Recruiting
Phase 3

Afimkibart

Sponsor:

Hoffmann-La Roche

Code:

NCT07158242

Conditions

Moderately to Severely Active Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

Afimkibart

Study Details

Brief summary:

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).

Conditions

Moderately to Severely Active Ulcerative Colitis

Study ID

NCT07158242

Start date

Apr 15, 2026

Status verified date

Nov, 2026

Completion date

Mar 31, 2031

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Bodyweight >= 10 kilogram (kg)
  • Confirmed diagnosis of UC
  • Moderately to severely active UC, defined as modified Mayo Score (mMS) or 5 to 9 points, including endoscopic score of 2 or 3, confirmed by centrally read endoscopy (flexible sigmoidoscopy or colonoscopy)
  • 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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Afimkibart

Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

Primary outcome measure

  • Percentage of Participants With Clinical Remission at Week 52 [ Time Frame: At Week 52 ]

Central Contacts and Locations

Central contacts

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

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30342

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Northwell Health

Recruiting

Lake Success, New York, United States, 11042

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Cleveland Clinic;Children's Institute

Recruiting

Cleveland, Ohio, United States, 44195

UPMC Childen?s Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Texas Digestive Specialists

Recruiting

Harlingen, Texas, United States, 78550

Hospital For Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Nov 5, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-15. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.