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 Langone Health
New York, New York, United States
RECRUITINGPercentage 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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Royal Children's Hospital
Parkville, Victoria, Australia
RECRUITINGPerth Children's Hospital
Nedlands, Western Australia, Australia
RECRUITINGChildren's Hospital ZheJiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGNational Taiwan University Hospital
Taipei, Taiwan
RECRUITINGChulalongkorn University
Bangkok, Thailand
RECRUITINGSiriraj Hospital
Bangkok, Thailand
RECRUITINGRamathibodi Hospital
Bangkok, Thailand
RECRUITINGBirmingham Children's Hospital
Birmingham, United Kingdom
RECRUITING...and 2 more locations
Change 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