Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-04 @ 7:56 AM
Study NCT ID:
NCT05744466
Status:
RECRUITING
Last Update Posted:
2024-07-23
First Post:
2023-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C000628674', 'term': 'deucravacitinib'}, {'id': 'C505730', 'term': 'apremilast'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2023-01-30', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body surface area (BSA)', 'timeFrame': 'At baseline and every 6 months up to 60 months or treatment discontinuation'}, {'measure': 'Investigator global assessment (IGA) response 0/1', 'timeFrame': 'Up to 60 months'}, {'measure': 'Dermatology life quality index (DLQI) response 0/1', 'timeFrame': 'Up to 60 months'}, {'measure': 'Time from date of treatment initiation to date of discontinuation', 'timeFrame': 'Up to 60 months'}], 'secondaryOutcomes': [{'measure': '75 percent improvement in Psoriasis area and severity index (PASI) score', 'timeFrame': 'At baseline and every 6 months up to 60 months or treatment discontinuation'}, {'measure': 'PASI score response ≤ 3', 'timeFrame': 'At baseline to follow-up, up to 60 months'}, {'measure': 'PASI score response ≤ 5', 'timeFrame': 'At baseline to follow-up, up to 60 months'}, {'measure': 'PASI score change from baseline', 'timeFrame': 'At baseline to follow-up, up to 60 months'}, {'measure': 'National psoriasis foundation (NPF) acceptable body surface area (BSA) response', 'timeFrame': 'At baseline to follow-up, up to 60 months'}, {'measure': 'NPF target BSA response', 'timeFrame': 'At baseline to follow-up, up to 60 months'}, {'measure': 'BSA ≤3%', 'timeFrame': 'At baseline to follow-up, up to 60 months'}, {'measure': 'Change in investigator global assessment (IGA) score', 'timeFrame': 'Up to 60 months'}, {'measure': 'Change in dermatology life quality index (DLQI) response', 'timeFrame': 'At baseline to follow-up, up to 60 months'}, {'measure': 'Change in DLQI response ≤5', 'timeFrame': 'At baseline to follow-up, up to 60 months'}, {'measure': 'Change in visual analog scale (VAS): Itch response', 'timeFrame': 'At baseline to follow-up, up to 60 months'}, {'measure': 'Change in VAS: Skin Pain response', 'timeFrame': 'At baseline to follow-up, up to 60 months'}, {'measure': 'Change in VAS: Fatigue Response', 'timeFrame': 'At baseline to follow-up, up to 60 months'}, {'measure': 'Merit-based Incentive Payment System (MIPS) Clinical Response to Oral Systemic or Biologic Medications', 'timeFrame': 'At baseline to follow-up, up to 60 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Real-world', 'Deucravacitinib', 'Observational'], 'conditions': ['Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand the comparative effectiveness of deucravacitinib versus apremilast in adults with plaque psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults diagnosed with moderate-to-severe plaque psoriasis who initiate deucravacitinib or apremilast within the CorEvitas Psoriasis Registry will be enrolled. Participants will be followed every 6 months from initiation up to 5 years or discontinuation, whichever occurs first. This is a real-world study and hence the follow-up are done based on the clinical practice done by dermatologists.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have been diagnosed with plaque psoriasis by a dermatologist\n* Newly initiating an eligible medication for enrollment (i.e., deucravacitinib, apremilast)\n* Actively enrolled in the CorEvitas Psoriasis Registry and have documented consent to allow copies of information from the registry be used for research purposes\n\nExclusion Criteria:\n\n* Participation (current or planned) in an interventional clinical trial (does not include observational registry or study)\n* Restart of treatments with the study eligible therapies previously received at any time during the participants' treatment history"}, 'identificationModule': {'nctId': 'NCT05744466', 'acronym': 'RePhlect', 'briefTitle': 'A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Real-world, Prospective, Observational Study of the Comparative Effectiveness of Deucravacitinib Versus Apremilast in Adults With Plaque Psoriasis - North American Region', 'orgStudyIdInfo': {'id': 'IM011-1105'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Participants that have initiated deucravacitinib', 'interventionNames': ['Drug: Deucravacitinib']}, {'label': 'Cohort 2', 'description': 'Participants that have initiated apremilast', 'interventionNames': ['Drug: Apremilast']}], 'interventions': [{'name': 'Deucravacitinib', 'type': 'DRUG', 'description': 'As prescribed by treating clinician', 'armGroupLabels': ['Cohort 1']}, {'name': 'Apremilast', 'type': 'DRUG', 'description': 'As prescribed by treating clinician', 'armGroupLabels': ['Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02451', 'city': 'Waltham', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}], 'centralContacts': [{'name': 'BMS Study Connect Contact Center www.BMSStudyConnect.com', 'role': 'CONTACT', 'email': 'Clinical.Trials@bms.com', 'phone': '855-907-3286'}, {'name': 'First line of the email MUST contain the NCT# and Site #.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}