Risankizumab for Hard-to-Treat Fistulas Around the Anus in Crohn's Disease

Trial details

Who runs it

Yuki Horio

Trial code

NCT07872449

Record updated

23 October 2026

Original description

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.Read full original descriptionShow less

Evaluation of Risankizumab for Refractory Perianal Fistulizing Crohn's Disease Using MRI-Based Remission Criteria: A Prospective, Single-Arm, Multicenter Study

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: 15 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; ③ Advanced therapies (infliximab, adalimumab, vedolizumab, ustekinumab, and upadacitinib): Standard therapy administered for 14 weeks or longer as induction or maintenance therapy; Patients who can agree to removal of the perianal seton by week 20 (week 20 ± 1 week) of administration, if patients already have setons inserted; Patients with draining fistulas that were drained at least 6 weeks prior to enrollment; Patients who have received a sufficient explanation regarding participation in this study, understood it fully, and provided their voluntary written consent, or patients whose legal representative received a sufficient explanation regarding participation in this study, understood it fully, and provided their voluntary written assent, if participating hospital/clinic requires.

Exclusion: Patients who are refractory to three or more prior lines of advanced therapy; Patients who are intolerant to two or more prior lines of advanced therapy; Patients previously treated with darvadstrocel; Patients receiving systemic steroids; Patients requiring new treatment with immunomodulators or advanced therapies during the screening period; Patients with concomitant uncontrolled liver disease, hematologic disease, gastrointestinal disease (excluding Crohn's disease), endocrine disease, pulmonary disease, cardiac disease, neurological disease, psychiatric disease, brain disease, or active infection; Patients who underwent major surgery or suffered severe trauma within the past 6 months; Patients who showed persistent positivity for HBsAg and HBV-PCR, or seropositivity for HCV and quantitative HCV-PCR within 6 months prior to the start of the screening period; Patients who received a live vaccine within 4 weeks prior to the start of risankizumab administration; Patients with a rectovaginal fistula at baseline (excluding past rectovaginal fistulas); Patients with a history of risankizumab, mirikizumab, or guselkumab administration; Patients with disease activity (CDAI) > 400; Patients with a history of malignancy (excluding carcinoma in situ); Patients with active tuberculosis; 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 colostomy or ileostomy; Patients undergoing cytapheresis; Patients who are breastfeeding, pregnant, or may be pregnant, or who plan to become pregnant during the study period; Other patients deemed inappropriate for trial participation by the principal/ sub-investigator responsible.

ClinicalTrials.gov NCT07872449