Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT06042920
Status:
TERMINATED
Last Update Posted:
2025-07-15
First Post:
2023-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'Italy', 'Poland', 'Spain']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'whyStopped': 'Business objectives have changed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-09-12', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a 75% Improvement in Palmoplantar Psoriasis Area and Severity Index (pp-PASI-75) Score', 'timeFrame': 'Baseline to Week 16'}, {'measure': 'Number of Participants With Static Physician Global Assessment Genitals (s-PGA-G) Score of 0 (Clear ) or 1 (Almost Clear), With At Least a 2-Point Reduction', 'timeFrame': 'Baseline to Week 16'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Palmoplantar Physician Global Assessment (pp-PGA) Score of 0 (Clear) or 1 (Almost Clear), With At Least a 2-Point Reduction', 'timeFrame': 'Baseline to Week 16'}, {'measure': 'Number of Participants With Static Physician Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear), With Least a 2-Point Reduction', 'timeFrame': 'Baseline to Week 16'}, {'measure': 'Change from baseline in Genital Psoriasis (GenPs) Itch Numeric Rating Scale (NRS) score', 'timeFrame': 'Baseline to Week 16'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to Week 16'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'Up to Week 16'}, {'measure': 'Number of Participants With Clinical Laboratory Abnormalities', 'timeFrame': 'Up to Week 16'}, {'measure': 'Number of Participants With Vital Sign Abnormalities', 'timeFrame': 'Up to Week 16'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deucravacitinib', 'BMS-986165', 'SOTYKTU', 'Plaque psoriasis'], 'conditions': ['Palmoplantar Psoriasis', 'Genital Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\nInclusion Criteria for Non-Pustular Palmoplantar Psoriasis\n\n* Men and women diagnosed with stable plaque psoriasis with involvement of the palm(s)and/or sole(s) for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.\n* Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1.\n* Moderate-to-severe non-pustular PP psoriasis, defined as pp-PGA score of ≥ 3 on a 5-pointscale and pp-PASI ≥ 8 at both screening visit and Day 1.\n\n * A total maximum of 5 sterile pustules across both palms and soles limited only to psoriatic plaques will be allowed.\n* Evidence of typical plaque psoriasis outside palms and soles at both screening visit and Day 1.\n* Deemed by the investigator to be a candidate for phototherapy or systemic therapy.\n* Failed to respond to, or intolerant of ≥ 1 topical therapy.\n\nInclusion Criteria for Genital Psoriasis\n\n* Men and women diagnosed with stable plaque psoriasis with involvement of the genital area for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.\n* Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1.\n* Moderate-to-severe GenPs, defined as static Physician's Global Assessment of Genitalia (s-PGA-G) score of ≥ 3 on a 6-point scale at both screening visit and Day 1.\n* Evidence of typical plaque psoriasis in a non-genital area at both screening visit and Day 1.\n* Deemed by the investigator to be a candidate for phototherapy or systemic therapy.\n* Failed to respond to, or intolerant of ≥ 1 topical therapy.\n\nKey Exclusion Criteria:\n\nTarget Disease Exceptions\n\n* Has non-plaque psoriasis (for PP pustulosis, PP pustular psoriasis, isolated pustules on palms or soles with or without erythema outside psoriatic plaques, guttate, pustular, erythrodermic, and drug-induced psoriasis) at screening or Day 1.\n\nOther protocol-defined inclusion/exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT06042920', 'briefTitle': 'A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Non-Pustular PalmoPlantar and Genital Psoriasis (Psoriatyk Special Sites)', 'orgStudyIdInfo': {'id': 'IM011-1112'}, 'secondaryIdInfos': [{'id': '2023-504663-16', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1289-6934', 'type': 'REGISTRY', 'domain': 'WHO Universal Trial Number (UTN)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deucravacitinib', 'interventionNames': ['Drug: Deucravacitinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo followed by Deucravacitinib', 'interventionNames': ['Drug: Deucravacitinib', 'Drug: Placebo']}], 'interventions': [{'name': 'Deucravacitinib', 'type': 'DRUG', 'otherNames': ['BMS-986165', 'SOTYKTU'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Deucravacitinib', 'Placebo followed by Deucravacitinib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Placebo followed by Deucravacitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006-2722', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution - 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