NCT07158242

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
59mo left

Started Apr 2026

Longer than P75 for phase_3

Geographic Reach
4 countries

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Mar 2031

First Submitted

Initial submission to the registry

August 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2031

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

August 28, 2025

Last Update Submit

April 22, 2026

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

  • +12 more secondary outcomes

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

AfimkibartDRUG

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 AAfimkibart Dose B

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

RECRUITING

NYU School of Medicine

New York, New York, 10016, United States

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

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: CA45905 https://forpatients.roche.com/

CONTACT

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

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

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Locations

TW(1)US(2)GB(3)TH(3)