Afimkibart for children with moderate to severe Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, double-blind, multicenter study in children with moderately to severely active Crohn's disease. Participants will receive Afimkibart as induction and maintenance therapy, with treatment continuing through the study to assess ongoing effects. Eligibility requires confirmed active disease, specific endoscopic scores, and prior inadequate response or intolerance to standard therapies. The trial will monitor pharmacokinetics, clinical outcomes, and safety in a pediatric population. Locations include sites in New York, Harlingen, and Brisbane, under Hoffmann-La Roche as lead sponsor.

Why it matters

Who can join: the full rules

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

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting
• Texas Digestive Specialists
  Harlingen, Texas, United States Recruiting
• Mater Hospital Brisbane
  South Brisbane, Queensland, Australia Recruiting
• Royal Children's Hospital
  Parkville, Victoria, Australia Recruiting
• Perth Children's Hospital
  Nedlands, Western Australia, Australia Recruiting
• Santa Casa de Misericordia de Porto Alegre
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: CP45906 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. and Canada)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating obefazimod for treating active Crohn's disease

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• Afimkibart subcutaneous induction in moderately to severely active ulcerative colitis

  This study tests whether a subcutaneous induction dose of afimkibart can help people with moderately to severely active ulcerative colitis feel better compared with placebo.

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• Afimkibart for children with moderately to severely active ulcerative colitis

  This Phase III study will try Afimkibart to see if it helps children with moderate to severe ulcerative colitis and is safe for them.

  Recruiting at 29 sites Phase 3 Hoffmann-La Roche · Aurora, Colorado and 28 other locations · NCT07158242

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.