Center PC /ID# 228073

location_facility: Essential Medical Research, LLC /ID# 228074

location_facility: Remington-Davis Clinical Research /ID# 229401

location_facility: Oregon Dermatology and Research Center /ID# 228007

location_facility: Yamanashi Prefectural Central Hospital /ID# 229441

location_facility: Centre de Recherche dermatologique du Quebec Metropolitain /ID# 228388

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Non-Segmental Vitiligo

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.

location_country:
United States
Canada
Japan
France


title: A Phase 1/1b Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN-2787 in Participants With BRAF and/or NRAS Mutation-positive Solid Tumors.

summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.

lead_sponsor: Kinnate Biopharma

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

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

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Providence Medical Foundation (St. Joseph's)

location_facility: Sarah Cannon Research Institute - Lake Nona

location_facility: Union Hospital of Tongji Medical College of HUST


title: A Phase 1/2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR- 707) Combined With Cemiplimab for the Treatment of Participants With Advanced Unresectable or Metastatic Skin Cancers

summary:
Primary Objective:

-To determine the antitumor activity of SAR444245 in combination with cemiplimab.

Secondary Objectives:

To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with cemiplimab
To assess other indicators of antitumor activity
To assess the concentrations of SAR444245 when given in combination with cemiplimab
To assess the immunogenicity of SAR444245
To assess active concentrations of cemiplimab when given in combination with SAR444245

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
Ireland
Italy
Portugal
Australia
United States
Spain
Chile
Russian Federation
France

location_facility: Beverly Hills Cancer Center & Optima Diagnostic Imaging-Site Number:8400007

location_facility: Mount Sinai Health System-Site Number:8400006

location_facility: University of Minnesota-Site Number:8400012


title: A Phase 1/2 Study of PBI-200 in Subjects With NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors

summary: This is a first-in-human, Phase 1/2 open-label, multicenter, dose-escalation, safety, PK, and biomarker study of PBI-200 in subjects with NTRK-fusion-positive advanced or metastatic solid tumors.

lead_sponsor: Pyramid Biosciences

location_country:
Germany
Italy
United Kingdom
Hong Kong
Denmark
Australia
Singapore
United States
Korea, Republic of
Spain
France

location_facility: Sarah Cannon Research Institute at HealthONE

location_facility: Seoul National University Bundang Hosptial

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: The Catholic University of Korea Soul St. Mary's Hosptial

location_facility: Dr. Senckenberg Institute of Neurooncology

location_facility: Severance Hosptial, Yonsei University Health System

location_facility: Royal Marsden Hospital Institute Cancer Research

location_facility: John Wayne Cancer Institute at St. Johns Health Center

location_facility: IRCCS (IEO) Istituto Europeo di Oncologia

location_facility: Azienda Ospedaliero Universitaria delle Marche

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Sylvester Comprehensive Cancer Center (University of Miami)

location_facility: Rigshospitalet, University Hospital of Copenhagen

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: The Catholic University of Korea St. Vincent Hosptial

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale


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

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

primary_purpose: Prevention

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

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

location_facility: North Texas Infectious Diseases Consultants

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

location_facility: Vancouver ID Research and Care Centre Society

location_facility: Ambulance name: Gynekologická ordinace MUDr

location_facility: Veterans Affairs Greater Los Angeles HCS

location_facility: The Second Affiliated Hospital of Guangzhou Medical University

location_facility: Royal Devon & Exeter NHS Foundation Trust

location_facility: Japan Community Health Care Organization Kyusyu Hospital

location_facility: Midlands Partnership NHS Foundation Trust

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Carolina Institute for Clinical Research

location_facility: The NIHR Manchester Clinical Research Facility

location_facility: Clinical Alliance for Research and Education

location_facility: Consorci D'Atenció Primària de Salut Barcelona Esquerra

location_facility: Mishawaka Osteopathic Clinic/MOC Research

location_facility: Multi-Specialty Research Associates, Inc.

location_facility: The Julius Center - Utrecht Science Park - Stratenum

location_facility: Japan Community Health Care Organization Osaka Hospital

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust

location_facility: Interspond-Clinical Research Institute of AZ

location_facility: West China School of Medicine/West China Hospital, Sichuan University

location_facility: King's College Hospital NHS Foundation Trust

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

location_facility: Charlottesville Medical Research Center, LLC

location_facility: Medical Corporation Toyoshikai Kano Hospital

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

location_facility: Aesculap Ambulance sro - Zdravotni Stredisko Centrum Zdravi

location_facility: Anhui Provincial Center for Disease Control and Prevention

location_facility: Samson Assuta Ashdod University Hospital

location_facility: Japan Community Health care Organization Kyushu Hospital

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Infectious Disease Associates of Central Virginia

location_facility: University Hospitals Of Leicester Nhs Trust

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: South Tees Hospitals NHS Foundation Trust

location_facility: Baptist Health Center for Clinical Research

location_facility: Hallym University Chuncehon Medical Center

location_facility: National Hospital Organization Yokohama Medical Center

location_facility: California Adult Circumcision - Alvarado La Mesa Urology Center

location_facility: West Roxbury Veterans Affairs Medical Center

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Southern California Permanente Medical Group

location_facility: Funan Center for Disease Control and Prevention

location_facility: Innovative Research of West Florida, Incorporated

location_facility: Barwon Health - University Hospital Geelong

location_facility: San Diego Sports Medicine & Family Health Center

location_facility: Southern Clinical Trials Totara Clinical Research

location_facility: Red-Institut für medizinische Forschung und Fortbildung

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Tropical Medicine Hospital, Mahidol University

intervention_type: Other


title: A Phase 2, Randomized, Open-Label Study of Trilaciclib Administered With First-Line Platinum-Based Chemotherapy and Avelumab Maintenance Therapy in Patients With Untreated, Locally Advanced or Metastatic Urothelial Carcinoma (PRESERVE 3)

summary: This is a Phase 2, multicenter, randomized, open-label study evaluating the safety and efficacy of trilaciclib administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy compared with platinum-based chemotherapy followed by avelumab maintenance therapy in patients receiving first-line treatment for advanced/metastatic bladder cancer.

lead_sponsor: G1 Therapeutics, Inc.

location_country:
Hungary
United States
Spain
Georgia
France

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Centre Léon Bérard - Département d'oncologie médicale

location_facility: National Center of Urology Named after Laur Managadze

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Hospital Clinic de Barcelona - Servicio de Oncología Médica

location_facility: LTD "Multiprofile Clinic Consilium Medulla"

location_facility: Hopitaux Universitaires de Strasbourg - Service Oncologie et Hématologie

location_facility: Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol

location_facility: The Harry and Jeanette Weinberg Cancer Institute

location_facility: University of North Carolina at Chapel Hill

location_facility: ALTHAIA, Xarxa Assistencial Universitiria de Manresa

location_facility: Institut Bergonié - Oncologie Médicale et Pédiatrique

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint

location_facility: Hôpital Européen Georges Pompidou - Service d'Oncologie Médicale

location_facility: Fundación Instituto Valenciano de Oncología


title: A Phase 1B/2 Randomized, Multicenter, Open-Label Study Of Iberdomide (CC-220) In Combination With Polatuzumab Vedotin Plus Rituximab Or Tafasitamab Or Rituximab Plus Chemotherapy For Subjects With Relapsed Or Refractory Aggressive B-Cell Lymphoma

summary: This is a Phase 1b/2 randomized study of Iberdomide (CC-220) added to 3 different combination regimens (polatuzumab vedotin plus rituximab (Cohort A), tafasitamab (Cohort B), rituximab plus gemcitabine and platinum-based chemotherapy (Cohort C)) for participants with relapsed or refractory aggressive B-cell lymphoma (R/R a-BCL). All 3 cohorts will be open for enrollment at study start. Part 1 (dose escalation) will be followed by Part 2 (dose expansion), in which participants will be randomized to one of three cohorts, with CC-220 at the recommended Phase 2 Dose in combination with the Cohorts A, B and C treatment that is compared to their individual standard of care regimen.

