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

Last updated: December 23, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

RO7790121

RVT-3101

Afimkibart

Clinical Study ID

NCT05910528
GA45392
2023-504265-23-00
  • Ages 18-75
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Moderately to severely active CD as defined by CDAI and SES-CD, assessed by centralread

  • Elevated very soft or liquid stool frequency and/or abdominal pain

  • Must have no response, insufficient response, loss of response and/or intolerance toat least 1 conventional therapy (e.g. corticosteroids) or advanced therapy

Exclusion

Exclusion Criteria:

  • Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis,ischemic colitis, infectious colitis, radiation colitis or active diverticulardisease

  • Short gut syndrome

  • Presence of an ostomy or ileoanal pouch

  • Bowel resection or diversion with ~6-months

Study Design

Total Participants: 21
Treatment Group(s): 3
Primary Treatment: RO7790121
Phase: 2
Study Start date:
July 24, 2023
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • Telavant Site

    Gent, 9000
    Belgium

    Site Not Available

  • UZ Gent

    Gent, 9000
    Belgium

    Site Not Available

  • AZ Delta

    Roeselare, 8800
    Belgium

    Site Not Available

  • Telavant Site

    Roeselare, 8800
    Belgium

    Site Not Available

  • AZ Delta

    Roeselare 2787889, 8800
    Belgium

    Site Not Available

  • MBAL Hadzi Dimitar

    Sliven, 8800
    Bulgaria

    Site Not Available

  • Telavant Site

    Sliven, 8800
    Bulgaria

    Site Not Available

  • Telavant Site

    Stara Zagora, 6000
    Bulgaria

    Site Not Available

  • UMHAT Prof. Dr. Stoyan Kirkovich

    Stara Zagora, 6000
    Bulgaria

    Site Not Available

  • (G.I.R.I.) GI Research Institute

    Vancouver, British Columbia V6Z 2K5
    Canada

    Site Not Available

  • TDDA Specialty Research

    Woodbridge, Ontario L4L 4Y7
    Canada

    Site Not Available

  • Telavant Site

    Vancouver, V6Z 2K5
    Canada

    Site Not Available

  • Telavant Site

    Vaughan, L4L 4Y7
    Canada

    Site Not Available

  • CHU de Nantes

    Nantes, 44093
    France

    Site Not Available

  • Roche Site

    Nantes, 44093
    France

    Site Not Available

  • CHU de Nantes

    Nantes 2990969, 44093
    France

    Site Not Available

  • CHU de Nantes

    Nantes cedex 1, 44093
    France

    Site Not Available

  • Institut des MICI, Clinique Ambroise Paré

    Neuilly sur Seine, 92200
    France

    Site Not Available

  • Institut des MICI, Clinique Ambroise Paré

    Neuilly-sur-Seine, 92200
    France

    Site Not Available

  • Roche Site

    Neuilly-sur-Seine, 92200
    France

    Site Not Available

  • Institut des MICI, Clinique Ambroise Paré

    Neuilly-sur-Seine 2990611, 92200
    France

    Site Not Available

  • CHRU de Nancy Brabois

    Vandoeuvre les nancy, 54500
    France

    Site Not Available

  • Roche Site

    Vandoeuvre les nancy, 54500
    France

    Site Not Available

  • CHRU de Nancy Brabois

    Vandœuvre-lès-Nancy 2970797, 54500
    France

    Site Not Available

  • Praxis Westend Studien

    Berlin, 14050
    Germany

    Site Not Available

  • Telavant Site

    Berlin, 14050
    Germany

    Site Not Available

  • Telavant Site

    Saarbrücken, 66111
    Germany

    Site Not Available

  • Zentrum für Gastroenterologie Saar MVZ GmbH

    Saarbrücken, 66111
    Germany

    Site Not Available

  • Clinexpert Kft.

    Budapest, 1033
    Hungary

    Site Not Available

  • Semmelweis Egyetem, II. Belgyógyászati Klinika

    Budapest, 1088
    Hungary

    Site Not Available

  • Semmelweis University Belgyogyaszati es Onkologiai Klinika

    Budapest, 1083
    Hungary

    Site Not Available

  • Telavant Site

    Budapest, 1033
    Hungary

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial w Czestochowie

    Cz?stochowa, 42-202
    Poland

    Site Not Available

  • Roche Site

    Czestochowa, 42-202
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial w Czestochowie

    Czestochowa, 42-202
    Poland

    Site Not Available

  • Telavant Site

    Czestochowa, 42-202
    Poland

    Active - Recruiting

  • MZ Badania Slowik Zymla Sp.j.

