[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"plaque-psoriasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:plaque-psoriasis":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,37,0,25,[9,46,68,94,127,151,176,203,223,253,276,298,324,357,378,398,419,439,460,482,504,524,544,567,592],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100627520","phase-2-an-open-label-extension-study-of-orka-001-in-participants-with-plaque-psoriasis-100627520",false,"NCT07449702","An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis","An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis","Inclusion Criteria:\n\n1. Signed informed consent by participants from previous trial choosing to transition into the OLE.\n2. Participants who have successfully completed the preceding trial.\n3. For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit.\n4. For women of childbearing potential and fertile male participants with a partner of childbearing potential must be willing to continue to use highly effective contraception\n\nExclusion Criteria:\n\n1. Participants who experienced any adverse events with ORKA-001 in the preceding trial that led to permanent investigational medicinal product discontinuation or, in the opinion of the Investigator, would preclude continued treatment with ORKA-001\n2. Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.\n3. Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding during the medical examination that, in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.\n4. Any clinically significant laboratory abnormality based on the last available lab results received during the preceding trial, that, according to the Investigator's medical assessment, precludes them from continued treatment with ORKA-001.\n5. Participant is pregnant or breastfeeding.","ALL","18 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.",[27],"Plaque Psoriasis",[29,30,31,32],"Phase 2","ORKA-001","Open Label Extension","OLE","RECRUITING","2026-06-30",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":37},"2026-02-23",{"date":41,"type":21},"2030-07",{"name":43,"class":44},"Oruka Therapeutics, Inc.","INDUSTRY",24,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100615281","phase-2-dose-ranging-study-of-orka-001-in-patients-with-moderate-to-severe-plaque-psoriasis-100615281","NCT07290569","Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis","A Multicenter, Randomized, Double-blinded, Placebo-controlled, Dose-range Finding Study of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis","EVERLAST-B","Inclusion Criteria:\n\n1. Participants ≥ 18 years of age\n2. Have a diagnosis of plaque psoriasis for \\> 6 months\n3. Have moderate-to-severe chronic plaque psoriasis defined as:\n\n   1. BSA ≥ 10%, and\n   2. PASI ≥ 12, and\n   3. IGA score of ≥ 3 on a 5-point scale\n4. Candidate for systemic therapy or phototherapy\n5. Women of childbearing potential must have a negative pregnancy test.\n\nExclusion Criteria:\n\n1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis\n2. Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, or psychiatric disorder, or any infectious disease\n3. History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence\n4. A known hypersensitivity to any components of the ORKA-001 drug product\n5. Women who are breastfeeding or plan to breastfeed during the study",{"count":55,"type":21},160,[24],"This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.",[27],[29,30,60],"Plaque psoriasis",{"date":36,"type":37},{"date":63,"type":37},"2025-12-03",{"date":65,"type":21},"2028-12",{"name":43,"class":44},36,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100595950","study-to-assess-change-in-quality-of-life-of-risankizumab-treatment-in-adult-participants-with-moderate-to-severe-plaque-psoriasis-100595950","NCT07039110","Study to Assess Change in Quality of Life of Risankizumab Treatment in Adult Participants With Moderate-to-Severe Plaque Psoriasis","The Real-World Impact of Risankizumab on the Quality of Life and Cumulative Life Course Impairment (CLCI) in Patients With Moderate-to-Severe Plaque Psoriasis (DREAM)","DREAM","Inclusion Criteria:\n\n* Participants with a Confirmed diagnosis of moderate-to-severe plaque psoriasis with or without joint involvement according to the treating physician's clinical judgment, prior to time of enrollment.\n* Treatment with risankizumab is indicated per summary of product characteristics (SmPC) or local label and local prescribing\u002Ftreatment guidelines.\n* Decision to treat with risankizumab is made prior to and independently of study participation.\n\nExclusion Criteria:\n\n* History of a sleep disorder diagnosis which the patient is currently being treated for.\n* Current or recent (within the last 30 days) participation in an interventional clinical trial or an observational study.\n* Currently receiving other biologic treatments and\u002For small molecules including Janus kinase (JAK) inhibitors, tyrosine kinase 2 (TYK2) inhibitors, and phosphodiesterase 4 (PDE4) inhibitors for any reason.",{"count":77,"type":21},700,"OBSERVATIONAL","Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study will assess the change in quality of life of risankizumab treatment in adult participants with moderate to severe plaque psoriasis real-world clinical practice.