[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653072":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":37,"studyPopulation":27,"armGroups":38,"interventions":50,"overallOfficials":27,"centralContacts":61,"locations":67,"responsibleParty":237,"collaborators":27,"id":239,"slug":240,"hasResults":241,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":27,"eligibilityCriteria":245,"healthyVolunteers":241,"sex":246,"minAge":247,"maxAge":248,"enrollmentInfo":249,"targetDuration":27,"studyType":252,"phases":253,"briefSummary":255,"conditions":256,"keywords":258,"overallStatus":70,"whyStopped":27,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},{"fullName":5,"class":6},"Oruka Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of participants achieving HiSCR75 at Week 16","At least a 75% reduction from Baseline in the total abscess and inflammatory nodule count, with no increase from Baseline in abscess or draining tunnel count.","Week 16",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Proportion of participants achieving HiSCR50 at Week 16","At least a 50% reduction from Baseline in the total abscess and inflammatory nodule count, with no increase from Baseline in abscess or draining tunnel count",{"measure":18,"description":19,"timeFrame":12},"Change from Baseline in the weekly mean of the Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) worst skin pain score at Week 16","This endpoint assesses the change from baseline to Week 16 in the average weekly patient-reported worst skin pain score, as recorded daily in the HSSDD.",{"measure":21,"description":22,"timeFrame":12},"Proportion of participants with a ≥ 3-point decrease from Baseline in the weekly mean of the HSSDD worst skin pain score at Week 16 among those with a Baseline score ≥ 3","This endpoint assesses the proportion of participants who achieve at least a 3-point reduction in their weekly mean worst skin pain score by Week 16.",{"measure":24,"description":25,"timeFrame":26},"Incidence of TEAEs, TESAEs, and TEAESIs and Observed values, potentially clinically important values, and change from baseline in vital signs, laboratory tests, and electrocardiograms","Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse events (TESAEs), and TEAEs of Special Interest (TEAESIs); These endpoints assess safety and tolerability of ORKA-002 in participants with moderate-to-severe HS.","Day 1 through Week 92",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":33,"maskingDescription":27,"whoMasked":34},"DOUBLE",[35,36],"PARTICIPANT","INVESTIGATOR","The study will evaluate an induction dosing regimen of ORKA-002 administered every 4 weeks for 12 weeks compared with placebo during a double-blind induction period through Week 16. This will be followed by an open-label maintenance period, during which ORKA-002 will be administered every 12 weeks. The study will consist of four periods:\n\n* Screening Period\n* Induction Period (double-blind)\n* Maintenance Period (open-label)\n* Post-Treatment Follow-Up Period",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"Induction Period - Arm 1 (ORKA-002)","EXPERIMENTAL","Participants will receive ORKA-002 per protocol Induction regimen.",[44],"Drug: ORKA-002",{"label":46,"type":41,"description":47,"interventionNames":48},"Induction Period - Arm 2 (Placebo)","Participants will receive Placebo per protocol Induction regimen.",[49],"Other: Placebo",[51,56],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":27},"DRUG","ORKA-002","ORKA-002 administered by subcutaneous (SC) injection",[40],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":27},"OTHER","Placebo","Placebo administered by subcutaneous (SC) injection",[46],[62],{"name":63,"role":64,"phone":65,"phoneExt":27,"email":66},"Oruka Clinical Trials Information","CONTACT","781-560-0299","clinicaltrials@orukatx.com",[68,85,96,106,117,128,139,150,161,172,183,195,206,217,227],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Oruka Therapeutics Investigative Site","RECRUITING","Birmingham","Alabama","35244","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-86.80249,33.52066,{"lat":80,"lon":79},[83],{"name":84,"role":64,"phone":27,"phoneExt":27,"email":66},"Oruka Investigative Site",{"facility":69,"status":70,"city":86,"state":87,"zip":88,"country":74,"countryCode":75,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Fountain Valley","California","92708",{"type":77,"coordinates":90},[91,92],-117.95367,33.70918,{"lat":92,"lon":91},[95],{"name":84,"role":64,"phone":65,"phoneExt":27,"email":66},{"facility":69,"status":70,"city":97,"state":87,"zip":98,"country":74,"countryCode":75,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Los Angeles","90045",{"type":77,"coordinates":100},[101,102],-118.24368,34.05223,{"lat":102,"lon":101},[105],{"name":84,"role":64,"phone":65,"phoneExt":27,"email":66},{"facility":69,"status":70,"city":107,"state":108,"zip":109,"country":74,"countryCode":75,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Cromwell","Connecticut","06416",{"type":77,"coordinates":111},[112,113],-72.64537,41.5951,{"lat":113,"lon":112},[116],{"name":84,"role":64,"phone":65,"phoneExt":27,"email":66},{"facility":69,"status":70,"city":118,"state":119,"zip":120,"country":74,"countryCode":75,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Sandy