protocolSection identificationModule nctId: NCT06382987, orgStudyIdInfo id: IM011-1124, briefTitle: A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect), acronym: RePhlect, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2029-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Bristol-Myers Squibb, class: INDUSTRY, descriptionModule briefSummary: This is a prospective, observational, real-world study of adult participants in Japan with physician-reported diagnosis of plaque psoriasis treated with deucravacitinib or apremilast., conditionsModule conditions: Plaque Psoriasis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Deucravacitinib, interventions name: Apremilast, outcomesModule primaryOutcomes measure: Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib., primaryOutcomes measure: Number of participants who achieved Physician's Global Assessment (PGA) of 0/1 from baseline to follow-up, primaryOutcomes measure: Number of participants who achieved Absolute Psoriasis Area and Severity Index (aPASI) of ≤2 from baseline to follow-up, primaryOutcomes measure: Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0 /1 from baseline to follow-up, primaryOutcomes measure: Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation), secondaryOutcomes measure: Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib or apremilast, secondaryOutcomes measure: Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0/1 from baseline to follow-up, secondaryOutcomes measure: Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) from baseline to follow-up, secondaryOutcomes measure: Number of participants treated with deucravacitinib with a change in Physician's Global Assessment (PGA) from baseline to follow-up, secondaryOutcomes measure: Number of participants treated with deucravacitinib with a change in Dermatology Life Quality Index (DLQI) from baseline to follow-up, secondaryOutcomes measure: Number of participants achieving a Dermatology Life Quality Index (DLQI) score of ≤5 from baseline to follow-up, secondaryOutcomes measure: Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 75 from baseline to follow-up, secondaryOutcomes measure: Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 90 from baseline to follow-up, secondaryOutcomes measure: Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤5 from baseline to follow-up, secondaryOutcomes measure: Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤3 from baseline to follow-up, secondaryOutcomes measure: Number of participants who achieve a National Psoriasis Foundation (NPF) Acceptable Body Surface Area response from baseline to follow-up, secondaryOutcomes measure: Number of participants who achieve an absolute scalp-specific Physician's Global Assessment (ss-PGA) of 0/1 from baseline to follow-up, secondaryOutcomes measure: Number of participants who achieve an absolute Physician's Global Assessment-Fingernail (PGA-F) of 0/1 from baseline to follow-up, secondaryOutcomes measure: Number of participants who achieve an absolute Palmoplantar Physician's Global Assessment (pp-PGA) of 0/1 from baseline to follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mebix. Inc., status: RECRUITING, city: Minato-ku, state: Tokyo, zip: 1070052, country: Japan, contacts name: Minoru Tonogai, Site 0001, role: CONTACT, geoPoint lat: 34.2152, lon: 135.1501, locations facility: Fukuoka University Hospital, status: RECRUITING, city: Fukuoka, country: Japan, geoPoint lat: 33.6, lon: 130.41667, hasResults: False