summary: The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).

ReferenceCitation: Ramalingam SS, Novello S, Guclu SZ, Bentsion D, Zvirbule Z, Szilasi M, Bernabe R, Syrigos K, Byers LA, Clingan P, Bar J, Vokes EE, Govindan R, Dunbar M, Ansell P, He L, Huang X, Sehgal V, Glasgow J, Bach BA, Mazieres J. Veliparib in Combination With Platinum-Based Chemotherapy for First-Line Treatment of Advanced Squamous Cell Lung Cancer: A Randomized, Multicenter Phase III Study. J Clin Oncol. 2021 Nov 10;39(32):3633-3644. doi: 10.1200/JCO.20.03318. Epub 2021 Aug 26.

repository_institution: Universidad de Sevilla - idUS

repository_institution: University of Turin - Institutional Research Information System University of Turin

repositories_concat: PubMed Central;idus.us.es;iris.unito.it

location_facility: Bobruysk Interdistrict Onco. /ID# 128999

location_facility: Cancercare Outeniqua Oncology Unit /ID# 126103

location_facility: Northwest Cancer Specialists, P.C. /ID# 127488

location_facility: Appalachian Regional Healthcare, Inc (ARH) /ID# 128061

location_facility: Volgograd Regional Clinical Oncology Dispensary /ID# 126350

location_facility: Netcare Oncology Intervent Ctr /ID# 126100

location_facility: East Kent Hosp Univ NHS Trust /ID# 125698

location_facility: Klinika za plucne bolesti Jordanovac /ID# 126537

location_facility: Mogilev Reg Clin Oncology Dis /ID# 128639

location_facility: CSSS Alphonse-Desjardins, CHAU de Levis /ID# 126149

location_facility: Virginia Oncology Associates /ID# 127458

location_facility: Northeast Arkansas Clinical Ch /ID# 128071

location_facility: The Queen Elizabeth Hospital /ID# 125607

location_facility: Wellington Hospital (Capital and Coast District Health Board) /ID# 125755

location_facility: Akdeniz University Medical Fac /ID# 126997

location_facility: Tudogyogyintezet Toeroekbalint /ID# 126111

location_facility: Klinicki bolnicki centar Osijek /ID# 132214

location_facility: Marmara University Medical Fac /ID# 126187

location_facility: Clinica de Neoplasias Litoral - Centro de Novos Tratamentos Itajai /ID# 127738

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127176

location_facility: Hospital Senhora da Oliveira de Guimaraes, EPE /ID# 126761

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 129228

location_facility: Flinders Centre for Innovation /ID# 125605

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 126120

location_facility: Istituto Oncologico del Medite /ID# 132844

location_facility: P. Stradins Clinical Univ Hosp /ID# 126322

location_facility: Parkland Health and Hosp Syste /ID# 128518

location_facility: University of Texas MD Anderson Cancer Center /ID# 127946

location_facility: Nebraska Hematology Oncology /ID# 127699

location_facility: Atrium-Orbis Zuyderland Medisch Centrum /ID# 125710

location_facility: Orenburg Regional Clinical Onc /ID# 137474

location_facility: Ege University Medical Faculty /ID# 126189

location_facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 128385

location_facility: Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 126548

location_facility: State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 128461

location_facility: CHRU de Brest - Hopital Morvan /ID# 127903

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 126186

location_facility: Goshen Center for Cancer Care /ID# 123875

location_facility: Bekes Megyei Pandy Kalman Korhaz /ID# 126117

location_facility: Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 128220

location_facility: Belgorod Oncology Dispensary /ID# 129899

location_facility: Smolensk Regional Onc Clin Dis /ID# 127144

location_facility: Debreceni Egyetem Klinikai Központ /ID# 126119

location_facility: Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 128218

location_facility: Norfolk and Norwich Univ Hosp /ID# 125697

location_facility: Institute for Oncology and Rad /ID# 128721

location_facility: Papageorgiou General Hospital Thessaloniki /ID# 125876

location_facility: Hospital Universitario Virgen del Rocio /ID# 125207

location_facility: Charite-Univ. Berlin, Benjamin-Franklin /ID# 125708

location_facility: Cancer Specialists of North Florida - Southpoint /ID# 127815

location_facility: UT Southwestern Medical Center /ID# 127876

location_facility: Instituto COI de Educacao e Pesquisa /ID# 127739

location_facility: Southern Medical Day Care Ctr /ID# 125604

location_facility: Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 126737

location_facility: Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 128223

location_facility: Minnesota Oncology Hematology, PA /ID# 127473

location_facility: Betsi Cadwaladr Univ Health Bo /ID# 127177

location_facility: Centro Hospitalar de Sao Joao, EPE /ID# 125875

location_facility: Centro Estatal de Cancerologia /ID# 127583

location_facility: Institute For Pulmonary Diseas /ID# 128737

location_facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 135234

location_facility: Princess Margaret Cancer Centre /ID# 126155

location_facility: Sparrow Regional Cancer Center, Sparrow Health System /ID# 127156

location_facility: Veszprem Megyei Tudogyogyintez /ID# 126121

location_facility: Cairo Uni Hosp Al Kasr El Ainy /ID# 128340

location_facility: SE Nebraska Hema/Oncology Consultants P.C.d/b/a Southeast Nebraska Cancer Center /ID# 126477

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 126736

location_facility: Cancerologia de Queretaro S.C. /ID# 125920

location_facility: The Royal Bournemouth Hospital /ID# 125690

location_facility: Comprehensive Cancer Ctrs Neva /ID# 127491

location_facility: Winship Cancer Institute of Emory University /ID# 124061

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 125877

location_facility: Franciscan St. Francis Health /ID# 126678

location_facility: North Devon District Hospital /ID# 125689

location_facility: Univerzitna Nemocnica Bratislava /ID# 126342

location_facility: NZOZ Magodent Ctr. Med. Ostro /ID# 126545

location_facility: North Estonian Medical Centre /ID# 128215

location_facility: Naser Institute for Res & Dev /ID# 129263

location_facility: St. Luke's Mountain States Tumor Institute - Boise /ID# 124059

location_facility: Sverdlovsk Regional Oncology Center Dispensary /ID# 128457

location_facility: State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 125815

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 125879

location_facility: University of Vermont Medical Center /ID# 128064

location_facility: University of Florida - Archer /ID# 126476

location_facility: Dr Albert, Bouwer and Jordaan Incorporated /ID# 126098

location_facility: Odense Universitets Hospital /ID# 125996

location_facility: Azienda Ospedaliero Uni Parma /ID# 125703

location_facility: Hadassah University Hospital /ID# 127077

location_facility: State Budgetary Healthcare Institution"Irkutsk Regional Oncology Center /ID# 128460

location_facility: Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 128219

location_facility: CCA Braga - Hospital de Braga /ID# 125837

location_facility: University Hospital Waterford /ID# 126178

location_facility: Ordensklinikum Linz GmbH, Elisabethinen /ID# 126183

location_facility: Assaf Harofeh Medical Center /ID# 127076

location_facility: Gabrail Cancer Center Research /ID# 127415

location_facility: Texas Oncology - South Austin /ID# 127476

location_facility: Fejer Megyei Szent Gyorgy Korh /ID# 126118

location_facility: Communal non-profit enterprise Regional Center of Oncology /ID# 128221

location_facility: Hospital Universitario Vall d'Hebron /ID# 125159

location_facility: Barwon Health University Hospital Geelong /ID# 125606

location_facility: Cancer Research Institute Siberian Branch of the Russian Academy of Medical Scie /ID# 127143

location_facility: University Hospital Linkoping /ID# 126443

location_facility: Nemocnice Kyjov, prispevkova organizace /ID# 125819

location_facility: Helsinki Univ Central Hospital /ID# 125897

location_facility: Hospital Universitario HM Sanchinarro /ID# 125162

location_facility: Petz Aladar Megyei Oktato Korh /ID# 126110

location_facility: The Clatterbridge Cancer Ctr /ID# 125695

location_facility: Hospital Angeles Centro Medico /ID# 127620

location_facility: NorthShore University HealthSystem - Evanston Hospital /ID# 128585

