[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660011":3},{"organization":4,"outcomesModule":7,"designInfo":64,"detailedDescription":70,"studyPopulation":16,"armGroups":71,"interventions":78,"overallOfficials":84,"centralContacts":88,"locations":96,"responsibleParty":145,"collaborators":149,"id":153,"slug":154,"hasResults":155,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":155,"sex":161,"minAge":162,"maxAge":16,"enrollmentInfo":163,"targetDuration":16,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":175,"overallStatus":179,"whyStopped":16,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"Hyogo Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":54},[9],{"measure":10,"description":11,"timeFrame":12},"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.","at Week 28",[14,18,20,22,24,26,28,30,32,34,36,38,40,42,44,46,48,50,52],{"measure":15,"description":16,"timeFrame":17},"Proportion of participants achieving combined fistula remission at Week 52",null,"at Week 52",{"measure":19,"description":16,"timeFrame":12},"Proportion of participants achieving clinical fistula improvement at Week 28 (Closure of ≥1 draining fistula compared to baseline)",{"measure":21,"description":16,"timeFrame":12},"Proportion of participants achieving clinical fistula remission at Week 28 (Closure of all draining fistulas compared to baseline)",{"measure":23,"description":16,"timeFrame":17},"Proportion of participants achieving clinical fistula improvement at Week 52 (Closure of ≥1 draining fistula compared to baseline)",{"measure":25,"description":16,"timeFrame":17},"Proportion of participants achieving clinical fistula remission at Week 52 (Closure of all draining fistulas compared to baseline)",{"measure":27,"description":16,"timeFrame":12},"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",{"measure":29,"description":16,"timeFrame":17},"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",{"measure":31,"description":16,"timeFrame":12},"Change from baseline in PDAI score at Week 28",{"measure":33,"description":16,"timeFrame":17},"Change from baseline in PDAI score at Week 52",{"measure":35,"description":16,"timeFrame":12},"Change from baseline in SIBDQ score at Week 28",{"measure":37,"description":16,"timeFrame":17},"Change from baseline in SIBDQ score at Week 52",{"measure":39,"description":16,"timeFrame":12},"Change from baseline in Van Assche score at Week 28",{"measure":41,"description":16,"timeFrame":17},"Change from baseline in Van Assche score at Week 52",{"measure":43,"description":16,"timeFrame":12},"Change from baseline in MAGNIFI-CD score at Week 28",{"measure":45,"description":16,"timeFrame":17},"Change from baseline in MAGNIFI-CD score at Week 52",{"measure":47,"description":16,"timeFrame":12},"Change from baseline in CDAI score at Week 28",{"measure":49,"description":16,"timeFrame":17},"Change from baseline in CDAI score at Week 52",{"measure":51,"description":16,"timeFrame":12},"Proportion of participants achieving combined fistula remission at Week 28 (Investigator assessment at site)",{"measure":53,"description":16,"timeFrame":12},"Proportion of participants achieving MRI fistula remission at Week 28 (Investigator assessment at site)",[55,58,60,62],{"measure":56,"description":16,"timeFrame":57},"Change from baseline in fecal calprotectin (up to Week 52)","up to Week 52",{"measure":59,"description":16,"timeFrame":57},"Change from baseline in LRG (leucine-rich alpha-2 glycoprotein) (up to Week 52)",{"measure":61,"description":16,"timeFrame":57},"Incidence proportion of serious adverse events \u002F adverse reactions (up to Week 52)",{"measure":63,"description":16,"timeFrame":57},"Incidence proportion of adverse events \u002F adverse reactions (up to Week 52)",{"allocation":65,"interventionModel":66,"interventionModelDescription":16,"primaryPurpose":67,"observationalModel":16,"timePerspective":16,"maskingInfo":68},"NA","SINGLE_GROUP","TREATMENT",{"masking":69,"maskingDescription":16,"whoMasked":16},"NONE","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.\n\nThe 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.",[72],{"label":73,"type":74,"description":75,"interventionNames":76},"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.",[77],"Drug: Risankizumab",[79],{"type":80,"name":81,"description":82,"armGroupLabels":83,"otherNames":16},"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).",[73],[85],{"name":86,"affiliation":5,"role":87},"Yuki Horio, MD, PhD","PRINCIPAL_INVESTIGATOR",[89,93],{"name":86,"role":90,"phone":91,"phoneExt":16,"email":92},"CONTACT","+81-798-45-6111","yu-horio@hyo-med.ac.jp",{"name":94,"role":90,"phone":91,"phoneExt":16,"email":95},"Tetsuya Takagawa, MD, PhD","takagawa@hyo-med.ac.jp",[97,111,120,134],{"facility":5,"status":16,"city":98,"state":16,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"Nishinomiya","663-8501","Japan","JP",{"type":103,"coordinates":104},"Point",[105,106],135.33199,34.71562,{"lat":106,"lon":105},[109,110],{"name":86,"role":90,"phone":91,"phoneExt":16,"email":92},{"name":94,"role":90,"phone":91,"phoneExt":16,"email":95},{"facility":112,"status":16,"city":113,"state":16,"zip":114,"country":100,"countryCode":101,"cosmosGeoPoint":16,"geoPoint":16,"contacts":115},"Department