A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
Not Applicable
Not yet recruiting
- Conditions
- Moderately to Severely Active Ulcerative Colitis
- Interventions
- Drug: Afimkibart
- Registration Number
- NCT07158242
- Lead Sponsor
- Hoffmann-La Roche
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Afimkibart Dose A Afimkibart Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection. Afimkibart Dose B Afimkibart Participants will receive Afimkibart IV followed by Afimkibart SC.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Percentage of Participants with PUCAI Remission At Week 12 Change from Baseline in Tummy Ulcerative Colitis (TUMMY-UC) Scores From Baseline to Week 12 Change from Baseline in Pediatric Ulcerative Colitis Activity Index (PUCAI) Response From Baseline, at Week 12 Percentage of Participants with Endoscopic Improvement At Week 52 Percentage of Participants with Histologic Improvement At Week 52 Percentage of Participants with Histologic-endoscopic Mucosal Improvement At Week 52 Percentage of Participants with Histologic-endoscopic Mucosal Remission At Week 52 Change from Baseline in PUCAI Response at Week 52 From Baseline, at Week 52 Percentage of Participants with PUCAI Remission at Week 52 At Week 52 Change from Baseline in TUMMY-UC Scores From Baseline to Week 52 Percentage of Participants with Clinical Remission without the use of Corticosteriods At Week 52 Percetage of Participants with Adverse Events (AEs) From Baseline up to approximately 4 years Serum Concentartion of Afimkibart Up to approximately 4 years