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 128217

location_facility: Azienda Ospedaliera San Gerardo di Monza _ Oncologia Medica /ID# 125704

location_facility: Azienda Ospedaliera-Universitaria di Perugia-Divisione di Oncologia Medica. /ID# 125699

location_facility: Guy's and St Thomas' NHS Found /ID# 125694

location_facility: Penn State University and Milton S. Hershey Medical Center /ID# 126676

location_facility: Texas Oncology - Austin Midtown /ID# 127477

location_facility: CHRU Lille - Hôpital Claude Huriez /ID# 126353

location_facility: Haukeland University Hospital /ID# 126338

location_facility: Orszagos Koranyi Pulmonologiai Intezet /ID# 126112

location_facility: Sunshine Coast University Hosp /ID# 125608

location_facility: University Hospital Limerick /ID# 126175

location_facility: Mazowiecki Szpital Onkologiczn /ID# 126546

location_facility: Northwest Cancer Specialists, P.C. /ID# 127486

location_facility: Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 127309

location_facility: Opca bolnica Dr. Josip Bencevi /ID# 126539

location_facility: Hospital Universitario Puerta de Hierro Majadahonda /ID# 125160

location_facility: Riga East Clinical Univ Hosp /ID# 125597

location_facility: Cairo Uni Hosp Al Kasr El Ainy /ID# 128338

location_facility: Vrije Universiteit Medisch Centrum /ID# 125578

location_facility: Centre Hosp Intercommunal de Creteil /ID# 125922

location_facility: Istituto Europeo di Oncologia /ID# 125702

location_facility: Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 128458

location_facility: Inselspital, Universitaetsklinik /ID# 126347

location_facility: Hopital Larrey - CHU de Toulouse /ID# 128394

location_facility: VA Caribbean Healthcare System /ID# 124562

location_facility: Fundacion Instituto Valenciano Oncologia IVO /ID# 125205

location_facility: VA Eastern Colorado Healthcare System /ID# 128065

location_facility: Dartmouth-Hitchcock Medical Center /ID# 128075

location_facility: University Hospital Bezanijska /ID# 128761

location_facility: Stavanger University Hospital /ID# 126336

location_facility: Oslo Universitetssykehus, Radiumhospitalet /ID# 126335

title: Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Australia
Brazil
Turkey
Croatia
Czechia
Canada
Serbia
France
Belarus
Lithuania
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Latvia
Ukraine
Estonia
Puerto Rico
Egypt
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Russian Federation
Israel


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: AbbVie

summary: This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.

ReferenceType: derived

ReferenceCitation: Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hebuterne X, D'Haens G, Nakase H, Panes J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26. Erratum In: Lancet. 2022 Sep 24;400(10357):996.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Sandborn WJ, Ghosh S, Panes J, Schreiber S, D'Haens G, Tanida S, Siffledeen J, Enejosa J, Zhou W, Othman AA, Huang B, Higgins PDR. Efficacy of Upadacitinib in a Randomized Trial of Patients With Active Ulcerative Colitis. Gastroenterology. 2020 Jun;158(8):2139-2149.e14. doi: 10.1053/j.gastro.2020.02.030. Epub 2020 Feb 22. Erratum In: Gastroenterology. 2020 Sep;159(3):1192.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repositories_concat: Pure (Denmark)

unpaywall_oa_status: hybrid

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location_facility: Ottawa Hospital Research Institute /ID# 151820

location_facility: Hospital de Clinicas de Porto Alegre /ID# 153743

location_facility: Huron Gastroenterology Assoc /ID# 152710

location_facility: Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 165815

location_facility: Hospital Clinic de Barcelona /ID# 150612

location_facility: Perm Clinical Center of the Federal Medical and Biological Agency /ID# 150386

location_facility: Sapporo Medical University Hospital /ID# 206492

location_facility: Klinicki bolnicki centar Rijeka /ID# 150708

location_facility: Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 151523

location_facility: The Catholic University of Korea, ST. Vincent's Hospital /ID# 150347

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 165782

location_facility: Sahlgrenska University Hospital /ID# 151496

location_facility: Southern Therapy and Advanced Research (STAR) LLC /ID# 170712

location_facility: Hometown Urgent Care and Resea /ID# 200065

location_facility: Atrium Health Carolinas Medical Center /ID# 156971

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 152484

location_facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 151609

location_facility: The University of Chicago DCAM /ID# 150547

location_facility: NorthShore University HealthSystem /ID# 150555

location_facility: Clinical Research Trials of Florida, Inc. /ID# 201790

location_facility: Municipal Enterprise "I.I. Mechnikov Dnipropetrovsk Regional Clinical Hospital" /ID# 207723

location_facility: CB Flock Research Corporation /ID# 165980

location_facility: St George's University Hospitals NHS Foundation Trust /ID# 208374

location_facility: CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 206940

location_facility: Immanuel Kant Baltic Federal University /ID# 200719

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 201725

location_facility: Montreal General Hospital - McGill University Health Centre /ID# 170012

location_facility: University Clinical Centre of the Republic of Srpska /ID# 150706

location_facility: Klinicki bolnicki centar Zagreb /ID# 150709

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215811

location_facility: Western Connecticut Medical Group /ID# 169210

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 151838

location_facility: MediSphere Medical Research Center /ID# 152064

location_facility: CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 216297

location_facility: Tsujinaka Hospital Kashiwanoha /ID# 209130

location_facility: NHS Greater Glasgow and Clyde /ID# 163787

location_facility: Baylor Scott & White Center for Diagnostic Medicine /ID# 204499

location_facility: Klinicki bolnicki centar Zagreb /ID# 150225

location_facility: West Tallinn Central Hospital /ID# 150419

location_facility: Medizinisches Versorgungszentrum Portal 10 /ID# 207135

location_facility: Fukuoka University Chikushi Hospital /ID# 152628

location_facility: Hospital Clinico Universidad De Los Andes /ID# 207422

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 151506

location_facility: Morales Vargas Centro de Investigacion S.C. /ID# 211325

location_facility: North Estonia Medical Centre /ID# 160870

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 211168

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 150461

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 201260

location_facility: Kitasato University Kitasato Institute Hospital /ID# 152686

location_facility: Hospital Garcia de Orta, EPE /ID# 151613

location_facility: The First Affiliated Hospital of Nanchang University /ID# 211750

location_facility: Medical College of Wisconsin /ID# 151843

location_facility: Clinical Center University of Sarajevo /ID# 150208

location_facility: Gastroenterologische Gemeinschaftspraxis Herne /ID# 214574

location_facility: Hospital Universitario Dr. Negrin /ID# 203937

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 151607

location_facility: Hospital Guillermo Grant Benavente de Concepción /ID# 212424

location_facility: Hospital Britanico de Buenos Aires /ID# 209495

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 151606

location_facility: Centex Studies, Inc. - Houston /ID# 201216

location_facility: Duplicate_Helsinki Univ Central Hospital /ID# 150407

location_facility: National Hospital Organization Mito Medical Center /ID# 152631

location_facility: Tokyo Medical And Dental University Hospital /ID# 152016

location_facility: Vitebsk Regional Advanced Clin /ID# 169612

location_facility: University Clinical Center Serbia /ID# 150428

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 216620

location_facility: Advanced Research Institute, Inc /ID# 163098

location_facility: Soroka University Medical Center /ID# 156561

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 157484

location_facility: St.Luke's International Hospital /ID# 208074

location_facility: Bekes Megyei Kozponti Korhaz /ID# 151572

location_facility: The Sixth Affiliated Hosp Sun /ID# 150456

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 150868

location_facility: Washington University-School of Medicine /ID# 150485

location_facility: Plains Clinical Research Center, LLC /ID# 170290

location_facility: Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 167169

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 150426

location_facility: Universitatsklinikum Munster /ID# 150158

location_facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 150358

location_facility: Kanazawa University Hospital /ID# 205099

location_facility: Percuro Clinical Research, Ltd /ID# 150367

location_facility: Hiroshima University Hospital /ID# 151951

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 167182

location_facility: Hamilton Health Sciences - McMaster University Medical Centre /ID# 150365

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 150309

location_facility: University of Iowa Hospitals and Clinics /ID# 157058

location_facility: Universitatsklinikum Mannheim /ID# 150173

location_facility: Erciyes University Medical Fac /ID# 150129

location_facility: ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216610

location_facility: Shoyukai Fujita Gastroenterological Hospital /ID# 216492

location_facility: Wake Forest Baptist Medical Center /ID# 150448

location_facility: East View Medical Research, LLC /ID# 171183

location_facility: Republican hospital named after V.A. Baranov /ID# 206506

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 150125

location_facility: Northwest Health Care Associates /ID# 151590

location_facility: Shanghai Tenth People's Hospital /ID# 150460

location_facility: Macquarie University Hospital /ID# 211951

location_facility: Leids Universitair Medisch Centrum /ID# 152624

location_facility: InSite Digestive Health Care - Oxnard /ID# 163414

location_facility: NYU Langone Long Island Clinical Research Association /ID# 155272