\n\nRisankizumab is an approved drug for treating participants with Psoriasis. Approximately 700 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately 70 sites worldwide.\n\nParticipants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 2.5 years.\n\nThere is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.",[27],[27,82,83],"Moderate to Severe Plaque Psoriasis","Risankizumab","2026-06-25",{"date":86,"type":37},"2026-06-29",{"date":88,"type":37},"2025-09-09",{"date":90,"type":21},"2028-03",{"name":92,"class":44},"AbbVie",78,{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100591363","phase-3-a-study-to-evaluate-the-efficacy-safety-and-drug-levels-of-deucravacitinib-bms-986165-in-adolescent-participants-with-moderate-to-severe-plaque-psoriasis-100591363","NCT06979453","A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescent Participants (12 Years to Less Than 18 Years) With Moderate to Severe Plaque Psoriasis","POETYK-PsO-Ped","Inclusion Criteria\n\n* Participants must have stable plaque psoriasis for 6 months or more prior to Screening.\n* Participants must have moderate to severe psoriasis defined by:.\n\n  i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1.\n\nii) Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day 1.\n\niii) Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day 1.\n\n\\- A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:.\n\ni) Is not an individual of childbearing potential (IOCBP).\n\nii) Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year) during the study intervention period and for at least 3 days after discontinuation of the study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.\n\nExclusion Criteria\n\n* Participants must not weigh \\\u003C 30.0 kg at Screening and Day 1.\n* Participants must not have non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) or any skin condition other than plaque psoriasis that could interfere with assessments of treatment effect at Screening or Day 1.\n* Participants must not have a history of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial treatment within 60 days prior to Day 1.\n* Participants must not have any untreated bacterial infection within 60 days prior to Day 1.\n* Participants must not have any ongoing evidence of chronic bacterial infection (eg, chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis).\n* Participants must not have herpes simplex\u002Fzoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions.\n* Participants must not have received live vaccines or BCG within 60 days prior to Day 1 or plans to receive a live vaccine during the study, or within 60 days after completing study intervention.\n* Participants must not have had any prior exposure to deucravacitinib.\n* Participants must not have received any medication that is specifically prohibited.\n* Participants must not have a laboratory finding that is exclusionary.\n* Participants must not have any major illness\u002Fcondition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurologic, immunologic, or local active infection\u002Finfectious illness) that, in the investigator's judgment or after consultation with the Sponsor's Medical Monitor, will substantially increase the risk to the participant if he or she participates in the study.\n* Participants must not have cancer or history of cancer (solid organ or hematologic including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","12 Years","17 Years",{"count":105,"type":21},366,[107],"PHASE3","The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis",[27],[111,112,113,114,115,116,117],"Psoriasis","Rash","Itch","Teen","Dermatology","Derm","POETYK-PsO-Peds-1","2026-06-17",{"date":120,"type":37},"2026-06-18",{"date":63,"type":37},{"date":123,"type":21},"2034-08-12",{"name":125,"class":44},"Bristol-Myers Squibb",127,{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":17,"minAge":134,"maxAge":103,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100612224","phase-3-a-long-term-study-of-zasocitinib-in-children-and-teenagers-with-plaque-psoriasis-100612224","NCT07250802","A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis","A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis","Inclusion Criteria:\n\n1. Participant has a diagnosis of chronic plaque psoriasis for greater than or equal to (\\>=) 6 months prior to the screening visit.\n2. Participant has stable plaque psoriasis defined as no significant flare or change in morphology (as assessed by the investigator) in psoriasis for \\>=6 months before screening.\n3. Participant has moderate-to-severe plaque psoriasis as defined by a Psoriasis Area and Severity Index (PASI) score \\>=12 and a Static Physician's Global Assessment (sPGA) score \\>=3 at screening and Day 1.\n4. Participant has plaque psoriasis covering \\>=10 percent (%) of total body surface area (BSA) at screening and Day 1.\n5. Participant must be a candidate for phototherapy or systemic therapy.\n6. Inclusion Criteria for Part A Cohort 1: The participant is male or female and aged 12 to less than (\\\u003C) 18 years, inclusive.