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

Conditions

• Moderately to Severely Active Ulcerative Colitis

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, 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).

Key Dates

Start date

Apr 15, 2026

Status verified

May 2026

Primary completion

Mar 31, 2030

Completion

Mar 31, 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 at Week 12 [ Time Frame: At Week 12 ]

Central Contacts

• Reference Study ID Number: CA45905 https://forpatients.roche.com/
  888-662-6728 (U.S. and Canada)
  [email protected]

Locations (2)

Find similar trials in Atlanta, GA

Related Studies

• A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis
  PHASE3 · Recruiting · Hoffmann-La Roche · Dothan, Alabama