of Coloproctology, Tokyo Yamate Medical Center","Shinjuku-Ku","Tokyo",[116],{"name":117,"role":90,"phone":118,"phoneExt":16,"email":119},"Satomi Furukawa, MD, PhD","+81-3-3364-0251","imotasf@yahoo.co.jp",{"facility":121,"status":16,"city":122,"state":16,"zip":123,"country":100,"countryCode":101,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Department of Inflammatory Bowel Disease (IBD), Yokohama Municipal Citizen's Hospital","Yokohama","221-0855",{"type":103,"coordinates":125},[126,127],139.65,35.43333,{"lat":127,"lon":126},[130],{"name":131,"role":90,"phone":132,"phoneExt":16,"email":133},"Kenji Tatsumi, MD, PhD","+81-45-316-4580","landy-tk@bd5.so-net.ne.jp",{"facility":135,"status":16,"city":122,"state":16,"zip":136,"country":100,"countryCode":101,"cosmosGeoPoint":137,"geoPoint":139,"contacts":140},"Inflammatory Bowel Disease Center, YCU Medical Center, Yokohama City University","232-0024",{"type":103,"coordinates":138},[126,127],{"lat":127,"lon":126},[141],{"name":142,"role":90,"phone":143,"phoneExt":16,"email":144},"Hideaki Kimura, MD, PhD","+81-45-261-5656","hkim@yokohama-cu.ac.jp",{"type":146,"investigatorFullName":147,"investigatorTitle":148,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"SPONSOR_INVESTIGATOR","Yuki Horio","Lecturer",[150],{"name":151,"class":152},"AbbVie","INDUSTRY","100660011","phase-4-risankizumab-for-refractory-perianal-fistulizing-crohns-disease-100660011",false,"NCT07872449","Risankizumab for Refractory Perianal Fistulizing Crohn's Disease","Evaluation of Risankizumab for Refractory Perianal Fistulizing Crohn's Disease Using MRI-Based Remission Criteria: A Prospective, Single-Arm, Multicenter Study","RIS-PERIANAL","Inclusion Criteria:\n\n1. 15 years of age or older\n2. Patients with an MRI-confirmed perianal fistula due to Crohn's disease\n3. Patients with a draining anal fistula (maximum of 2 internal openings and maximum of 3 external openings) persisting for at least 2 weeks\n4. Patients who have experienced inadequate response, diminished response, or intolerance to one or more of the following treatments in the past:\n\n   ① Antibiotics (ciprofloxacin or metronidazole): Treatment lasting one month or longer.\n\n   ② Immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate): Treatment for 3 months or longer.\n\n   ③ Advanced therapies (infliximab, adalimumab, vedolizumab, ustekinumab, and upadacitinib): Standard therapy administered for 14 weeks or longer as induction or maintenance therapy.\n5. 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.\n6. Patients with draining fistulas that were drained at least 6 weeks prior to enrollment.\n7. 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\u002Fclinic requires.\n\nExclusion Criteria:\n\n1. Patients with a rectovaginal fistula at baseline (excluding past rectovaginal fistulas)\n2. Patients with severe rectal and\u002For anal stricture and\u002For severe proctitis (defined as the presence of large ulcers exceeding 0.5 cm in the rectum)\n3. Patients with abscesses or fluid collections exceeding 2 cm\n4. Patients for whom MRI is contraindicated\n5. Patients with a history of risankizumab, mirikizumab, or guselkumab administration\n6. Patients who are refractory to three or more prior lines of advanced therapy\n7. Patients who are intolerant to two or more prior lines of advanced therapy\n8. Patients previously treated with darvadstrocel\n9. Patients with a colostomy or ileostomy\n10. Patients with disease activity (CDAI) \\> 400\n11. Patients receiving systemic steroids\n12. Patients requiring new treatment with immunomodulators or advanced therapies during the screening period\n13. Patients undergoing cytapheresis\n14. Patients with a history of malignancy (excluding carcinoma in situ)\n15. 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\n16. Patients who underwent major surgery or suffered severe trauma within the past 6 months\n17. Patients who are breastfeeding, pregnant, or may be pregnant, or who plan to become pregnant during the study period\n18. 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\n19. Patients who received a live vaccine within 4 weeks prior to the start of risankizumab administration\n20. Patients with active tuberculosis\n21. Other patients deemed inappropriate for trial participation by the principal\u002F sub-investigator responsible","ALL","15 Years",{"count":164,"type":165},25,"ESTIMATED","INTERVENTIONAL",[168],"PHASE4","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.",[171,172,173,174],"Crohn Disease","Perianal Fistula","Perianal Fistula Due to Crohn's Disease","Perianal Crohn's Disease",[81,176,177,178],"Crohn's Disease","Perianal Fistulizing Crohn's Disease","IL-23 inhibitor","NOT_YET_RECRUITING","2026-10-07",{"date":182,"type":183},"2026-10-13","ACTUAL",{"date":185,"type":165},"2026-10-01",{"date":187,"type":165},"2029-03-31",{"name":147,"class":6},4]