Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT06329258
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2024-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination of Sotyktu and Enstilar for Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-01-30', 'mcpReleaseN': 1, 'releaseDate': '2025-01-07'}], 'estimatedResultsFirstSubmitDate': '2025-01-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C517164', 'term': 'betamethasone dipropionate, calcipotriol drug combination'}, {'id': 'C055085', 'term': 'calcipotriene'}, {'id': 'D001623', 'term': 'Betamethasone'}, {'id': 'C000628674', 'term': 'deucravacitinib'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-30', 'size': 834542, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-14T10:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'open label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2024-03-14', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psoriasis Area and Severity Index 75 at week 12', 'timeFrame': '12 weeks', 'description': 'Proportion of subjects achieving PASI 75 at week 12 for patients in the Deucravacitinib + Enstilar combination arm.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'combination deucravacitinib and enstilar foam', 'detailedDescription': '30 adult patients with moderate to severe plaque psoriasis will be given Deucravacitinib 6mg QD for the first 8 weeks of the study.\n\nAt week 8:\n\nSubjects who do not meet PASI 25 at week 8 will be discontinued from the study as non-responders.\n\nSubjects who achieve ≥PASI 75 at week 8 will remain enrolled and continue Deucravacitinib 6mg QD monotherapy through week 24.\n\nSubjects who achieved between PASI 25-74 response will receive 4 weeks of Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064% applied QD in addition to continuing Deucravacitinib 6mg QD.\n\nAt week 12, (after 4 consecutive weeks of Enstilar), subjects in the PASI 25-74 group, will discontinue Enstilar QD and continue Deucravacitinib as monotherapy through week 24.\n\nSubjects will return at week 28 for safety follow evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female adult ≥ 18 years of age;\n2. Diagnosis of chronic plaque-type psoriasis\n3. Moderate to severe plaque type psoriasis as defined at baseline by:\n\n * BSA affected by plaque-type psoriasis of 10% or greater\n * PGA score of 3 or greater\n * PASI ≥ 12.\n4. Able and willing to give written informed consent prior to performance of any study-related procedures Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.\n\nExclusion Criteria:\n\n1. Other than psoriasis, any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled.\n2. Forms of psoriasis other than chronic plaque-type (e.g., Pustular erythrodermic and/or guttate psoriasis) or drug induced psoriasis\n3. Use of oral systemic medications or PUVA phototherapy for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin and cyclosporine).\n4. Prior use of biologics within the following periods:\n\n * Etanercept - 4 weeks\n * Adalimumab or certolizumab pegol - 8 weeks\n * IL-17 antagonists - 16 weeks\n * Ustekinumab or IL-23 pathway inhibitors - 24 weeks\n * Other biologics - 5 half-lives\n5. Patient used topical therapies or UVB phototherapy to treat psoriasis within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).'}, 'identificationModule': {'nctId': 'NCT06329258', 'briefTitle': 'Combination of Sotyktu and Enstilar for Plaque Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Psoriasis Treatment Center of Central New Jersey'}, 'officialTitle': 'A Single Center Study to Evaluate the Effectiveness and Safety of SOTYKTU® (Deucravacitinib) in Combination With Enstilar® for Moderate to Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'PTC09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deucravacitinib in combination with Enstilar', 'description': 'deucravacitinib in combination with Enstilar', 'interventionNames': ['Drug: Enstilar', 'Drug: Deucravacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Deucravacitinib monotherapy', 'description': 'monotherapy', 'interventionNames': ['Drug: Deucravacitinib']}], 'interventions': [{'name': 'Enstilar', 'type': 'DRUG', 'otherNames': ['calcipotriene and betamethasone'], 'description': 'Add on Enstilar', 'armGroupLabels': ['Deucravacitinib in combination with Enstilar']}, {'name': 'Deucravacitinib', 'type': 'DRUG', 'otherNames': ['Sotyktu'], 'description': '6mg QD', 'armGroupLabels': ['Deucravacitinib in combination with Enstilar', 'Deucravacitinib monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08520', 'city': 'East Windsor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Schweiger Derm Group', 'geoPoint': {'lat': 40.268, 'lon': -74.54043}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Psoriasis Treatment Center of Central New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}