Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-30 @ 4:53 AM
Study NCT ID:
NCT07247266
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of JTE-162 in Subjects With Cryopyrin-Associated Periodic Syndrome (CAPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056587', 'term': 'Cryopyrin-Associated Periodic Syndromes'}], 'ancestors': [{'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000094482', 'term': 'Chronic Inducible Urticaria'}, {'id': 'D000080223', 'term': 'Chronic Urticaria'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D000096703', 'term': 'Cold Urticaria'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change and percent change from baseline to end of treatment (EOT) in high-sensitivity C-reactive protein (hs-CRP)', 'timeFrame': '2 Weeks'}, {'measure': 'Change and percent change from baseline to EOT in Serum amyloid A (SAA)', 'timeFrame': '2 Weeks'}, {'measure': 'Change and percent change from baseline to EOT in Interleukin (IL)-6', 'timeFrame': '2 Weeks'}, {'measure': 'Change and percent change from baseline to EOT in Key symptom score (KSS)', 'timeFrame': '2 Weeks'}, {'measure': 'Change and percent change from baseline to EOT in Individual symptom score on Daily Health Assessment Form, Second Generation (DHAF2)', 'timeFrame': '2 Weeks'}, {'measure': 'Change and percent change from baseline to EOT in Global assessments of disease activity on DHAF2', 'timeFrame': '2 Weeks'}, {'measure': 'Change and percent change from baseline to EOT in Global CAPS symptom assessment by the Investigator', 'timeFrame': '2 Weeks'}, {'measure': 'Change and percent change from baseline to EOT in Individual CAPS symptom assessment by the Investigator', 'timeFrame': '2 Weeks'}, {'measure': 'Number of adverse events', 'timeFrame': '4 Weeks'}, {'measure': 'JTE-162 post-dose plasma concentrations on Day 1', 'timeFrame': '1 Day'}, {'measure': 'JTE-162 trough plasma concentrations on Days 2, 3 and 4, and at the Week 2 Visit (Day 15±2)', 'timeFrame': 'Day 2, Day 3, Day 4 and Day 15±2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['JTE-162', 'Efficacy', 'Safety', 'Tolerability', 'Cryopyrin-associated periodic syndromes', 'CAPS', 'Pharmacokinetics'], 'conditions': ['Cryopyrin-associated Periodic Syndromes (CAPS)']}, 'descriptionModule': {'briefSummary': '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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/malaise, 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)/neonatal-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'}, 'identificationModule': {'nctId': 'NCT07247266', 'briefTitle': 'Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of JTE-162 in Subjects With Cryopyrin-Associated Periodic Syndrome (CAPS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akros Pharma Inc.'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'AE162-X-24-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JTE-162 Tablets', 'description': 'Dose 1 once daily for 2 Weeks', 'interventionNames': ['Drug: JTE-162']}], 'interventions': [{'name': 'JTE-162', 'type': 'DRUG', 'description': 'Tablets containing JTE-162', 'armGroupLabels': ['JTE-162 Tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M3B 3S6', 'city': 'North York', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Gordon Sussman Clinical Research Inc.'}], 'centralContacts': [{'name': 'Takanori Nemoto, M.S.', 'role': 'CONTACT', 'email': 'ClinicalTrials@akrospharma.com', 'phone': '609-919-9570'}, {'name': 'Kala Patel, R.Ph., RAC', 'role': 'CONTACT', 'email': 'ClinicalTrials@akrospharma.com', 'phone': '609-919-9570'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akros Pharma Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'PPD Development, LP', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}