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)

• Status: Active, not recruiting
• Trial end date: 2022-12-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Vedolizumab

Criteria

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