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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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2041250143
Enrollment
17
Registered
2025-12-15
Start date
2026-02-26
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Interventions

DRUG: RO7837195 DRUG: RO7837195 Matched Placebo

Sponsors

jRCT Inquiry Receipt Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Percentage of Participants With Clinical Remission at Week 12—

Countries

Australia, Brazil, Canada, China, Czech Republic, France, Germany, India, Italy, Japan, Mexico, Poland, South Korea, United Kingdom, United States

Contacts

Public ContactjRCT Inquiry Receipt Center

IQVIA Services Japan G.K.

Koji.ikegami@iqvia.com+81-3-6859-9500

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: May 30, 2026