\n7. Inclusion Criteria for Part A Cohort 2 and for Part B: The participant is male or female and aged 4 to \\\u003C12 years, inclusive.\n8. Inclusion Criteria for Part A Cohort 1: The participant must weigh \\>=40 kilograms (kg) at the time of screening.\n\nExclusion Criteria:\n\n1. Participant has evidence of nonplaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis). If a participant meets criteria for inclusion based on typical plaque psoriasis presentation, a limited amount of inverse psoriasis is not exclusionary.\n2. Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs (NSAIDs), during the trial period for an immune-related disease.\n3. Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.\n4. Participant has history of active TB infection, regardless of treatment status and has signs or symptoms of active TB or evidence of latent tuberculosis infection (LTBI).\n5. Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 or a history of serious herpetic infection.\n6. Participant has a history of chronic or recurrent bacterial disease.\n7. Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).\n8. Participant has any clinically significant medical condition, evidence of an unstable clinical condition or vital signs\u002Fphysical examination\u002Flaboratory\u002FECG abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of trial results.\n9. Participant has any previous exposure to zasocitinib (also known as TAK-279 or NDI-034858) or other TYK2 inhibitors or participated in any trial that included a tyrosine kinase 2 (TYK2) inhibitor, unless participant has documentation of posttrial unblinding that confirms the participant did not receive a TYK2 inhibitor.\n10. Participant is not up to date on all required vaccinations according to current immunization guidelines as noted by country-specific pediatric authorities.\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply.","4 Years",{"count":136,"type":21},110,[107],"The main aim of this study is to see how well the medicine zasocitinib works, how safe it is, and how children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis respond to it.\n\nThe study will be done in 2 parts: Part A will include both children and teenagers, while part B will only include children.\n\nAt first, only teenagers who meet the study rules can participate in this study. Children may only start to participate once enough information has been collected from other studies with zasocitinib.\n\nParticipants in Part A will initially be assigned to receive either zasocitinib or placebo for the first 16 weeks of treatment, then all participants will receive zasocitinib through the end of the study. All participants in Part B will be assigned to receive treatment with zasocitinib throughout the study.\n\nParticipants will be in the study for up to 4 years and 2 months (217 weeks), including up to 35 days for the screening period, 208 weeks of treatment (Part A and Part B) and a 4-week safety follow-up period. During the study, participants will visit their study site multiple times.",[27],[141],"Drug Therapy","2026-06-16",{"date":118,"type":37},{"date":145,"type":37},"2025-12-04",{"date":147,"type":21},"2033-01-24",{"name":149,"class":44},"Takeda",40,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":17,"minAge":158,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":164,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},"100601935","phase-3-long-term-safety-study-of-deucravacitinib-versus-ustekinumab-in-participants-with-psoriasis-pragmatyk-100601935","NCT07116967","Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)","A Phase 3b\u002F4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants With Moderate-to-Severe Plaque Psoriasis","Inclusion Criteria:\n\n* Participants with moderate-to-severe plaque psoriasis:\n\n  1. Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;\n  2. Have at least 1 of the following cardiovascular risk factors:\n* Current cigarette smoker\n* Diagnosis of hypertension\n* Diagnosis of hyperlipidemia\n* Diabetes mellitus type 1 or 2\n* History of one or more of the following cardiovascular events: Coronary intervention (PCI) or coronary artery bypass grafting (CABG), myocardial infarction (heart attack), cardiac arrest, hospitalization for unstable angina, acute coronary syndrome, stroke, or transient ischemic attack\n* Obesity\n* Family history of premature coronary heart disease or sudden death in a first-degree male relative younger than 55 years of age or in a first-degree female relative younger than 65 years of age.\n\nExclusion Criteria:\n\n* Participants must not have recent history of 1 of the following cardiovascular events: MI, stroke, or coronary revascularization, or VTE within 90 days prior to Day 1.\n* Participants must not have unstable CVD, defined as a recent clinical cardiovascular event (eg, unstable angina, rapid atrial fibrillation), or a cardiac hospitalization (eg, pacemaker implantation, HF) within 90 days prior to Day 1.\n* Participants must not have evidence of active cancer or history of cancer (solid organ or hematologic malignancy including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has been treated with no evidence of recurrence).\n* Other protocol define inclusion\u002Fexclusion criteria apply.","40 Years",{"count":160,"type":21},3040,[107],"A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis",[27],[165,60,166,167],"Deucravacitinib","Cardiovascular risk","PRAGMATYK","2026-06-15",{"date":142,"type":37},{"date":171,"type":37},"2025-09-22",{"date":173,"type":21},"2031-01-16",{"name":125,"class":44},383,{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":17,"minAge":134,"maxAge":18,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},"100421767","phase-3-a-study-to-evaluate-the-drug-levels-efficacy-and-safety-of-deucravacitinib-in-children-and-adolescent-participants-with-moderate-to-severe-plaque-psoriasis-100421767","NCT04772079","A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis","A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis","Inclusion Criteria\n\n* Males and females aged 12 to \\\u003C18 years for Cohort 1. Males and females aged 4 to \\\u003C12 years for Cohort 2.\n* Plaque psoriasis for at least 6 months.\n* Moderate to severe disease.\n* Candidate for phototherapy or systemic therapy.\n* Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period.\n\nExclusion Criteria\n\n* Participants weighing ≤ 30.0 kg at screening for Cohort 1 (age 12 to \\\u003C 18 years), Part A and Part B. Participants weighing \\\u003C 18.0 kg at screening for Cohort 2 (age 4 to \\\u003C 12 years), Part A and Part B.\n* Other forms of psoriasis.\n* History of recent infection.\n* Prior exposure to deucravacitinib (BMS-986165) or another active comparator.\n* Evidence of active TB for LTE period.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":184,"type":21},153,[107],"The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in children and adolescent participants aged 4 to \\\u003C18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to \\\u003C18 years) and Cohort 2 (age 4 to \\\u003C12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in children and adolescent participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in children and adolescent participants with psoriasis who have completed Parts A or B of the study.",[27],[189,190,191,165,192,193,27,111],"Adolescent Psoriasis","BMS-986165","Clinical trial","Children Psoriasis","Pediatric Psoriasis","2026-06-05",{"date":196,"type":37},"2026-06-09",{"date":198,"type":37},"2021-03-23",{"date":200,"type":21},"2033-09-08",{"name":125,"class":44},63,{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100632281","phase-3-a-phase-3-clinical-study-of-ql2106-injection-100632281","NCT07511647","A Phase 3 Clinical Study of QL2106 Injection","A Multicenter, Randomized, Double-Blind, Parallel, Active-Controlled Phase 3 Clinical Study to Compare the Efficacy and Safety of QL2106 Injection to Tremfya® in Patients With Moderate to Severe Plaque Psoriasis","Inclusion Criteria:\n\n* Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), prior to the first administration of study intervention\n* Total body surface area (BSA) greater than or equal to (\\>=)10 percent (%) at screening and baseline\n* Total psoriasis area and severity index (PASI) \\>=12 at screening and baseline\n* Total investigator global assessment (IGA) \\>=3 at screening and baseline\n* Candidate for phototherapy or systemic treatment for plaque psoriasis\n\nExclusion Criteria:\n\n* Nonplaque form of psoriasis (for example \\[e.g.\\], erythrodermic, guttate, or pustular)\n* Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)",{"count":211,"type":21},318,[107],"It is a multicenter randomized, double-blinded, parallel, positive-controlled, Phase 3 comparative study to evaluate the efficacy and safety of QL2106 injection to Tremfya® in Patients with Moderate to Severe Plaque Psoriasis. A total of 318 subjects are planned to be included and randomized at a ratio of 1:1 to receive QL2106 injection orTremfya®",[27],"2026-06-03",{"date":194,"type":37},{"date":168,"type":21},{"date":219,"type":21},"2028-02-28",{"name":221,"class":44},"Qilu Pharmaceutical Co., Ltd.",1,{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":231,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":252},"100545449","modifying-pest-for-psoriatic-arthritis-screening-100545449","NCT06382051","Modifying PEST for Psoriatic Arthritis Screening","A Multicenter, Prospective, Study to Evaluate the Impact of Modifying the Validated Psoriasis Epidemiology Screening Tool (PEST) on the Potential Diagnosis of Psoriatic Arthritis in Adult Patients With Moderate-to-severe Plaque Psoriasis in Canada (\"ScreenX\")","ScreenX","Key inclusion criteria:\n\n1. Moderate-to-severe plaque PsO patients who are candidates for bDMARDs, according to physician's clinical judgement at the time of patient enrollment.\n2. Adult patients at the time of informed consent signature\n3. Patients able to understand and willing to comply with protocol requirements, instructions, and restrictions\n4. Residents of Canada\n\nKey exclusion criteria:\n\n1. Patients who have previously screened positive for PsA through PEST.\n2. Patients who have been diagnosed with PsA.