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 150486

location_facility: Tyler Research Institute, LLC /ID# 169146

location_facility: Pusan National University Hospital /ID# 159481

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 150357

location_facility: National Cheng Kung University Hospital /ID# 151749

location_facility: Riga East Clinical University Hospital /ID# 150354

location_facility: University Clinical Center Tuzla /ID# 150211

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 151689

location_facility: Nagoya City University Hospital /ID# 151950

location_facility: Asahikawa Medical University Hospital /ID# 170289

location_facility: Niigata University Medical & Dental Hospital /ID# 218048

location_facility: Ishida Clinic of IBD and Gastroenterology /ID# 210117

location_facility: Calderdale and Huddersfield NHS Foundation Trust /ID# 217658

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 150710

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location_facility: Duplicate_Stavropol State Medical Univ /ID# 150387

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location_facility: Massachusetts General Hospital /ID# 165676

location_facility: Marmara University Medical Fac /ID# 213969

location_facility: Richmond University Medical Center /ID# 201859

location_facility: Universal Axon Clinical Research /ID# 213461

location_facility: Yonsei University Health System Severance Hospital /ID# 159478

location_facility: Showa University Fujigaoka Hospital /ID# 208222

location_facility: Yamanashi Prefectural Central Hospital /ID# 151908

location_facility: National Hospital Organization Sendai Medical Center /ID# 209527

location_facility: Kazan State Medical University /ID# 166042

location_facility: Kitakyushu Municipal Med Ctr /ID# 152588

location_facility: Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211885

location_facility: Citrus Valley Gastroenterology /ID# 151914

location_facility: Kyiv Municipal Clinical Hospital #18 /ID# 150372

location_facility: Hospital Universitario La Paz /ID# 214539

location_facility: Ctr for Gastrointestinal Healt /ID# 153360

location_facility: Toronto Digestive Disease Asso /ID# 150363

location_facility: Yeungnam University Medical Center /ID# 150345

location_facility: University Clinical Center Kragujevac /ID# 150430

location_facility: St Vincent's Hospital Melbourne /ID# 152472

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 151610

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 165807

location_facility: Encore Borland-Groover Clinical Research /Id# 170912

location_facility: TX Clinical Research Institute /ID# 151526

location_facility: Atlanta Gastroenterology Spec /ID# 150548

location_facility: Hospital Nossa Senhora das Graças /ID# 152480

location_facility: CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 150361

location_facility: Dayton Gastroenterology, Inc. /ID# 167631

location_facility: Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 207042

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 151065

location_facility: NW State Medical Univ na Mechn /ID# 169322

location_facility: Tokyo Women's Medical University Hospital /ID# 205977

location_facility: Klinicki bolnicki centar Split /ID# 213988

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 200006

location_facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 169822

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 153742

location_facility: Universitetssykehuset Nord-Norge /ID# 152835

location_facility: Options Health Research, LLC /ID# 150554

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 150912

location_facility: University of Mississippi Medical Center /ID# 213139

location_facility: Duplicate_Klinicki bolnicki centar Osijek /ID# 150216

location_facility: Hospital Universitario y Politecnico La Fe /ID# 150611

location_facility: Crystal Pharmacology Research /ID# 151841

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC /ID# 157080

location_facility: University Clinical Hospital Mostar /ID# 150705

location_facility: Kaiser Clinica e Hospital Dia /ID# 152483

location_facility: Hospital Universitario de San /ID# 155387

location_facility: Hayang University GuriHospital /ID# 150344

location_facility: Klaipeda University Hospital /ID# 158862

location_facility: West China Hospital, Sichuan University /ID# 167040

location_facility: Aurora Medical Center - Grafto /ID# 151717

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location_facility: Revival Research Institute, LLC /ID# 207280

location_facility: Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 151564

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161981

location_facility: St. Marianna University School of Medicine Hospital /ID# 208654

location_facility: Medical Center CONSILIUM MEDICAL /ID# 217446

location_facility: Juntendo University Urayasu Hospital /ID# 208781

location_facility: Gazi Universitesi Tip Fakultes /ID# 150127

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 150250

location_facility: Hampshire Hospitals NHS Foundation Trust /ID# 150380

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202100

location_facility: Gastro Health & Nutrition - Victoria /ID# 167761

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 151140

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167088

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 150337

location_facility: Aichi Medical University Hospital /ID# 151993

location_facility: Digestive Disease Specialists /ID# 201056

location_facility: Toyohashi Municipal Hospital /ID# 171457

location_facility: Radboud Universitair Medisch Centrum /ID# 151700

location_facility: Shengjing Hospital of China Medical University /ID# 166920

location_facility: Caprock Gastro Research, LLC /ID# 214754

location_facility: Xiangya Hospital Central South University /ID# 167229

location_facility: Hadassah Medical Center-Hebrew University /ID# 165118

location_facility: Medical Research Center of CT /ID# 150482

location_facility: Omega Research Maitland, LLC /ID# 200269

location_facility: Chung Shan Medical University Hospital /ID# 150573

location_facility: Texas Digestive Disease Consultants /ID# 209804

location_facility: Japanese Red Cross Osaka Hospital /ID# 209476

location_facility: CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 217372

location_facility: Yokohama City University Medical Center /ID# 169899

location_facility: Texas Digestive Disease Consultants /ID# 209947

location_facility: Columbia Univ Medical Center /ID# 163410

location_facility: Great Lakes Medical Research, LLC /ID# 201772

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 151360

location_facility: Nature Coast Clinical Research - Inverness /ID# 154064

location_facility: United Medical Doctors - Murrieta /ID# 151211

location_facility: Center Hospital of the National Center for Global Health and Medicine /ID# 209267

location_facility: Carl R. Meisner Medical Clinic /ID# 171061

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 150575

location_facility: Vanderbilt University Medical Center /ID# 153355

location_facility: The First Affiliated Hospital, Sun Yat-sen University /ID# 150455

location_facility: Gastoenterology Group of Rochester /ID# 151079

location_facility: Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216405

location_facility: Duplicate_University of New Mexico Department of Internal Medicine /ID# 214396

location_facility: Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 157821

location_facility: Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 200770

location_facility: University Clinical Center of Nis /ID# 151903

location_facility: Hospital Universitario de Salamanca /ID# 150509

location_facility: Taipei Veterans General Hosp /ID# 151748

location_facility: MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 150766

location_facility: Virginia Mason Medical Center /ID# 153026

location_facility: Osaka City University Hospital /ID# 152682

location_facility: General Hospital of Thessaloniki Hippokrateio /ID# 209521

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215732

location_facility: East Tallinn Central Hospital /ID# 150417

location_facility: Atlantic Gastroenterology Clinical Research /ID# 151899

location_facility: Toho University Sakura Medical Center /ID# 151936

location_facility: Saiseikai Fukuoka Genaral Hospital /ID# 209479

location_facility: Atlantic Digestive Health Inst /ID# 150447

location_facility: Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 150785

location_facility: Medical Center of the "Health /ID# 151274

location_facility: University General Hospital of Ioannina /ID# 164248

location_facility: Mautalen Salud e Investigacion /ID# 171173

location_facility: Louisana Research Center, LLC /ID# 150446

location_facility: Healthcare Research Consultant /ID# 163100

location_facility: Emeritas Research Group, LLC /ID# 150258

location_facility: Universitaetsklinimum Tuebingen /ID# 150767

location_facility: Consultants for Clinical Research /ID# 151679

location_facility: Slovak Research Center Team Me /ID# 150257

location_facility: PE PMC Acinus, Medical and Diagnostic Center /ID# 217216

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 150382

location_facility: General Hospital of Athens Laiko /ID# 208669

location_facility: Hospital Universitario Ramon y Cajal /ID# 151067

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 150334

location_facility: Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 151275

location_facility: AGA Clinical Research Associates, LLC /ID# 153040

location_facility: Lviv Regional Clinical Hospital /ID# 150375

location_facility: Velocity Clinical Research - Salt Lake City /ID# 163181

location_facility: CHU de Saint-Etienne, Hopital Nord /ID# 154453

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 150580

location_facility: Royal Devon and Exeter NHS Trust Hospital /ID# 150379

location_facility: DiGiovanna Institute for Medical Education & Research /ID# 201533

location_facility: Utah Gastroenternology - St. Mark's Office /ID# 163101

location_facility: Private Practice Dr MN Rajabally /ID# 155144

location_facility: Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 150333

location_facility: Pauls Stradins Clinical University Hospital /ID# 151409

location_facility: National University Hospital /ID# 150453

location_facility: University Clinical Centre of the Republic of Srpska /ID# 150209

location_facility: National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210709

