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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
RECRUITINGNYU School of Medicine
New York, New York, United States
RECRUITINGNational Taiwan University Hospital
Taipei, Taiwan
Percentage of Participants with Clinical Remission at Week 12
Time frame: At Week 12
Percentage of Participants with Clinical Remission at Week 52
Time frame: At Week 52
Change from Baseline in Pediatric Ulcerative Colitis Activity Index (PUCAI) Response
Time frame: From Baseline, at Week 12
Percentage of Participants with PUCAI Remission
Time frame: At Week 12
Change from Baseline in Tummy Ulcerative Colitis (TUMMY-UC) Scores
Time frame: From Baseline to Week 12
Percentage of Participants with Endoscopic Improvement
Time frame: At Week 12
Percentage of Participants with Histologic Improvement
Time frame: At Week 12
Percentage of Participants with Histologic-endoscopic Mucosal Improvement
Time frame: At Week 12
Percentage of Participants with Histologic-endoscopic Mucosal Remission
Time frame: At Week 12
Change from Baseline in PUCAI Response at Week 52
Time frame: From Baseline, at Week 52
Percentage of Participants with PUCAI Remission at Week 52
Time frame: At Week 52
Reference Study ID Number: CA45905 https://forpatients.roche.com/
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Birmingham Children's Hospital
Birmingham, United Kingdom
RECRUITINGAddenbrooke's Hospital
Cambridge, United Kingdom
RECRUITINGSheffield Childrens Hospital
Sheffield, United Kingdom
RECRUITINGChange from Baseline in TUMMY-UC Scores
Time frame: From Baseline to Week 52
Percentage of Participants with Endoscopic Improvement
Time frame: At Week 52
Percentage of Participants with Histologic Improvement
Time frame: At Week 52
Percentage of Participants with Histologic-endoscopic Mucosal Improvement
Time frame: At Week 52
Percentage of Participants with Histologic-endoscopic Mucosal Remission
Time frame: At Week 52
Percentage of Participants with Clinical Remission without the use of Corticosteriods
Time frame: At Week 52
Percetage of Participants with Adverse Events (AEs)
Time frame: From Baseline up to approximately 4 years
Serum Concentartion of Afimkibart
Time frame: Up to approximately 4 years