Springs","Georgia","30328",{"type":77,"coordinates":122},[123,124],-84.37854,33.92427,{"lat":124,"lon":123},[127],{"name":84,"role":64,"phone":65,"phoneExt":27,"email":66},{"facility":69,"status":70,"city":129,"state":130,"zip":131,"country":74,"countryCode":75,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Chicago","Illinois","60602",{"type":77,"coordinates":133},[134,135],-87.65005,41.85003,{"lat":135,"lon":134},[138],{"name":84,"role":64,"phone":65,"phoneExt":27,"email":66},{"facility":69,"status":70,"city":140,"state":141,"zip":142,"country":74,"countryCode":75,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"New Orleans","Louisiana","70115",{"type":77,"coordinates":144},[145,146],-90.07507,29.95465,{"lat":146,"lon":145},[149],{"name":84,"role":64,"phone":65,"phoneExt":27,"email":66},{"facility":69,"status":70,"city":151,"state":152,"zip":153,"country":74,"countryCode":75,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Canton","Michigan","48187",{"type":77,"coordinates":155},[156,157],-83.48216,42.30865,{"lat":157,"lon":156},[160],{"name":84,"role":64,"phone":65,"phoneExt":27,"email":66},{"facility":69,"status":70,"city":162,"state":163,"zip":164,"country":74,"countryCode":75,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"New Brighton","Minnesota","55112",{"type":77,"coordinates":166},[167,168],-93.20189,45.06552,{"lat":168,"lon":167},[171],{"name":84,"role":64,"phone":65,"phoneExt":27,"email":66},{"facility":69,"status":70,"city":173,"state":174,"zip":175,"country":74,"countryCode":75,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Omaha","Nebraska","68144",{"type":77,"coordinates":177},[178,179],-95.94043,41.25626,{"lat":179,"lon":178},[182],{"name":84,"role":64,"phone":65,"phoneExt":27,"email":66},{"facility":69,"status":184,"city":185,"state":186,"zip":187,"country":74,"countryCode":75,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"NOT_YET_RECRUITING","Chapel Hill","North Carolina","27516",{"type":77,"coordinates":189},[190,191],-79.05584,35.9132,{"lat":191,"lon":190},[194],{"name":84,"role":64,"phone":65,"phoneExt":27,"email":66},{"facility":69,"status":70,"city":196,"state":197,"zip":198,"country":74,"countryCode":75,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Portland","Oregon","97201",{"type":77,"coordinates":200},[201,202],-122.67621,45.52345,{"lat":202,"lon":201},[205],{"name":84,"role":64,"phone":65,"phoneExt":27,"email":66},{"facility":69,"status":70,"city":207,"state":208,"zip":209,"country":74,"countryCode":75,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Dallas","Texas","75246",{"type":77,"coordinates":211},[212,213],-96.80667,32.78306,{"lat":213,"lon":212},[216],{"name":84,"role":64,"phone":65,"phoneExt":27,"email":66},{"facility":69,"status":70,"city":218,"state":208,"zip":219,"country":74,"countryCode":75,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Missouri City","77459",{"type":77,"coordinates":221},[222,223],-95.53772,29.61857,{"lat":223,"lon":222},[226],{"name":84,"role":64,"phone":65,"phoneExt":27,"email":66},{"facility":69,"status":70,"city":228,"state":208,"zip":229,"country":74,"countryCode":75,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"San Antonio","78213",{"type":77,"coordinates":231},[232,233],-98.49363,29.42412,{"lat":233,"lon":232},[236],{"name":84,"role":64,"phone":65,"phoneExt":27,"email":66},{"type":238,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100653072","phase-2-orka-002-versus-placebo-in-participants-with-moderate-to-severe-hidradenitis-suppurativa-100653072",false,"NCT07783542","ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa","A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-002 in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa","Inclusion Criteria:\n\n1. Has signs and symptoms of HS for at least 6 months;\n2. Has HS lesions present in ≥ 2 distinct anatomic areas, one of which must be at least Hurley Stage II or III;\n3. Has a history of inadequate response to systemic antibiotic treatment for HS, exhibited recurrence of HS symptoms after discontinuation of systemic antibiotics for HS, demonstrated intolerance to systemic antibiotics for HS, or has a contraindication to systemic antibiotics for HS\n\nExclusion Criteria:\n\n1. Presence of any other active skin disease or condition that may interfere with the assessment of HS;\n2. Diagnosis or suspected diagnosis of autoimmune diseases or inflammatory conditions other than HS","ALL","18 Years","79 Years",{"count":250,"type":251},200,"ESTIMATED","INTERVENTIONAL",[254],"PHASE2","This is a multicenter, randomized, double-blinded, placebo-controlled clinical study of ORKA-002 in adult participants with moderate-to-severe HS.",[257],"Hidradenitis Suppurativa (HS)",[259,53,260,261],"Phase 2","Hidradenitis Suppurativa","HS","2026-09-22",{"date":264,"type":265},"2026-09-24","ACTUAL",{"date":267,"type":265},"2026-08-21",{"date":269,"type":251},"2029-09",{"name":5,"class":6},15]