A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
Recruiting · NCT07158242 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
2 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
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)
Where it is running
22 locations listed across 4 US states.
- Children's Hospital Colorado - Aurora, Colorado, United States
- University of South Florida - Tampa, Florida, United States
- Children's Healthcare of Atlanta - Atlanta, Georgia, United States
- Northwell Health - Lake Success, New York, United States
- NYU Langone Health - New York, New York, United States
- Chulalongkorn University - Bangkok, Thailand
- Siriraj Hospital - Bangkok, Thailand
- Ramathibodi Hospital - Bangkok, Thailand
- Birmingham Children's Hospital - Birmingham, United Kingdom
- IATROS International - Bloemfontein, South Africa
- Addenbrooke's Hospital - Cambridge, United Kingdom
- Emmed Research - Pretoria, South Africa
- Ruijin Hospital Shanghai Jiaotong University School of Medicine - Shanghai, China
- Sheffield Childrens Hospital - Sheffield, United Kingdom
- National Taiwan University Hospital - Taipei, Taiwan
- Hospital For Sick Children - Toronto, Ontario, Canada
- Mater Hospital Brisbane - South Brisbane, Queensland, Australia
- CECIP - Centro de Estudos Clínicos do Interior Paulista - Jaú, São Paulo, Brazil
- BR Trials - Pesquisa Clínica - São Paulo, São Paulo, Brazil
- Royal Childrens Hospital - Parkville, Victoria, Australia
- Perth Children's Hospital - Nedlands, Western Australia, Australia
- Children's Hospital ZheJiang University School of Medicine - Hangzhou, Zhejiang, China