RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Risankizumab for Crohn Disease

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).

Official registry: https://clinicaltrials.gov/study/NCT07872449 · Yuki Horio · enrollment listed as 25

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Risankizumab. The registry lists allocation as na. 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.

They plan to enroll about 25 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Risankizumab

Primary outcome (registry wording): The proportion of participants achieving combined fistula remission at Week 28

Who it is for (from inclusion criteria)

Ages 15 Years to any
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

Who the registry excludes

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
Patients who are intolerant to two or more prior lines of advanced therapy

Public study contact (from the registry)

Yuki Horio, MD, PhD

+81-798-45-6111

yu-horio@hyo-med.ac.jp

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

4 listed

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)

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FAQ about this NCT record

Is NCT07872449 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07872449?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07872449?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary