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

NCT07158242 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CA459052025-522518-22-00
• Study Type: interventional
• Target: 100
• Locations: 7 countries
• Sites: 15

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Clinical Remission at Week 12

  At Week 12

• Percentage of Participants with Clinical Remission at Week 52

  At Week 52

Secondary Outcomes (17)

• Change from Baseline in Pediatric Ulcerative Colitis Activity Index (PUCAI) Response

  From Baseline, at Week 12

• Percentage of Participants with PUCAI Remission

  At Week 12

• Change from Baseline in Tummy Ulcerative Colitis (TUMMY-UC) Scores

  From Baseline to Week 12

• Percentage of Participants with Endoscopic Improvement

  At Week 12

• Percentage of Participants with Histologic Improvement

  At Week 12

Study Arms (2)

Afimkibart Dose A

EXPERIMENTAL

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

Drug: Afimkibart

Afimkibart Dose B

EXPERIMENTAL

Participants will receive Afimkibart IV followed by Afimkibart SC.

Drug: Afimkibart

Interventions

Afimkibart DRUG

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

Also known as: PF-06480605, RVT-3101, RG6631, RO7790121

Afimkibart Dose A; Afimkibart Dose B

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (15)

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Mater Hospital Brisbane

South Brisbane, Queensland, 4101, Australia

RECRUITING

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

RECRUITING

Perth Children's Hospital

Nedlands, Western Australia, 6009, Australia

RECRUITING

Children's Hospital ZheJiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

RECRUITING

Emmed Research

Pretoria, 0002, South Africa

RECRUITING

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Chulalongkorn University

Bangkok, 10330, Thailand

RECRUITING

Siriraj Hospital

Bangkok, 10700, Thailand

RECRUITING

Ramathibodi Hospital

Bangkok, Thailand

RECRUITING

Birmingham Children's Hospital

Birmingham, B4 6NH, United Kingdom

RECRUITING

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Sheffield Childrens Hospital

Sheffield, S10 2TH, United Kingdom

RECRUITING

Related Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: CA45905 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2031
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

TW (1); US (3); GB (3); TH (3); ZA (1); CN (1); AU (3)