NCT07158242RecruitingPhase 3
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
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
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 28 Aug 2025
- Start date
- 15 Apr 2026
- Primary completion date
- 31 Mar 2030
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Ulcerative colitis
- NCT number
- NCT07158242
- EU CT number
- 2025-522518-22-01
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 100
- From 15 Apr 2026 to the primary completion date, 31 Mar 2030
- 26 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any major surgery within 6 weeks prior to screening or a major planned surgery during the study
Other illness
- 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
- Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)
Other
- Presence of an ostomy or ileoanal pouch
- Current diagnosis or suspicion of primary sclerosing cholangitis
Who the study is looking for
- 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
Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Perth Children's Hospital Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| Royal Childrens Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
| Mater Hospital Brisbane Coordinator of this site? Confirm its status | South Brisbane | Australia | Recruiting |
| CECIP - Centro de Estudos Clínicos do Interior Paulista Coordinator of this site? Confirm its status | Jaú | Brazil | Recruiting |
| Santa Casa de Misericordia de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| BR Trials - Pesquisa Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Children's Hospital, Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Birmingham Children's Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| Sheffield Childrens Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Chulalongkorn University Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| Ramathibodi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Children's Healthcare of Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Connecticut Children's Medical Center Coordinator of this site? Confirm its status | Hartford | United States | Recruiting |
| Northwell Health Coordinator of this site? Confirm its status | Lake Success | United States | Recruiting |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| UPMC Childen?s Hospital of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| IATROS International Coordinator of this site? Confirm its status | Bloemfontein | South Africa | Recruiting |
| Emmed Research Coordinator of this site? Confirm its status | Pretoria | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.