[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611952":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":29,"responsibleParty":38,"collaborators":40,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":20,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":20,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":32,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Akros Pharma Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"JTE-162 Tablets","EXPERIMENTAL","Dose 1 once daily for 2 Weeks",[13],"Drug: JTE-162",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","JTE-162","Tablets containing JTE-162",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Takanori Nemoto, M.S.","CONTACT","609-919-9570","ClinicalTrials@akrospharma.com",{"name":28,"role":24,"phone":25,"phoneExt":20,"email":26},"Kala Patel, R.Ph., RAC",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":20,"geoPoint":20,"contacts":20},"Gordon Sussman Clinical Research Inc.","RECRUITING","North York","Ontario","M3B 3S6","Canada","CA",{"type":39,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[41],{"name":42,"class":6},"PPD Development, LP","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":54,"type":55},5,"ESTIMATED","INTERVENTIONAL",[58],"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)",[61],"Cryopyrin-associated Periodic Syndromes (CAPS)",[17,63,64,65,66,67,68],"Efficacy","Safety","Tolerability","Cryopyrin-associated periodic syndromes","CAPS","Pharmacokinetics","2026-02-05",{"date":71,"type":72},"2026-02-09","ACTUAL",{"date":74,"type":72},"2026-02-02",{"date":76,"type":55},"2026-12",{"name":5,"class":6},1]