title: A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer

summary: The purpose of this study is to find out whether it is better to receive a new drug, MEDI4736, or better to receive no further treatment after surgery (and possibly chemotherapy) for lung cancer.

lead_sponsor: Canadian Cancer Trials Group

location_country:
Poland
Taiwan
Brazil
Spain
Italy
Australia
New Zealand
Canada
Ukraine
Hungary
Korea, Republic of
United States
France
China
Singapore
Romania
Japan
Netherlands
Bulgaria

location_facility: The Affiliated Hospital Of Xuzhou Medical College

location_facility: Sir run run shaw hospital School of Medicine

location_facility: Hematology and Oncology Associates of NEPA

location_facility: Hospital Evangelico de Cachoeiro de Itapemirim

location_facility: The Affiliated Hospital Of Qingdao University

location_facility: Japanese Red Cross Nagoya Daiichi Hospital

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences

location_facility: Klinika Onkologii i Radioterapii Uniwersyteckie

location_facility: UOC Oncologia Medica II Instituto Oncologio Veneto

location_facility: OUC Oncologia Medica - Presidio Ospedaliero

location_facility: IRCCS Ospedale Oncologico Giovanni Paolo II

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Kinki University Hospital Faculty of Medicine

location_facility: Hospital General Universitario de Valencia

location_facility: Dnipropetrovsk City Clinical Hospital No.4

location_facility: Centro de Oncologia e Radioterapia (COR) Mae de Deus

location_facility: Azienda Ospedaliera di Perugia Santa Maria

location_facility: Liverpool Cancer Therapy Centre, Liverpool Hospital

location_facility: National Hospital Organization Kinki-Chuo

location_facility: Oncologia Medica IRCCS Arcispedale Maria

location_facility: Spitalul de Psihiatrie Dr. Constantin Gorgos

location_facility: PO A Perrino ASL Brindisi - UOC Oncologia Medica

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Semmelweis University Pulmonology Department

location_facility: Azienda USL di Piacenza, Ospedale Gugliemimo Salieto

location_facility: Istituti Fisioterapici Ospitalieri IFO Istituto

location_facility: The People Hospital of Guangxi Zhuang Autonomous Reg

location_facility: Unita Sperimentazioni Cliniche Istituto per lo

location_facility: U.O. di Oncologia Medica Azienda Ospedaliera G Rummo

location_facility: AOU Policlinico Vittorio Emanuele UOC di Oncologia

location_facility: Universita Federico II UOC Oncologia Medica

location_facility: Dott. Fortunato Ciardiello,Cattedra Oncologia Medica

location_facility: Frankston Hospital - Peninsula Oncology Centre

location_facility: The Second Affiliated Hosp of Shantou Medical Colleg

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: CHUM-Centre Hospitalier de l'Universite de Montreal

location_facility: Ospedale S. Paolo - U.O. di Oncologia Medica

location_facility: Hospital of the University of Occupational and

location_facility: Universitair medisch centrum Nijmegen st Radboud

location_facility: National Hospital Organization Kure Medical Center

location_facility: Centre Hospitalier Regional Hopital de la Source

location_facility: Azienda Ospedaliera di Rilievo Nazionale

location_facility: The Catholic University of Korea Bucheon

location_facility: Thunder Bay Regional Health Sciences Centre/Thunder

location_facility: Fondazione Salvatore Maugeri Oncologia Medica

location_facility: Keimyung University Dongsan Medical Center

location_facility: The Research Institute of the McGill University

location_facility: Samodzielny Publiczny Szpital Specjalistyczny

location_facility: Centre hospitalier universitaire de Montpellier

location_facility: National Hospital Organization Yamaguchi

location_facility: Vinnytsia Regional Clinical Oncology Dispensary

location_facility: Centre Hospitalier Intercommunal - Elbeuf

location_facility: Taipei Medical University - Shuang Ho Hospital

location_facility: Suporte Nutricional e Quimioterapia LTDA PRONUTRIR

location_facility: Complejo Asistencial Universitario de Leon

location_facility: The Second Xiangya Hospital of Central South Univer

location_facility: Annemasse - Centre Hospitalier Alpes Leman

location_facility: Chang-Gung Memorial Hospital - Kaohsiung

location_facility: Thonon-les-Bains - Hopital Georges Pianta

location_facility: Royal Melbourne Hospital Research Foundation

location_facility: Centre Integre Universitaire De Sante Et De Services

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Stronach Regional Health Centre at Southlake


title: Real-World Treatment Patterns, BRCA Testing Practices, Outcomes, and Health Care Utilization in Platinum-Sensitive Recurrent Serous Ovarian Cancer: A Multi-Country Retrospective Study

acronym: OSCA

summary: This study will be carried out as a retrospective, non-interventional observational review of medical records for patients in multiple countries with platinum-sensitive recurrent serous ovarian cancer. The objectives are to describe in a real-world population, treatment patterns, BRCA mutation testing and results, overall survival, health care utilization and also to estimate rates of selected treatment- and/or disease-related side effects

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: AstraZeneca

location_country:
Portugal
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Switzerland
Korea, Republic of
France
Israel
Belgium
Germany

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

type: EudraCT Number

title: A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy

summary: The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Mateos MV, Rigaudeau S, Basu S, Spicka I, Schots R, Wrobel T, Cook G, Beksac M, Gries KS, Kudva A, Tromp B, Van Rampelbergh R, Pei H, Wroblewski S, Carson R, Delioukina M, White D. Switching to daratumumab SC from IV is safe and preferred by patients with multiple myeloma. J Oncol Pharm Pract. 2022 Sep 6:10781552221103551. doi: 10.1177/10781552221103551. [Epub ahead of print]

ReferenceCitation: Facon T, Kumar SK, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Mace JR, Raje N, Tiab M, Macro M, Frenzel L, Leleu X, Ahmadi T, Wang J, Van Rampelbergh R, Uhlar CM, Tromp B, Delioukina M, Vermeulen J, Usmani SZ. Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Nov;22(11):1582-1596. doi: 10.1016/S1470-2045(21)00466-6. Epub 2021 Oct 13.

ReferenceCitation: Cavo M, San-Miguel J, Usmani SZ, Weisel K, Dimopoulos MA, Avet-Loiseau H, Paiva B, Bahlis NJ, Plesner T, Hungria V, Moreau P, Mateos MV, Perrot A, Iida S, Facon T, Kumar S, van de Donk NWCJ, Sonneveld P, Spencer A, Krevvata M, Heuck C, Wang J, Ukropec J, Kobos R, Sun S, Qi M, Munshi N. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA. Blood. 2022 Feb 10;139(6):835-844. doi: 10.1182/blood.2021011101.

ReferenceCitation: San-Miguel J, Avet-Loiseau H, Paiva B, Kumar S, Dimopoulos MA, Facon T, Mateos MV, Touzeau C, Jakubowiak A, Usmani SZ, Cook G, Cavo M, Quach H, Ukropec J, Ramaswami P, Pei H, Qi M, Sun S, Wang J, Krevvata M, DeAngelis N, Heuck C, Van Rampelbergh R, Kudva A, Kobos R, Qi M, Bahlis NJ. Sustained minimal residual disease negativity in newly diagnosed multiple myeloma and the impact of daratumumab in MAIA and ALCYONE. Blood. 2022 Jan 27;139(4):492-501. doi: 10.1182/blood.2020010439.

ReferenceCitation: Perrot A, Facon T, Plesner T, Usmani SZ, Kumar S, Bahlis NJ, Hulin C, Orlowski RZ, Nahi H, Mollee P, Ramasamy K, Roussel M, Jaccard A, Delforge M, Karlin L, Arnulf B, Chari A, He J, Ho KF, Van Rampelbergh R, Uhlar CM, Wang J, Kobos R, Gries KS, Fastenau J, Weisel K. Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial. J Clin Oncol. 2021 Jan 20;39(3):227-237. doi: 10.1200/JCO.20.01370. Epub 2020 Dec 16.

ReferenceCitation: Facon T, Kumar S, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Mace JR, Raje N, Attal M, Tiab M, Macro M, Frenzel L, Leleu X, Ahmadi T, Chiu C, Wang J, Van Rampelbergh R, Uhlar CM, Kobos R, Qi M, Usmani SZ; MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med. 2019 May 30;380(22):2104-2115. doi: 10.1056/NEJMoa1817249.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Denmark
United Kingdom
Ireland
Austria
Australia
Netherlands
Canada
Sweden
United States
France
Israel
Belgium
Germany

intervention_type: Drug

status_simplified: Ongoing


title: A Prospective, Observational Study to Estimate the Proportion of Subjects With Plaque Psoriasis Who Achieve Complete Clearance on Biologics

summary: To estimate the real-world effectiveness of approved biologics in subjects with moderate-to-severe plaque psoriasis who are either starting or switching biologic medication.

time_perspective: Prospective

location_country:
United Kingdom
Italy
United States
France
Germany


title: A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate Cancer

summary: The purpose of this registry is to document the characteristics and management of patients with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice, independent of treatment used. Given the rapidly evolving landscape in mCRPC treatments, there is a need for a current and improved understanding of how these treatments fit into the current treatment paradigm for mCRPC, how they are combined and sequenced, and how their relative effectiveness profiles emerge outside of a clinical trial setting. This will be based on documentation and description of sequencing of treatment initiation, termination, and duration; relative effectiveness of treatments; defined medical resource utilization (MRU) and quality-of-life parameters and follow-up for survival.

