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

Recruiting now · Phase 3

Conditions studied: Moderately to Severely Active Crohns Disease

In brief

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).

Key facts

Study ID

NCT07298421

Run by

Hoffmann-La Roche

People needed

100

Starts

2026-08-31

Expected to finish

2031-05-30

Last updated by the study team

2026-08-10

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

• NYU Langone Health — New York, New York, United States (enrolling)
• Royal Children's Hospital — Parkville, Victoria, Australia (enrolling)
• Perth Children's Hospital — Nedlands, Western Australia, Australia (enrolling)
• CECIP - Centro de Estudos Clínicos do Interior Paulista — Jaú, São Paulo, Brazil (enrolling)
• FAICIC Clinical Research — Veracruz, Mexico (enrolling)
• National Taiwan University Hospital — Taipei, Taiwan (enrolling)
• Chulalongkorn University — Bangkok, Thailand (enrolling)
• Siriraj Hospital — Bangkok, Thailand (enrolling)
• Ramathibodi Hospital — Bangkok, Thailand (enrolling)
• Sheffield Childrens Hospital — Sheffield, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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