Testing Afimkibart for Moderate to Severe Crohn's Disease in Children
Tests afimkibart in children aged 2 to 17 with active Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Birmingham, London, and Sheffield, United KingdomSee the 3 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 17 years old?
Source: NCT07298421, who can take part
Where in United Kingdom
- Birmingham Children's HospitalBirmingham, United KingdomTaking people
- King's College HospitalLondon, United KingdomTaking people
- Sheffield Childrens HospitalSheffield, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07298421EU 2025-523318-96-00
- Record updated
- 5 November 2026
- Original description
This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).Read full original descriptionShow less
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 Crohn's Disease
This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).
Inclusion: Body weight >= 10 kilogram (kg); Active CD confirmed by endoscopy (ileocolonoscopy); Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score >= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) >=6 (or >=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy; Inadequate response, loss of response, and/or intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and/or immunosuppressants) or advanced therapies (including anti-tumor necrosis factor, anti-interleukin, anti-integrin, or Janus Kinase (JAK) inhibitors).
Exclusion: Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD); History of >= 3 bowel resections: > 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; Current diagnosis of ulcerative colitis (UC), abdominal/intraabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease; Symptomatic bowel strictures, fulminant colitis, or toxic megacolon; Presence of abdominal or perianal abscess; Current diagnosis or suspicion of primary sclerosing cholangitis.