ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Perianal fistulizing Crohn's disease causes major quality-of-life problems and is often hard to treat. This trial tests risankizumab in people who did not respond to or could not tolerate other standard therapies, and it uses MRI plus clinical assessment to measure healing.
Who Should Pay Attention
Adults and teens with Crohn's disease and perianal fistulas (especially those refractory to antibiotics, immunomodulators, or biologics/JAK inhibitors); colorectal surgeons and IBD clinicians; researchers studying IL-23 blockade or PFCD outcomes.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 4
Enrollment25 participants
Study statusNot_yet_recruiting
Source depthTrial registry record
What To Know
This is a ClinicalTrials.gov record for a Phase 4 interventional study (not yet recruiting) testing risankizumab (an IL-23 inhibitor) for refractory perianal fistulizing Crohn's disease in Japan. The trial will use combined clinical and MRI endpoints to assess fistula remission at Week 28 and enroll about 25 participants.
Eligibility requires MRI-confirmed perianal fistula and prior inadequate response or intolerance to antibiotics, immunomodulators, or advanced therapies (including anti-TNFs, vedolizumab, ustekinumab, and upadacitinib). Dosing includes IV induction (600 mg) then SC maintenance (360 mg every 8 weeks) with a possible IV rescue dose (1200 mg) if needed.
Keep In Mind
This is a trial record (not results). Phase 4 here indicates post‑marketing study context; the registry status is NOT_YET_RECRUITING. The primary outcome is combined clinical and MRI fistula remission at Week 28 — the study will not provide evidence of efficacy until completed and reported.
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
SponsorYuki Horio
Trial IDNCT07872449
Study typeInterventional
Trial phasePhase 4
Enrollment25 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedOct 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.
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