A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)
Completed · Phase 2 · Has a placebo group
Conditions studied: Ulcerative Colitis
In brief
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.
Key facts
- Study ID
- NCT03558152
- Run by
- Genentech, Inc.
- People needed
- 195
- Starts
- 2018-10-26
- Expected to finish
- 2021-12-15
- Last updated by the study team
- 2023-04-14
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of UC
- Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score
- Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor [TNF] inhibitors [maximum of 2 prior TNF inhibitors]) and/or corticosteroid treatment
- Use of highly effective contraception as defined by the protocol
You may not qualify if…
- History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year; or primary sclerosing cholangitis
- History of cancer as defined by the protocol
- Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders (excluding UC)
- Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC
- Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis or toxic megacolon within 12 months prior to screening
- Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
- Current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of the colon
- History or current evidence of unresectable colonic mucosal dysplasia or history of high-grade colonic mucosal dysplasia
- Prior treatment with UTTR1147A
- Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents
- Prior treatment with rituximab
- Use of prohibited therapies, as defined by the protocol, prior to randomization
- Congenital or acquired immune deficiency
- Evidence or treatment of infections or history of infections, as defined by the protocol
Where it is running
- University of Utah School of Medicine; Gastroenterology Division — Salt Lake City, Utah, United States
- MHAT Saint Karidad EAD — Plovdiv, Bulgaria
- Multiprofile Hospital for Active Treatment Hadji Dimitar OOD — Sliven, Bulgaria
- LLC ARENSIA Exploratory Medicine — Tbilisi, Georgia
- Gastroenterologische Spezialpraxis-Berlin-Karlshorst — Berlin, Germany
- Universitaetsklinikum Carl Gustav Carus TU Dresden — Dresden, Germany
- St. Marien Krankenhaus; Med. Klinik — Ludwigshafen, Germany
- Universitatsklinikum Schleswig-Holstein — Lübeck, Germany
- Universitätsklinikum Ulm; Klinik für Innere Medizin II — Ulm, Germany
- Iatriko Palaiou Falirou; Gastrointestinal Department — Palaió Fáliro, Greece
- EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department — Thessaloniki, Greece
- Magyar Honvédség Egészségügyi Központ; Országos Haemophilia Központ — Budapest, Hungary
- Portiuncula Hospital, Ballinasloe — Co Galway, Ireland
- Shaare Zedek Medical Center; Bait Vagan — Jerusalem, Israel
- Policlinico Universitario Campus Biomedico Di Roma — Rome, Lazio, Italy
- Complesso Integrato Columbus — Rome, Lazio, Italy
- ASST di Monza - Azienda Ospedaliera San Gerardo; U.O. Farmacia -Settore A - Corpo Posteriore — Monza, Lombardy, Italy
- Istituto Clinico Humanitas — Rozzano (MI), Lombardy, Italy
- Azienda Ospedaliera Di Padova — Padova, Veneto, Italy
- ICS ARENSIA Exploratory Medicine — Chisinau, Moldova
- SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk. — ?ód?, Poland
- Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Centrum Endoskopii Zabiegowej — Bydgoszcz, Poland
- Synexus Polska Sp. z o.o. Oddzial w Czestochowie — Cz?stochowa, Poland
- Synexus Polska Sp. z o.o. Oddzial w Gdansku — Gda?sk, Poland
- Carolina Digestive Diseases — Greenville, North Carolina, United States
Full record on ClinicalTrials.gov
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