ReferenceCitation: Verry C, Vincendeau S, Massetti M, Blachier M, Vimont A, Bazil ML, Bernardini P, Pettré S, Timsit MO. Pattern of Clinical Progression Until Metastatic Castration-Resistant Prostate Cancer: An Epidemiological Study from the European Prostate Cancer Registry. Target Oncol. 2022 Jul;17(4):441-451. doi: 10.1007/s11523-022-00899-6. Epub 2022 Jul 16.

ReferenceCitation: Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, Birtle A, Kramer G, Kalinka E, Spaëth D, Feyerabend S, Matveev V, Lefresne F, Lukac M, Wapenaar R, Costa L, Chowdhury S. Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry. Target Oncol. 2021 May;16(3):357-367. doi: 10.1007/s11523-021-00807-4. Epub 2021 Apr 7.

ReferenceCitation: Chowdhury S, Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, Birtle A, Kramer G, Kalinka E, Spaëth D, Feyerabend S, Matveev V, Lefresne F, Lukac M, Wapenaar R, Costa L. Real-World Outcomes in First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer: The Prostate Cancer Registry. Target Oncol. 2020 Jun;15(3):301-315. doi: 10.1007/s11523-020-00720-2.

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Poland
Portugal
Luxembourg
Slovenia
Spain
Austria
Russian Federation
United Kingdom
Switzerland
Sweden
France
Israel
Turkey
Belgium
Germany


type: Registry Identifier

title: A Phase 3, Multicenter, Randomized, Open-label Trial to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Docetaxel in Previously Treated Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (LEAP-008)

summary: This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).

enrollment_type: Anticipated

ReferenceCitation: Xing P, Wang M, Zhao J, Zhong W, Chi Y, Xu Z, Li J. Study protocol: A single-arm, multicenter, phase II trial of camrelizumab plus apatinib for advanced nonsquamous NSCLC previously treated with first-line immunotherapy. Thorac Cancer. 2021 Oct;12(20):2825-2828. doi: 10.1111/1759-7714.14113. Epub 2021 Aug 18.

ReferenceCitation: Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

ipd_sharing: Yes

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Portugal
Spain
Greece
Italy
Australia
Russian Federation
Argentina
Canada
United Kingdom
Hungary
Korea, Republic of
United States
France
Israel
Puerto Rico
Colombia
Japan
Germany

location_facility: Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 1604)

location_facility: University of Kentucky School of Medicine & Hospitals ( Site 1621)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0610)

location_facility: Birmingham Heartlands Hospital ( Site 1103)

location_facility: Southern Medical Day Care Centre ( Site 0001)

location_facility: Hematology and Oncology Institute ( Site 2105)

location_facility: Seoul National University Bundang Hospital ( Site 0204)

location_facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0808)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 1301)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0918)

location_facility: Tudogyogyintezet Torokbalint ( Site 0602)

location_facility: Hospital Universitario 12 de Octubre ( Site 1006)

location_facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 1662)

location_facility: Istituto Nazionale dei Tumori ( Site 0806)

location_facility: Consorci Hospitalari Mataro ( Site 1008)

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház ( Site 0601)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 1501)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1305)

location_facility: Massachusetts General Hospital ( Site 1622)

location_facility: Cancer Specialists of North Florida - Fleming Island ( Site 1675)

location_facility: Chungbuk National University Hospital ( Site 0201)

location_facility: AOU Policlinico Vittorio Emanuele ( Site 0811)

location_facility: Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site

location_facility: The Cancer Institute Hospital of JFCR ( Site 0100)

location_facility: European Interbalkan Medical Center ( Site 1704)

location_facility: GBUZ Republican Clinical Oncological Dispensary ( Site 0922)

location_facility: Hopital Europeen Georges Pompidou ( Site 0408)

location_facility: Princess Alexandra Hospital - Division of Cancer Services ( Site 0002)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 0603)

location_facility: Pavlov First Saint Petersburg State Medical University ( Site 0917)

location_facility: Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1801)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 1011)

location_facility: Princess Margaret Cancer Centre ( Site 1502)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1304)

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello P.O. Villa Sofia ( Site 0810)

location_facility: University Hospital of Ioannina ( Site 1701)

location_facility: Thompson Cancer Survival Center ( Site 1695)

location_facility: Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1102)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 0608)

location_facility: Port Macquarie Base Hospital ( Site 0003)

location_facility: Hospital Britanico de Buenos Aires ( Site 2002)

location_facility: Evangelisches Krankenhaus Hamm gGmbH ( Site 0504)

location_facility: Memorial Sloan Kettering Cancer Center - Nassau ( Site 1670)

location_facility: Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 1666)

location_facility: Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0501)

location_facility: Kingston Health Sciences Centre ( Site 1503)

location_facility: Policlinico San Matteo - Fondazione IRCCS ( Site 0812)

location_facility: Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 1644)

location_facility: University Hospital Coventry and Warwickshire NHS Trust ( Site 1112)

location_facility: Shaare Zedek Medical Center-Oncology ( Site 0706)

location_facility: Hospital Central de Asturias ( Site 1002)

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0606)

location_facility: Hospital Universitario Quiron Madrid ( Site 1012)

location_facility: CHU Caen Service de Pneumologie ( Site 0401)

location_facility: Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0905)

location_facility: Hospital Universitari Vall d Hebron ( Site 1004)

location_facility: Centre Hospitalier General - Avignon ( Site 0407)

location_facility: Central Clinical Hospital of the Administration of the President ( Site 0910)

location_facility: Kanagawa Cardiovascular and Respiratory Center ( Site 0105)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1003)

location_facility: Ad-Vance Medical Research LLC ( Site 2103)

location_facility: Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 1108)

location_facility: Calvary Central Districts Hospital ( Site 0007)

location_facility: SPb SBHI City Clinical Oncological Dispensary ( Site 0901)

location_facility: Azienda Ospedaliera di Perugia ( Site 0805)

location_facility: Hospital Universitario Fundacion Jimenez Diaz ( Site 1005)

location_facility: Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1664)

location_facility: Instituto de Investigaciones Metabolicas ( Site 2004)

location_facility: Azienda Ospedaliera San Giuseppe Moscati ( Site 0809)

location_facility: Memorial Sloan-Kettering Cancer Center ( Site 1661)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 1514)

location_facility: Memorial Sloan-Kettering Cancer Center at Montvale ( Site 1667)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 0609)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1800)

location_facility: St James s University Hospital ( Site 1106)

location_facility: Nottingham City Hospital Campus ( Site 1105)

location_facility: Ospedale San Gerardo - ASST Monza ( Site 0804)

location_facility: Severance Hospital Yonsei University Health System ( Site 0202)

location_facility: Hospital Universitario Puerta de Hierro ( Site 1007)

location_facility: Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0807)

location_facility: General Hospital of Chest Diseases "Sotiria" ( Site 1703)

location_facility: Medstar Good Samaritan Hospital ( Site 1625)

location_facility: Metropolitan Hospital-4th Oncology Dept ( Site 1700)

location_facility: Bozeman Health Deaconness Cancer Center ( Site 1632)

location_facility: Hospital Clinico de Valencia ( Site 1010)

location_facility: Memorial Sloan-Kettering Cancer Center at Middletown ( Site 1665)

location_facility: New York Cancer and Blood Specialists ( Site 1696)

location_facility: North Middlesex University Hospital NHS Trust ( Site 1109)

location_facility: University of Massachusetts Medical School ( Site 1693)

location_facility: Harry & Jeanette Weinberg Cancer Institute ( Site 1626)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0903)

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 0503)

location_facility: Administradora Country SA - Clinica del Country ( Site 1307)

location_facility: MGH - North Shore Cancer Center ( Site 1668)

location_facility: Niigata Cancer Center Hospital ( Site 0101)

location_facility: Kansai Medical University Hospital ( Site 0104)

location_facility: Sourasky Medical Center (Ichilov) - Oncology Clinic ( Site 0705)

location_facility: Puerto Rico Medical Research Center LLC ( Site 2101)

location_facility: London Regional Cancer Program - London HSC ( Site 1505)

location_facility: National Cancer Center Hospital ( Site 0103)

location_facility: The Mass General Cancer Center at Newton-Wellesley ( Site 1692)

location_facility: Veszprem Megyei Tudogyogyintezet ( Site 0607)

intervention_type: Biological


title: Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes

acronym: SOUL

summary: The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. The study will last for about 3.5-5 years. Participants will have up to 25 clinic visits and 1 phone call with the study doctor. Women cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during the study period.

