Authorised Therapeutic exploratory (Phase II) Moderately to Severely Active Ulcerative Colitis (UC)

A Study to Assess the Efficacy, Safety, and what the body does to RO7837195 in Participants with Moderately to Severely Active Ulcerative Colitis

EU CTIS ID: 2025-520690-39-00

What this study is testing

To evaluate the efficacy of RO7837195 compared with placebo in inducing remission

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Diagnosis of UC established at least 3 months prior to screening, confirmed by clinical and endoscopic evidence during screening
  • Evidence of UC extending a minimum of 15 cm from the anal verge as determined by baseline endoscopy (flexible sigmoidoscopy or colonoscopy) performed during screening
  • Colonoscopy within 2 years prior to screening or willingness to undergo colonoscopy in lieu of a flexible sigmoidoscopy at screening
  • Moderately to severely active UC, defined as a modified Mayo Score (mMS) of 5-9 including an endoscopic subscore of ≥ 2 during the screening period
  • Agreement to adhere to the contraception requirements
  • Prior advanced therapy failure and/or conventional therapy failure

You likely can't join if

  • Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required
  • Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
  • History of or current ileostomy or colostomy
  • Diagnosis of Crohn’s disease or indeterminate colitis
  • Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
  • Diagnosis of toxic megacolon within 12 months prior to screening

The study team makes the final eligibility decision.

Where it's taking place

  • China
  • Japan
  • India
  • United States
  • Korea, Republic of
  • Mexico
  • Brazil
  • United Kingdom
  • Australia
  • Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include China; Japan; India; United States; Korea, Republic of; Mexico and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.