    Knurów, 44-190
    Poland

    Site Not Available

  • Roche Site

    Knurów, 44-190
    Poland

    Site Not Available

  • Telavant Site

    Knurów, 44-190
    Poland

    Active - Recruiting

  • Roche Site

    Szczecin, 71-434
    Poland

    Site Not Available

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-434
    Poland

    Site Not Available

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin 3083829, 71-434
    Poland

    Site Not Available

  • Roche Site

    Warsaw, 00-728
    Poland

    Site Not Available

  • Telavant Site

    Warsaw, 00-728
    Poland

    Active - Recruiting

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728
    Poland

    Site Not Available

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw 756135, 00-728
    Poland

    Site Not Available

  • WIP Warsaw IBD Point Profesor Kierkus

    Warszawa, 00-728
    Poland

    Site Not Available

  • MIGRE Polskie Centrum Leczenia Migreny

    Wroc?aw, 52-210
    Poland

    Site Not Available

  • MIGRE Polskie Centrum Leczenia Migreny

    Wrocław, 52-210
    Poland

    Site Not Available

  • Roche Site

    Wrocław, 52-210
    Poland

    Site Not Available

  • Telavant Site

    Wrocław, 52-210
    Poland

    Active - Recruiting

  • ABAWI spol. s r.o.

    Bratislava, 821 07
    Slovakia

    Site Not Available

  • Telavant Site

    Bratislava, 82107
    Slovakia

    Site Not Available

  • Gastro Ambulancia - Endomed

    Košice, 040 13
    Slovakia

    Site Not Available

  • Telavant Site

    Košice, 04013
    Slovakia

    Site Not Available

  • Telavant Site

    Fuenlabrada, 28942
    Spain

    Site Not Available

  • Hospital Universitario de Fuenlabrada

    Madrid, 28942
    Spain

    Site Not Available

  • FISEVI

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital Universitario y Politecnico la Fe de Valencia

    Valencia, 46026
    Spain

    Site Not Available

  • Telavant Site

    Valencia, 46026
    Spain

    Site Not Available

  • Digestive Health Specialists

    Dothan, Alabama 36305
    United States

    Site Not Available

  • Roche Site

    Dothan, Alabama 36301
    United States

    Site Not Available

  • Telavant Site

    Dothan, Alabama 36301
    United States

    Active - Recruiting

  • Digestive Health Specialists

    Dothan 4059102, Alabama 4829764 36305
    United States

    Site Not Available

  • Roche Site

    Garden Grove, California 92845
    United States

    Site Not Available

  • Telavant Site

    Garden Grove, California 92845
    United States

    Active - Recruiting

  • VVCRD Research

    Garden Grove, California 92845
    United States

    Site Not Available

  • United Medical Doctors

    Los Alamitos, California 90702
    United States

    Site Not Available

  • Roche Site

    Los Angeles, California 90015
    United States

    Site Not Available

  • Telavant Site

    Los Angeles, California 90015
    United States

    Active - Recruiting

  • Roche Site

    Murrieta, California 92563
    United States

    Site Not Available

  • Telavant Site

    Murrieta, California 92563
    United States

    Active - Recruiting

  • NRC Research Institute

    Orange, California 92868
    United States

    Site Not Available

  • Inland Empire Liver Foundation

    Rialto, California 92377
    United States

    Site Not Available

  • Roche Site

    Rialto, California 92377
    United States

    Site Not Available

  • Telavant

    Rialto, California 92377
    United States

    Active - Recruiting

  • Telavant Site

    Rialto, California 92377
    United States

    Active - Recruiting

  • Amicis Research Center

    Santa Clarita, California 91355
    United States

    Site Not Available

  • Roche Site

    Santa Clarita, California 91355
    United States

    Site Not Available

  • Televant Site

    Santa Clarita, California 91355
    United States

    Active - Recruiting

  • Televant Site

    Valencia, California 91325
    United States

    Site Not Available

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut 06518
    United States

    Site Not Available

  • Roche Site

    Hamden, Connecticut 06518
    United States

    Site Not Available

  • Telavant Site

    Hamden, Connecticut 06518
    United States

    Active - Recruiting

  • Medical Research Center of Connecticut, LLC

    Hamden 4835654, Connecticut 4831725 06518
    United States

    Site Not Available

  • Access Research Institute

    Brooksville, Florida 34613
    United States

    Site Not Available

  • Roche Site

    Brooksville, Florida 34613
    United States

    Site Not Available

  • Telavant Site

    Brooksville, Florida 34613
    United States

    Active - Recruiting

  • I.H.S Health Northwell Health

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Roche Site

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Telavant Site

    Kissimmee, Florida 34741
    United States

    Active - Recruiting

  • Digestive Disease Consultants

    Orange Park, Florida 32073
    United States

    Site Not Available

  • Roche Site

    Orange Park, Florida 32073
    United States

    Site Not Available

  • Telavant Site

    Orange Park, Florida 32073
    United States

    Active - Recruiting

  • Endoscopic Research, Inc.

    Orlando, Florida 32803
    United States

    Site Not Available

  • Revival Clinical Research

    Orlando, Florida 32807
    United States

    Site Not Available

  • Roche Site

    Orlando, Florida 32807
    United States

    Site Not Available

  • Telavant Site

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • I.H.S Health Northwell Health

    Kissimmee 4160983, Florida 4155751 34741
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Roche Site

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Roche Site

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan 48047
    United States

    Site Not Available

  • Roche Site

    Chesterfield, Michigan 48047
    United States

    Site Not Available

  • Telavant Site

    Chesterfield, Michigan 48047
    United States

    Active - Recruiting

  • Clinical Research Institute of Michigan

    Chesterfield 4988681, Michigan 5001836 48047
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Baylor College of Medicine.

    Houston, Texas 77030
    United States

    Site Not Available

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