Afimkibart for children with moderately to severely active ulcerative colitis
A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2 - 17 Years With Moderately to Severely Active Ulcerative Colitis
This Phase III study will try Afimkibart to see if it helps children with moderate to severe ulcerative colitis and is safe for them.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 9 sites (Atlanta, Georgia and 8 other locations) |
| Trial ID | NCT07158242 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, multicenter Phase III trial enrolls pediatric participants with moderate to severe active ulcerative colitis who have had inadequate response or intolerance to systemic corticosteroids, immunomodulators, or biologic therapies. Participants receive Afimkibart during an induction period and responders enter a maintenance phase to compare longer-term efficacy and safety against placebo or comparator. The protocol includes pharmacokinetic sampling to establish pediatric dosing, regular safety monitoring, and efficacy endpoints such as clinical remission and symptom improvement. The study is conducted at major pediatric and academic centers in the United States and Taiwan.
Who should consider this trial
Good fit: Children with a confirmed diagnosis of moderate to severe ulcerative colitis who weigh at least 10 kg and who have had an inadequate response or intolerance to systemic corticosteroids, immunomodulators, or biologic therapies.
Not a fit: Patients with Crohn's disease or other non-UC colitis diagnoses, monogenic infant-onset IBD, an ostomy or ileoanal pouch, suspected primary sclerosing cholangitis, active tuberculosis, or recent major surgery are excluded and unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, Afimkibart could provide a new treatment option that reduces symptoms and helps maintain remission in children whose ulcerative colitis is not controlled by current therapies.
How similar studies have performed: Earlier-phase trials of Afimkibart and related biologic agents in adults and preliminary pediatric data have shown promising safety and efficacy signals, but robust pediatric Phase III evidence is still needed.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Atlanta, Georgia and 8 other locations
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
- NYU School of Medicine — New York, New York, United States (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
- Chulalongkorn University — Bangkok, Thailand (Recruiting)
- Siriraj Hospital — Bangkok, Thailand (Recruiting)
- Ramathibodi Hospital — Bangkok, Thailand (Recruiting)
- Birmingham Children's Hospital — Birmingham, United Kingdom (Recruiting)
- Addenbrooke's Hospital — Cambridge, United Kingdom (Recruiting)
- Sheffield Childrens Hospital — Sheffield, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: CA45905 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.