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

Sponsor
Hoffmann-La Roche
Study ID
NCT07298421
Phase
PHASE3
Status
Recruiting
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Conditions

  • Moderately to Severely Active Crohns Disease

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Afimkibart — DRUG
    Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

Study Details

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 Dates

Start date
May 29, 2026
Status verified
May 2026
Primary completion
May 31, 2030
Completion
May 30, 2031

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Afimkibart Dose A
    Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.
  • Experimental: Afimkibart Dose B
    Participants will receive Afimkibart IV followed by Afimkibart SC.

Primary Outcome Measure

Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI) [ Time Frame: At Week 52 ]

Central Contacts

  • Reference Study ID Number: CP45906 https://forpatients.roche.com/
    888-662-6728 (U.S. and Canada)
    [email protected]

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