A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

In plain English

What this trial is testing

This study is testing RO7837195 (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.

Participants are assigned to groups by chance (randomized).

Some participants receive a placebo or sham for comparison.

It is blinded: participants and the study team do not know who receives what.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

• Ages 18 and older
• Any sex

Some of the main requirements, copied from the record:

• 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

There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 224 participants are expected to take part.
• The study has 5 groups.
• Start date: 2025-09-29.
• Main results expected around 2027-08-25 (estimate from the record).
• 108 study sites listed (103 marked recruiting) in Australia, Brazil, Canada, China and Czechia and 10 more countries.

Groups in this study

• RO7837195 Dose Regimen 1 (listed as: experimental group)
• RO7837195 Dose Regimen 2 (listed as: experimental group)
• RO7837195 Dose Regimen 3 (listed as: experimental group)
• RO7837195 Dose Regimen 4 (listed as: experimental group)
• RO7837195 Matched Placebo/ RO7837195 (listed as: experimental group)

Main thing being measured

• Percentage of Participants With Clinical Remission at Week 12 (At Week 12)

In the researchers’ words

The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed.

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.