Skip to main content
Back to Trials
NCT07298421PHASE3Recruiting

A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease

Hoffmann-La Roche

Start Date

8/18/2026

Completion Date

5/30/2031

Summary

This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).

Eligibility Criteria

Age Range: 2 years to 17 years

Inclusion Criteria: * Body weight \>= 10 kilogram (kg) * Active CD confirmed by endoscopy (ileocolonoscopy) * Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score \>= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) \>=6 (or \>=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy * Inadequate response, loss of response, and/or intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and/or immunosuppressants) or advanced therapies (including anti-tumor necrosis factor, anti-interleukin, anti-integrin, or Janus Kinase (JAK) inhibitors) Exclusion Criteria: * Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD) * History of \>= 3 bowel resections: \> 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum * Current diagnosis of ulcerative colitis (UC), abdominal/intraabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease. * Symptomatic bowel strictures, fulminant colitis, or toxic megacolon * Presence of abdominal or perianal abscess * Current diagnosis or suspicion of primary sclerosing cholangitis

Interventions

DRUG

Afimkibart

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Moderately to Severely Active Crohns Disease

Locations

NYU Langone Health

New York, New York 10016

United States

Mater Hospital Brisbane

South Brisbane, Queensland 4101

Australia

Royal Children's Hospital

Parkville, Victoria 3052

Australia

Perth Children's Hospital

Nedlands, Western Australia 6009

Australia

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul 90035-074

Brazil

CECIP - Centro de Estudos Clínicos do Interior Paulista

Jaú, São Paulo 17201-130

Brazil

BR Trials - Pesquisa Clínica

São Paulo, São Paulo 01236-030

Brazil

Centro de Investigación Clínica Acelerada, S.C

Mexico City, Mexico CITY (federal District) 07369

Mexico

FAICIC Clinical Research

Veracruz, 91900

Mexico

Emmed Research

Pretoria, Gauteng 84

South Africa

IATROS International

Bloemfontein, 9301

South Africa

National Taiwan University Hospital

Taipei, 100

Taiwan

Chulalongkorn University

Bangkok, 10330

Thailand

Siriraj Hospital

Bangkok, 10700

Thailand

Ramathibodi Hospital

Bangkok,

Thailand

King's College Hospital

London, SE5 9RS

United Kingdom

Sheffield Childrens Hospital

Sheffield, S10 2TH

United Kingdom