Risankizumab for Refractory Perianal Fistulizing Crohn's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 4 trial in Japan evaluates the efficacy of risankizumab for perianal fistulizing Crohn’s disease using both clinical assessments and MRI imaging. Eligible participants are 15 years or older with MRI-confirmed PFCD and a draining fistula that has persisted despite prior therapies. The study emphasizes a composite evaluation combining symptoms, fistula drainage status, and MRI findings to standardize outcomes. Remission and response will be interpreted through integrated clinical and radiologic criteria to inform future guidelines. The trial is led by Yuki Horio with collaboration from AbbVie and multiple institutions in Hyogo, Tokyo, and Yokohama.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 15 years of age or older
2. Patients with an MRI-confirmed perianal fistula due to Crohn's disease
3. Patients with a draining anal fistula (maximum of 2 internal openings and maximum of 3 external openings) persisting for at least 2 weeks
4. 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.
5. 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.
6. Patients with draining fistulas that were drained at least 6 weeks prior to enrollment.
7. 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 Criteria:

1. Patients with a rectovaginal fistula at baseline (excluding past rectovaginal fistulas)
2. 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)
3. Patients with abscesses or fluid collections exceeding 2 cm
4. Patients for whom MRI is contraindicated
5. Patients with a history of risankizumab, mirikizumab, or guselkumab administration
6. Patients who are refractory to three or more prior lines of advanced therapy
7. Patients who are intolerant to two or more prior lines of advanced therapy
8. Patients previously treated with darvadstrocel
9. Patients with a colostomy or ileostomy
10. Patients with disease activity (CDAI) \> 400
11. Patients receiving systemic steroids
12. Patients requiring new treatment with immunomodulators or advanced therapies during the screening period
13. Patients undergoing cytapheresis
14. Patients with a history of malignancy (excluding carcinoma in situ)
15. 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
16. Patients who underwent major surgery or suffered severe trauma within the past 6 months
17. Patients who are breastfeeding, pregnant, or may be pregnant, or who plan to become pregnant during the study period
18. 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
19. Patients who received a live vaccine within 4 weeks prior to the start of risankizumab administration
20. Patients with active tuberculosis
21. Other patients deemed inappropriate for trial participation by the principal/ sub-investigator responsible

Where it's running

• Hyogo Medical University
  Nishinomiya, Japan Recruiting
• Department of Coloproctology, Tokyo Yamate Medical Center
  Shinjuku-Ku, Japan Not yet recruiting
• Department of Inflammatory Bowel Disease (IBD), Yokohama Municipal Citizen's Hospital
  Yokohama, Japan Not yet recruiting
• Inflammatory Bowel Disease Center, YCU Medical Center, Yokohama City University
  Yokohama, Japan Not yet recruiting

Study contacts

• Principal investigator: Yuki Horio, MD, PhD — Hyogo Medical University
• Study coordinator: Yuki Horio, MD, PhD
• Email: yu-horio@hyo-med.ac.jp
• Phone: +81-798-45-6111

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.