A Phase 4 interventional study of Risankizumab in Crohn Disease, Perianal Fistula and Perianal Fistula Due to Crohn's Disease, sponsored by Yuki Horio. Recruiting at 4 sites in Japan. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Yuki Horio · Phase 4, Interventional, and Treatment
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.
PFCD remains a debilitating condition with high morbidity and severely impaired QOL, and an optimal treatment strategy has yet to be established. While combined seton drainage and pharmacotherapy have achieved clinical remission in several studies, the definition of "remission" varies, leading to difficulties in standardizing outcomes. Consequently, there is growing consensus that combining clinical and radiologic (particularly MRI-based) assessments provides a more comprehensive and reliable evaluation of treatment efficacy in PFCD. Ongoing trials of upadacitinib and guselkumab in PFCD are adopting composite endpoints combining clinical and MRI remission. Risankizumab, a selective interleukin-23 (IL-23) inhibitor, has shown favorable anti-inflammatory effects in CD; however, no prospective studies have yet evaluated its efficacy for PFCD using objective imaging modalities such as MRI.
The present study is the first prospective investigation to comprehensively assess the therapeutic efficacy of risankizumab for PFCD through combined clinical and MRI evaluations. This research aims to contribute to establishing new therapeutic strategies and standardizing outcome assessments for PFCD. The findings are expected to clarify the role of IL-23 inhibitors in PFCD management and provide scientific evidence supporting the development of future international treatment guidelines.
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's planned enrollment of 25 is below the median of 66 across 1,212 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →This is the only study on the registry with Yuki Horio as lead sponsor.
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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.
Exclusion Criteria:
Risankizumab 600 mg is administered intravenously over 4 weeks at 3 intervals (initial, 4 weeks, 8 weeks). Starting 4 weeks after completion of the induction therapy with risankizumab intravenous infusion, risankizumab 360 mg is administered subcutaneously at 8-week intervals. If efficacy diminishes 16 weeks or later after initiating maintenance therapy with the subcutaneous formulation of risankizumab (at visit 7, week 28 of this study), a single intravenous infusion of 1200 mg may be administered (rescue therapy). Eight weeks after the single 1200 mg intravenous infusion, administer risankizumab 360 mg subcutaneously.
Drug: Risankizumab
Risankizumab (Skyrizi®, AbbVie Inc.) is a humanized IgG1 monoclonal antibody targeting the p19 subunit of interleukin-23 (IL-23). For Crohn's disease, participants receive 600 mg intravenously (IV) at Weeks 0, 4, and 8 as induction therapy, followed by 360 mg subcutaneously (SC) at Week 12 and every 8 weeks thereafter as maintenance therapy. If efficacy diminishes 16 weeks or later after initiating maintenance therapy with the subcutaneous formulation of risankizumab, a single intravenous infusion of 1200 mg may be administered (rescue therapy).
The proportion of participants achieving combined fistula remission at Week 28
To confirm the efficacy of risankizumab, a combined evaluation of clinical symptoms and objective MRI findings will be used.
Time frame: at Week 28
Proportion of participants achieving combined fistula remission at Week 52
Time frame: at Week 52
Proportion of participants achieving clinical fistula improvement at Week 28 (Closure of ≥1 draining fistula compared to baseline)
Time frame: at Week 28
Proportion of participants achieving clinical fistula remission at Week 28 (Closure of all draining fistulas compared to baseline)
Time frame: at Week 28
Proportion of participants achieving clinical fistula improvement at Week 52 (Closure of ≥1 draining fistula compared to baseline)
Time frame: at Week 52
Proportion of participants achieving clinical fistula remission at Week 52 (Closure of all draining fistulas compared to baseline)
Time frame: at Week 52
Proportion of participants achieving MRI fistula remission at Week 28 *Defined as the absence of fluid collection exceeding 2 cm in at least two of three dimensions confirmed by central MRI
Time frame: at Week 28
Proportion of participants achieving MRI fistula remission at Week 52 *Defined as the absence of fluid collection exceeding 2 cm in at least two of three dimensions confirmed by central MRI
Time frame: at Week 52
Change from baseline in PDAI score at Week 28
Perianal Crohn's Disease Activity Index (PDAI). Minimum score 0, maximum score 20; higher scores mean a worse outcome.
Time frame: at Week 28
Change from baseline in PDAI score at Week 52
Perianal Crohn's Disease Activity Index (PDAI). Minimum score 0, maximum score 20; higher scores mean a worse outcome.
Time frame: at Week 52
Change from baseline in SIBDQ score at Week 28
Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Minimum score 10, maximum score 70; higher scores mean a better outcome.
Time frame: at Week 28
Change from baseline in SIBDQ score at Week 52
Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Minimum score 10, maximum score 70; higher scores mean a better outcome.
Time frame: at Week 52
Change from baseline in Van Assche score at Week 28
Van Assche score. Minimum score 0, maximum score 22; higher scores mean a worse outcome.
Time frame: at Week 28
Change from baseline in Van Assche score at Week 52
Van Assche score. Minimum score 0, maximum score 22; higher scores mean a worse outcome.
Time frame: at Week 52
Change from baseline in MAGNIFI-CD score at Week 28
Magnetic Resonance Novel Index for Fistula Imaging in Crohn's Disease (MAGNIFI-CD). Minimum score 0, maximum score 25; higher scores mean a worse outcome.
Time frame: at Week 28
Change from baseline in MAGNIFI-CD score at Week 52
Magnetic Resonance Novel Index for Fistula Imaging in Crohn's Disease (MAGNIFI-CD). Minimum score 0, maximum score 25; higher scores mean a worse outcome.
Time frame: at Week 52
Change from baseline in CDAI score at Week 28
Crohn's Disease Activity Index (CDAI). Minimum score 0, maximum score 600; higher scores mean a worse outcome.
Time frame: at Week 28
Change from baseline in CDAI score at Week 52
Crohn's Disease Activity Index (CDAI). Minimum score 0, maximum score 600; higher scores mean a worse outcome.
Time frame: at Week 52
Proportion of participants achieving combined fistula remission at Week 28 (Investigator assessment at site)
Time frame: at Week 28
Proportion of participants achieving MRI fistula remission at Week 28 (Investigator assessment at site)
Time frame: at Week 28
Change from baseline in fecal calprotectin (up to Week 52)
Fecal calprotectin concentration (unit of measure: micrograms per gram of stool, µg/g), measured by central laboratory assay. This outcome measure reports a laboratory analyte concentration rather than a score on a scale; a defined scale minimum/maximum therefore does not apply. Higher concentrations indicate greater disease activity (a worse outcome).
Time frame: up to Week 52
Change from baseline in LRG (leucine-rich alpha-2 glycoprotein) (up to Week 52)
Serum leucine-rich alpha-2 glycoprotein (LRG) concentration (unit of measure: micrograms per milliliter, µg/mL), measured by central laboratory assay. This outcome measure reports a laboratory analyte concentration rather than a score on a scale; a defined scale minimum/maximum therefore does not apply. Higher concentrations indicate greater disease activity (a worse outcome).
Time frame: up to Week 52
Incidence proportion of serious adverse events / adverse reactions (up to Week 52)
Time frame: up to Week 52
Incidence proportion of adverse events / adverse reactions (up to Week 52)
Time frame: up to Week 52
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Risankizumab