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

NCT05910528 · tracked via the Priya Life Science USA tracker

Sponsor

Hoffmann-La Roche

Phase

Phase 2

Started

2023-07-24

Last updated

2026-09-16

Condition(s) studied

Crohns Disease

Investigational drug(s) / intervention(s)

Afimkibart

Afimkibart: Afimkibart will be administered during the Induction, Maintenance and OLE period.

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

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

Primary outcome measure(s)

Incidence of Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and AE Leading to Discontinuation — Until end of study, approximately 5 years

Trial sites (11)

Facility	City	Region
Digestive Health Specialists	Dothan	Alabama
Medical Research Center of Connecticut, LLC	Hamden	Connecticut
I.H.S Health Northwell Health	Kissimmee	Florida
Brigham and Women's Hospital	Boston	Massachusetts
Clinical Research Institute of Michigan	Chesterfield	Michigan
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
WIP Warsaw IBD Point Profesor Kierkus	Warsaw	Poland

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Other trials for the same condition

Evaluating the Efficacy and Safety of Mirikizumab in Adults Over 60 With Moderate to Severe Crohn's Disease and Ulcerative Colitis Starting soon

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05910528 on ClinicalTrials.gov ↗ ← All trials in the USA