location_facility: Hamamatsu University Hospital /ID# 205708

location_facility: St Vincent's University Hospital /ID# 150318

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 150338

location_facility: Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 150454

location_facility: Hospital Universitario Reina Sofia /ID# 151066

location_facility: Markusovszky Egyetemi Oktatokorhaz /ID# 150313

location_facility: University of Alberta - Zeidler Ledcor Centre /ID# 151100

location_facility: China Medical University Hospital /ID# 150571

location_facility: Montefiore Medical Center - Moses Campus /ID# 150543

location_facility: Akershus universitetssykehus /ID# 150317

location_facility: CCA Braga - Hospital de Braga /ID# 151608

location_facility: Clinical Hosp Center Zvezdara /ID# 150427

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 203911

location_facility: Inselspital, Universitätsspital Bern /ID# 152590

location_facility: Clin Res Inst of Michigan, LLC /ID# 153027

location_facility: Tokai University Hachioji Hospital /ID# 152587

location_facility: Theageneio Anticancer Hospital /ID# 163896

location_facility: Delsol Research Management, Ll /Id# 170131

location_facility: Newport Huntington Medical Group /ID# 217005

location_facility: Umraniye Training and Res Hosp /ID# 162659

location_facility: Hospital Privado Univesitario /ID# 164185

location_facility: Nemocnice Pardubickeho kraje, a.s. /ID# 213539

location_facility: Sapporo Higashi Tokushukai Hospital /ID# 208487

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 150253

location_facility: National Taiwan University Hospital /ID# 150574

location_facility: The First Hospital of Jilin University /ID# 209986

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167078

location_facility: Yamagata University Hospital /ID# 171454

location_facility: CHU Amiens-Picardie Site Sud /ID# 163456

location_facility: Yokkaichi Hazu Medical Center /ID# 214347

location_facility: Lenasia Clinical Trial Centre /ID# 214344

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 152606

location_facility: Ohio Clinical Research Partner /ID# 154068

location_facility: Faculdade de Medicina do ABC /ID# 152481

location_facility: Univ of California San Francis /ID# 164581

location_facility: Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 150256

location_facility: Hyogo College of Medicine College Hospital /Id# 152434

location_facility: Digestive Health Partners, P.A /ID# 167237

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 150541

location_facility: Premier Medical Group - GI Division /ID# 153357

location_facility: Houma Digestive Health Special /ID# 151844

location_facility: Agaplesion Markus Krankenhaus /ID# 161982

location_facility: Moonshine Research Center, Inc /ID# 152533

location_facility: ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 150602

location_facility: Centro de Investigaciones Clínicas Viña del Mar /ID# 150212

location_facility: Next Innovative Clinical Research - Chicago /ID# 216060

location_facility: Dartmouth-Hitchcock Medical Center /ID# 150549

location_facility: CHA University Bundang Medical Center /ID# 159479

location_facility: Northwest Gastroenterology Clinic /ID# 152527

location_facility: Japanese Red Cross Kyoto Daiichi Hosital /ID# 152359

location_facility: Universitair Medisch Centrum Utrecht /ID# 152775

location_facility: Iwate Medical University Uchimaru Medical Center /ID# 203411

location_facility: East Tennessee Research Institute /ID# 203610

location_facility: CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 154452

location_facility: Mentahaz Maganorvosi Kozpont /ID# 205884

location_facility: South Denver Gastroenterology /ID# 151223

location_facility: Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 151611

location_facility: Tianjin Medical University General Hospital /ID# 170604

location_facility: Birmingham Gastroenterology Associates P.C /ID# 151276

location_facility: Southern Star Research Institute, LLC /ID# 169396

location_facility: Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216221

location_facility: The Vancouver Clinic, INC. PS /ID# 162333

location_facility: Inland Empire Clinical Trials, LLC /ID# 216038

location_facility: University of Maryland Med Ctr /ID# 150449

location_facility: Medizinische Universitaet Wien /ID# 150614

location_facility: Universitair Ziekenhuis Leuven /ID# 150332

location_facility: Charlotte Gastroenterology and Hepatology, PLLC /ID# 150545

location_facility: Fakultna nemocnica s poliklinikou Nove Zamky /ID# 211370

location_facility: Centro Hospitalar de Entre Douro e Vouga /ID# 152335

status: Completed

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

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

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Bosnia and Herzegovina
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Belarus
Lithuania
Colombia
Portugal
Slovakia
Hungary
Switzerland
United States
Latvia
Ukraine
Belgium
China
Malaysia
Estonia
Puerto Rico
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


acronym: Heads Up

summary: This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

ReferenceType: result

ReferenceCitation: Blauvelt A, Teixeira HD, Simpson EL, Costanzo A, De Bruin-Weller M, Barbarot S, Prajapati VH, Lio P, Hu X, Wu T, Liu J, Ladizinski B, Chu AD, Eyerich K. Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2021 Sep 1;157(9):1047-1055. doi: 10.1001/jamadermatol.2021.3023. Erratum In: JAMA Dermatol. 2022 Feb 1;158(2):219. JAMA Dermatol. 2022 Feb 1;158(2):219.

evidence: open (via free pdf)

repository_institution: Technical University Munich - mediaTUM – the media and publications repository of the Technical University Munich

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central;mediatum.ub.tum.de

publisher_dissemination: American Medical Association

location_facility: National Taiwan University Hospital /ID# 208309

location_facility: IBD Center - IRCCS Istituto Clinico Humanitas /ID# 215726

location_facility: Universitair Medisch Centrum Utrecht /ID# 208579

location_facility: Northwestern University Feinberg School of Medicine /ID# 208680

location_facility: The Community Research of South Florida /ID# 211145

location_facility: Royalderm Agnieszka Nawrocka /ID# 211015

location_facility: Medical Dermatology Associates of Chicago /ID# 210265

location_facility: China Medical University Hosp /ID# 209770

location_facility: Hospital Universitario de Bellvitge /ID# 207063

location_facility: Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 213374

location_facility: Medizinische Hochschule Hannover /ID# 210939

location_facility: Hautklinik Klinikum Darmstadt /ID# 210938

location_facility: Epiphany Dermatology - Fort Worth /ID# 211187

location_facility: Cardiff & Vale University Health Board /ID# 209745

location_facility: Universitetssykehuset N-Norge, Tromso /ID# 209103

location_facility: Klinika Ambroziak Sp. z o.o. /ID# 207443

location_facility: Hospital Universitario y Politecnico La Fe /ID# 207064

location_facility: University of Arkansas for Medical Sciences /ID# 211688

location_facility: University Hospital Waterford /ID# 208442

location_facility: Chung Shan Medical University /ID# 208311

location_facility: DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 209935

location_facility: Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 209937

location_facility: Florida International Rsrch cr /ID# 211562

location_facility: Clinical Research Solutions, LLC /ID# 212542

location_facility: ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210434

location_facility: Oregon Health and Science University /ID# 208809

location_facility: Royal Alex Childrens County Hospital /ID# 209709

location_facility: Ospedale San Giovanni di Dio /ID# 209109

location_facility: Universitaetsklinikum Frankfurt /ID# 210934

location_facility: ClinicMed Daniluk, Nowak Sp.j. /ID# 211112

location_facility: Hopital Larrey - CHU de Toulouse /ID# 208976

location_facility: Clinical Research Partners, LLC /ID# 212262

location_facility: Karolinska University Hospital /ID# 207909

location_facility: Allergy, Asthma & Immunology Associates, PC /ID# 213481

location_facility: Keski-pohjanmaa Central Hospital /ID# 209534

location_facility: St Vincent's University Hosp /ID# 208441

location_facility: Hospital Pakar Sultanah Fatimah /ID# 210185

location_facility: Georgia Pollens Clinical Research Centers, Inc /ID# 211092

location_facility: Dermatology Research Associates /ID# 209097

location_facility: National University Hospital /ID# 208774

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 209317

location_facility: Nemocnice Jihlava, prispevkova organizace /ID# 209131

location_facility: A.O. Policlinico Sant'Orsola Malpighi /ID# 209111

location_facility: Dr. Wei Jing Loo Medicine Prof /ID# 211400

location_facility: Oregon Medical Res Center PC /ID# 208807

location_facility: Niakosari Medicine Professional Corporation /ID# 211401

location_facility: Sneeze, Wheeze, & Itch Associates, LLC /ID# 212058

location_facility: Kyiv City Clinical Skin and Venereal Hospital /ID# 210755

location_facility: Clinical Research Institute, Inc /ID# 210852

location_facility: California Allergy and Asthma Medical Group /ID# 213680

location_facility: Integrated Clinical Research LLC /ID# 208831

location_facility: Wellington Hospital (Capital and Coast District Health Board) /ID# 215001

