RO7790121 for Ulcerative Colitis

(Ametrine-2 Trial)

Recruiting at 82 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Hoffmann-La Roche

Must not be taking: Anti-TL1A therapy

Disqualifiers: Crohn's disease, Pregnancy, Malignancy, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with RO7790121 compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that certain prohibited medicines, including anti-TL1A therapy, are not allowed. It's best to discuss your current medications with the trial team.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for people with moderately to severely active ulcerative colitis, a type of inflammatory bowel disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on other medical conditions or treatments.

Inclusion Criteria

I weigh at least 40 kg.

I have tried at least one bladder cancer treatment without success or could not tolerate it.

I am following the required birth control measures as per the study.

Exclusion Criteria

I have severe complications from ulcerative colitis.

I have an ostomy or ileoanal pouch.

I am currently diagnosed with or suspected to have primary sclerosing cholangitis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive induction therapy with RO7790121 or placebo

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 weeks

Treatment Details

Interventions

• RO7790121 (Monoclonal Antibodies)

Trial Overview The study is testing the effectiveness and safety of RO7790121 as an induction therapy for ulcerative colitis. It's a Phase III trial where some patients will receive RO7790121 while others will get a placebo, without knowing which one they're getting.

Participant Groups

Group I: RO7790121 Experimental Treatment 1 Intervention

Participants will receive RO7790121 intravenously (IV) followed by RO7790121 subcutaneous (SC) injection.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo IV followed by placebo SC.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University