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
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:
• Bodyweight \>= 10 kilogram (kg)
• Confirmed diagnosis of UC
• Moderately to severely active UC, defined as modified Mayo Score (mMS) or 5 to 9 points, including endoscopic score of 2 or 3, confirmed by centrally read endoscopy (flexible sigmoidoscopy or colonoscopy)
• 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
Locations
United States
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Florida
University of South Florida
RECRUITING
Tampa
Georgia
Children's Healthcare of Atlanta
RECRUITING
Atlanta
New York
Northwell Health
RECRUITING
Lake Success
NYU Langone Health
RECRUITING
New York
Other Locations
Australia
Perth Children's Hospital
RECRUITING
Nedlands
Royal Childrens Hospital
RECRUITING
Parkville
Mater Hospital Brisbane
RECRUITING
South Brisbane
Brazil
CECIP - Centro de Estudos Clínicos do Interior Paulista
RECRUITING
Jaú
BR Trials - Pesquisa Clínica
RECRUITING
São Paulo
Canada
Hospital For Sick Children
RECRUITING
Toronto
China
Children's Hospital ZheJiang University School of Medicine
RECRUITING
Hangzhou
Ruijin Hospital Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
South Africa
IATROS International
RECRUITING
Bloemfontein
Emmed Research
RECRUITING
Pretoria
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Thailand
Chulalongkorn University
RECRUITING
Bangkok
Ramathibodi Hospital
RECRUITING
Bangkok
Siriraj Hospital
RECRUITING
Bangkok
United Kingdom
Birmingham Children's Hospital
RECRUITING
Birmingham
Addenbrooke's Hospital
RECRUITING
Cambridge
Sheffield Childrens Hospital
RECRUITING
Sheffield
Contact Information
Primary
Reference Study ID Number: CA45905 https://forpatients.roche.com/ No attachments to email below.
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Backup
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Time Frame
Start Date: 2026-04-15
Estimated Completion Date: 2031-03-31
Participants
Target number of participants: 100
Treatments
Experimental: Afimkibart Dose A
Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.
Experimental: Afimkibart Dose B
Participants will receive Afimkibart IV followed by Afimkibart SC.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche