protocolSection identificationModule nctId: NCT06323356, orgStudyIdInfo id: TAK-279-PsO-3005, secondaryIdInfos id: jRCT2031230714, type: REGISTRY, domain: jRCT, briefTitle: A Study of TAK-279 in Adult Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2026-03-27, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Takeda, class: INDUSTRY, descriptionModule briefSummary: The main aim of this study is to check if TAK-279 improves symptoms of With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP) and side effect from the study treatment or TAK-279.All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules.Participants will be in the study for up to 61 weeks including 52 weeks of study treatment. During the study, participants will visit their study clinic for multiple times., conditionsModule conditions: Generalized Pustular Psoriasis, conditions: Erythrodermic Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: TAK-279, outcomesModule primaryOutcomes measure: Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16, primaryOutcomes measure: Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16, secondaryOutcomes measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 52, secondaryOutcomes measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Both Week 16 and Week 52 Visits, secondaryOutcomes measure: Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 and Week 52, secondaryOutcomes measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52, secondaryOutcomes measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52 Visits, secondaryOutcomes measure: Percentage of Participants Achieving PASI-75 at Week 52, secondaryOutcomes measure: Percentage of Participants Achieving PASI-90 at Week 16 and Week 52, secondaryOutcomes measure: Percentage of Participants Achieving PASI-100 at Week 16 and Week 52, secondaryOutcomes measure: Percentage of Participants Achieving PASI-75 at Both the Week 16 and Week 52 Visits, secondaryOutcomes measure: Percentage of Participants Achieving PASI-90 at Both the Week 16 and Week 52 Visits, secondaryOutcomes measure: Percentage of Participants Achieving a Scalp-specific Physician's Global Assessment (ssPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 and Week 52, secondaryOutcomes measure: Change from baseline in ssPGA at Weeks 16 and 52, secondaryOutcomes measure: Percentage of Participants Achieving a PGA of the Hands and/or Feet of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Weeks 16 and Week 52, secondaryOutcomes measure: Percentage of Participants with a Baseline Dermatology Life Quality Index (DLQI) Score ≥2 who Achieve DLQI Score of 0 or 1 at Week 16 and Week 52, secondaryOutcomes measure: Change from Baseline in DLQI at Week 16 and Week 52, secondaryOutcomes measure: Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 and Week 52 Among Participants with Nail Involvement at Baseline, secondaryOutcomes measure: Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 and Week 52, secondaryOutcomes measure: Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a Generalized Pustular Psoriasis Global Assessment (GPPGA) Pustulation Subscore of No Visible Pustules (0) at Week 16 and Week 52, secondaryOutcomes measure: Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) or Almost Clear (1) at Weeks 16 and Week 52, secondaryOutcomes measure: Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) at Week 16 and Week 52, secondaryOutcomes measure: Percentage of Participants with Generalized Pustular Psoriasis Who Achieve ≥75% Improvement from Baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) Score at Week 16 and Week 52, secondaryOutcomes measure: Change from Baseline in Japanese Dermatological Association Severity Index (JDASI) Score at Week 16 and Week 52 for Participants with Generalized Pustular Psoriasis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nagoya City University Hospital, status: NOT_YET_RECRUITING, city: Nagoya, state: Aichi, country: Japan, geoPoint lat: 35.18147, lon: 136.90641, locations facility: Fujita Health University Hospital, status: NOT_YET_RECRUITING, city: Toyoake, state: Aichi, country: Japan, geoPoint lat: 35.038, lon: 136.99931, locations facility: Kimitsu Chuo Hospital, status: RECRUITING, city: Kisarazu, state: Chiba, country: Japan, geoPoint lat: 35.38329, lon: 139.93254, locations facility: Juntendo University Urayasu Hospital, status: NOT_YET_RECRUITING, city: Urayasu, state: Chiba, country: Japan, geoPoint lat: 35.67054, lon: 139.88862, locations facility: Hospital of the University of Occupational and Environmental Health, Japan, status: RECRUITING, city: Kitakyushu, state: Fukuoka, country: Japan, geoPoint lat: 33.85181, lon: 130.85034, locations facility: Isesaki Municipal Hospital, status: NOT_YET_RECRUITING, city: Isesaki, state: Gunma, country: Japan, geoPoint lat: 36.31667, lon: 139.2, locations facility: Kobe University Hospital, status: NOT_YET_RECRUITING, city: Kobe, state: Hyogo, country: Japan, geoPoint lat: 34.6913, lon: 135.183, locations facility: Tokai University Hospital, status: NOT_YET_RECRUITING, city: Isehara, state: Kanagawa, country: Japan, geoPoint lat: 35.39932, lon: 139.31019, locations facility: Mie University Hospital, status: NOT_YET_RECRUITING, city: Tsu, state: Mie, country: Japan, geoPoint lat: 34.73333, lon: 136.51667, locations facility: Kansai Medical University Hospital, status: NOT_YET_RECRUITING, city: Hirakata, state: Osaka, country: Japan, geoPoint lat: 34.81352, lon: 135.64914, locations facility: Saitama Medical University Hospital, status: NOT_YET_RECRUITING, city: Iruma, state: Saitama, country: Japan, locations facility: St.Luke's International Hospital, status: NOT_YET_RECRUITING, city: Chuo City, state: Tokyo, country: Japan, geoPoint lat: 35.57779, lon: 139.71685, locations facility: Teikyo University Hospital, status: NOT_YET_RECRUITING, city: Itabashi-ku, state: Tokyo, country: Japan, geoPoint lat: 35.74893, lon: 139.71497, locations facility: The Jikei University Hospital, status: NOT_YET_RECRUITING, city: Minato-ku, state: Tokyo, country: Japan, geoPoint lat: 34.2152, lon: 135.1501, locations facility: Tokyo Medical University Hospital, status: NOT_YET_RECRUITING, city: Shinjuku-ku, state: Tokyo, country: Japan, geoPoint lat: 35.2946, lon: 139.57059, locations facility: Fukuoka University Hospital, status: NOT_YET_RECRUITING, city: Fukuoka, country: Japan, geoPoint lat: 33.6, lon: 130.41667, locations facility: University Hospital, Kyoto Prefectural University of Medicine, status: NOT_YET_RECRUITING, city: Kyoto, country: Japan, geoPoint lat: 35.02107, lon: 135.75385, locations facility: Okayama University Hospital, status: NOT_YET_RECRUITING, city: Okayama, country: Japan, geoPoint lat: 34.65, lon: 133.93333, locations facility: Nippon Life Hospital, status: NOT_YET_RECRUITING, city: Osaka, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Osaka Metropolitan University Hospital, status: NOT_YET_RECRUITING, city: Osaka, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, hasResults: False