study_start_date_type: Anticipated

status: Withdrawn

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

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

lead_sponsor: Celgene

location_country:
United Kingdom
Austria
Belgium
United States
Korea, Republic of
Spain
Taiwan
France

location_facility: University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Nottingham University Hospitals NHS Trust

location_facility: University of Michigan Comprehensive Cancer Center

status_simplified: Unknown


lead_sponsor: Kite, A Gilead Company

summary: The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: University California Los Angeles (UCLA)

location_facility: Johannes Gutenberg University Hospital-University Mainz

location_facility: Munich University of Technology-Medical Faculty- Ethics Committee

location_facility: Advocate Aurora Health - Advocate Lutheran General Hospital

title: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma

location_country:
Germany
United Kingdom
Netherlands
United States
Spain
France


title: A Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple Sclerosis

summary:
Primary Objective:

To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions

Secondary Objective:

To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures
To evaluate the safety and tolerability of SAR441344
To evaluate pharmacokinetics of SAR441344

location_country:
Germany
United States
Spain
Turkey
Czechia
Ukraine
Bulgaria
Canada
Russian Federation
France

location_facility:
Investigational Site Number :7920001
Investigational Site Number :7920003
Investigational Site Number :2760004
Investigational Site Number :8400002
Investigational Site Number :8400007
Investigational Site Number :7920004
Investigational Site Number :6430007
Investigational Site Number :2030001
Investigational Site Number :8400004
Investigational Site Number :8400006
Investigational Site Number :7920002
Investigational Site Number :1000003
Investigational Site Number :1000001
Investigational Site Number :8040008
Investigational Site Number :8400003
Investigational Site Number :1240001
Investigational Site Number :8400001
Investigational Site Number :2030004
Investigational Site Number :2760012
Investigational Site Number :6430001
Investigational Site Number :2030005
Investigational Site Number :2500002
Investigational Site Number :6430008
Investigational Site Number :2030002
Investigational Site Number :2500004
Investigational Site Number :2030003
Investigational Site Number :6430004
Investigational Site Number :8040006
Investigational Site Number :8040003
Investigational Site Number :6430006
Investigational Site Number :8040004
Investigational Site Number :6430003
Investigational Site Number :2760005
Investigational Site Number :2500006
Investigational Site Number :2500007
Investigational Site Number :7240002
Investigational Site Number :8040002
Investigational Site Number :8040005
Investigational Site Number :2760001
Investigational Site Number :1000002
Investigational Site Number :7240003
Investigational Site Number :2760003
Investigational Site Number :2760011
Investigational Site Number :6430005
Investigational Site Number :8040010
Investigational Site Number :2500003
Investigational Site Number :6430002
Investigational Site Number :7240004


title: Renal Mode of Action of Semaglutide in Patients With Type 2 Diabetes and Chronic Kidney Disease

acronym: REMODEL

summary:
We are doing this study to learn more about how semaglutide may help fight chronic kidney disease in people with type 2 diabetes. We are doing this by looking into how semaglutide works in the kidneys.

Participants will either get semaglutide or placebo (a 'dummy' medicine) - which treatment participants get is decided by chance.

Semaglutide is a medicine doctors can prescribe in some countries for the treatment of type 2 diabetes.

Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine into the skin once a week.

The study will last for about 1 year. Participants will have 11 visits to the clinic, and 2 phone visits. Some of the visits could be in different locations.

Study staff will take blood samples at most of these visits. At 9 visits, participants will be asked to bring a sample of their first morning urine. At 4 of the visits participants will have to bring urine that they have collected over the last 24 hours.

The study includes magnetic resonance imaging (MRI) scans of participants' kidneys which is a test that shows a detailed picture of organs and other parts inside the body. The scan will last for 30 minutes, and is free of radiation.

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

location_country:
Italy
Poland
Denmark
United States
Spain
South Africa
Canada
France


acronym: COMMUTE-a

lead_sponsor: Hoffmann-La Roche

summary: This study aims to evaluate the efficacy and safety of crovalimab in adult and adolescent participants with aHUS.

sponsor_collaborators:
Hoffmann-La Roche
Chugai Pharmaceutical

location_facility: Erciyes University Medical Faculty; Internal Medicine

location_facility: Az. Osp. Careggi; Reparto Di Nefrologia, Dialisi E Trapianti

location_facility: Hôpital Robert Debré; Nephrologie pediatrique

location_facility: Universitätsklinikum Essen; Klinik für Kinder- und Jugendmedizin Pädiatrie II

