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 Hospital Colorado
Aurora, Colorado, United States
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
Partial Modified Mayo Score (pmMS)
Time frame: At Week 12
Percentage of Participants With Symptomatic Response
Time frame: At Week 12
Percentage of Participants With Symptomatic 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
Change From Baseline in TUMMY-UC Scores
Time frame: From Baseline to Week 52
Percentage of Participants With Endoscopic Remission
Time frame: At Week 52
Reference Study ID Number: CA45905 https://forpatients.roche.com/ No attachments to email below.
CONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of South Florida
Tampa, Florida, United States
RECRUITINGChildren's Healthcare of Atlanta
Atlanta, Georgia, United States
RECRUITINGNorthwell Health
Lake Success, New York, United States
RECRUITINGNYU Langone Health
New York, New York, United States
RECRUITINGMater Hospital Brisbane
South Brisbane, Queensland, Australia
RECRUITINGRoyal Childrens Hospital
Parkville, Victoria, Australia
RECRUITINGPerth Children's Hospital
Nedlands, Western Australia, Australia
RECRUITINGCECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, Brazil
RECRUITINGBR Trials - Pesquisa Clínica
São Paulo, São Paulo, Brazil
RECRUITING...and 12 more locations
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 Corticosteroids
Time frame: At Week 52
Percentage of Participants With Adverse Events (AEs)
Time frame: From Baseline up to approximately 4 years
Serum Concentration of Afimkibart
Time frame: Up to approximately 4 years