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

lead_sponsor: Novo Nordisk A/S

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
South Africa
Czechia
Hong Kong
Austria
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Malaysia
Slovakia
Brazil
Canada
China
Germany
Denmark
Taiwan
Thailand
Algeria
France
Korea, Republic of
Colombia
Netherlands


title: A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-67856633, an Inhibitor of MALT1, in Participants With NHL and CLL

summary: The purpose of this study is to determine the recommended Phase 2 dose regimen or the maximum tolerated dose of JNJ-67856633 in participants with relapsed/ refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia.

design_allocation: Non-Randomized

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:
Spain
Greece
Italy
Australia
United Kingdom
Korea, Republic of
United States
France
China
Israel
Japan
Germany

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

location_facility: Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science

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

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole


title: A Study of Disease Progression in Genetically Defined Subjects With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

summary: An observational study to evaluate the natural progression of dry AMD in genetically defined subjects

status: Recruiting

lead_sponsor: Gyroscope Therapeutics Limited

location_country:
Poland
Spain
United Kingdom
Australia
Netherlands
United States
France
Germany

location_facility: Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu

location_facility: Retinal Research Institute (retina consultants of AZ)

location_facility: Johns Hopkins University School of Medicine

location_facility: The University of Melbourne - The Centre for Eye Research Australia (CERA)

location_facility: Specjalistyczny Osrodek Okulistyczny Oculomedica

location_facility: Klinika Okulistyczna Jasne Blonia Sp. z o.o.

location_facility: Hospital General de Catalunya Sant Cugat del Valles

location_facility: University Hospital Schleswig-Holstein - Campus Luebeck

location_facility: Oftalmika - Prywatna Klinika Okulistyczna

location_facility: Retina Vitreous Associates Medical Group


title: Prospective, Single Arm, Multi-centre, Observational Registry to Further Validate Safety and Efficacy of the Ultimaster Des System in Unselected Patients Representing Everyday Clinical Practice

acronym: e-Ultimaster

summary: The e-Ultimaster will further validate the safety and efficacy of Ultimaster DES system in unselected patients representing everyday clinical practice. Also the study will assess the impact of non-compliance with dual antiplatelet therapy, one month after stent implementation (frequently observed in every day clinical practice), on stent thrombosis.

status: Unknown status

ReferenceCitation: Kobo O, Saada M, von Birgelen C, Tonino PAL, Íñiguez-Romo A, Fröbert O, Halabi M, Oemrawsingh RM, Polad J, IJsselmuiden AJJ, Roffi M, Aminian A, Mamas MA, Roguin A. Impact of Multisite artery disease on Clinical Outcomes After Percutaneous Coronary Intervention: An Analysis from the e-Ultimaster Registry. Eur Heart J Qual Care Clin Outcomes. 2022 Jul 25. pii: qcac043. doi: 10.1093/ehjqcco/qcac043. [Epub ahead of print]

lead_sponsor: Terumo Europe N.V.

location_country:
Serbia
Saudi Arabia
Armenia
Spain
United Kingdom
Lithuania
Ukraine
Kazakhstan
Belgium
Iceland
Japan
Romania
South Africa
Uzbekistan
Czechia
Poland
Portugal
Austria
Argentina
Tunisia
Indonesia
India
Israel
Mexico
Malaysia
Sweden
Slovakia
Egypt
Kuwait
Brazil
Lebanon
Bangladesh
Switzerland
Hungary
North Macedonia
Bulgaria
Belarus
Jordan
Ireland
Georgia
Estonia
Oman
Thailand
Vietnam
France
Chile
Colombia
Netherlands
Morocco
United Arab Emirates

location_facility: Szatmar-Szabolcs-Bereg county hospital and university teaching hospital

location_facility: OLVZ Aalst, Onze Lieve Vrouw Ziekenhuis vzw-Campus Aalst

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Clinique St Augustin Bordeaux-Centre d'exploration-chirurgie

location_facility: Institute of cardiovascular diseases Vojvodina

location_facility: Hosp Universitario de Gran Canaria Dr. Negrin

location_facility: Cardiology Clinic, Clinical Centre of Serbia

location_facility: Stredodlovensky Ustav Srdcovych A Cievnych Chorob

location_facility: Universitario central de Asturias (Oviedo)

location_facility: Markusovszky University Teaching Hospital

location_facility: Dr. Wahidin Sudirohusodo General Hospital

location_facility: Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

location_facility: Polyclinique El Bassatine SFAX_Dr. Sami Fourati

location_facility: Krankenanstalt Rudolfstiftung der Stadt Wien

location_facility: Nottingham University Hospitals - Queen's Medical Centre

location_facility: Hopital privé St Martin Pessac (DR Levy)

location_facility: Hospital e Maternidade Dr. Christóvão da Gama

location_facility: Landspitali National University hospital

location_facility: Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego w Poznaniu

location_facility: Polyclinique Bassatine Cite gardin Sfax_Dr. Zeineb Grati Guermazi

location_facility: Dr Hussien Heshmat - As Salam International Hospital

location_facility: National Heart Foundation Hospital and Research Institute

location_facility: NAMS Amosov | X-Ray diagnostics and invasive cardiology department

location_facility: Saitama Cardiovascular and Respiratory Center

location_facility: Instituto Cardiologico Hospital Campo Grande (Valladolid)

location_facility: Groupe Hospitalier de la Rochelle Ré Aunis

location_facility: Dr JCW Badenhorst - Netcare Unitas Hospital

location_facility: Max Super Speciality Hospital, Saket, Delhi

location_facility: S.P.M.C. of Pediatric Cardiology and Cardiac Surgery

location_facility: Yerevan State medical University Hospital

location_facility: Polyclinique El bassatine_Dr. Mohamed Najeh Abid

location_facility: NAMS Amosov | Emergency Endovascular Surgery department

location_facility: City General Hospital 8th September Skopje

location_facility: Clinical Center of Cardiac Surgery and Transplantation

location_facility: National Cardiovascular Center Harapan Kita

location_facility: Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

location_facility: City clinic University Multi-Profile Hospital for Acute Care,Sofia

location_facility: Clinique Général et Cardiovasculaire de Tunis_Dr. Saloua Trabelsi

location_facility: Strazhesko Institute of Cardiology (National Scientific Centre)

location_facility: National Scientific Medical Research Center JSC

location_facility: Clinique Générale et Cardiovasculaire de Tunis_Dr. Saloua TRABELSI

location_facility: Clinique Générale et Cardiovasculaire de Tunis_Dr. Sami Bouziri

location_facility: Specialized Cardiology Hospital for Active Treatment

location_facility: Hospital Universitario Lucus Augusti (HULA)

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Hanusch Krankenhaus der Wiener Gebietskrankenkasse

location_facility: Clinique Hannibal Lac 2_Dr. Mohamed Drissa

location_facility: National Institute of Cardiovascular Surgery NAMS

location_facility: National Institute of Surgery and Transplantology NAMS

location_facility: Prince Abdullah Bin Abdulaziz Cardiac Center

location_facility: Hospital Clínico Lozano Blesa de Zaragoza

location_facility: Hospital Marqués de Valdecilla, Santander

location_facility: Medical University Clinic West Kazakhstan

location_facility: Institut Arnault Tzanck St Laurent du Var

location_facility: Complexo Hospitalario Universitario A Coruña (CHUAC)

location_facility: H.J. Doshi Ghatkopar Hindusabha Hospital

location_facility: Hospital General Universitario de Burgos

location_facility: Polyclinique El Bassatine_Dr. Ridha Ennouri

location_facility: Saiseikai Yokohama City Eastern Hospital

location_facility: G. Kuppuswamy Naidu Memorial Hospital (GKNM), Coimbatore

location_facility: HRH Princess Maha Chakri Sirindhorn Medical Center (Nakornayok)

location_facility: HRH Princess Maha Chakri Siridhorn Medical Center

location_facility: Clinica Hospital San Jose de Navojoa SA de CV

location_facility: Government institution Regional centre of cardiac and vessel disease

location_facility: Universitario Santa Lucia (Hospital Nostra Señora Rossell) (Cartagena)

location_facility: Le Confluent Nouvelles Cliniques Nantaises

status_simplified: Unknown


title: A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Osimertinib Following SBRT, a Single Arm Cohort for Patients With Unresected Stage I/II, Lymph Node Negative NSCLC Harboring a Sensitizing EGFR Mutation

source: euctr

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

location_country:
Poland
Spain
Greece
Italy
Australia
Netherlands
Canada
Russian Federation
United Kingdom
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany
Puerto Rico
Turkey

summary:
This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.

An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.


title: Phase IIa Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose Study on ABX464 in Combination With Methotrexate (MTX), in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have Inadequate Response to MTX or/and to an Anti- Tumor Necrosis Factor Alpha (Tnfα) Therapy, or Intolerance to Anti-Tnfα Therapy

summary: This Phase IIa study aims at investigating the safety and tolerability of 2 dose-levels of ABX464 administered daily in combination with methotrexate (MTX) in patients with moderate to severe active Rheumatoid Arthritis (RA) who had an inadequate response to MTX or/and to one or more anti- tumor necrosis factor alpha (TNFα) therapies.

ReferenceCitation: Daien C, Krogulec M, Gineste P, Steens JM, Desroys du Roure L, Biguenet S, Scherrer D, Santo J, Ehrlich H, Durez P. Safety and efficacy of the miR-124 upregulator ABX464 (obefazimod, 50 and 100 mg per day) in patients with active rheumatoid arthritis and inadequate response to methotrexate and/or anti-TNFalpha therapy: a placebo-controlled phase II study. Ann Rheum Dis. 2022 May 31;81(8):1076-84. doi: 10.1136/annrheumdis-2022-222228. Online ahead of print.

ipd_sharing: Undecided

lead_sponsor: Abivax S.A.

location_country: Poland Hungary France Belgium Czechia

location_facility: CMed Rehabilitációs és Diagnosztikai Központ


title: A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease

summary: The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD. Published studies which assessed the use of an 'open' triple therapy (use of Inhaled Corticosteroid [ICS]/ Long-acting Muscarinic Receptor Antagonists [LAMA])/ Long Acting Beta-Agonist [LABA] delivered via multiple inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared to dual therapy (ICS/LABA) or LAMA alone. These studies have also shown similar safety profile with dual or monotherapy doses for periods of up to one year. Given the clinical experience with FF, UMEC and VI, and that the associated risks with these compounds are anticipated from their known pharmacology, the potential benefit of a new therapy option in patients with moderate to severe COPD supports the further development of the closed triple combination (delivered via one inhaler). In the current study subjects meeting all inclusion/exclusion criteria will complete 2-week run-in period; 52 week treatment period and a 1-week safety follow-up period. Eligible subjects will be randomized to one of the following double-blind treatment groups FF/UMEC/VI 100 micrograms (mcg)/62.5 mcg/25 mcg once daily (QD), FF/VI 100 mcg/25 mcg QD, or UMEC/VI 62.5 mcg/25 mcg QD

ReferenceCitation: Dransfield MT, Criner GJ, Halpin DMG, Han MK, Hartley B, Kalhan R, Lange P, Lipson DA, Martinez FJ, Midwinter D, Singh D, Wise R, Kunisaki KM. Time-Dependent Risk of Cardiovascular Events Following an Exacerbation in Patients With Chronic Obstructive Pulmonary Disease: Post Hoc Analysis From the IMPACT Trial. J Am Heart Assoc. 2022 Sep 20;11(18):e024350. doi: 10.1161/JAHA.121.024350. Epub 2022 Sep 14.