location_facility: Universitair Medisch Centrum Groningen /ID# 208583

location_facility: Holdsworth House Medical Practice /ID# 214565

location_facility: Somogy Megyei Kaposi Mor Oktat /ID# 210149

location_facility: Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 210435

location_facility: Dartmouth-Hitchcock Medical Center /ID# 213727

location_facility: Clinical Research Trials of Florida, Inc. /ID# 210751

location_facility: Hospital Universitario Dr. Negrin /ID# 208969

location_facility: Klinicki bolnicki centar Zagreb /ID# 209976

location_facility: Taipei Municipal Wan Fang Hospital /ID# 209987

location_facility: Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 210892

location_facility: Dermatology Research Institute Inc. /ID# 210942

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 210632

location_facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 209498

location_facility: Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy /ID# 211103

location_facility: Medical University of South Carolina /ID# 211054

location_facility: Meridian Clinical Research Dermatology /ID# 213251

location_facility: Dr. Chih-ho Hong Medical Inc. /ID# 211032

location_facility: Hospital Universitario Arnau Vilanova /ID# 207065

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 210893

location_facility: Policlinico Univ Tor Vergata /ID# 209112

location_facility: Guy's and St Thomas' NHS Found /ID# 208881

location_facility: Complejo Hospitalario Universitario de Pontevedra /ID# 207139

location_facility: Universitetssykehuset N-Norge, Harstad /ID# 209105

location_facility: Miami Dermatology and Laser Institute /ID# 212938

location_facility: Universitatsklinikum Munster /ID# 210935

location_facility: Progressive Medical Research /ID# 211994

location_facility: Forest Hills Dermatology Group /ID# 209249

location_facility: Sugar Land Allergy, Asthma, and Immunology Center /ID# 211153

location_facility: Beacon Clinical Research, LLC /ID# 209280

title: A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Australia
Croatia
Czechia
Canada
France
Hungary
United States
Ukraine
Malaysia
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Spain
Taiwan
Israel


title: Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined With Chemotherapy, in Patients With Refractory Hematologic Malignancies or Solid Tumors

summary: GSK-3β is a potentially important therapeutic target in human malignancies. The Actuate 1801 Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3β inhibitor, as a single agent and in combination with cytotoxic agents, in patients with refractory cancers.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Ugolkov AV, Bondarenko GI, Dubrovskyi O, Berbegall AP, Navarro S, Noguera R, O'Halloran TV, Hendrix MJ, Giles FJ, Mazar AP. 9-ING-41, a small-molecule glycogen synthase kinase-3 inhibitor, is active in neuroblastoma. Anticancer Drugs. 2018 Sep;29(8):717-724. doi: 10.1097/CAD.0000000000000652.

oa_host_type: repository

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Karmali R, Chukkapalli V, Gordon LI, Borgia JA, Ugolkov A, Mazar AP, Giles FJ. GSK-3beta inhibitor, 9-ING-41, reduces cell viability and halts proliferation of B-cell lymphoma cell lines as a single agent and in combination with novel agents. Oncotarget. 2017 Nov 11;8(70):114924-114934. doi: 10.18632/oncotarget.22414. eCollection 2017 Dec 29.

oa_colors: green gold

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

unpaywall_oa_status: gold

publisher_dissemination: Impact Journals, LLC

ReferenceCitation: Ugolkov A, Qiang W, Bondarenko G, Procissi D, Gaisina I, James CD, Chandler J, Kozikowski A, Gunosewoyo H, O'Halloran T, Raizer J, Mazar AP. Combination Treatment with the GSK-3 Inhibitor 9-ING-41 and CCNU Cures Orthotopic Chemoresistant Glioblastoma in Patient-Derived Xenograft Models. Transl Oncol. 2017 Aug;10(4):669-678. doi: 10.1016/j.tranon.2017.06.003. Epub 2017 Jun 30.

evidence: oa journal (via doaj)

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Curtin University - eSpace

repositories_concat: PubMed Central;espace.curtin.edu.au

repositories_institution:
Curtin University - eSpace
PubMed Central - Europe PMC

ReferenceCitation: Ugolkov A, Gaisina I, Zhang JS, Billadeau DD, White K, Kozikowski A, Jain S, Cristofanilli M, Giles F, O'Halloran T, Cryns VL, Mazar AP. GSK-3 inhibition overcomes chemoresistance in human breast cancer. Cancer Lett. 2016 Oct 1;380(2):384-392. doi: 10.1016/j.canlet.2016.07.006. Epub 2016 Jul 14.

ReferenceCitation: Pal K, Cao Y, Gaisina IN, Bhattacharya S, Dutta SK, Wang E, Gunosewoyo H, Kozikowski AP, Billadeau DD, Mukhopadhyay D. Inhibition of GSK-3 induces differentiation and impaired glucose metabolism in renal cancer. Mol Cancer Ther. 2014 Feb;13(2):285-96. doi: 10.1158/1535-7163.MCT-13-0681. Epub 2013 Dec 10.

oa_colors: green other

repository_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Walz A, Ugolkov A, Chandra S, Kozikowski A, Carneiro BA, O'Halloran TV, Giles FJ, Billadeau DD, Mazar AP. Molecular Pathways: Revisiting Glycogen Synthase Kinase-3beta as a Target for the Treatment of Cancer. Clin Cancer Res. 2017 Apr 15;23(8):1891-1897. doi: 10.1158/1078-0432.CCR-15-2240. Epub 2017 Jan 4.

ReferenceCitation: Ugolkov AV, Matsangou M, Taxter TJ, O'Halloran TV, Cryns VL, Giles FJ, Mazar AP. Aberrant expression of glycogen synthase kinase-3beta in human breast and head and neck cancer. Oncol Lett. 2018 Nov;16(5):6437-6444. doi: 10.3892/ol.2018.9483. Epub 2018 Sep 21.

ReferenceCitation: Sahin I, Eturi A, De Souza A, Pamarthy S, Tavora F, Giles FJ, Carneiro BA. Glycogen synthase kinase-3 beta inhibitors as novel cancer treatments and modulators of antitumor immune responses. Cancer Biol Ther. 2019;20(8):1047-1056. doi: 10.1080/15384047.2019.1595283. Epub 2019 Apr 12.

ReferenceCitation: Wu X, Stenson M, Abeykoon J, Nowakowski K, Zhang L, Lawson J, Wellik L, Li Y, Krull J, Wenzl K, Novak AJ, Ansell SM, Bishop GA, Billadeau DD, Peng KW, Giles F, Schmitt DM, Witzig TE. Targeting glycogen synthase kinase 3 for therapeutic benefit in lymphoma. Blood. 2019 Jul 25;134(4):363-373. doi: 10.1182/blood.2018874560. Epub 2019 May 17.

ReferenceCitation: Ding L, Madamsetty VS, Kiers S, Alekhina O, Ugolkov A, Dube J, Zhang Y, Zhang JS, Wang E, Dutta SK, Schmitt DM, Giles FJ, Kozikowski AP, Mazar AP, Mukhopadhyay D, Billadeau DD. Glycogen Synthase Kinase-3 Inhibition Sensitizes Pancreatic Cancer Cells to Chemotherapy by Abrogating the TopBP1/ATR-Mediated DNA Damage Response. Clin Cancer Res. 2019 Nov 1;25(21):6452-6462. doi: 10.1158/1078-0432.CCR-19-0799. Epub 2019 Sep 18. Erratum In: Clin Cancer Res. 2021 Jul 15;27(14):4128.

ReferenceCitation: Jeffers A, Qin W, Owens S, Koenig KB, Komatsu S, Giles FJ, Schmitt DM, Idell S, Tucker TA. Glycogen Synthase Kinase-3beta Inhibition with 9-ING-41 Attenuates the Progression of Pulmonary Fibrosis. Sci Rep. 2019 Dec 12;9(1):18925. doi: 10.1038/s41598-019-55176-w.

ReferenceCitation: Kuroki H, Anraku T, Kazama A, Bilim V, Tasaki M, Schmitt D, Mazar AP, Giles FJ, Ugolkov A, Tomita Y. 9-ING-41, a small molecule inhibitor of GSK-3beta, potentiates the effects of anticancer therapeutics in bladder cancer. Sci Rep. 2019 Dec 27;9(1):19977. doi: 10.1038/s41598-019-56461-4.

ReferenceCitation: Anraku T, Kuroki H, Kazama A, Bilim V, Tasaki M, Schmitt D, Mazar A, Giles FJ, Ugolkov A, Tomita Y. Clinically relevant GSK-3beta inhibitor 9-ING-41 is active as a single agent and in combination with other antitumor therapies in human renal cancer. Int J Mol Med. 2020 Feb;45(2):315-323. doi: 10.3892/ijmm.2019.4427. Epub 2019 Dec 12.

