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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

NCT07298421

RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Moderately to Severely Active Crohns Disease

Interventions: Afimkibart

Countries: Australia, Taiwan, Thailand, United Kingdom

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 overview

Sex: ALL

Age: 2 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (7)

Parkville, Victoria, Australia
Nedlands, Western Australia, Australia
Taipei, Taiwan
Bangkok, Thailand
Bangkok, Thailand
Bangkok, Thailand
Sheffield, United Kingdom