Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT05739435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-27
First Post:
2023-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-24', 'studyFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety and tolerability of long-term ESK-001 treatment', 'timeFrame': 'Approximately 3 years', 'description': 'Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)'}], 'secondaryOutcomes': [{'measure': 'To assess the long-term efficacy of ESK-001', 'timeFrame': 'Approximately 3 years', 'description': 'Change from baseline in Psoriasis Area and Severity Index (PASI) over time'}, {'measure': 'To assess the change in quality of life (QoL) with long-term ESK-001 administration', 'timeFrame': 'Approximately 3 years', 'description': 'Change from baseline in Dermatology Life Quality Index (DLQI) over time'}, {'measure': 'To assess the pharmacokinetics (PK) of ESK-001 (ctrough)', 'timeFrame': '2 years', 'description': 'Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, open-label extension (OLE) study in patients with plaque psoriasis who have completed their participation in a previous plaque psoriasis study of ESK-001.', 'detailedDescription': 'This study will consist of patients who have completed their participation in a previous plaque psoriasis study of ESK-001. Each patient will be assigned to receive ESK-001 at one of two open-label dose levels. Patients have the option to remain on study until ESK-001 is commercially available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have completed a prior ESK-001 study\n* Men and Women must use highly effective methods of contraception for the entirety of the study\n\nExclusion Criteria:\n\n* Pregnancy\n* Received a prohibited concomitant medication'}, 'identificationModule': {'nctId': 'NCT05739435', 'briefTitle': 'Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alumis Inc'}, 'officialTitle': 'A Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Patients With Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'ESK-001-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESK-001 Dose Level 1', 'description': 'ESK-001 administered as an oral tablet', 'interventionNames': ['Drug: ESK-001']}, {'type': 'EXPERIMENTAL', 'label': 'ESK-001 Dose Level 2', 'description': 'ESK-001 administered as an oral tablet', 'interventionNames': ['Drug: ESK-001']}], 'interventions': [{'name': 'ESK-001', 'type': 'DRUG', 'description': 'Oral tablet', 'armGroupLabels': ['ESK-001 Dose Level 1', 'ESK-001 Dose Level 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigator Site # 1029', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigator Site #1001', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigator Site # 1023', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site #1021', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site #1018', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site #1007', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site #1002', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator site # 1030', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site #1025', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator site # 1028', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site # 1013', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '31217', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigator Site #1035', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '30328', 'city': 'Sandy Springs', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigator Site #1043', 'geoPoint': {'lat': 33.92427, 'lon': -84.37854}}, {'zip': '60008', 'city': 'Rolling Meadows', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigator Site #1005', 'geoPoint': {'lat': 42.08419, 'lon': -88.01313}}, {'zip': '47201', 'city': 'Columbus', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigator Site # 1011', 'geoPoint': {'lat': 39.20144, 'lon': -85.92138}}, {'zip': '46617', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigator Site #1027', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigator SIte#1036', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '42301', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigator Site #1017', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigator Site #1026', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '48346', 'city': 'Clarkston', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigator Site #1010', 'geoPoint': {'lat': 42.73586, 'lon': -83.41883}}, {'zip': '55112', 'city': 'New Brighton', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Investigator Site #1031', 'geoPoint': {'lat': 45.06552, 'lon': -93.20189}}, {'zip': '73071', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Investigator Site #1033', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '97223', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigator Site #1019', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigator Site #1022', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '57702', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Investigator Site # 1012', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '77056', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site #1015', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78213', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site # 1006', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84095', 'city': 'South Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigator Site # 1041', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}, {'zip': 'T6G 1C3', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Investigator Site #2001', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V3V 0C6', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Investigator Site # 2008', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'R3M 3Z4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Investigator Site #2003', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'N6H 5L5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigator Site #2006', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L4Y 4C5', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigator Site # 2004', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'PiB 3Z7', 'city': 'North Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigator Site # 2007', 'geoPoint': {'lat': 46.3168, 'lon': -79.46633}}, {'zip': 'L6J 7W5', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigator Site #2005', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'M3H 5Y8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigator Site #2009', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N2J 1C4', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigator Site # 2002', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'zip': 'G1V 4X7', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Investigator Site # 2010', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alumis Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}