ReferenceCitation: Hsu A, Huntington KE, De Souza A, Zhou L, Olszewski AJ, Makwana NP, Treaba DO, Cavalcante L, Giles FJ, Safran H, El-Deiry WS, Carneiro BA. Clinical activity of 9-ING-41, a small molecule selective glycogen synthase kinase-3 beta (GSK-3beta) inhibitor, in refractory adult T-Cell leukemia/lymphoma. Cancer Biol Ther. 2022 Dec 31;23(1):417-423. doi: 10.1080/15384047.2022.2088984.

ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.

location_country:
Portugal
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: START Madrid-HM CIOCC Hospital Universitario

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Sarah Cannon Research Institute- Tennessee Oncology-Nashville

location_facility: Texas Oncology- Charles A. Sammons Cancer Center

location_facility: Center Hospitalier Regional Universitaire de Besancon - Site Jean Minjoz

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Centro Hospitalar Universitario Sao Joao

location_facility: MetroMetro-Minnesota Community Oncology Research Consortium (MMCORC)

location_facility: Columbia University- Irving Medical Center

location_facility: Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre

location_facility: Des Moines Oncology Research Association

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University


summary: This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.

ReferenceCitation: D'Haens GR, Sandborn WJ, Loftus EV Jr, Hanauer SB, Schreiber S, Peyrin-Biroulet L, Panaccione R, Panes J, Baert F, Colombel JF, Ferrante M, Louis E, Armuzzi A, Zhou Q, Goteti VS, Mostafa NM, Doan TT, Petersson J, Finney-Hayward T, Song AP, Robinson AM, Danese S. Higher vs Standard Adalimumab Induction Dosing Regimens and Two Maintenance Strategies: Randomized SERENE CD Trial Results. Gastroenterology. 2022 Jun;162(7):1876-1890. doi: 10.1053/j.gastro.2022.01.044. Epub 2022 Feb 3.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

repositories_concat: LIRIAS (KU Leuven);orbi.ulg.ac.be

ReferenceCitation: Greener T, Boland K, Milgrom R, Ben-Bassat O, Steinhart AH, Silverberg MS, Narula N. Higher adalimumab maintenance regimen is more effective than standard dose in anti-TNF experienced Crohn's disease patients. Eur J Gastroenterol Hepatol. 2021 Oct 1;33(10):1274-1279. doi: 10.1097/MEG.0000000000002250.

location_facility: State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 127753

location_facility: Gastroenterologicka ambulancia /ID# 137964

location_facility: Birmingham Gastroenterology Associates O.C /ID# 137282

location_facility: CHU Amiens-Picardie Site Sud /ID# 126237

location_facility: Charite Universitaetsmedizin Berlin /ID# 126196

location_facility: Winnipeg Regional Health Authority /ID# 119015

location_facility: Lviv Regional Clinical Hospital /ID# 126234

location_facility: Medical University of South Carolina /ID# 138122

location_facility: Texas Digestive Disease Consultants - Dallas /ID# 138121

location_facility: Texas Digestive Disease Consultants - Southlake /ID# 137283

location_facility: Israelitisches Krankenhaus Hamburg /ID# 136549

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 140425

location_facility: Azienda Ospedaliera di Padova /ID# 126267

location_facility: Erlanger Institute for Clinical Research /ID# 129008

location_facility: Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 126262

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 119036

location_facility: Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 126200

location_facility: IBD Center - IRCCS Istituto Clinico Humanitas /ID# 126226

location_facility: University of Michigan Health Systems /ID# 119076

location_facility: Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 129856

location_facility: University of Calgary Cumming School of Medicine Adult Cystic Fibrosis Clinic /ID# 119017

location_facility: Private Practice - Dr. Michael R. MroB Dipl. med. S. Schache /ID# 126257

location_facility: Krankenhaus der Barmherzigen Bruder /ID# 126270

location_facility: Hull University Teaching Hospitals NHS Trustust /ID# 126265

location_facility: Azienda Ospedaliera Spedali Civili /ID# 127744

location_facility: Kansas City Research Institute /ID# 119034

location_facility: Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Medizin 1 /ID# 126249

location_facility: Hospital Universitario de Girona Doctor Josep Trueta /ID# 137976

location_facility: New River Valley Research Inst /ID# 127807

location_facility: KH der Elisabethinen Linz GmbH /ID# 126280

location_facility: Soroka University Medical Center /ID# 126243

location_facility: Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 137895

location_facility: The Oregon Clinic, Gastroenterology - West /ID# 135272

location_facility: UOSD - Azienda Ospedaliera San Camillo Forlanini /ID# 127745

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 119056

location_facility: Louisana Research Center, LLC /ID# 136749

location_facility: London Health Sciences Centre - University Hospital /ID# 119026

location_facility: Commonwealth Clinical Studies /ID# 136850

location_facility: Centrum Medyczne sw. Lukasza Sp. z o.o. /ID# 126271

location_facility: Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 138331

location_facility: CHU NANCY - Hopital Brabois Adultes /ID# 127742

location_facility: Nemocnice Ceske Budejovice a.s. /ID# 126266

location_facility: Universitatsklinikum Magdeburg /ID# 126256

location_facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 137735

location_facility: Centrum.Medyczne. Szpital Swietej Rodziny /ID# 137974

location_facility: Shafran Gastroenterology Ctr /ID# 119057

location_facility: Investigative Clinical Research /ID# 119033

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 127743

location_facility: Austin Institute for Clinical Research /ID# 125500

location_facility: Toronto Digestive Disease Asso /ID# 119019

location_facility: CHU de Saint-Etienne, Hopital Nord /ID# 134450

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 126221

location_facility: Rocky Mountain Gastroenterology /ID# 119038

location_facility: Salvo-san Ciobanca SRL / Medicina Interna /ID# 126224

location_facility: Policlinico Agostino Gemelli /ID# 127746

location_facility: Winship Cancer Institute of Emory University /ID# 136851

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 126252

location_facility: The Royal Wolverhampton NHS Tr /ID# 126201

location_facility: University Hospital Southampton NHS Fundation Trust /ID# 126225

location_facility: Gastroenterology Group Naples /ID# 122493

location_facility: Guy's and St Thomas' NHS Found /ID# 144366

location_facility: Asklepios Westklinikum Hamburg /ID# 126275

location_facility: Universitaetsklinikum Schleswig-Holstein /ID# 126260

location_facility: Wake Research Associates, LLC /ID# 119029

location_facility: Public Institution 6th City Clinical Hospital /ID# 126236

location_facility: Gastroenterology Institute, Division of Medicine /ID# 126245

location_facility: MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 119042

location_facility: Vseobecna Nemocnica s poliklinikou Lucenec n.o. /ID# 127748

location_facility: Kyiv City Clinical Hospital No.8 /ID# 126232

location_facility: Cabinet Medical Dr. Fratila SRL /ID# 126247

location_facility: KO-Med Centra Kliniczne Pulawi /ID# 126278

location_facility: Hepato-Gastroenterologie HK s.r.o. /ID# 126269

location_facility: Centrum Endoskopii Zabiegowej /ID# 126272

location_facility: Northwestern University Feinberg School of Medicine /ID# 119043

location_facility: Charlotte Gastroenterology and Hepatology, PLLC /ID# 119041

location_facility: Ctr for Digest and Liver Dis /ID# 119040

location_facility: Complejo Hospitalario Universitario de Pontevedra /ID# 138126

location_facility: Norfolk and Norwich Univ Hosp /ID# 126197

location_facility: Froedtert Memorial Lutheran Hospital /ID# 119081

location_facility: Medizinische Universitat Wien /ID# 126279

location_facility: Magyar Elhizastudomanyi KKft. /ID# 126276

location_facility: Consultants for Clinical Res /ID# 119052

location_facility: Carle Foundation Hospital Digestive Health Research Center /ID# 136008

location_facility: Minnesota Gastroenterology, P. A. /ID# 137280

location_facility: NYU Langone Long Island Clinical Research Associates /ID# 119035

location_facility: Hospital Clinico Universitario San Carlos /ID# 126253

location_facility: Public Institution Kherson City Clinical Hospital named after le.le. Karabelesha /ID# 127754

location_facility: Hospital Parc Tauli de Sabadell /ID# 138124

location_facility: Montreal General Hospital - McGill University Health Center /ID# 119025

location_facility: Moore UC San Diego Cancer Center /ID# 119053

location_facility: Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 126277

location_facility: Digestive Health Specialists of the Southeast /ID# 122483

location_facility: Academisch Medical center Amsterdam /ID# 126227

title: A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

location_country:
Germany
Poland
Czechia
Canada
France
Slovakia
Hungary
Denmark
Switzerland
United States
Ukraine
Romania
Belgium
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Spain
Israel


type: Registry Identifier

title: A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL OF ARV-471 (PF-07850327) VS FULVESTRANT IN PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE BASED TREATMENT FOR ADVANCED DISEASE (VERITAC-2)

summary: A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.

