RO7837195 for Colitis

Recruiting at 3 trial locations

Overseen By Reference Study ID Number: GA45977 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Genentech, Inc.

Must not be taking: TL1a, IL-12, IL-23

Disqualifiers: Crohn's disease, Indeterminate colitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

224 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called RO7837195 for individuals with moderately to severely active ulcerative colitis, particularly those who haven't responded to other treatments. Researchers aim to evaluate the medication's effectiveness compared to a placebo (a substance with no active drug). Participants will try different dosing regimens to identify the most effective one. Individuals with a confirmed diagnosis of ulcerative colitis for at least three months and who have struggled with past treatments may be suitable for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in ulcerative colitis treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications. However, if you are on advanced therapies targeting TL1a or IL-12/IL-23, you may not be eligible to participate.

Is there any evidence suggesting that RO7837195 is likely to be safe for humans?

Research shows that RO7837195 is being tested for safety in people with ulcerative colitis. Although detailed safety information from earlier studies is unavailable, reaching Phase 2 of clinical trials indicates it was deemed safe enough in earlier phases for testing on more people. By this stage, a treatment has usually demonstrated some level of safety in humans, though side effects might still occur.

If RO7837195 had already received FDA approval for other uses, it would suggest safety. However, the available information does not mention such approval. As with any trial, participants should be aware of potential risks, but the trial team will closely monitor safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for colitis?

Researchers are excited about RO7837195 for colitis because it offers a potentially new approach to treatment. Unlike current options like corticosteroids, aminosalicylates, or biologics that target inflammation broadly, RO7837195 might work through a novel mechanism, targeting specific pathways involved in the disease more precisely. This could mean fewer side effects and more effective symptom control. Additionally, the study includes various dosing regimens, which might help tailor treatment to individual needs, providing more personalized care. This innovative approach could represent a significant advancement in managing colitis.

What evidence suggests that RO7837195 might be an effective treatment for ulcerative colitis?

Research has shown that RO7837195 reduces inflammation in the colon, a major issue in ulcerative colitis. Early results suggest that patients taking RO7837195 experienced fewer symptoms and higher remission rates compared to those on a placebo. In past studies, RO7837195 improved the condition of patients who did not respond well to other treatments. This trial will evaluate different dosing regimens of RO7837195. These early findings are encouraging for its effectiveness in people with moderate to severe ulcerative colitis, especially when other therapies haven't worked. While more information is needed, these early findings remain promising. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Genentech, Inc.

Are You a Good Fit for This Trial?

This trial is for people with moderate to severe ulcerative colitis (UC) who haven't had success with standard or advanced treatments. Participants must have been diagnosed with UC at least 3 months ago and be struggling despite previous therapies.

Inclusion Criteria

I was diagnosed with ulcerative colitis over 3 months ago.

My ulcerative colitis is moderate to severe.

My UC treatments have not worked or caused side effects.

Exclusion Criteria

I have had, or will have, major surgery for ulcerative colitis.

I am receiving treatment targeting TL1a in my cancer therapy.

I have been diagnosed with Crohn's disease or indeterminate colitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 5 weeks

Induction

Participants receive RO7837195 or placebo for 12 weeks to assess efficacy and safety

12 weeks

Active Treatment Extension

All participants receive active study drug for 40 weeks regardless of initial treatment response

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

What Are the Treatments Tested in This Trial?

Interventions

• RO7837195

Trial Overview The study tests RO7837195 against a placebo in individuals with UC. The goal is to see if RO7837195 is more effective in managing symptoms of UC compared to a non-active treatment, while also assessing the drug's safety and how it moves through the body.

How Is the Trial Designed?

Group I: RO7837195 Matched Placebo/ RO7837195 Experimental Treatment 2 Interventions

Participants will receive RO7837195 matched placebo and RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases, respectively.

Group II: RO7837195 Dose Regimen 4 Experimental Treatment 1 Intervention

Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.

Group III: RO7837195 Dose Regimen 3 Experimental Treatment 1 Intervention

Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.

Group IV: RO7837195 Dose Regimen 2 Experimental Treatment 1 Intervention

Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.

Group V: RO7837195 Dose Regimen 1 Experimental Treatment 1 Intervention

Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06979336

NCT06979336 | A Study to Evaluate the Efficacy, Safety ... The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis ...

2. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/autoimmune-disorder/ibd/a-study-to-evaluate-the-efficacy--safety--and-pharmacok-27348.html

Clinical trial for Ulcerative Colitis-Genentech A Member ... The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis.

3. trialx.com trialx.com/clinical-trials/listings/308061/a-study-to-evaluate-the-efficacy-safety-and-pharmacokinetics-pk-of-ro7837195-in-participants-with-moderately-to-severely-active-ulcerative-colitis-uc/

A Study to Evaluate the Efficacy, Safety, and ... The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis ...

4. clinicaltrials.eu clinicaltrials.eu/trial/study-of-ro7837195-injection-compared-to-placebo-to-treat-moderate-to-severe-ulcerative-colitis/

Study of RO7837195 injection compared to placebo to treat ... The purpose of this study is to determine if RO7837195 is effective in inducing remission in people with moderately to severely active ...

5. withpower.com withpower.com/trial/phase-2-ulcerative-colitis-4-2025-3747a

RO7837195 for Colitis · Recruiting Participants for Phase ... The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative ...

6. forpatients.roche.com forpatients.roche.com/en/trials/autoimmune-disorder/ulcerative-colitis/a-study-to-evaluate-the-safety--tolerability--processing-by-the-.html

Clinical trial for Ulcerative Colitis-ForPatients by Roche A study to evaluate the safety, tolerability, processing by the body and mechanism of action of RO7486967 in participants with ulcerative colitis.