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Instytut ?Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii

location_facility: Istanbul University Istanbul Medical Faculty; Department of Internal Medicine

location_facility: Beijing Children's Hospital, Capital Medical University

location_facility: Medizinische Hochschule Hannover; Klinik für Nieren- und Hochdruckerkrankungen

location_facility: Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases

location_facility: Rambam Medical Center; Department of Nephrology and Hypertension

location_facility: Del- Pesti Centrumkorhaz- Szent Laszlo Korhaz Telephely

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Hôpital Arnaud de Villeneuve; Néphrologie pédiatrique

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Klinik II für Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Nefrologia

location_facility: Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdzia?em Dializoterapii

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

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS; U.O.C. Nefrologia

location_facility: UT Health Science Center; SouthTexas Pediatric Blood and Cancer Ctr

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadci?nienia Dzieci i Mlodziezy

location_facility: The Ohio State University Wexner Medical Center

location_facility: Auckland City Hospital; Renal Unit, Level 15

location_facility: A.O. Universitaria S. Martino Di Genova; Nefrologia

location_facility: Presidio Ospedaliero Maggiore Policlinico Fondazione IRCCS; Pad Croff Div Nefrologia Dialisi

location_facility: Instituto Nacional de Ciencias; Medicas y Nutricion; Salvador Zubiran

location_facility: SAMODZIELNY PUBLICZNY CENTRALNY SZPITAL KLINICZNY; Department KLINIKA NEFROLOGII, DIALIZOTERAPII I C

location_facility: Hospital de Especialidades Puerta de Hierro S.A de C.V.

location_facility: Inkosi Albert Luthuli Central Hospital; Pediatric Nephrology

location_facility: Klinik für Nephrologie des Universitätsklinikum Essen; Klinik für Infektiologie - MFZ

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Hospital Clinic i Provincial; Servicio de Nefrologia

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

location_facility: UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu

location_facility: University of California Irvine Chao Family Comprehensive Cancer Center

location_facility: New Zealand Clinical Research - Christchurch

location_facility: Inonu University Faculty of Medicine Turgut Ozal Medical Center

location_facility: Hospital Universitario 12 de Octubre; Servicio de Nefrologia

location_facility: Peking University First Hospital; NEPHROLOGY

title: A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

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

location_country:
Germany
Italy
Poland
New Zealand
Hungary
Israel
Japan
Brazil
Mexico
Belgium
United States
China
Spain
South Africa
Turkey
Peru
Canada
France


title: A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment of Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)

acronym: FOREST-HCM

summary: The purpose of this study is to collect long-term safety and tolerability data for aficamten (CK-3773274)

status: Enrolling by invitation

lead_sponsor: Cytokinetics

location_country:
Germany
Italy
Poland
Portugal
Hungary
Israel
Denmark
United Kingdom
Netherlands
United States
Spain
Czechia
France

location_facility: UC San Diego Health - Sulpizio Cardiovascular Center

location_facility: Maastricht University Medical Center (MUMC)

location_facility: Unit Cardiomiopatie, Dipartimento Cardio ToracoVascolare

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: University of Virginia Health System University Hospital

location_facility: Holy Cross Hospital / Cardiology Associates

location_facility: Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)

location_facility: Dipartimento di Medicina Clinica e Molecolare Universita Sapienza di Roma Unita di Terapia Intensiva Cardiologica Azienda Ospedaliero Universitaria Sant'Andrea

location_facility: Hospital Universitario Virgen Macarena-merge

location_facility: Il. Interni klinika kardiologie a angiologie

location_facility: Columbia University Medical Center/New York Presbyterian Hospital

location_facility: Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika

location_facility: Sanger Heart & Vascular Institute - HCM Clinic

location_facility: Universitaetsmedizin Goettingen Klinik fur Kardiologie und Pneumologie

location_facility: Department of Cardiology Aarhus University Hospital

location_facility: Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego - Panstwowy Instytut Badawczy Centrum Zaburzen Rytmu Serca

location_facility: University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Center)

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: CHU de Nantes Institut Du Thorax et du systeme nerveux Clinique Cardiologique et des Maladies Vasculaires

location_facility: Oxford Centre for Clinical Magnetic Resonance Research (OCMR) Division of Cardiovascular Medicine Radcliffe Department of Medicine University of Oxford

location_facility: St George's University Hospitals NHS Foundation Trust

location_facility: The University of Texas Southwestern Medical Center at Dallas

location_facility: Queen Elizabeth Hospital Birmingham University Hospitals Birmingham NHS Foundation Trust

location_facility: Ascension St. John Clinical Research Institute

location_facility: Michigan Medicine - University of Michigan

location_facility: Hopital de la Timone Service de cardiologie

location_facility: Centro Hospitalar Do Baixo Vouga, EPE Cardiology Department

location_facility: The Heart Center, Department of Cardiology

location_facility: Cedars-Sinai Medical Center (Smidt Heart Institute)

location_facility: Universitaetskinikum Wuerzburg Deutsches Zentrum fur Herzinsuffzienz Wurzburg (DZHI) Comprehensive Heart Failure Center (CHFC)

location_facility: Erasmus Medical Center Department of Cardiology

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Fondazione toscana Gabriele Monesterio per la ricarca medica Dipartimento Cardiotoracico UOC Cardiologia e Medicina Cardiovasculare Ospedale San Cataldo

location_facility: Glasgow Clinical Research Facility Neuroscience Institute


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging, Phase 2b Study to Evaluate Efficacy and Safety of Tezepelumab for the Treatment of Chronic Spontaneous Urticaria

acronym: INCEPTION

summary: The primary objective of this study is to evaluate the effect of tezepelumab on improvement in the Urticaria Activity Score over 7 days (UAS7).

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

lead_sponsor: Amgen

location_country:
Germany
Italy
Poland
Japan
United States
Korea, Republic of
Spain
Greece
Canada
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Attikon University General Hospital of Athens

location_facility: The Allergy Asthma and Sinus Center, East Tennessee Center for Clinical Research

location_facility: Family Allergy and Asthma Research Institute

location_facility: George Papageorgiou General Hospital of Thessaloniki

location_facility: Kliniczny Szpital Wojewodzki nr 1 im Fryderyka Chopina

location_facility: Henry Ford Medical Center - New Center One

location_facility: Cutis Wellness Dermatology and Dermatopathology, PLLC

location_facility: Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Klinika Osipowicz and Turkowski Spzoo Opieka Wielospecjalistyczna Osipowicz and Turkowski

location_facility: David Fivenson MD Professional Liability Company

location_facility: Hospital General Universitario de Valencia

location_facility: Gordon Sussman Clinical Research Incorporated

location_facility: AMICARE z ograniczona odpowiedzialnoscia spolka komandytowa

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

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

location_facility: Azienda Ospedaliero Universitaria di Modena

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Clinique Spécialisée en Allergie de la Capitale

location_facility: Fujita Health University Bantane Hospital

location_facility: Dermatology and Ophthalmology Kume Clinic

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Centre Hospitalier Universitaire de Brest - Hôpital Morvan

location_facility: Hallym University Dongtan Sacred Heart Hospital

location_facility: Dermatology Research Institute Incorporated

location_facility: Centre Hospitalier Universitaire Archet 2

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

location_facility: Clinical Research Center Spzoo Medic-R Spolka Komandytowa


title: A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination With Gemcitabine in Adult and Pediatric Subjects With Relapsed or Refractory Osteosarcoma

summary: This is a phase 1/2 study of ZN-c3 in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma.

lead_sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

location_country:
United States
France

location_facility: University of Florida College of Medicine


title: A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd

summary: A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd

lead_sponsor: Ambrx, Inc.

location_country:
United States
Australia
Korea, Republic of
France

location_facility:
University Hospital Geelong
Research site
Korea University Anam Hospital
Research Site


summary:
The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol.

The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.

title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Complement 3 Glomerulopathy.

location_country:
Germany
Argentina
Japan
Brazil
Turkey
Czechia
Canada
France
Switzerland
United States
India
Belgium
China
Italy
United Kingdom
Netherlands
Spain
Greece
Israel


title: A Phase 1b/2 Study of BMS-986158 Monotherapy and in Combination With Either Ruxolitinib or Fedratinib in Participants With DIPSS-Intermediate or High Risk Myelofibrosis

summary: The purpose of this study is to assess the safety, tolerability, and efficacy of BMS-986158 alone and in combination with either Ruxolitinib or Fedratinib in participants with Dynamic International Prognostic Scoring System (DIPSS)-intermediate or high risk blood cancer. Part 1 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and Part 2 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and BMS-986158 alone.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
Poland
Israel
Romania
Australia
United States
Korea, Republic of
Spain
Greece
Turkey
France

location_facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan-Institut de cancérologie et héma

location_facility: University of Massachusetts Medical School-Division of Hematology/Oncology

location_facility: University of North Carolina Medical Center

location_facility: Florida Cancer Specialists Lake Mary Drug Development Unit

location_facility: Hôpital Saint-Louis-Centre d'Investigations Cliniques

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Moores Cancer Center-Clinical Trials Office - Hematology

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


title: Open Label, Multicenter Phase II Study of the C5a Antibody IFX-1 Alone or IFX-1 + Pembrolizumab in Patients With PD-1 or PD-L1 Resistant/Refractory Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC)

summary: This is an open-label, "non comparative", non-randomized, Phase II study. Patients will be enrolled in 2 treatment arms

lead_sponsor: InflaRx GmbH

location_country:
Germany
Belgium
United States
Spain
France

location_facility: Frankfurt University Clinic, Department of Dermatology, Venereology and Allergology

location_facility: CHU APHM la Timone / Aix Marseille University, Dermatology and Skin Cancer Department

location_facility: University Hospital Erlangen, Department of Dermatology

location_facility: University Hospital Tuebingen, Department of Dermatology

location_facility: MD Anderson International Cancer Center Spain

location_facility: University Hospital Leipzig, Department of Dermatology, Venereology and Allergology

location_facility: University Hospital Center of Poitiers, Department of Oncology

location_facility: University Hospital Center of Grenoble Alpes, Department of Dermatology

location_facility: University Hospital Regensburg, Clinic and Policlinic for Dermatology

location_facility: University Clinical Hospital of Salamanca

location_facility: University Duisburg-Essen, University Hospital Essen, Department of Dermatology

location_facility: H. Lee Moffitt Cancer Center & Research Institute


title: A First in Human Study of the Menin-KMT2A (MLL1) Inhibitor JNJ-75276617 in Participants With Acute Leukemia

summary: The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of JNJ-75276617 in Part 1 (Dose Escalation) and to determine safety and tolerability at the RP2D(s) in Part 2 (Dose Expansion).

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
United Kingdom
Australia
United States
Spain
France

location_facility: University of California Irvine Medical Center

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

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie

location_facility: Institut Universitaire du Cancer Toulouse Oncopole


lead_sponsor: Neurocrine Biosciences

summary: This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 28 weeks in approximately 81 pediatric participants with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The study consists of a 28-week double blind, placebo-controlled period, followed by 24 weeks of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 14 months for the core study and will be a variable amount of time per participant for the OLE (estimated to be approximately 3 years).

location_facility:
Neurocrine Clinical Site
Neurocrine Clinical site

title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

location_country:
Germany
Italy
Poland
United Kingdom
Belgium
United States
Spain
Greece
Canada
France


title: A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis

summary:
This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial. Participants will be screened within 6 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks.

The trial will include up to a 42-day Screening Period and a 52-week Double-blind Treatment Period. Participants will take their first dose of trial drug at the clinic and will participate in trial visits at Week 4 and every 6 weeks thereafter until Week 52.

All participants who complete the Double-blind Treatment Period (Week 52) will be eligible to enter a 52-week extension trial (HZNP-HZN-825-302, NCT05626751). Participants not entering the extension trial will participate in a Safety Follow-up Visit 4 weeks after the last dose of trial drug.

lead_sponsor: Horizon Therapeutics Ireland DAC

location_country:
Germany
Poland
Argentina
Japan
Chile
France
Portugal
Switzerland
United States
Romania
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Israel

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Mayo Clinic - Cancer Center - Rochester - PPDS

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL

location_facility: Tokyo Women's Medical University Hospital

location_facility: Centro de Investigaciones Médicas Tucumán

location_facility: Centro de Estudios de Investigacion Basica Y Clinica SC

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Friedrich Alexander Universität Erlangen Nürnberg

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

location_facility: CITER, Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas SA de CV

location_facility: Consultorio de Investigaciones Reumatologicas

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

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

location_facility: Ippokratio General Hospital of Thessaloniki

location_facility: University of Miami Miller School of Medicine

location_facility: Centro de Investigación Clínica de la Universidad Católica

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

location_facility: Seoul National University Bundang Hospital

location_facility: Clinica de Investigacion en Reumatologia y Obesidad

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Centro de Investigación y Tratamiento Reumatológico S.C

location_facility: Michigan Medicine University of Michigan

location_facility: Hospital de Merida-Avenida d' Antonio Campos Hoyos 26

location_facility: Arizona Arthritis and Rheumatology Research, PLLC

location_facility: Medicover Integrated Clinical Services sp. z o.o

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Hospital Conde de Bertiandos Unidade Local de Saúde Do Alto Minho

location_facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi

location_facility: Medizinische Universitat Wien (Medical University of Vienna)

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Unidad de Atencion Medica e Investigacion en Salud

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Aprillus Asistencia e Investigacion de Arcis Salud SRL


summary:
Primary Objective:

Primary population (former smokers cohort):

Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD

Secondary Objectives:

Primary population (former smokers cohort):

Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD
Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD
Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD
Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD

Secondary population (current smokers cohort)

Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD
Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD
Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD
Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD
Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_facility: Smart Medical Research Site Number : 8400191

location_facility: CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760009

location_facility: Kaiser Permanente Center for Health Research Site Number : 8400039

location_facility: Toledo Institute of Clinical Research Site Number : 8400014

location_facility: Sciences Connections, LLC Site Number : 8400045

location_facility: Meris Clinical Research Site Number : 8400021

location_facility: Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A Site Number : 0760017

location_facility: Clinical Trials Center of Middle Tennessee Site Number : 8400025

location_facility: Washington University School of Medicine Site Number : 8400035

location_facility: Allianz Research Institute Colorado Site Number : 8400061

location_facility: Probe Clinical Research Corporation Site Number : 8400188

location_facility: Clinical Research Of West Florida Inc Site Number : 8400008

location_facility: Lowcountry Lung & Critical Care Site Number : 8400175

location_facility: United Memorial Medical Center (UMMC) Site Number : 8400193

location_facility: Columbus Clinical Services Site Number : 8400054

location_facility: Sun Research Institute Site Number : 8400183

location_facility: St. Luke's University Health Network Site Number : 8400187

location_facility: Y and L Advance Health Care, Inc D/B/A Elite Clinical Res Site Number : 8400009

location_facility: Remington-Davis Inc Site Number : 8400004

location_facility: Lexington VA Health Care System Site Number : 8400036

location_facility: University of Cincinnati Site Number : 8400042

location_facility: Aurora BayCare Medical Center Site Number : 8400046

location_facility: Heuer M.D. Research Site Number : 8400016

location_facility: Advanced Pulmonary Research Institute Site Number : 8400018

location_facility: OK Clinical Research LLC Site Number : 8400001

location_facility: VA Western New York Healthcare System Site Number : 8400050

location_facility: Pulmonary & Critical Care Site Number : 8400047

location_facility: BRCR Medical Center Site Number : 8400180

location_facility: CMPC - Consultoria Médica e Pesquisa Clínica Site Number : 0760008

location_facility: Faculdade de Medicina da Universidade Estadual Paulista Site Number : 0760005

location_facility: Palmtree Clinical Research Site Number : 8400184

location_facility: BRCR Medical Center, Inc. Site Number : 8400190

location_facility: CECAP - Centro de Cardiologia Clinica e Pesquisa Dra. Juliana Souza Site Number : 0760018

location_facility: Sarasota Memorial Health Care System Clinical ResearchCenter Site Number : 8400178

location_facility: Medster Research, LLC Site Number : 8400051

location_facility: CETI - Centro de Estudos em Terapias Inovadoras Site Number : 0760012

location_facility: VitaLink Research- Gaffney Site Number : 8400003

location_facility: Innovative Research of West Florida, Inc Site Number : 8400041

location_facility: Phoenix Medical Research Site Number : 8400019

location_facility: Hospital Sao Lucas da PUCRS Site Number : 0760007

location_facility: American Health Research Site Number : 8400002

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clinicos Site Number : 0760015