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

lead_sponsor: Pfizer

sponsor_collaborators:
Pfizer
Arvinas Estrogen Receptor, Inc.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Slovakia
Switzerland
United States
India
Belgium
China
Puerto Rico
Italy
Norway
Sweden
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Israel

location_facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

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

location_facility: Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuor

location_facility: Fakultna nemocnica s poliklinikou J.A. Reimana Presov

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

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

location_facility: COPERNICUS PL, Wojewodzkie Centrum Onkologii

location_facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

location_facility: Louisiana State University Health Sciences Shreveport

location_facility: The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center

location_facility: Kantonsspital Münsterlingen - Spital Thurgau AG

location_facility: The Second Affiliated hospital of Zhejiang University school of medicine

location_facility: Azienda Ospedaliero Universitaria delle Marche

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia

location_facility: Sahyadri Super Speciality Hospital, Hadapsar

location_facility: Specialized Hospital for Active Treatment of Oncology - Haskovo

location_facility: Chang Gung Memorial Hospital at Kaohsiung

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Mid Florida Hematology and Oncology Center

location_facility: Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.

location_facility: Pan American Center for Oncology Trials- Hospital Oncologico

location_facility: Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Institut Català d'Oncologia - L'Hospitalet

location_facility: Torrance Memorial Physician Network / Cancer Care

location_facility: Norton Cancer Institute, St Matthews Campus

location_facility: The First Affiliated Hospital of Nanchang University

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

location_facility: Sunshine Coast University Private Hospital

location_facility: Hematology Oncology Associates of Rockland

location_facility: Tokyo Metropolitan Komagome Hospital, Department of Breast Surgery

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

location_facility: Hospital Universitario Arnau de Vilanova de Lleida

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Vychodoslovensky onkologicky ustav, a.s.

location_facility: Norton Cancer Institute, Brownsboro Hospital Campus

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Guangxi Medical University Affiliated Tumor Hospital

location_facility: Fondazione IRCCS San Gerardo dei Tintori

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

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer

location_facility: Fujian Medical University Union Hospital-1 Bingfanglou

location_facility: Rajiv Gandhi Cancer Institute And Research Centre

location_facility: Seoul National University Bundang Hospital

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo

location_facility: Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.

location_facility: Unité de Recherche Clinique du CISSS des Laurentides

location_facility: Providence Queen of the Valley Medical Center

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Kantonsspital Frauenfeld - Spital Thurgau AG

location_facility: University General Hospital of Heraklion

location_facility: National Center for Global Health and Medicine

location_facility: Bhakti Vedanta Hospital and Research Institute

location_facility: Morton Plant Hospital - BayCare Health System

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: California Cancer Associates for Research and Excellence, Inc. (cCARE)

location_facility: Althaia, Xarxa Assistencial Universitària de Manresa

location_facility: Hematology-Oncology Associates of Central New York, PC

location_facility: Centro de Pesquisa Clínica - Área Administrativa

location_facility: Hematology Oncology Associates of Fredericksburg

location_facility: Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Chang Gung Medical Foundation-Linkou Branch

status_simplified: Ongoing


title: Interventional, Open-label, Fixed-dose Multiple Administration Study to Evaluate Long-term Treatment With Eptinezumab in Patients With Chronic Cluster Headache

acronym: CHRONICLE

summary: The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.

lead_sponsor: H. Lundbeck A/S

location_country:
Germany
Finland
Italy
United Kingdom
Denmark
Netherlands
United States
Spain
France

location_facility: Centre Hospitalier Universitaire de Saint-Étienne

location_facility: Hospitalsenhed Midt og Regionshospitalet Viborg

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Ospedale Molinette - Clinica Neurologica II - Centro Cefalee

location_facility: Michigan Headache and Neurological Institute

location_facility: Thomas Jefferson University Hospital - Center City Campus

location_facility: IRCCS Istituto Delle Scienze Neurologiche di Bologna

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana

location_facility: New England Institute for Neurology and Headache

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Cleveland Clinic - Neurological Institute

location_facility: Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...


type: Other Identifier

title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer

acronym: CYCLONE 2

summary: This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. Prednisolone may be used instead of prednisone per local regulation.

status: Active, not recruiting

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

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Denmark
Australia
Japan
Netherlands
Romania
United States
China
Korea, Republic of
Spain
France

location_facility: Wannan Medical College Yijishan Hospital

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Baylor Scott & White Medical Center - Temple

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: The University of Vermont Medical Center Inc.

location_facility: Associated Medical Professionals - Urology

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Xinjiang Medical University Cancer Hospital - Urumqi

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: Kobe City Medical Center General Hospital

location_facility: Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center

location_facility: Private Practice - Dr. Stammel & Dr. Garcia

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: UCLA Hematology/Oncology - Westwood (Building 100)

location_facility: Universitätsklinikum Münster - Albert Schweitzer Campus

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Texas Oncology Cancer Care and Research Center

location_facility: TRIO-US (Translational Research in Oncology-US)

location_facility: Second Affiliated hospital of Anhui Medical University

location_facility: The First Affiliated Hospital of Henan University of Science &Technology

location_facility: M Health Fairview University of Minnesota Medical Center - East Bank

location_facility: The Second Hospital of Tianjin Medical University

location_facility: Harbin Medical University Cancer Hospital

location_facility: St. Antonius Ziekenhuis, locatie Utrecht

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: New York Oncology Hematology (NYOH) - Clifton Park Cancer Center

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Tongji Hospital Tongji Medical,Science & Technology

location_facility: The University of Arizona Cancer Center - North Campus

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

location_facility: Huashan Hospital Affiliated Fudan University

location_facility: Studienzentrum Bayenthal Urologische Partnerschaft Köln


title: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

summary:
The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in adult subjects with active systemic lupus erythematosus.

Approximately 280 subjects with a documented diagnosis of SLE will be randomized 2:2:1:2 to receive CC-220 (0.45 mg QD, 0.3 mg QD or 0.15 mg QD) or identically appearing placebo.

ReferenceType: background

ReferenceCitation: Nakayama Y, Kosek J, Capone L, Hur EM, Schafer PH, Ringheim GE. Aiolos Overexpression in Systemic Lupus Erythematosus B Cell Subtypes and BAFF-Induced Memory B Cell Differentiation Are Reduced by CC-220 Modulation of Cereblon Activity. J Immunol. 2017 Oct 1;199(7):2388-2407. doi: 10.4049/jimmunol.1601725. Epub 2017 Aug 28.

ReferenceCitation: Lipsky PE, Vollenhoven RV, Dorner T, Werth VP, Merrill JT, Furie R, Petronijevic M, Velasco Zamora B, Majdan M, Irazoque-Palazuelos F, Terbrueggen R, Delev N, Weiswasser M, Korish S, Stern M, Hersey S, Ye Y, Gaudy A, Liu Z, Gagnon R, Tang S, Schafer PH. Biological impact of iberdomide in patients with active systemic lupus erythematosus. Ann Rheum Dis. 2022 Apr 27;81(8):1136-42. doi: 10.1136/annrheumdis-2022-222212. Online ahead of print.

repository_institution: The Hong Kong University of Science and Technology - Rare & Special e-Zone

repositories_concat: PubMed Central;repository.hkust.edu.hk

publisher_dissemination: British Medical Journal

ReferenceCitation: Merrill JT, Werth VP, Furie R, van Vollenhoven R, Dorner T, Petronijevic M, Velasco J, Majdan M, Irazoque-Palazuelos F, Weiswasser M, Korish S, Ye Y, Gaudy A, Schafer PH, Liu Z, Agafonova N, Delev N. Phase 2 Trial of Iberdomide in Systemic Lupus Erythematosus. N Engl J Med. 2022 Mar 17;386(11):1034-1045. doi: 10.1056/NEJMoa2106535.

oa_host_type: publisher

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

publisher_dissemination: Wiley

ipd_sharing: No

lead_sponsor: Celgene

location_country:
Germany
Italy
Poland
Colombia
Hungary
Argentina
Brazil
Mexico
Belgium
United States
Spain
Canada
Serbia
Russian Federation
France

location_facility: University of Maryland - School of Medicine

location_facility: Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S. - Cireem S.A.S

location_facility: Hospital General de Agudos Dr. Jose Maria Ramos Mejia

location_facility: Clinical and Translational Research Center of Alabama, PC

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

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg

location_facility: Hospital Universitario Araba - Txagorritxu

location_facility: Integral Rheumatology and Immunology Specialists

location_facility: University of Ferrara, Azienda Ospedaliera-Universitaria S.Anna

location_facility: University of California San Diego Medical Center

location_facility: Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.

