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.
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 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 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
Single group
Risankizumab
DrugRisankizumab (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.
Proportion of participants achieving combined fistula remission at Week 52
Proportion of participants achieving clinical fistula improvement at Week 28 (Closure of ≥1 draining fistula compared to baseline)
Proportion of participants achieving clinical fistula remission at Week 28 (Closure of all draining fistulas compared to baseline)
Proportion of participants achieving clinical fistula improvement at Week 52 (Closure of ≥1 draining fistula compared to baseline)
Change from baseline in fecal calprotectin (up to Week 52)
Change from baseline in LRG (leucine-rich alpha-2 glycoprotein) (up to Week 52)
Incidence proportion of serious adverse events / adverse reactions (up to Week 52)
Incidence proportion of adverse events / adverse reactions (up to Week 52)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
