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Afimkibart (RO7790121) for the Treatment of Moderate to Severe Active Crohn's Disease | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Afimkibart (RO7790121) for the Treatment of Moderate to Severe Active Crohn's Disease

A Phase 2, Multicenter, Double-blind, Two-arm Study of Subcutaneous RO7790121 for the Treatment of Subjects With Moderate to Severe Active Crohn's Disease

NCT05910528•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of Afimkibart (RO7790121, RVT-3101) in adult participants with moderate to severe active Crohn's disease.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Moderately to severely active CD as defined by CDAI and SES-CD, assessed by central read
•Elevated very soft or liquid stool frequency and/or abdominal pain
•Must have no response, insufficient response, loss of response and/or intolerance to at least 1 conventional therapy (e.g. corticosteroids) or advanced therapy

Exclusion Criteria

•Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease
•Short gut syndrome
•Presence of an ostomy or ileoanal pouch
•Bowel resection or diversion with \~6-months

Locations (11)

Digestive Health Specialists

Dothan, Alabama, United States

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, United States

I.H.S Health Northwell Health

Kissimmee, Florida, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Clinical Research Institute of Michigan

Chesterfield, Michigan, United States

AZ Delta

Roeselare, Belgium

CHU de Nantes

Nantes, France

Institut des MICI, Clinique Ambroise Paré

Neuilly-sur-Seine, France

CHRU de Nancy Brabois

Vandœuvre-lès-Nancy, France

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, Poland

Key Dates

Start Date

July 24, 2023

Primary Completion Date

December 31, 2030

Completion Date

December 31, 2030

Last Updated

December 24, 2025

Enrollment

ACTUAL participants

Conditions

Crohns Disease

Interventions

Afimkibart

DRUG

Magnesium in Gastrointestinal Disease

NCT07338565

Colitis UlcerosaColitis Ulcerative+10 more

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RECRUITING

Pregnant Women With and Without Crohns Disease to Explore the Role of Plastics and Toxins in Intestinal Inflammation

NCT06001450

Crohns DiseasePregnancy+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Afimkibart (RO7790121) for the Treatment of Moderate to Severe Active Crohn's Disease

Inclusion Criteria

Exclusion Criteria

Magnesium in Gastrointestinal Disease

Pregnant Women With and Without Crohns Disease to Explore the Role of Plastics and Toxins in Intestinal Inflammation

Treatment of Moderate to Severe Refractory Crohn's Disease

A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Crohn Disease on Advanced Therapies

Development and Validation of a New Paediatric Inflammatory Bowel Disease NUTrition Risk Score (PIBD-NUTS)

Virtual Versus Dye-based Chromoendoscopy in Inflammatory Bowel Disease Surveillance Colonoscopy