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A PHASE IIb, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED INDUCTION STUDY WITH AN ACTIVE TREATMENT EXTENSION TO ASSESS THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF RO7837195 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Ulcerative Colitis
Date of first enrollment	22/01/2025
Target sample size	17
Countries of recruitment	Australia,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czech Republic,Japan,France,Japan,Germany,Japan,India,Japan,Italy,Japan,South Korea,Japan,Mexico,Japan,Poland,Japan,United Kingdom,Japan,United States,Japan
Study type	Interventional
Intervention(s)	DRUG: RO7837195 DRUG: RO7837195 Matched Placebo

Outcome(s)

Primary Outcome	Percentage of Participants With Clinical Remission at Week 12
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	-Diagnosis of ulcerative colitis (UC) established at least 3 months -Moderately to severely active UC assessed by mMS -Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC
Exclude criteria	-Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC -Diagnosis of Crohn's disease or indeterminate colitis -Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a) -Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and/or IL-23