ReferenceCitation: Thomashow B, Stiegler M, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lange P, Martinez FJ, Midwinter D, Singh D, Tabberer M, Wise RA, Lipson DA, Jones P. Higher COPD Assessment Test Score Associated With Greater Exacerbations Risk: A Post Hoc Analysis of the IMPACT Trial. Chronic Obstr Pulm Dis. 2022 Jan 27;9(1):68-79. doi: 10.15326/jcopdf.2021.0259.

ReferenceCitation: Bafadhel M, Barnes N, Bourke SC, Compton C, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Hartley B, Jones CE, Lange P, Lettis S, Lipson DA, Lomas DA, Martin N, Martinez FJ, Wise R, Singh D. A single blood eosinophil count measurement is as good as two for prediction of ICS treatment response in the IMPACT trial. Eur Respir J. 2021 Sep 23;58(3). pii: 2004522. doi: 10.1183/13993003.04522-2020. Print 2021 Sep.

ReferenceCitation: Singh D, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lange P, Lettis S, Lipson DA, Mannino D, Martin N, Martinez FJ, Miller BE, Wise R, Zhu CQ, Lomas D. InforMing the PAthway of COPD Treatment (IMPACT) trial: fibrinogen levels predict risk of moderate or severe exacerbations. Respir Res. 2021 Apr 28;22(1):130. doi: 10.1186/s12931-021-01706-y.

ReferenceCitation: Halpin DMG, Criner GJ, Dransfield MT, Han MK, Hartley B, Harvey C, Jones CE, Kato M, Lange P, Lettis S, Lomas DA, Martinez FJ, Martin N, Singh D, Wise R, Zheng J, Lipson DA. Triple Versus Dual Combination Therapy in Chronic Obstructive Pulmonary Disease in Asian Countries: Analysis of the IMPACT Trial. Pulm Ther. 2021 Jun;7(1):101-118. doi: 10.1007/s41030-020-00136-3. Epub 2020 Nov 17.

ReferenceCitation: Bourdin A, Criner G, Devouassoux G, Dransfield M, Halpin DMG, Han MK, Jones CE, Kalhan R, Lange P, Lettis S, Lipson DA, Lomas DA, Echave-Sustaeta María-Tomé JM, Martin N, Martinez FJ, Quasny H, Sail L, Siler TM, Singh D, Thomashow B, Watz H, Wise R, Hanania NA. InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD: Analysis of the Western Europe and North America Regions. Chronic Obstr Pulm Dis. 2021 Jan;8(1). doi: 10.15326/jcopdf.2020.0158.

ReferenceCitation: Zheng J, Zhong N, Wang C, Wei LP, Zhou XD, Zhao L, Dong Yuan Y, He B, Wu B, Du X, Song J, Lipson DA. Single inhaler triple therapy (FF/UMEC/VI) versus FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the China cohort in the IMPACT trial. Curr Med Res Opin. 2021 Jan;37(1):145-155. doi: 10.1080/03007995.2020.1844646. Epub 2020 Dec 7.

ReferenceCitation: Marín JM, Mateos L, Roldán J, Echave-Sustaeta JM, Pascual-Guardia S, Pardo MV, Velasco B, Jones CE, Kilbride S, Lipson DA. Efficacy of FF/UMEC/VI compared with FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the Spain cohort in IMPACT. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620963021. doi: 10.1177/1753466620963021.

ReferenceCitation: Hanania NA, Mannino DM, Criner GJ, Dransfield MT, Han MK, Jones CE, Kilbride S, Lomas DA, Martin N, Martinez FJ, Singh D, Wise RA, Halpin DMG, Lima R, Lipson DA. Effect of Age on the Efficacy and Safety of Once-Daily Single-Inhaler Triple-Therapy Fluticasone Furoate/Umeclidinium/Vilanterol in Patients With COPD: A Post Hoc Analysis of the Informing the Pathway of COPD Treatment Trial. Chest. 2021 Mar;159(3):985-995. doi: 10.1016/j.chest.2020.09.253. Epub 2020 Oct 5.

ReferenceCitation: Tabberer M, Jones CE, Kilbride S, Halpin DMG, Lomas DA, Pascoe S, Singh D, Wise RA, Criner GJ, Lange P, Dransfield MT, Han MK, Martinez FJ, Kaisermann MC, Lipson DA. Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD: The IMPACT Study. Adv Ther. 2020 Sep;37(9):3775-3790. doi: 10.1007/s12325-020-01409-8. Epub 2020 Jul 9. Erratum in: Adv Ther. 2022 Mar;39(3):1446.

ReferenceCitation: Han MK, Criner GJ, Dransfield MT, Halpin DMG, Jones CE, Kilbride S, Lange P, Lettis S, Lipson DA, Lomas DA, Martin N, Wise RA, Singh D, Martinez FJ. The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study. A Randomized, Double-Blind, Multicenter Clinical Trial. Am J Respir Crit Care Med. 2020 Nov 1;202(9):1237-1243. doi: 10.1164/rccm.201912-2478OC.

ReferenceCitation: Day NC, Kumar S, Criner G, Dransfield M, Halpin DMG, Han MK, Jones CE, Kaisermann MC, Kilbride S, Lange P, Lomas DA, Martin N, Martinez FJ, Singh D, Wise R, Lipson DA. Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial. Respir Res. 2020 Jun 5;21(1):139. doi: 10.1186/s12931-020-01398-w.

ReferenceCitation: Bogart MR, Hopson SD, Shih HC, Stanford RH, Coutinho AD. COPD exacerbation costs in the IMPACT study: a within-trial analysis. Am J Manag Care. 2020 May 1;26(5):e150-e154. doi: 10.37765/ajmc.2020.43157.

ReferenceCitation: Halpin DMG, Dransfield MT, Han MK, Jones CE, Kilbride S, Lange P, Lipson DA, Lomas DA, Martinez FJ, Pascoe S, Singh D, Wise R, Criner GJ. The effect of exacerbation history on outcomes in the IMPACT trial. Eur Respir J. 2020 May 21;55(5). pii: 1901921. doi: 10.1183/13993003.01921-2019. Print 2020 May. Erratum in: Eur Respir J. 2020 Jun 18;55(6):.

ReferenceCitation: Lipson DA, Crim C, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Lettis S, Manchester P, Martin N, Midwinter D, Morris A, Pascoe SJ, Singh D, Wise RA, Martinez FJ. Reduction in All-Cause Mortality with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2020 Jun 15;201(12):1508-1516. doi: 10.1164/rccm.201911-2207OC.

ReferenceCitation: Ismaila AS, Risebrough N, Schroeder M, Shah D, Martin A, Goodall EC, Ndirangu K, Criner G, Dransfield M, Halpin DM, Han MK, Lomas DA. Cost-Effectiveness Of Once-Daily Single-Inhaler Triple Therapy In COPD: The IMPACT Trial. Int J Chron Obstruct Pulmon Dis. 2019 Nov 29;14:2681-2695. doi: 10.2147/COPD.S216072. eCollection 2019.

ReferenceCitation: Mehta R, Farrell C, Hayes S, Birk R, Okour M, Lipson DA. Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2020 Jan;59(1):67-79. doi: 10.1007/s40262-019-00794-w.

ReferenceCitation: Pascoe S, Barnes N, Brusselle G, Compton C, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Hartley B, Lange P, Lettis S, Lipson DA, Lomas DA, Martinez FJ, Papi A, Roche N, van der Valk RJP, Wise R, Singh D. Blood eosinophils and treatment response with triple and dual combination therapy in chronic obstructive pulmonary disease: analysis of the IMPACT trial. Lancet Respir Med. 2019 Sep;7(9):745-756. doi: 10.1016/S2213-2600(19)30190-0. Epub 2019 Jul 4. Erratum in: Lancet Respir Med. 2021 Dec;9(12):e114.

ReferenceCitation: Lipson DA, Barnhart F, Brealey N, Brooks J, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Martinez FJ, Singh D, Tabberer M, Wise RA, Pascoe SJ; IMPACT Investigators. Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD. N Engl J Med. 2018 May 3;378(18):1671-1680. doi: 10.1056/NEJMoa1713901. Epub 2018 Apr 18.

ReferenceCitation: Pascoe SJ, Lipson DA, Locantore N, Barnacle H, Brealey N, Mohindra R, Dransfield MT, Pavord I, Barnes N. A phase III randomised controlled trial of single-dose triple therapy in COPD: the IMPACT protocol. Eur Respir J. 2016 Aug;48(2):320-30. doi: 10.1183/13993003.02165-2015. Epub 2016 Jul 13.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
United Kingdom
Ukraine
United States
Peru
Belgium
Japan
Philippines
Romania
South Africa
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Israel
Turkey
Norway
Singapore
Sweden
Brazil
Canada
China
Germany
Denmark
New Zealand
Finland
Thailand
Vietnam
Korea, Republic of
France
Chile
Colombia
Netherlands


type: Other Grant/Funding Number

title: A Randomised, Open-label Phase III Trial Evaluating the Addition of Denosumab to Standard First-line Anticancer Treatment in Advanced NSCLC

acronym: SPLENDOUR

summary: The purpose of this study is to investigate how well the standard treatment (platinum-based doublet chemotherapy) in combination with denosumab works compared with the standard treatment alone in patients with a type of lung cancer called "non small cell lung cancer" (NSCLC) that has spread to other parts of the body.

ReferenceType: background

ReferenceCitation: Rosen LS, Gordon D, Tchekmedyian NS, Yanagihara R, Hirsh V, Krzakowski M, Pawlicki M, De Souza P, Zheng M, Urbanowitz G, Reitsma D, Seaman J. Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with nonsmall cell lung carcinoma and other solid tumors: a randomized, Phase III, double-blind, placebo-controlled trial. Cancer. 2004 Jun 15;100(12):2613-21.

ReferenceCitation: Tsuya A, Kurata T, Tamura K, Fukuoka M. Skeletal metastases in non-small cell lung cancer: a retrospective study. Lung Cancer. 2007 Aug;57(2):229-32. Epub 2007 Apr 23.

ReferenceCitation: Henry DH, Costa L, Goldwasser F, Hirsh V, Hungria V, Prausova J, Scagliotti GV, Sleeboom H, Spencer A, Vadhan-Raj S, von Moos R, Willenbacher W, Woll PJ, Wang J, Jiang Q, Jun S, Dansey R, Yeh H. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011 Mar 20;29(9):1125-32. doi: 10.1200/JCO.2010.31.3304. Epub 2011 Feb 22.

ReferenceCitation: Tan W, Zhang W, Strasner A, Grivennikov S, Cheng JQ, Hoffman RM, Karin M. Tumour-infiltrating regulatory T cells stimulate mammary cancer metastasis through RANKL-RANK signalling. Nature. 2011 Feb 24;470(7335):548-53. doi: 10.1038/nature09707. Epub 2011 Feb 16.

ReferenceCitation: Scagliotti GV, Hirsh V, Siena S, Henry DH, Woll PJ, Manegold C, Solal-Celigny P, Rodriguez G, Krzakowski M, Mehta ND, Lipton L, García-Sáenz JA, Pereira JR, Prabhash K, Ciuleanu TE, Kanarev V, Wang H, Balakumaran A, Jacobs I. Overall survival improvement in patients with lung cancer and bone metastases treated with denosumab versus zoledronic acid: subgroup analysis from a randomized phase 3 study. J Thorac Oncol. 2012 Dec;7(12):1823-1829. doi: 10.1097/JTO.0b013e31826aec2b.

ipd_sharing: No

lead_sponsor: ETOP IBCSG Partners Foundation

location_country:
Poland
Slovenia
Ireland
Austria
Italy
Spain
United Kingdom
Switzerland
France
Belgium
Germany

location_facility: Centre hospitalier universitaire d'Angers

location_facility: Centre Hospitalier Regional De La Citadelle

location_facility: Assistance Publique-Hôitaux de Marseille

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: ASKLEPIOS - Fachkliniken München - Gauting

location_facility: Institut Català d'Oncologia - L'Hospitalet

location_facility: Hôpitale de la Cavale Blanche - CHRU de BREST


title: A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy

acronym: PROTECT

summary: To determine the long-term (approximately 2 years) nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with immunoglobulin A nephropathy (IgAN).

lead_sponsor: Travere Therapeutics, Inc.

location_country:
Croatia
Poland
Hong Kong
Portugal
Spain
Italy
Taiwan
Australia
Estonia
Lithuania
New Zealand
United Kingdom
Korea, Republic of
United States
France
Belgium
Germany
Czechia


acronym: NIAGARA

title: A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Philippines
Japan
Czechia
Poland
Russian Federation
Australia
Israel
Turkey
Brazil
Canada
Germany
Taiwan
Vietnam
Korea, Republic of
France
Chile
Netherlands

summary: A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer


status: Terminated

title: An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Pediatric Subjects

lead_sponsor: Incyte Corporation

location_country:
Spain
Italy
United Kingdom
United States
France
Germany

location_facility: Great Ormond Street Hospital for Children

location_facility: Universitatsklinikum Jena, Klinik fur Kinder und Jugendmedizin

location_facility: Central Manchester University Hospital - Royal Manchester Children's Hospital

location_facility: Children's Hospital of Philadelphia - Center for Childhood Cancer Research

location_facility: Nemours/A.I. duPont Hospital for Children

location_facility: Azienda Ospedaliero Unversitatia Policlinico - Vittorio Emanuele - Presido Ospedaliero G. Rodolico

location_facility: AOU Citta della Salute e della Scienza di Torino - Ospedale Regina Margherita

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: University Hospitals Cleveland Medical Center - Rainbow Babies and Children's Hospital

location_facility: Doernbecher Children's Hospital - Division of Pediatric Hematology

location_facility: Children's Hospital Colorado - Center for Cancer and Blood Disorders

location_facility: Hospital Clinico de Santiago de Compostela

location_facility: Centre Hospitalier Universitaire de Rennes

summary: The purpose of this study is to evaluate itacitinib in combination with corticosteroids for the treatment of Grades II to IV acute graft-versus-host disease (aGVHD) in steroid-naive pediatric participants.


title: A Phase 3, Matrix Design, Partially Double-Blind, Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib/100 mg Ritonavir BID With and Without 180 mcg PEG IFN-alfa-2a for 48 Weeks Compared With PEG IFN-alfa-2a Monotherapy and Placebo Treatment in Patients Chronically Infected With Hepatitis Delta Virus Being Maintained on Anti-HBV Nucleos(t)Ide Therapy (D-LIVR)

acronym: D-LIVR

summary: Two LNF-containing regimens will be evaluated in the D-LIVR Phase 3 study: (1) LNF/RTV/PEG IFN-alfa-2a and (2) LNF/RTV. Each of these arms will have efficacy endpoints that measure clinical benefit with regard to viral suppression and alanine aminotransferase (ALT) normalization. For each LNF-containing regimen, a composite endpoint of EOT (48 weeks) virologic response and ALT normalization will be used. Virologic response will be defined as a 2 log10 IU/mL reduction from baseline.

lead_sponsor: Eiger BioPharmaceuticals

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
Russian Federation
Israel
Turkey
Sweden
Canada
Switzerland
Germany
Bulgaria
Moldova, Republic of
Taiwan
Greece
New Zealand
Mongolia
France
Pakistan

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

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Acibadem City Clinic Tokuda Hospital Ead

location_facility: Inselspital Bern, Hepatologie, Bauchzentrum, INO- A, Ms. Kathrin Husi

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Municipal Enterprise "Poltava Regional Clinical Infectious Hospital of Poltava Regional Council"

location_facility: Krasnodar specialized clinical infectious diseases hospital

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Clinic of the Ministry of health of the South Ural state medical UNIVERSITY Russia, 2 infectious diseases Department.

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

location_facility: University of California Davis Health System

location_facility: McGill University Health Centre/Glen Site / Royal Victoria Hospital

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

location_facility: Hospital of the state institution "National Institute of Therapy named after L.T. Maloi of the National Academy of Medical Sciences of Ukraine"

location_facility: Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: State Budgetary Educational Institution of Higher Profesional Education "Stavropol State Medical University" of MoH

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

location_facility: University Hospital of Sumy State University

location_facility: Office for treatment of patients with viral hepatitis GBU Sakha (Yakutia) "Yakut Republican clinical hospital"

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: Municipal non-profit enterprise " Vinnytsia city clinical hospital No. 1"

location_facility: ISMP Spitalul Clinic Republican "Timofei Mosneaga"

location_facility: University of Miami Schiff Center for Liver Disease

location_facility: Universita di Modena e Reggio Emilia. Nuovo Ospedale civil

location_facility: Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"

location_facility: Medical Center 'Ok!Clinic+' of International Institute of Clinical Research LLC

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

location_facility: Kaiser Permanente Medical Center Sacramento

location_facility: University of Texas Southwestern Medical Center

location_facility: National medical research center Phthisiopulmonology and infectious diseases of the Ministry of health of the Russian Federation


acronym: SUNSHINE

title: A Randomized, Double-blind, Multi-center Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNSHINE).

lead_sponsor: Novartis Pharmaceuticals

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

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

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Philippines
Japan
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Sweden
Slovakia
Canada
Switzerland
Hungary
Germany
Bulgaria
Taiwan
Greece
Korea, Republic of
France

summary: The purpose of this study is to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study will also assess the safety and tolerability of secukinumab.


acronym: INFINITE

title: A Phase 3, Open-Label, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intrapleural Administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in Combination With Celecoxib and Gemcitabine in Patients With Malignant Pleural Mesothelioma

lead_sponsor: Trizell Ltd

location_country:
Poland
United Kingdom
Italy
Russian Federation
Australia
Canada
United States
France
Germany

location_facility: Institut Universitaire de Cardiologie et de Pneumologie De Quebec

location_facility: Budget Healthcare Institution of Omsk region Clinical Oncology Dispensary

location_facility: Petrov National Medical Research Center of Oncology

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: University of California, San Francisco (UCSF)

location_facility: Volgograd Regional Clinical Oncology Dispensary

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

location_facility: Azienda Ospedaliero Universitaria Senese, Cancer Immunotherapy

location_facility: New York University (NYU) Clinical Cancer Center

location_facility: University of California, Los Angeles (UCLA) - Medical Center

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej - Curie, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

location_facility: Masonic Cancer Center - University of Minnesota

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: State Budget Educational Institution of Higher Professional Education Pavlov First Saint Petersburg State Medical University of Ministry of Healthcare of Russian Federation

summary:
This study will evaluate intrapleural administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in combination with Celecoxib and Gemcitabine in patients with histologically confirmed Malignant Pleural Mesothelioma (MPM) who have failed a minimum of 1 treatment regimen and a maximum of 2 treatment regimens, 1 of which must have been an anti-folate and platinum combination regimen.

