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Active Not RecruitingPhase 2NCT05910528

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

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 mode...

Lead sponsor: Hoffmann-La Roche•5 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Hoffmann-La Roche

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 24, 2025Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

PhasePHASE2

Enrollment21

Start dateJul 2023

Last updatedDec 24, 2025

Condition

Locations shown

Digestive Health Specialists

Dothan, Alabama

Medical Research Center of Connecticut, LLC

Hamden, Connecticut

I.H.S Health Northwell Health

Kissimmee, Florida

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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: May 10, 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.

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