[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Akros Pharma Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100611952","phase-1-study-to-evaluate-the-safety-tolerability-efficacy-and-pharmacokinetics-of-jte-162-in-subjects-with-cryopyrin-associated-periodic-syndrome-caps-100611952",false,"NCT07247266","Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of JTE-162 in Subjects With Cryopyrin-Associated Periodic Syndrome (CAPS)","A Phase 1b, Open-label, Single-arm Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of JTE-162 in Subjects With Cryopyrin-Associated Periodic Syndrome (CAPS)","Inclusion Criteria:\n\n* Diagnosed with familial cold autoinflammatory syndrome (FCAS) or Muckle-Wells syndrome (MWS) confirmed by:\n* Clinical History: At least 2 typical clinical symptoms (e.g., urticarial skin rash, myalgia, arthralgia, recurrent fever, fatigue\u002Fmalaise, conjunctivitis or other autoinflammatory symptoms) prior to the Screening Visit; AND\n* Genetic Confirmation: Confirmed nucleotide-binding and oligomerization domain (NOD)-like receptor family pyrin domain containing 3 (NLRP3) mutation;\n* Willing to discontinue current anti-interleukin (IL)-1 treatment, if applicable;\n* Demonstrates de novo flaring of CAPS during the Screening Period.\n\nExclusion Criteria:\n\n* Has chronic infantile neurologic cutaneous articular syndrome (CINCA)\u002Fneonatal-onset multisystem inflammatory disease (NOMID);\n* Has a history or presence of amyloidosis, progressive hearing loss, organ damage or any symptom contraindicating anti-IL-1 treatment washout;\n* Has active systemic bacterial, fungal or viral infection(s) within 14 days prior to Day 1 or a history of clinically significant recurrent infectious diseases","ALL","18 Years","80 Years",{"count":20,"type":21},5,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-162 administered once daily for 2 weeks in subjects with cryopyrin-associated periodic syndrome (CAPS)",[27],"Cryopyrin-associated Periodic Syndromes (CAPS)",[29,30,31,32,33,34,35],"JTE-162","Efficacy","Safety","Tolerability","Cryopyrin-associated periodic syndromes","CAPS","Pharmacokinetics","RECRUITING","2026-02-05",{"date":39,"type":40},"2026-02-09","ACTUAL",{"date":42,"type":40},"2026-02-02",{"date":44,"type":21},"2026-12",{"name":46,"class":47},"Akros Pharma Inc.","INDUSTRY",""]