ClinicalTrials.gov
Cure8 trial brief
Why This Matters
A successful Phase 3 trial could provide a new treatment option specifically studied in children with moderate‑to‑severe Crohn's disease, addressing a pediatric population often underrepresented in trials.
Who Should Pay Attention
Pediatric patients with moderate‑to‑severe Crohn's disease and their caregivers, pediatric gastroenterologists, and researchers involved in pediatric IBD drug development.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 3
Enrollment100 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This is a registered interventional Phase 3, double‑blind, treat‑through study enrolling about 100 children. Afimkibart is given both IV and SC in the study arms. Eligible children must have active moderate–severe disease by PCDAI and endoscopy and have had inadequate response or intolerance to prior conventional or advanced therapies.
The primary outcomes are clinical remission (PCDAI) and endoscopic response at Week 52. The trial excludes children with certain complications (for example current abscess, symptomatic strictures, fulminant colitis, toxic megacolon) and some other diagnoses (eg, ulcerative colitis, primary sclerosing cholangitis).
Locations include sites in Australia, Taiwan, and Thailand.
Keep In Mind
This entry is a clinicaltrials.gov record (Phase 3, recruiting). It describes study design and planned outcomes but does not contain efficacy or safety results. Afimkibart is investigational (RO7790121) and not yet an approved IBD therapy.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
Trial IDNCT07298421
Study typeInterventional
Trial phasePhase 3
Enrollment100 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedJul 13, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
This trial is testing an investigational anti-TL1A antibody (tulisokibart/MK-7240) as a potential new treatment for moderate to severe Crohn's disease. Results could affect future treatment options if the drug proves...
Eli Lilly presents positive results from VIVID-2 open-label extension study of Omvoh to treat Crohn's disease at Crohn's and Colitis Congress
These are multi‑year clinical results for a newly approved IL‑23p19 inhibitor (mirikizumab) showing sustained clinical and endoscopic benefit for many patients with moderate‑to‑severe Crohn’s disease, including some who...
Teva's Duvakitug Set To Shake Up IBD Treatment, Analyst Highlights Competitive Data
The article spotlights duvakitug and the anti‑TL1A drug class as potential new options for ulcerative colitis and Crohn’s disease, especially for treatment‑experienced patients. Biomarker‑driven studies could help...