\n3. Patients who have been diagnosed with inflammatory arthritis unrelated to PsA (rheumatoid arthritis, reactive arthritis, enteropathic arthritis, axial spondyloarthritis)\n4. Patients treated with a bDMARD for moderate-to-severe plaque PsO or any other medical condition within the last 6 months prior to patient enrollment.",true,{"count":233,"type":21},502,[235],"NA","The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada.",[27,238],"Psoriatic Arthritis",[111,238,240,27,241,242,243],"PsA","PsO","Implementation Science","Psoriasis Epidemiology Screening Tool","2026-06-02",{"date":215,"type":37},{"date":247,"type":37},"2025-01-23",{"date":249,"type":21},"2026-08-28",{"name":251,"class":44},"Novartis Pharmaceuticals",29,{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":265,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},"100629447","phase-2-dose-ranging-study-of-orka-002-in-patients-with-moderate-to-severe-plaque-psoriasis-100629447","NCT07474792","Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis","A Multicenter, Randomized, Double-Blinded, Placebo- Controlled, Dose-Range Finding Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-002 in Participants With Moderate-to-Severe Plaque Psoriasis","Inclusion Criteria:\n\n1. Participants ≥ 18 and \\\u003C 80 years of age at the time of consent\n2. Have a diagnosis of plaque psoriasis for \\> 6 months\n3. Have moderate-to-severe chronic plaque psoriasis defined as:\n\n   1. BSA ≥ 10%, and\n   2. PASI ≥ 12, and\n   3. IGA score of ≥ 3 on a 5-point scale\n4. Candidate for systemic therapy or phototherapy\n5. Women of childbearing potential must have a negative pregnancy test\n\nExclusion Criteria:\n\n1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis)\n2. Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, or psychiatric disorder, or any infectious disease\n3. History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence\n4. A known hypersensitivity to any components of the ORKA-002 drug product\n5. Women who are breastfeeding or plan to breastfeed during the study","79 Years",{"count":55,"type":21},[24],"This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-002 in adult participants with moderate-to-severe plaque psoriasis.",[27],[29,60,266],"ORKA-002","2026-05-22",{"date":269,"type":37},"2026-05-27",{"date":271,"type":37},"2026-03-19",{"date":273,"type":21},"2029-04",{"name":43,"class":44},31,{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":222},"100618068","phase-3-a-clinical-study-to-evaluate-the-efficacy-and-safety-of-d-2570-in-the-treatment-of-moderate-to-severe-plaque-psoriasis-100618068","NCT07326813","A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis","A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis","Inclusion Criteria:\n\n* The patient voluntarily participates in this study after providing fully informed consent, signs a written informed consent form, and agrees to comply with the procedures specified in the study protocol;\n* Aged between 18 and 70 years old (inclusive) at the time of signing the informed consent form, regardless of gender;\n* The investigator assesses that the subject has plaque psoriasis suitable for systemic therapy, and the condition has been stable for ≥ 6 months before signing the informed consent form;\n* At the screening stage and Day 1 (D1) of the treatment period, the Psoriasis Body Surface Area (BSA) is ≥10%, the Physician Global Assessment (PGA) score is ≥ 3 points, and the Psoriasis Area and Severity Index (PASI) score is ≥ 12 points;\n* Hematology, Blood chemistry and Urinalysis examination were basically normal;\n* Male subjects and female subjects of childbearing potential must agree to abstain from sexual intercourse or adopt effective contraceptive measures from the time of signing the informed consent form (ICF) until 30 days after the last administration of the investigational product.\n\nExclusion Criteria:\n\n* Suffering from any type of psoriasis including erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, inverse psoriasis, or drug-induced psoriasis;\n* Having other skin lesions that may interfere with the assessment of treatment outcomes, such as eczema;\n* A history of severe herpes zoster\u002Fsimplex infection;\n* A history of tuberculosis, active tuberculosis, latent tuberculosis, or clinical manifestations suggestive of tuberculosis infection\n* Having language barriers, or being unwilling or unable to fully understand and cooperate;\n* Being pregnant or lactating women;\n* Other circumstances that the investigator deems unsuitable for the subject to participate in the study.","70 Years",{"count":285,"type":21},477,[107],"This study is a randomized, double-blind, placebo- and active-controlled multicenter clinical trial involving patients with moderate to severe plaque psoriasis.\n\nSafety and efficacy assessments will be conducted during the scheduled study visits throughout the trial. After completing the respective treatment, all subjects will undergo a safety follow-up. Both the investigators and subjects will remain blinded throughout the entire treatment period.