RightFit
RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well RO7837195 works compared with a placebo, a treatment with no active drug. It also studies safety and how the body handles the drug. It is for people with moderate to severe ulcerative colitis, a disease that causes swelling and sores in the large intestine, whose past treatments did not work well or caused side effects they could not tolerate.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You were diagnosed with ulcerative colitis at least 3 months ago.
  • Your ulcerative colitis is moderate to severe, based on a disease activity score called mMS.
  • Past standard or advanced treatments did not work well, stopped working, or caused side effects you could not tolerate.

Who can't join

  • You have had a large part or all of your colon removed, or you plan to have surgery for ulcerative colitis.
  • You have Crohn’s disease or colitis whose type is unclear.
  • You have received an advanced treatment that targets TL1a, a protein involved in inflammation.
  • An advanced treatment targeting IL-12, IL-23, or both did not work well, stopped working, or caused side effects you could not tolerate. These are proteins involved in inflammation.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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: * 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

Study sites (8)

CA

CO

FL

IL

NC

NY

UT