RO7790121 for Crohn's Disease

(SIBERITE-2 Trial)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Hoffmann-La Roche

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 in participants with moderately to severely active Crohn's disease (CD).

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with Crohn's Disease who haven't responded well to other treatments. They must weigh at least 40 kg and follow specific contraception rules if they can have children. People can't join if they're pregnant, breastfeeding, planning pregnancy, have certain types of fistulas or bowel issues, a history of some infections or cancers within the last five years, or have used prohibited medications.

Inclusion Criteria

I have been diagnosed with Crohn's disease.

My Crohn's disease is moderate to severe.

I am following the required birth control measures.

Exclusion Criteria

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

I have a fistula with more than 3 openings.

I have an ileostomy, colostomy, or ileoanal pouch.

Treatment Details

Interventions

• RO7790121 (Monoclonal Antibodies)

Trial Overview The study tests RO7790121 against a placebo in people with moderate to severe Crohn's Disease. It's a Phase III trial where participants are randomly assigned to receive either the experimental drug or an inactive substance without knowing which one they get (double-blind).

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.

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