\n\nDuring the study, subjects are required to provide blood samples for pharmacokinetic (PK) and pharmacodynamic (PD) analyses at the time points specified in the trial protocol.",[27],"2026-04-23",{"date":291,"type":37},"2026-04-29",{"date":293,"type":37},"2026-01-12",{"date":295,"type":21},"2027-12-03",{"name":297,"class":44},"InventisBio Co., Ltd",{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":231,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":222},"100515705","collection-of-samples-from-subjects-with-various-skin-conditions-and-healthy-volunteers-100515705","NCT05994976","Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers","Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers for Molecular Characterization of Inflammatory Skin Diseases","Inclusion Criteria:\n\nAll subjects:\n\n1. Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.\n2. Subject must be willing to comply with all study procedures and must be available for the duration of the study.\n\n   Healthy volunteers:\n3. Male or female subject aged 18 years or older, at the time of consent.\n4. Subject is in good general health, according to the investigator's judgment.\n\n   Subjects with Acne:\n5. Male or female subject aged 18 to 45 years old, inclusive, at the time of consent.\n\n   Subjects with AD:\n6. Male or female subject aged 18 years or older, at the time of consent.\n7. Subject has clinically confirmed diagnosis of active AD, according to Hanifin and Rajka criteria.\n\n   Subjects with CHE:\n8. Male or female subject aged 18 years or older, at the time of consent.\n9. Subject has at least a 6-month history of CHE before Screening (information obtained from medical chart or subject's physician, or directly from the subject).\n\n   Subjects with HS:\n10. Male or female subject aged 18 years or older, at the time of consent.\n11. Subject has a clinically confirmed diagnosis of active HS with a disease duration of ≥ 6 months before screening as determined by the investigator through subject interview and\u002For review of the medical history.\n\n    Subjects with PPP:\n12. Male or female subject aged 18 years or older at the time of consent.\n13. Subject has at least a 6-month history of PPP as defined by the presence of pustules on palms and\u002For soles, but without evidence of infection on palms and soles (information obtained from medical chart or subject's physician, or directly from the subject).\n\n    Subjects with psoriasis:\n14. Male or female subject aged 18 years or older, at the time of consent.\n\nExclusion Criteria:\n\nAll subjects:\n\n1. Subject is a female who is pregnant or who is planning to become pregnant during the study.\n2. Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.",{"count":306,"type":21},500,"The purpose of the study is to collect different samples for molecular characterization of inflammatory skin diseases.",[309,310,311,312,27,313],"Acne","Atopic Dermatitis","Chronic Hand Eczema","Hidradenitis Suppurativa","Palmoplantar Pustulosis","2026-03-25",{"date":316,"type":37},"2026-03-30",{"date":318,"type":37},"2023-10-17",{"date":320,"type":21},"2028-08",{"name":322,"class":323},"Innovaderm Research Inc.","OTHER",{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":22,"phases":334,"briefSummary":336,"conditions":337,"keywords":340,"overallStatus":348,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":222},"100630291","phase-4-metformin-combined-with-secukinumab-for-moderate-to-severe-plaque-psoriasis-in-overweight-or-obese-chinese-patients-100630291","NCT07485764","Metformin Combined With Secukinumab for Moderate-to-Severe Plaque Psoriasis in Overweight or Obese Chinese Patients","A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Metformin in Combination With Secukinumab for the Treatment of Moderate-to-Severe Plaque Psoriasis in Overweight or Obese Chinese Patients","Inclusion Criteria:\n\n1. Subjects voluntarily participate in the study and sign the informed consent form.\n2. Aged 18-75 years (inclusive) at the time of signing informed consent, male or female.\n3. Diagnosed with chronic plaque psoriasis for \\>=6 months prior to the first study drug administration.\n4. Overweight\u002Fobesity: Body mass index (BMI) \\>=25 kg\u002Fm².\n5. Moderate-to-severe plaque psoriasis (defined as):\n\n   Psoriasis Area and Severity Index (PASI) score \\>=12 at screening and prior to first dose.\n\n   Investigator's Global Assessment (IGA) score \\>=3 at screening and prior to first dose.\n\n   Stable disease within 2 months prior to randomization.\n6. Deemed candidates for phototherapy or systemic therapy by the investigator, defined as subjects with moderate-to-severe chronic plaque psoriasis uncontrolled by:\n\n   Topical therapy and\u002For phototherapy and\u002For prior systemic therapy.\n7. Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study medication (Day 0). Both women of childbearing potential and male patients with reproductive capacity must agree to use highly effective contraceptive methods during the study and for 15 weeks following the last dose.\n8. Lactating women agree to discontinue breastfeeding during the study and for 15 weeks following the last dose of study medication.\n9. Subjects must be capable of effective communication with investigators and adhere to the clinical trial protocol to complete all study requirements. -\n\nExclusion Criteria:\n\n* 1: BMI \\\u003C25 kg\u002Fm². 2: Presence of guttate, pustular, or erythrodermic psoriasis, or other diseases that may confound treatment outcomes (e.g., cutaneous lesions, systemic autoimmune diseases).