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)

  • End date
    Dec 29, 2022
  • participants needed
  • sponsor
    Genentech, Inc.
Updated on 26 May 2021
Carolina Digestive Diseases (2.7 mi away) Contact
tumor necrosis factor
tumour necrosis


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.

Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment Vedolizumab, UTTR1147A, Vedolizumab Placebo, UTTR1147A Placebo
Clinical Study IdentifierNCT03558152
SponsorGenentech, Inc.
Last Modified on26 May 2021


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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