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NCT Number: NCT06979336

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mater Misericordiae Limited, South Brisbane, Queensland, Australia

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About this study

This study consists of up to 5-week screening period, a 12-week induction phase, a 40-week active treatment extension, and a safety follow-up period following the last dose of study treatment. The induction phase will be placebo-controlled and after its completion, all participants will receive treatment with active study drug, regardless of the treatment response.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO7837195

Drug

RO7837195 will be administered as per the schedule specified in the protocol.

RO7837195 Matched Placebo

Drug

RO7837195 matched placebo will be administered as per the schedule specified in the protocol.

Primary outcomes

  1. Percentage of Participants With Clinical Remission at Week 12

    Time frame: At Week 12

    Clinical remission is defined as the Modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore of ≤ 1, rectal bleeding subscore of 0, and endoscopy subscore of ≤ 1.

Secondary outcomes

  1. Percentage of Participants With Clinical Response at Week 12

    Time frame: At Week 12

    Clinical response is defined as decrease from baseline in the mMS by ≥2 and ≥ 30% reduction from baseline, with either a decrease of ≥1 in the rectal bleeding subscore or an absolute rectal bleeding subscore of ≤1.

  2. Percentage of Participants With Endoscopic Improvement at Week 12

    Time frame: At Week 12

    Endoscopic improvement is defined as a Mayo endoscopy subscore of ≤ 1.

  3. Percentage of Participants With Endoscopic Remission at Week 12

    Time frame: At Week 12

    Endoscopic remission is defined as a Mayo endoscopy subscore of 0.

  4. Number of Participants With Adverse Events (AEs)

    Time frame: Up to Weeks 65

  5. Serum Concentration of RO7837195

    Time frame: Up to Weeks 65

  6. Percentage of Participants With Anti-drug Antibodies to RO7837195

    Time frame: Up to Weeks 65

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: GA45977 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S.)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 18, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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