\n\n  3: Drug-induced psoriasis (e.g., new-onset or exacerbated psoriasis caused by beta-blockers, calcium channel blockers, or lithium).\n\n  4: Use of prohibited medications: Systemic non-biologic agents (e.g., glucocorticoids, leflunomide, methotrexate, cyclosporine, retinoids, azathioprine, mycophenolate mofetil, traditional Chinese medicines for psoriasis) within 4 weeks prior to screening.\n\nEtanercept or its biosimilars within 4 weeks prior to screening; TNF-α inhibitors or their biosimilars within 12 weeks prior to screening.\n\nOther biologic agents for psoriasis (e.g., IL-12\u002F23 or IL-23 inhibitors) within 5 half-lives of the drug prior to screening.\n\n5: Prior use of secukinumab or other IL-17A\u002FIL-17R-targeted biologic agents within 12 weeks prior to screening.\n\n6: History of malignancy within the past 5 years (e.g., cutaneous squamous cell carcinoma, basal cell carcinoma, cervical carcinoma in situ).\n\n7: Active inflammatory diseases other than psoriasis that may confound the evaluation of secukinumab efficacy.\n\n8: Metabolic or inflammatory diseases (e.g., type 2 diabetes) that may confound the evaluation of metformin efficacy.\n\n9: History of lymphoproliferative disorders (e.g., lymphoma, lymphadenopathy) or splenomegaly.\n\n10: Opportunistic infections within 6 months prior to screening (e.g., herpes zoster, CMV, Mycoplasma, Pneumocystis jirovecii, histoplasmosis, candidiasis, aspergillosis, NTM).\n\n11: Chronic or recurrent infectious diseases (e.g., chronic hepatitis, pyelonephritis) or severe\u002Flife-threatening infections within 6 months prior to screening; current signs\u002Fsymptoms suggestive of infection (e.g., fever, cough, dysuria, abdominal pain, diarrhea, infected skin wounds).\n\n12: High risk of infection (e.g., leg ulcers, indwelling urinary catheters, recurrent chest infections, bedridden\u002Fwheelchair-bound status).\n\n13: Major surgery within 8 weeks prior to screening or planned during the study, deemed to pose unacceptable risk by the investigator.\n\n14: Live virus\u002Fbacterial vaccines (e.g., BCG) within 6 weeks prior to screening or planned during the study\u002Fwithin 15 weeks after last dose.\n\n15: Participation in another clinical trial within 4 weeks prior to screening or within 5 half-lives of the investigational product (whichever is longer).\n\n16: Laboratory abnormalities: Hemoglobin \\\u003C8.5 g\u002FdL WBC \\\u003C2,500\u002FμL ANC \\\u003C1,500\u002FμL Platelets \\\u003C100,000\u002FμL ALT\u002FAST \\>2×ULN Creatinine \\>176.8 μmol\u002FL (2.0 mg\u002FdL) 17: Active hepatitis B (positive HBsAg). 18: Positive HCV antibody. 19: HIV infection or positive HIV antibody. 20: Syphilis infection. 21: Active or latent tuberculosis at screening. 22: Hypersensitivity to trial drug excipients, murine\u002Fhuman proteins, or immunoglobulin products.\n\n23: Inability to communicate\u002Fcomply (e.g., psychiatric disorders, frequent travel, lack of motivation).\n\n24: Other conditions deemed by the investigator to compromise study participation.","75 Years",{"count":333,"type":21},186,[335],"PHASE4","This is a randomized, double-blind, placebo-controlled, multicenter clinical trial conducted in China. The study aims to evaluate the efficacy and safety of metformin combined with secukinumab in the treatment of moderate-to-severe plaque psoriasis in overweight or obese Chinese patients.\n\nA total of approximately 186 participants will be enrolled and randomly assigned in a 1:1 ratio to receive either secukinumab plus metformin or secukinumab plus placebo. The study consists of a screening period, an induction period, a maintenance period, and a follow-up period, with a total duration of 60 weeks.\n\nThe primary endpoints are the proportions of participants achieving PASI75 (≥75% improvement in Psoriasis Area and Severity Index) and an IGA score of 0 or 1 (clear or almost clear) at Week 24. Secondary endpoints include PASI90, quality of life (DLQI), pruritus NRS score, metabolic parameters, and safety assessments.\n\nThis study aims to provide a more effective combination therapy for psoriasis patients with overweight or obesity.",[111,27,338,339],"Moderate-to-severe Plaque Psoriasis","Overweight , Obesity",[341,342,343,344,345,346,347],"Metformin","Secukinumab","IL-17 Inhibitor","Randomized Controlled Trial","Double-Blind","Placebo-Controlled","Chinese Patients","NOT_YET_RECRUITING","2026-03-22",{"date":314,"type":37},{"date":352,"type":21},"2026-06",{"date":354,"type":21},"2029-06",{"name":356,"class":323},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":364,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":222},"100365279","early-phase-1-triamcinolone-with-vitamin-d-synergistic-efficacy-in-psoriasis-100365279","NCT04036188","Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis","Inclusion Criteria:\n\n* Age 18 and older\n* Mild to severe plaque psoriasis (2% or greater Body Surface Area; Psoriasis Area and Severity Score of 2 or greater; Investigator Grade Assessment of mild-severe)\n\nExclusion Criteria:\n\n* Currently taking medication that alters the normal ion balance of low-dose in blood.