location_facility: Centro de Investigacion en Artritis y Osteoporosis

location_facility: Instituto de Investigaciones Clinicas de Quilmes

location_facility: Arthritis and Osteoporosis Associates of New Mexico

location_facility: Azienda Ospedaliero - Universitaria di Cagliari

location_facility: Clinica Integral de Osteoporosis y Artitis Reumatoide CLINOSAR

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Reumatologii i Ukladowych Chorob Tkanki Laczne

location_facility: North Shore-LIJ Health System-Division of Rheumatology

location_facility: Consultora Integral de Salud Centro Médico Privado

location_facility: Centro Integral en Reumatología, S.A. de C.V.

location_facility: Unidad de Atencion Medica e Investigacion en Salud, S.C.

location_facility: Centro de Imunoterapia de Ipanema (CITIPA)

location_facility: Advanced Rheumatology & Arthritis Research Center, PC

location_facility: Samodzielny Publiczny Zespól Opieki Zdrowotnej w Koscianie Szpital im. Teodora Dunina

location_facility: Santa Casa de Misericórdia de Belo Horizonte

location_facility: University of Florida College of Medicine

location_facility: Institution of the Russian Academy of Medical Sciences Research Institute of Rheumatology of the Ru

location_facility: University of Pennsylvania Department of Dermatology

location_facility: Centro de Estudos em Terapias Inovadoras LTDA

location_facility: Centre For Rheumatology, Immun. And Arthritis

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet

location_facility: Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy

location_facility: Saint Petersburg Research Institute for Emergency Medical Care

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: University of Pittsburgh UPMC Lupus Center of Excellence

location_facility: IPS Centro Integral de Reumatologia del Caribe Circaribe S.A.S.

location_facility: Reumalab - Centro Integral de Reumatologia

location_facility: Clinique de Rhumatologie Du Centre Du Quebec

location_facility: Centro de Investigación y Tratamiento Reumatológico


title: A Phase 3, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel Group Study, Followed by an Active-treatment Phase to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Subjects With Active Behcet's Disease

summary: The main objective of this study is to evaluate the efficacy and safety of apremilast in the treatment of oral ulcers in adults with active Behçet's disease (BD).

ReferenceCitation: Hatemi G, Mahr A, Takeno M, Kim D, Melikoglu M, Cheng S, McCue S, Paris M, Chen M, Yazici Y. Impact of apremilast on quality of life in Behcet's syndrome: analysis of the phase 3 RELIEF study. RMD Open. 2022 Jul;8(2):e002235. doi: 10.1136/rmdopen-2022-002235.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Yonsei University Medical Library - YUHSpace

repositories_concat: PubMed Central;ir.ymlib.yonsei.ac.kr

ReferenceCitation: Hatemi G, Mahr A, Ishigatsubo Y, Song YW, Takeno M, Kim D, Melikoglu M, Cheng S, McCue S, Paris M, Chen M, Yazici Y. Trial of Apremilast for Oral Ulcers in Behcet's Syndrome. N Engl J Med. 2019 Nov 14;381(20):1918-1928. doi: 10.1056/NEJMoa1816594.

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

lead_sponsor: Amgen

location_country:
Germany
France
Italy
Japan
Lebanon
United States
Korea, Republic of
Greece
Turkey
Israel

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Arizona Arthritis and Rheumatology Research, PLLC

location_facility: American University of Beirut Medical Center

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: University of California Davis Medical Center

location_facility: Medical Hospital of Tokyo Medical and Dental University

location_facility: St Marianna University School of Medicine Hospital

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: University of Pennsylvania Health Systems

location_facility: University of Occupational and Environmentall Health

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Ippokratio General Hospital of Thessaloniki


title: Multiple Patient Program to Ensure Access to LCZ696 Treatment to Patients Diagnosed With Heart Failure With Reduced Ejection Fraction (HF-rEF)

summary: Novartis has set up this global Multiple Patient Program (MPP) treatment plan to provide access to life-saving treatment with LCZ696 for patients that were not previously exposed to LCZ696 but have no other option to receive LCZ696 in their country prior to market authorization OR commercial availability, based on local regulatory and legal requirements.

status: No longer available

study_type: Expanded Access

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Ireland
Cyprus
Slovenia
Australia
Brazil
Malta
Austria
Lebanon
Switzerland
United States
Spain
United Arab Emirates
Greece
Croatia
Panama
Philippines
France

status_simplified: Unknown


title: VERDICT: In actiVE Ulcerative Colitis, a RanDomIzed Controlled Trial for Determination of the Optimal Treatment Target

acronym: VERDICT

summary:
Disease activity and response to therapy in ulcerative colitis (UC) can be assessed by a range of endpoints including symptoms, endoscopic mucosal activity, histological disease activity, and biomarkers. This study aims to determine the optimal treatment target, which is a research priority for the management of UC both to inform clinical practice and to help inform regulatory endpoints and targets for drug development.

Participants with active UC will be randomized in a 2:3:5 ratio to 1 of 3 groups, each with a different treatment target. Treatment targets will be defined as:

Group 1: corticosteroid-free symptomatic remission
Group 2: corticosteroid-free endoscopic + symptomatic remission
Group 3: corticosteroid-free histological + endoscopic + symptomatic remission

ipd_sharing: Undecided

lead_sponsor: Alimentiv Inc.

collaborators: Takeda Development Center Americas, Inc.

location_country:
Poland
United Kingdom
Netherlands
Belgium
United States
Canada
Ukraine
France

location_facility: London Health Sciences Centre - University Campus

location_facility: Barts Health NHS Trust / Whipps Cross University Hospital

location_facility: Vinnytsia City Clinical Hospital #1, Dept of Gastroenterology

location_facility: Szpital Miejski Sw. Jana Pawla II w Elblagu

location_facility: Toronto Immune and Digestive Health Institute (TIDHI)

location_facility: CHU de Bordeaux - Hopital Haut Leveque - Groupe Hospitalier Sud

location_facility: Asheville Gastroenterology Associates, PA

location_facility: UZ Leuven - University Hospital Gasthuisberg

location_facility: City Clinical Hospital #9 Dept of Gastrosurgery SI Zaporizhzhia MA of PGE of MoHU

location_facility: Icahn School of Medicine at Mt Sinai Hospital

location_facility: Huron Gastroenterology Associates - Center for Digestive Care

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

location_facility: Amsterdam UMC - Academisch Medisch Centrum

location_facility: Ternopil City Communal Emergency Medical Care Hosp

location_facility: Vinnytsia M.I. Pyrohov Regional Clinical Hospital

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Oddział Gastroenterologiczny SP ZOZ w Łęcznej

intervention_type: Biological


title: A Phase 1/2 Study on the Safety of Rovalpituzumab Tesirine Administered in Combination With Nivolumab or Nivolumab and Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer

summary: The purpose of this study is to assess the safety and efficacy of rovalpituzumab tesirine administered in combination with nivolumab or nivolumab and ipilimumab in participants with extensive-stage small cell lung cancer (SCLC).

status: Terminated

design_allocation: Non-Randomized

sponsor_collaborators:
AbbVie
Bristol-Myers Squibb

location_country:
Germany
Italy
United States
Spain
France

location_facility: Medical University of South Carolina /ID# 161007

location_facility: Rutgers Cancer Institute of NJ /ID# 161032

location_facility: Memorial Sloan Kettering Cancer Center /ID# 161010

location_facility: Oregon Health and Science University /ID# 161029

location_facility: Lungenfachklinik Immenhausen /ID# 165181

location_facility: CHU de Besancon - Jean Minjoz /ID# 165173

location_facility: The University of Kansas Clini /ID# 162915

location_facility: Asklepios Fachkliniken M. Gaut /ID# 165183

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 165164

location_facility: Hospital Universitario Madrid /ID# 165163

location_facility: Duke University Medical Center /ID# 161009

location_facility: University Cancer & Blood Cent /ID# 161028

location_facility: University of Wisconsin Clinic /ID# 161013

location_facility: Istituto Europeo di Oncologia /ID# 165175

location_facility: Hospital Genl Gregorio Maranon /ID# 165162

location_facility: Clinica Universitar de Navarra - Pamplona /ID# 165165

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele /ID# 165178

location_facility: Washington University-School of Medicine /ID# 161011

location_facility: Centro di Riferimento Oncologi /ID# 165174

location_facility: Vanderbilt University Med Ctr /ID# 162916

location_facility: CHRU de Brest - Hospital Morva /ID# 165170