A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis

Purpose

This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).

Condition

  • Moderately to Severely Active Ulcerative Colitis

Eligibility

Eligible Ages
Between 2 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Bodyweight >= 10 kilogram (kg) - Confirmed diagnosis of UC - Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and/or biologic therapies as outlined in the protocol

Exclusion Criteria

  • Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD) - Current diagnosis of Crohn's disease (CD), abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease - Presence of an ostomy or ileoanal pouch - Current diagnosis or suspicion of primary sclerosing cholangitis - Any major surgery within 6 weeks prior to screening or a major planned surgery during the study - Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Afimkibart Dose A 		Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.
  • Drug: Afimkibart
    Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
    Other names:
    • PF-06480605
    • RVT-3101
    • RG6631
    • RO7790121
Experimental
Afimkibart Dose B 		Participants will receive Afimkibart IV followed by Afimkibart SC.
  • Drug: Afimkibart
    Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
    Other names:
    • PF-06480605
    • RVT-3101
    • RG6631
    • RO7790121

Recruiting Locations

University of South Florida
Tampa, Florida 33612

Children's Healthcare of Atlanta
Atlanta, Georgia 30342

NYU Langone Health
New York, New York 10016

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: CA45905 https://forpatients.roche.com/ No attachments to email below.
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com