NCT07872449
Risankizumab for Refractory Perianal Fistulizing Crohn's Disease
Recruiting · Phase 4 · Yuki Horio · registry updated 2026-10-23
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
Crohn's disease is an inflammatory bowel disease characterized by relapses and remissions, causing lesions throughout the digestive tract and accompanied by diarrhea, abdominal pain, and nutritional disorders. In Japan particularly, the incidence of anal lesions is high, with approximately half of patients developing fistulas or abscesses, significantly impairing quality of life (QOL). For perianal fistulizing Crohn's disease (PFCD), combined treatment with surgical intervention (e.g., seton placement) and medical therapy centered on anti-TNF agents is standard. However, challenges remain regarding efficacy rates and evaluation criteria. Novel therapies such as stem cell therapy, JAK inhibitors, and IL-23 inhibitors are gaining attention. This study using risankizumab aims to be the first in Japan to comprehensively evaluate the therapeutic efficacy of PFCD using both clinical and MRI assessments, thereby contributing to future treatment standardization and guideline development.
Inclusion
- years of age or older
- Patients with an MRI-confirmed perianal fistula due to Crohn's disease
- Patients with a draining anal fistula (maximum of 2 internal openings and maximum of 3 external openings) persisting for at least 2 weeks
- Patients who have experienced inadequate response, diminished response, or intolerance to one or more of the following treatments in the past:
- ① Antibiotics (ciprofloxacin or metronidazole): Treatment lasting one month or longer.
- ② Immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate): Treatment for 3 months or longer.
Exclusion
- Patients with a rectovaginal fistula at baseline (excluding past rectovaginal fistulas)
- Patients with severe rectal and/or anal stricture and/or severe proctitis (defined as the presence of large ulcers exceeding 0.5 cm in the rectum)
- Patients with abscesses or fluid collections exceeding 2 cm
- Patients for whom MRI is contraindicated
- Patients with a history of risankizumab, mirikizumab, or guselkumab administration
- Patients who are refractory to three or more prior lines of advanced therapy