RO7790121 for Ulcerative Colitis

(Ametrine-1 Trial)

Recruiting at 192 trial locations

Overseen By Reference Study ID Number: GA45329 https://forpatients.roche.com/

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, Cancer, 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, treat-through study will evaluate the efficacy and safety of 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 medicines are prohibited, including anti-TL1A therapy, so you may need 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, which is a type of inflammatory bowel disease causing ulcers and long-lasting inflammation in the digestive tract.

Inclusion Criteria

I have been diagnosed with ulcerative colitis.

My ulcerative colitis is moderate to severe.

My weight is at least 40 kg.

Exclusion Criteria

Presence of an ostomy or ileoanal pouch

Pregnancy or breastfeeding, or intention of becoming pregnant during the study

I have active TB or untreated/under-treated latent TB.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive RO7790121 or placebo intravenously for induction of remission

12 weeks

Maintenance Treatment

Participants continue with RO7790121 or placebo subcutaneous injections to maintain remission

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks

Treatment Details

Interventions

• RO7790121 (Monoclonal Antibodies)

Trial Overview The study tests RO7790121 against a placebo to see if it's more effective and safe as an induction and maintenance therapy for ulcerative colitis. It's conducted across multiple centers where participants are randomly assigned to receive either the drug or placebo.

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

Chugai Pharmaceutical

Industry Sponsor

Trials

105

Recruited

25,000+

Dr. Osamu Okuda

Chugai Pharmaceutical

Chief Executive Officer since 2020

MD from Kyoto University

Dr. Mariko Y. Momoi

Chugai Pharmaceutical

Chief Medical Officer

MD from Jichi Medical University