Crohn DiseasePhase 4RIS-PERIANALNCT07872449
Risankizumab for Refractory Perianal Fistulizing Crohn's Disease
A Phase 4 study testing Risankizumab in people with Crohn Disease and Perianal Fistula, run by Yuki Horio at 4 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Crohn Disease, Perianal Fistula, Perianal Fistula Due to Crohn's Disease
- What is being tested?
- Risankizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesJapan
- Study dates
- 1 Oct 2026to 31 Mar 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- Patients who are intolerant to two or more prior lines of advanced therapy
- Patients previously treated with darvadstrocel
- Patients with a colostomy or ileostomy
- Patients with disease activity (CDAI) > 400
- Patients receiving systemic steroids
- Patients requiring new treatment with immunomodulators or advanced therapies during the screening period
- Patients undergoing cytapheresis
- Patients with a history of malignancy (excluding carcinoma in situ)
- 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 are breastfeeding, pregnant, or may be pregnant, or who plan to become pregnant during the study period
- 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 active tuberculosis
- Other patients deemed inappropriate for trial participation by the principal/ sub-investigator responsible
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan4 sites, 4 recruiting
- Recruiting
Hyogo Medical University
Nishinomiya, 663-8501
Yuki Horio, MD, PhD, +81-798-45-6111, yu-horio@hyo-med.ac.jp
Tetsuya Takagawa, MD, PhD, +81-798-45-6111, takagawa@hyo-med.ac.jp
- Not yet recruiting
Department of Coloproctology, Tokyo Yamate Medical Center
Shinjuku-Ku, Tokyo
Satomi Furukawa, MD, PhD, +81-3-3364-0251, imotasf@yahoo.co.jp
- Not yet recruiting
Department of Inflammatory Bowel Disease (IBD), Yokohama Municipal Citizen's Hospital
Yokohama, 221-0855
Kenji Tatsumi, MD, PhD, +81-45-316-4580, landy-tk@bd5.so-net.ne.jp
- Not yet recruiting
Inflammatory Bowel Disease Center, YCU Medical Center, Yokohama City University
Yokohama, 232-0024
Hideaki Kimura, MD, PhD, +81-45-261-5656, hkim@yokohama-cu.ac.jp
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Crohn Disease, Perianal Fistula, Perianal Fistula Due to Crohn's Disease, Perianal Crohn's Disease
- Being tested
- Risankizumab
- Keywords
- Risankizumab, Crohn's Disease, Perianal Fistulizing Crohn's Disease, IL-23 inhibitor
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisankizumabDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Risankizumab Treatment Arm | Experimental | 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. Receives: Drug: Risankizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at Week 28
Secondary outcomes (19)
Proportion of participants achieving combined fistula remission at Week 52
Measured: at Week 52
Proportion of participants achieving clinical fistula improvement at Week 28 (Closure of ≥1 draining fistula compared to baseline)
Measured: at Week 28
Proportion of participants achieving clinical fistula remission at Week 28 (Closure of all draining fistulas compared to baseline)
Measured: at Week 28
Proportion of participants achieving clinical fistula improvement at Week 52 (Closure of ≥1 draining fistula compared to baseline)
Measured: at Week 52
Proportion of participants achieving clinical fistula remission at Week 52 (Closure of all draining fistulas compared to baseline)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at Week 52
Proportion of participants achieving combined fistula remission at Week 28 (Investigator assessment at site)
Measured: at Week 28
Proportion of participants achieving MRI fistula remission at Week 28 (Investigator assessment at site)
Measured: at Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion13 Oct 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuki Horio
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor-investigator, Yuki Horio, Hyogo Medical University
- Investigators
- Yuki Horio, MD, PhD, Principal investigator, Hyogo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872449
- Sponsor's protocol ID
- HMU-004/B26-324
- Acronym
- RIS-PERIANAL
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No