Eligible patients will be randomized 1:1 to either:

Treatment group: rAd-IFN + Celecoxib followed by Gemcitabine
Control group: Celecoxib followed by Gemcitabine

Patients randomized to the treatment group will receive rAd-IFN administered into the pleural space via an Intrapleural catheter (IPC) or similar intrapleural device on study Day 1.

The primary objective of this study is to compare the overall survival (OS) associated with rAd IFN, when administered with celecoxib and gemcitabine, versus that associated with celecoxib and gemcitabine alone for the treatment of patients with MPM


acronym: CIRRUS I

title: A Partially-blinded, Active-controlled, Multicenter, Randomized Study Evaluating Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in de Novo and Maintenance Kidney Transplant Recipients (CIRRUS I)

location_country:
Brazil
Spain
Italy
Latvia
Australia
Netherlands
Argentina
Canada
Switzerland
United Kingdom
Sweden
Hungary
Korea, Republic of
United States
France
Norway
Belgium
Japan
Germany
Czechia

summary:
The purpose of this study is to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of three CFZ533 dose regimens in kidney transplant recipients.

This study will allow assessment of the ability of CFZ533 to replace Calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing better renal function with a better safety and tolerability profile. Results of this study will be used to inform the CFZ533 dose and regimen selection for investigation in later phases of clinical development.


title: A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

location_country:
Poland
Brazil
Spain
United Kingdom
Netherlands
Canada
France
United States
Israel
Turkey
Japan
Germany
Czechia

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

location_facility: Instituto de Ensino E Pesquisa Sao Lucas

location_facility: University of Texas, MD Anderson Cancer Center

location_facility: Ankara University School of Medicine, Cebeci Hospital

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni

location_facility: Institut Universitaire du cancer de Toulouse-Oncopole

location_facility: Kobe City Medical Center General Hospital

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: National Hospital Organization Matsumoto Medical Center

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

location_facility: University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

location_facility: The Gordon & Leslie Diamond Health Care Center

location_facility: Instituto COI de Pesquisa, Educacao e Gestao

location_facility: Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

location_facility: Rambam Med.Center - Hematology Institute

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Cancer & Hematology Centers of Western Michigan, PC

location_facility: Klinikum Großhadern der Ludwig-Maximilians-Universität

location_facility: phase 3 - Hämatoonkologischer Studienkreis am Klinikum Aschaffenburg

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: Saint Luke's Hospital - Saint Luke's Cancer Specialists

location_facility: Centre Hospitalier Départmental La Roche sur Yon

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

location_facility: Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

location_facility: IBCC Instituto Brasileiro de Controle do Cancer

location_facility: Albert Schweitzer ziekenhuis-lokatie Dordwijk

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Po

location_facility: National Hospital Organization Kumamoto Medical Center

summary: The purpose of this study to determine if the addition of daratumumab to bortezomib + lenalidomide + dexamethasone (VRd) will improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.


title: A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)

lead_sponsor: Celgene

location_country:
Spain
Italy
United Kingdom
Netherlands
Canada
Switzerland
Sweden
United States
France
Norway
Belgium
Japan
Germany

location_facility: Duke Clinical Research Institute Duke University School of Medicine

location_facility: UCLA Medical Centre-Santa Monica Hematology and Oncology

location_facility: University of Pittsburgh Medical Center - William M. Cooper Ambulatory Care Pavilion

location_facility: University of Utah Huntsman Cancer Center

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Centre Hospitalier Univ De Nantes Hotel-Dieu

location_facility: Sarah Cannon Research Institute Center for Blood

location_facility: University of Colorado Anschutz Cancer Pavilion

location_facility: University of Pittsburgh Medical Center William M. Cooper Ambulatory Care Pavillion

location_facility: Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi - Istituto di Ematolog

location_facility: Washington University School of Medicine, Siteman Cancer Center

location_facility: Karolinska Universitetssjukhuset - Huddinge

location_facility: New York Presbyterian Hospital Weil Cornell Medical College

location_facility: Blood and Marrow Transplant Group of Georgia

location_facility: Baylor University Medical Center at Dallas

location_facility: University of Wisconsin Carbone Cancer Center

summary:
This is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM).

The study is anticipated to randomize approximately 381 subjects with RRMM. Approximately 254 subjects will be randomized to Treatment Arm A and approximately 127 subjects will be randomized to Treatment Arm B.


title: A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment With the Nuvaira™ Lung Denervation System in Patients With Chronic Obstructive Pulmonary Disease (COPD)

summary: The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System (Nuvaira System) in the treatment of COPD.

ReferenceCitation: Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344. Review.

ReferenceCitation: Slebos DJ, Degano B, Valipour A, Shah PL, Deslée G, Sciurba FC; AIRFLOW-3 Trial Study Group. Design for a multicenter, randomized, sham-controlled study to evaluate safety and efficacy after treatment with the Nuvaira® lung denervation system in subjects with chronic obstructive pulmonary disease (AIRFLOW-3). BMC Pulm Med. 2020 Feb 13;20(1):41. doi: 10.1186/s12890-020-1058-5.

ipd_sharing_description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

lead_sponsor: Nuvaira, Inc.

location_country:
United Kingdom
Austria
Netherlands
United States
France
Germany

location_facility: Medical University of South Carolina (MUSC)

location_facility: University of Alabama at Birmingham (UAB) Lung Health Center

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: University Medical Center Groningen (UMCG)

location_facility: Ohio State University Wexner Medical Center


title: An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease

acronym: STAR Extension

summary: To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).

lead_sponsor: H. Lundbeck A/S

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Romania
South Africa
Czechia
Poland
Portugal
Argentina
Israel
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Estonia
Finland
Korea, Republic of
France
Chile


acronym: First-in-Human (FIH) Trial in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma

title: A Phase 1/2, Open-Label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma EPCORE™NHL-1

lead_sponsor: Genmab

ReferenceCitation: Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, Lewis DJ, Sureda Balari A, Cunningham D, Oliveri RS, Elliott B, DeMarco D, Azaryan A, Chiu C, Li T, Chen KM, Ahmadi T, Lugtenburg PJ. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021 Sep 25;398(10306):1157-1169. doi: 10.1016/S0140-6736(21)00889-8. Epub 2021 Sep 8.

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Australia
Netherlands
Finland
Canada
Sweden
Korea, Republic of
United States
France
Singapore
Germany

location_facility: Policlinico S. Orsola-Ematologia LA Seragnoli

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: University of California at San Francisco

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute

location_facility: Akademiska sjukhuset Uppsala University Hospital

location_facility: Der Universität Munchen Medizinische Klinik III LMU

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

location_facility: Klinik fur Innere Medizin Hamatologie and Onkologie

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Northside Hospital- The Blood Marrow Transplant Group

location_facility: H. Lee Moffitt Cancer Center and Research Institute

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

location_facility: Istituto di Candiolo- Fondazione del Piemonte per l'Oncologia

location_facility: Szpital Uniwersytecki nr 2 im dr. Jana Biziela

location_facility: Seoul National University Bundang Hospital

location_facility: Plymouth University School of Medicine- Derriford Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

location_facility: Hospital Universitario Fundacin Jimnez Daz

location_facility: Integrated Clinical Oncology Network Pty Ltd (ICON)

summary: The trial is a global, multi-center safety trial of Epcoritamab, an antibody also known as GEN3013 (DuoBody®-CD3xCD20). The trial consists of three parts: a dose-escalation part (Phase 1, first-in-human (FIH)), an expansion part (Phase 2a) and a dose optimization part (Phase 2a)


acronym: CREDENCE

title: A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy

lead_sponsor: Janssen Research & Development, LLC

ReferenceCitation: Sarraju A, Bakris G, Cannon CP, Cherney D, Damaraju CV, Figtree GA, Gogate J, Greene T, Heerspink HJL, Januzzi JL Jr, Neal B, Jardine MJ, Blais J, Kosiborod M, Levin A, Lingvay I, Weir MR, Perkovic V, Mahaffey KW. Cardiovascular Effects of Canagliflozin in Relation to Renal Function and Albuminuria. J Am Coll Cardiol. 2022 Nov 1;80(18):1721-1731. doi: 10.1016/j.jacc.2022.08.772.

ReferenceCitation: Li JW, Arnott C, Heerspink HJL, MBiostat QL, Cannon CP, Wheeler DC, Charytan DM, Barraclough J, Figtree GA, Agarwal R, Bakris G, de Zeeuw D, Greene T, Levin A, Pollock C, Zhang H, Zinman B, Mahaffey KW, Perkovic V, Neal B, Jardine MJ. Effect of Canagliflozin on Total Cardiovascular Burden in Patients With Diabetes and Chronic Kidney Disease: A Post Hoc Analysis From the CREDENCE Trial. J Am Heart Assoc. 2022 Aug 16;11(16):e025045. doi: 10.1161/JAHA.121.025045. Epub 2022 Aug 5.

ReferenceCitation: Charytan DM, Yu J, Jardine MJ, Cannon CP, Agarwal R, Bakris G, Greene T, Levin A, Pollock C, Powe NR, Arnott C, Mahaffey KW; CREDENCE study investigators. Potential Effects of Elimination of the Black Race Coefficient in eGFR Calculations in the CREDENCE Trial. Clin J Am Soc Nephrol. 2022 Mar;17(3):361-373. doi: 10.2215/CJN.08980621. Epub 2022 Jan 21.

