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

Roche

Status and phase: Begins enrollment in 1 month; Phase 3

Conditions: Moderately to Severely Active Ulcerative Colitis

Treatments: Drug: Afimkibart

Study type: Interventional

Funder types: Industry

Identifiers

NCT07158242

2025-522518-22-00 (EU Trial (CTIS) Number)

CA45905

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Afimkibart Dose A

Experimental group

Description:

Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.

Treatment:

Drug: Afimkibart

Afimkibart Dose B

Experimental group

Description:

Participants will receive Afimkibart IV followed by Afimkibart SC.

Treatment:

Drug: Afimkibart