RO7790121 for Crohn's Disease

(SIBERITE-1 Trial)

Recruiting at 83 trial locations

Overseen By Reference Study ID Number: GA45331 https://forpatients.roche.com/

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must not be taking: Anti-TL1A therapy

Disqualifiers: Ulcerative colitis, Short bowel, Pregnancy, Infections, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

600 Participants Needed

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 induction and maintenance 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 a confirmed diagnosis of moderately to severely active Crohn's Disease who weigh at least 40 kg. They must have tried other treatments without success or couldn't tolerate them. Participants need to follow specific contraception guidelines if they can have children.

Inclusion Criteria

My Crohn's disease is moderate to severe.

I have been diagnosed with Crohn's disease.

I weigh at least 40 kg.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Therapy

Participants receive induction therapy with RO7790121 intravenously

12 weeks

Multiple visits (in-person)

Maintenance Therapy

Participants continue with maintenance therapy using RO7790121 subcutaneous injections

40 weeks

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RO7790121

Trial Overview The study is testing RO7790121, a potential new treatment for Crohn's Disease. It compares the effects of this drug against a placebo during two phases: induction and maintenance therapy, in a controlled environment where neither the participants nor the researchers know who receives which treatment.

Participant Groups

Group I: Arm 2: RO7790121 Experimental Treatment 1 Intervention

Participants will receive RO7790121 IV followed by RO7790121 SC injection.

Group II: Arm 1: RO7790121 Experimental Treatment 1 Intervention

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

Group III: Arm 3: 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