ReferenceCitation: Heerspink HJL, Oshima M, Zhang H, Li J, Agarwal R, Capuano G, Charytan DM, Craig J, de Zeeuw D, Di Tanna GL, Levin A, Neal B, Perkovic V, Wheeler DC, Yavin Y, Jardine MJ. Canagliflozin and Kidney-Related Adverse Events in Type 2 Diabetes and CKD: Findings From the Randomized CREDENCE Trial. Am J Kidney Dis. 2022 Feb;79(2):244-256.e1. doi: 10.1053/j.ajkd.2021.05.005. Epub 2021 May 23.

ReferenceCitation: Zhou Z, Jardine MJ, Li Q, Neuen BL, Cannon CP, de Zeeuw D, Edwards R, Levin A, Mahaffey KW, Perkovic V, Neal B, Lindley RI; CREDENCE Trial Investigators*. Effect of SGLT2 Inhibitors on Stroke and Atrial Fibrillation in Diabetic Kidney Disease: Results From the CREDENCE Trial and Meta-Analysis. Stroke. 2021 May;52(5):1545-1556. doi: 10.1161/STROKEAHA.120.031623. Epub 2021 Apr 20.

ReferenceCitation: Yu J, Li J, Leaver PJ, Arnott C, Huffman MD, Udell JA, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Rosenthal N, Neal B, Figtree GA. Effects of canagliflozin on myocardial infarction: a post hoc analysis of the CANVAS programme and CREDENCE trial. Cardiovasc Res. 2022 Mar 16;118(4):1103-1114. doi: 10.1093/cvr/cvab128.

ReferenceCitation: Jardine M, Zhou Z, Lambers Heerspink HJ, Hockham C, Li Q, Agarwal R, Bakris GL, Cannon CP, Charytan DM, Greene T, Levin A, Li JW, Neuen BL, Neal B, Oh R, Oshima M, Pollock C, Wheeler DC, de Zeeuw D, Zhang H, Zinman B, Mahaffey KW, Perkovic V. Kidney, Cardiovascular, and Safety Outcomes of Canagliflozin according to Baseline Albuminuria: A CREDENCE Secondary Analysis. Clin J Am Soc Nephrol. 2021 Mar 8;16(3):384-395. doi: 10.2215/CJN.15260920. Epub 2021 Feb 22.

ReferenceCitation: Ye N, Jardine MJ, Oshima M, Hockham C, Heerspink HJL, Agarwal R, Bakris G, Schutte AE, Arnott C, Chang TI, Górriz JL, Cannon CP, Charytan DM, de Zeeuw D, Levin A, Mahaffey KW, Neal B, Pollock C, Wheeler DC, Luca Di Tanna G, Cheng H, Perkovic V, Neuen BL. Blood Pressure Effects of Canagliflozin and Clinical Outcomes in Type 2 Diabetes and Chronic Kidney Disease: Insights From the CREDENCE Trial. Circulation. 2021 May 4;143(18):1735-1749. doi: 10.1161/CIRCULATIONAHA.120.048740. Epub 2021 Feb 8.

ReferenceCitation: Sarraju A, Li J, Cannon CP, Chang TI, Agarwal R, Bakris G, Charytan DM, de Zeeuw D, Greene T, Heerspink HJL, Levin A, Neal B, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Perkovic V, Jardine M, Mahaffey KW. Effects of canagliflozin on cardiovascular, renal, and safety outcomes in participants with type 2 diabetes and chronic kidney disease according to history of heart failure: Results from the CREDENCE trial. Am Heart J. 2021 Mar;233:141-148. doi: 10.1016/j.ahj.2020.12.008. Epub 2020 Dec 22.

ReferenceCitation: Durkin M, Blais J. Linear Projection of Estimated Glomerular Filtration Rate Decline with Canagliflozin and Implications for Dialysis Utilization and Cost in Diabetic Nephropathy. Diabetes Ther. 2021 Feb;12(2):499-508. doi: 10.1007/s13300-020-00953-4. Epub 2020 Dec 18.

ReferenceCitation: Willis M, Nilsson A, Kellerborg K, Ball P, Roe R, Traina S, Beale R, Newell I. Cost-Effectiveness of Canagliflozin Added to Standard of Care for Treating Diabetic Kidney Disease (DKD) in Patients with Type 2 Diabetes Mellitus (T2DM) in England: Estimates Using the CREDEM-DKD Model. Diabetes Ther. 2021 Jan;12(1):313-328. doi: 10.1007/s13300-020-00968-x. Epub 2020 Dec 2.

ReferenceCitation: Willis M, Asseburg C, Slee A, Nilsson A, Neslusan C. Development and Internal Validation of a Discrete Event Simulation Model of Diabetic Kidney Disease Using CREDENCE Trial Data. Diabetes Ther. 2020 Nov;11(11):2657-2676. doi: 10.1007/s13300-020-00923-w. Epub 2020 Sep 15.

ReferenceCitation: Jardine MJ, Zhou Z, Mahaffey KW, Oshima M, Agarwal R, Bakris G, Bajaj HS, Bull S, Cannon CP, Charytan DM, de Zeeuw D, Di Tanna GL, Greene T, Heerspink HJL, Levin A, Neal B, Pollock C, Qiu R, Sun T, Wheeler DC, Zhang H, Zinman B, Rosenthal N, Perkovic V; CREDENCE Study Investigators. Renal, Cardiovascular, and Safety Outcomes of Canagliflozin by Baseline Kidney Function: A Secondary Analysis of the CREDENCE Randomized Trial. J Am Soc Nephrol. 2020 May;31(5):1128-1139. doi: 10.1681/ASN.2019111168.

ReferenceCitation: Cannon CP, Perkovic V, Agarwal R, Baldassarre J, Bakris G, Charytan DM, de Zeeuw D, Edwards R, Greene T, Heerspink HJL, Jardine MJ, Levin A, Li JW, Neal B, Pollock C, Wheeler DC, Zhang H, Zinman B, Mahaffey KW. Evaluating the Effects of Canagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease According to Baseline HbA1c, Including Those With HbA1c <7%: Results From the CREDENCE Trial. Circulation. 2020 Feb 4;141(5):407-410. doi: 10.1161/CIRCULATIONAHA.119.044359. Epub 2019 Nov 11.

ReferenceCitation: Mahaffey KW, Jardine MJ, Bompoint S, Cannon CP, Neal B, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Capuano G, de Zeeuw D, Greene T, Levin A, Pollock C, Sun T, Wheeler DC, Yavin Y, Zhang H, Zinman B, Rosenthal N, Brenner BM, Perkovic V. Canagliflozin and Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus and Chronic Kidney Disease in Primary and Secondary Cardiovascular Prevention Groups. Circulation. 2019 Aug 27;140(9):739-750. doi: 10.1161/CIRCULATIONAHA.119.042007. Epub 2019 Jul 11.

ReferenceCitation: Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14.

ReferenceCitation: Jardine MJ, Mahaffey KW, Neal B, Agarwal R, Bakris GL, Brenner BM, Bull S, Cannon CP, Charytan DM, de Zeeuw D, Edwards R, Greene T, Heerspink HJL, Levin A, Pollock C, Wheeler DC, Xie J, Zhang H, Zinman B, Desai M, Perkovic V; CREDENCE study investigators. The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Study Rationale, Design, and Baseline Characteristics. Am J Nephrol. 2017 Dec 13;46(6):462-472. doi: 10.1159/000484633. [Epub ahead of print]

location_country:
Serbia
Spain
United Kingdom
Lithuania
Ukraine
United States
Romania
Japan
Philippines
South Africa
Czechia
Poland
Russian Federation
Australia
Argentina
Puerto Rico
India
Mexico
Malaysia
Slovakia
Brazil
Canada
Guatemala
Hungary
China
Germany
Bulgaria
Taiwan
New Zealand
Korea, Republic of
France
Chile
Colombia
United Arab Emirates

summary: The goal of this study is to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).


acronym: RELAX-AHF-EU

title: A Multicenter, Prospective, Randomized, Open-label Study to Assess the Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients

ReferenceCitation: Grand J, Miger K, Sajadieh A, Køber L, Torp-Pedersen C, Ertl G, López-Sendón J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.

ReferenceCitation: Grand J, Miger K, Sajadieh A, Køber L, Torp-Pedersen C, Ertl G, López-Sendón J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials. J Am Heart Assoc. 2021 Sep 21;10(18):e022288. doi: 10.1161/JAHA.121.022288. Epub 2021 Sep 13.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Romania
Belgium
Iceland
Czechia
Poland
Portugal
Slovenia
Austria
Russian Federation
Slovakia
Switzerland
Hungary
Germany
Bulgaria
Greece
Latvia
Estonia
Finland
France

summary: This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF).


title: Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism

acronym: EinsteinChoice

summary:
This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy.

Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial

primary_purpose: Prevention

ReferenceCitation: Weitz JI, Bauersachs R, Beyer-Westendorf J, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Holberg G, Kakkar A, Lensing AW, Prins M, Haskell L, van Bellen B, Verhamme P, Wells PS, Prandoni P; EINSTEIN CHOICE Investigators. Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study. Thromb Haemost. 2015 Aug 31;114(3):645-50. doi: 10.1160/TH15-02-0131. Epub 2015 May 21.

ReferenceCitation: Flumignan CD, Nakano LC, Baptista-Silva JC, Flumignan RL. Antiplatelet agents for the treatment of deep venous thrombosis. Cochrane Database Syst Rev. 2022 Jul 25;7:CD012369. doi: 10.1002/14651858.CD012369.pub2. Review.

ReferenceCitation: Weitz JI, Lensing AWA, Prins MH, Bauersachs R, Beyer-Westendorf J, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Decousus H, Freitas MCS, Holberg G, Kakkar AK, Haskell L, van Bellen B, Pap AF, Berkowitz SD, Verhamme P, Wells PS, Prandoni P; EINSTEIN CHOICE Investigators. Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism. N Engl J Med. 2017 Mar 30;376(13):1211-1222. doi: 10.1056/NEJMoa1700518. Epub 2017 Mar 18.

lead_sponsor: Bayer

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Philippines
South Africa
Czechia
Poland
Austria
Australia
Russian Federation
Israel
Turkey
Mexico
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
New Zealand
Thailand
Vietnam
Korea, Republic of
France
Netherlands


title: A Multicenter, Long-Term Extension to Evaluate the Long-term Safety and Maintenance of Treatment Effect of LY3074828 in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-3

lead_sponsor: Eli Lilly and Company

ipd_sharing_description:
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

location_country:
Poland
Taiwan
Spain
Italy
Russian Federation
Australia
United Kingdom
Argentina
Canada
Hungary
Korea, Republic of
United States
France
Israel
Puerto Rico
Mexico
Japan
Germany
Czechia

location_facility: SPb SBHI Skin-venerologic dispensary #10

location_facility: California Dermatology & Clinical Research Institute

location_facility: University of North Carolina Dermatology and Skin Cancer Cen

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

location_facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Centralny Szpital Kliniczny MSW Klinika Dermatologii

location_facility: GOU VPO 'Smolensk State Medical Academy of Ministry of Health and Social Development of Russian Federation'

location_facility: Shiga University of Medical Science Hosptial

location_facility: Mount Sinai School of Medicine Dermatology Clinical Trials

location_facility: Instituto de Neumonología Y Dermatología

location_facility: Keck School of Medicine University of Southern California

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Toho University School of Medicine, Sakura Hospital

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Etická komise Krajské zdravotní, a.s. - Masarykovy nemocnice v Ústí nad Labem, o.z.

location_facility: University Hospitals Cleveland Medical Center

location_facility: Psoriasis Treatment Center of Central New Jersey

location_facility: LASER CLINIC Specjalistyczne Gabinety Lekarskie

location_facility: Florida Academic Centers Research and Education, LLC

location_facility: The Pennsylvania Centre for Dermatology, LLC

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Eastern Canada Cutaneous Research Assoicates Ltd

location_facility: NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

location_facility: Presidio Ospedaliero Firenze Centro Piero Palagi

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: GBUZ Clinical dermatology and venereological dispensary

location_facility: Tokai University Hospital- Isehara Campus

location_facility: Kyoto Furitsu Medical University Hospital

location_facility: Tokyo Medical University Ibaraki Medical Center

location_facility: National Taiwan University Hospital - Hsinchu branch

location_facility: Clinica De Enfermedades Cronicas y Procedimientos Especiales

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

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: State scientific centre for dermatovenerology and cosmetolog

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

location_facility: The South Bend Clinic Center for Research

location_facility: Taipei Medical University Shuang Ho Hospital

summary: The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-2

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

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Argentina
Canada
Hungary
Korea, Republic of
United States
France
Israel
Puerto Rico
Japan
Germany
Czechia

location_facility: CEDIC-Centro de Investigaciones Clinicas

location_facility: Austin Institute for Clinical Research, Inc.

location_facility: University of North Carolina Dermatology and Skin Cancer Cen

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Tien Q. Nguyen, MD inc. DBA First OC Dermatology

location_facility: Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

location_facility: Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude

location_facility: Instituto de Neumonología y Dermatología

location_facility: Centralny Szpital Kliniczny MSW Klinika Dermatologii

location_facility: Bakersfield Dermatology and Skin Cancer Medical Group

location_facility: San Luis Dermatology & Laser Clinic, Inc

location_facility: Kyoto Prefectural University of Medicine

location_facility: Shiga University of Medical Science Hosptial

location_facility: Mount Sinai School of Medicine Dermatology Clinical Trials

location_facility: Keck School of Medicine University of Southern California

location_facility: California Dermatology and Clinical Research Institute

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: University Hospitals Cleveland Medical Center

location_facility: Psoriasis Treatment Center of Central New Jersey

location_facility: LASER CLINIC Specjalistyczne Gabinety Lekarskie

location_facility: Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

location_facility: Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Eastern Canada Cutaneous Research Assoicates Ltd

location_facility: NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

location_facility: Seoul National University Bundang Hospital

location_facility: The Guenther Dermatology Research Centre

location_facility: Severance Hospital Yonsei University Health System

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

summary: The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.


title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non-Muscle Invasive Bladder Cancer Patients

acronym: POTOMAC

summary: This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer.

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

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

lead_sponsor: AstraZeneca

location_country:
Poland
Spain
United Kingdom
Austria
Australia
Netherlands
Canada
Russian Federation
France
Belgium
Japan
Germany


title: A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

summary: This is a 30-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
New Zealand
United States
France
Israel
Germany
Czechia

location_facility: National Ophthalmic Research Institute (Retina Consultants of Southwest Florida)

location_facility: Liverpool University Hospitals NHS Foundation Trust

location_facility: Northwestern Feinberg School of Medicine

location_facility: University of Utah - John A. Moran Center

location_facility: Byers Eye Institute at Stanford, Stanford School of Medicine

location_facility: University of California, San Diego, Jacobs Retina

location_facility: Centre Ophtalmologique d'Imagerie et Laser

location_facility: Retina Vitreous Associates Medical Group

location_facility: Vitreous Retina Macula Consultants of NY

location_facility: Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky

location_facility: New York Eye and Ear Infirmary of Mount Sinai

location_facility: York Teaching Hospital NHS Foundation Trust

location_facility: Blue Ocean Clinical Research / The Macula Center

location_facility: Radboud University Medical Center Oogheelkunde

location_facility: Vision Research Center Eye Associates of NM

location_facility: Centre Hospitalier Intercommunal de Créteil


acronym: PEGASUS

title: A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

ReferenceCitation: de Latour RP, Szer J, Weitz IC, Röth A, Höchsmann B, Panse J, Usuki K, Griffin M, Kiladjian JJ, de Castro CM, Nishimori H, Ajayi T, Al-Adhami M, Deschatelets P, Francois C, Grossi F, Risitano AM, Hillmen P. Pegcetacoplan versus eculizumab in patients with paroxysmal nocturnal haemoglobinuria (PEGASUS): 48-week follow-up of a randomised, open-label, phase 3, active-comparator, controlled trial. Lancet Haematol. 2022 Sep;9(9):e648-e659. doi: 10.1016/S2352-3026(22)00210-1.

ReferenceCitation: Cella D, Sarda SP, Hsieh R, Fishman J, Hakimi Z, Hoffman K, Al-Adhami M, Nazir J, Cutts K, Lenderking WR. Changes in hemoglobin and clinical outcomes drive improvements in fatigue, quality of life, and physical function in patients with paroxysmal nocturnal hemoglobinuria: post hoc analyses from the phase III PEGASUS study. Ann Hematol. 2022 Sep;101(9):1905-1914. doi: 10.1007/s00277-022-04887-8. Epub 2022 Jul 23.

ReferenceCitation: Hakimi Z, Wilson K, McAughey E, Pochopien M, Wojciechowski P, Toumi M, Knight C, Sarda SP, Patel N, Wiseman C, de Castro NP, Nazir J, Kelly RJ. The cost-effectiveness, of pegcetacoplan compared with ravulizumab for the treatment of paroxysmal nocturnal hemoglobinuria, in a UK setting. J Comp Eff Res. 2022 Sep;11(13):969-985. doi: 10.2217/cer-2022-0076. Epub 2022 Jul 7.

ReferenceCitation: Bhak RH, Mody-Patel N, Baver SB, Kunzweiler C, Yee CW, Sundaresan S, Swartz N, Duh MS, Krishnan S, Sarda SP. Comparative effectiveness of pegcetacoplan versus ravulizumab in patients with paroxysmal nocturnal hemoglobinuria previously treated with eculizumab: a matching-adjusted indirect comparison. Curr Med Res Opin. 2021 Nov;37(11):1913-1923. doi: 10.1080/03007995.2021.1971182. Epub 2021 Sep 3.

ReferenceCitation: Hillmen P, Szer J, Weitz I, Röth A, Höchsmann B, Panse J, Usuki K, Griffin M, Kiladjian JJ, de Castro C, Nishimori H, Tan L, Hamdani M, Deschatelets P, Francois C, Grossi F, Ajayi T, Risitano A, Peffault de la Tour R. Pegcetacoplan versus Eculizumab in Paroxysmal Nocturnal Hemoglobinuria. N Engl J Med. 2021 Mar 18;384(11):1028-1037. doi: 10.1056/NEJMoa2029073.

location_country:
Spain
United Kingdom
Russian Federation
Australia
Canada
Korea, Republic of
United States
France
Belgium
Japan
Germany

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Institution of Health Care of Tyumen Region

location_facility: Japanese Red Cross Nagoya Daiichi Hospital

location_facility: Hospital Universitario Politécnico La Fe

location_facility: St. James' Institute of Oncology, Leeds Teaching Hospitals

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Investigative Clinical Research of Indiana

location_facility: Cancer & Hematology Centers of Western Michigan

location_facility: Soonchunhyang University Bucheon Hospital

location_facility: Hospital Universitario de Gran Canaria Dr. Negrín

location_facility: Pavlov First Saint Petersburg State Medical University of Russian Ministry of Health

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Winship Cancer Institute of Emory University

summary: Evaluation of the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria