A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Phase 2

Withdrawn

• Conditions: Ulcerative colitis; 10018027

• Registration Number: NL-OMON46667
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 2

Inclusion Criteria

- Age 18-80 years
- Diagnosis of Ulcerative Colitis (UC)
- Moderate to severely active UC, defined by the Mayo Clinic Score
- Inadequate response, loss of response, or intolerance to prior
immunosuppressant treatment and 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 and primary sclerosing
cholangitis
- History of cancer as defined by the protocol
- Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal,
hepatic, endocrine, or GI 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
and toxic megacolon within 12 months prior to screening
- Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
- Current fistula or history of fistula, current pericolonic abscess and
Stricture (stenosis) of the colon
- History or current evidence of unresectable colonic mucosal dysplasia
and high-grade colonic mucosal dysplasia
- Prior treatment with vedolizumab, etrolizumab, natalizumab,
efalizumab, or any other anti-integrin agents and rituximab
- Use of prohibited therapies as defined by the protocol prior to
randomization
- Evidence or treatment of infections or history of infections as defined
by the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the efficacy of UTTR1147A compared with placebo and compared with<br /><br>vedolizumab </p><br>