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760001

location_facility: Inspire Pulmonary & Sleep Medicine Specialists Site Number : 8400232

location_facility: Synexus Phoenix Central (Central Phoenix Medical Clinic) Site Number : 8400333

location_facility: Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao Site Number : 0760006

location_facility: Schenectady Pulmonary and Critical Care Associates Site Number : 8400029

location_facility: Pines Care Research Center LLC Site Number : 8400056

location_facility: Rutgers Institute for Translational Medicine and Science/Rutgers University Site Number : 8400059

location_facility: Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760013

location_facility: PUC Campinas - Sociedade Campineira de Educaçao e Instruçao Site Number : 0760010

location_facility: Genesis Clinical Research, LLC Site Number : 8400182

location_facility: Multi-Specialty Research Associates, Inc Site Number : 8400044

location_facility: Temple University Hospital Site Number : 8400062

location_facility: Finlay Medical Research Site Number : 8400011

location_facility: Sierra Clinical Research Site Number : 8400005

location_facility: Johns Hopkins Asthma and Allergy Center Site Number : 8400055

location_facility: Hospital Sao Domingos Site Number : 0760016

location_facility: Captain James A. Lovell Federal Health Care Center Site Number : 8400032

location_facility: Finlay Medical Research Site Number : 8400007

location_facility: The Rheumatology and Pulmonary Clinic Site Number : 8400053

location_facility: Innovation Medical Research Center Site Number : 8400067

location_facility: Cardiopulmonary Research Site Number : 8400040

location_facility: Cotton O'Neil Garfield Site Number : 8400063

location_facility: North Georgia Clinical Research Site Number : 8400013

location_facility: My Community Research Center Site Number : 8400060

location_facility: Allegheny Health Network Site Number : 8400058

location_facility: Helix Biomedics, LLC Site Number : 8400049

location_facility: Advanced Respiratory and Sleep Medicine Site Number : 8400022

location_facility: Midwest Pulmonology, Critical Care and Sleep Associates Site Number : 8400033

location_facility: WellNow Urgent Care Site Number : 8400379

location_facility: Santa Casa de Belo Horizonte - Hospital Emygdio Germano Site Number : 0760014

location_facility: Centro Avancado de Oncologia CECAN - Liga Contra o Cancer Site Number : 0760019

location_facility: Illinois Lung Institute Site Number : 8400024

location_facility: Direct Helpers Medical Center Inc Site Number : 8400065

location_facility: Renstar Medical Research Site Number : 8400015

location_facility: Oviedo Medical Research Site Number : 8400026

location_facility: Beautiful Minds Clinical Research Center Site Number : 8400352

location_facility: Central Florida Pulmonary Group, PA Site Number : 8400192

location_facility: North Florida/South Georgia Veterans Health System Site Number : 8400176

location_facility: Revive Research Institute Site Number : 8400186

location_facility: AES Salt Lake City Site Number : 8400332

location_facility: New York - Presbyterian Queens Site Number : 8400028

title: Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/ REGN3500/ Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

location_country:
Germany
Poland
Argentina
Japan
Brazil
Turkey
Chile
Czechia
Canada
France
Lithuania
Portugal
Hungary
Denmark
United States
Latvia
India
Estonia
Puerto Rico
Norway
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Georgia
Russian Federation
Israel


lead_sponsor: Daiichi Sankyo, Inc.

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC).

sponsor_collaborators:
Daiichi Sankyo, Inc.
AstraZeneca

location_facility: Asst Grande Ospedale Metropolitano Niguarda

location_facility: National Hospital Organization Osaka National Hospital

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Sarah Cannon (Tennessee Oncology - Nashville)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Seoul National University Bundang Hospital

location_facility: Severance Hospital Yonsei University Health System

location_facility: Hospital Clinico y Provincial de Barcelona

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: National Hospital Organization Shikoku Cancer Center

title: A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)

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

location_country:
Italy
United Kingdom
Australia
Japan
Belgium
United States
Korea, Republic of
Spain
Taiwan
France