\n* No calcium supplements 1 month prior to baseline (not including multivitamins).\n* Unstable or uncontrolled illness, including but not limited to cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or psychiatric disease at screening.\n* Abnormal laboratory values at screening, that in the opinion of the investigator, would potentially affect patient safety or data integrity.\n* Not on systemic non-biologic therapy (including, but not limited to, oral psoralen plus ultraviolet A \\[photochemotherapy (PUVA)\\] light therapy; cyclosporine; corticosteroids; methotrexate; oral retinoids; apremilast; tofacitinib; mycophenolate mofetil; thioguanine; hydroxyurea; sirolimus; tacrolimus; azathioprine; leflunomide; fumaric acid derivatives; or 1, 25 dihydroxy vitamin D3 and analogues) within 28 days prior to baseline.\n* No phototherapy (including either oral and topical PUVA light therapy, ultraviolet B, excimer laser, or self-treatment with tanning beds or therapeutic sunbathing) within 28 days prior to baseline.\n* No topical treatment (including, but not limited to, corticosteroids \\[upper mid strength or lower potency topical steroids are permitted on the intertriginous areas and face\\], crisaborole, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, pimecrolimus, tacrolimus, emollients and other nonprescription topical products containing urea, \\>3% salicylic acid, alpha- or beta-hydroxyl acids, or medicated shampoos \\[for example those that contain \\>3% salicylic acid, corticosteroids, coal tar, or vitamin D3 analogues\\]) within 14 days prior to baseline.\n* No biologic agents within 8 weeks or three half-lives, whichever is greater prior to baseline.\n* History of renal impairment.\n* History of renal stones.\n* History of parathyroid abnormalities\n* Osteoporosis\n* History of severe arthritis\n* Ongoing use of tanning bed or other UV device or excessive sunlight\n* Unable to understand\u002Fcomplete informed consent.",{"count":45,"type":21},[365],"EARLY_PHASE1","These studies are designed to assess the synergistic efficacy of topical 0.1% triamcinolone cream paired with 40,000 IU of oral vitamin D3 daily in treating mild to moderate psoriasis. The study is designed to have all subjects treated with triamcinolone cream (TAC) for 4 weeks, then will be randomized 1:1 into vitamin D3 or placebo for an additional 12 weeks. At that time, the study will become open-label and all subjects will be placed on (or continue) vitamin D3 for an additional 12 weeks. The study will take place over 28 weeks total.",[27,368],"Vitamin D3","2026-02-17",{"date":371,"type":37},"2026-02-19",{"date":373,"type":37},"2019-10-16",{"date":375,"type":21},"2026-12",{"name":377,"class":323},"Wright State University",{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":331,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":348,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":4},"100621686","phase-4-vunakizumab-combined-with-recaticimab-in-subjects-with-moderate-to-severe-plaque-psoriasis-and-dyslipidemia-100621686","NCT07373847","Vunakizumab Combined With Recaticimab in Subjects With Moderate to Severe Plaque Psoriasis and Dyslipidemia","A Single-center, Randomized, Placebo-controlled Trial Study to Compare Efficacy, Safety and Tolerability of Vunakizumab Combined With Recaticimab in Subjects With Moderate to Severe Plaque Psoriasis and Dyslipidemia","Inclusion Criteria:\n\n\\-\n\nSubjects who meet all of the following criteria may be enrolled in this study:\n\nAdults aged 18 to 75 years, inclusive.\n\nClinically confirmed diagnosis of psoriasis.\n\nAt screening or on Day 1 of study treatment, a PASI score ≥10, BSA involvement ≥10%, and PGA score ≥3.\n\nPresence of dyslipidemia at screening or on Day 1 of study treatment, defined as fasting LDL-C ≥2.6 mmol\u002FL and \\\u003C4.9 mmol\u002FL in subjects without concomitant atherosclerotic cardiovascular disease (ASCVD).\n\nFasting triglycerides (TG) \\\u003C5.6 mmol\u002FL and 10-year ASCVD risk score \\\u003C10%.\n\nWomen of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline, and must agree to use effective contraception throughout the study and for 30 days after the end of the study.\n\nSubjects must voluntarily participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria will be excluded from the study:\n\nPresence of non-plaque psoriasis at screening or on Day 1 of the study, including guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis.\n\nFever or active infection within 7 days prior to study initiation.\n\nHistory of serious infection within 60 days prior to study initiation (including but not limited to bacterial, viral, or fungal infections requiring hospitalization or intravenous antimicrobial therapy), or any untreated infection.\n\nHistory of chronic infection, such as chronic pyelonephritis or chronic osteomyelitis.\n\nPositive hepatitis B virus (HBV) DNA with abnormal liver function, or HBV DNA \\>1 × 10⁵ copies\u002FmL, indicating active infection.\n\nPositive test results for human immunodeficiency virus (HIV) or Treponema pallidum (syphilis) antibodies.\n\nClinical signs or symptoms suggestive of active tuberculosis (TB) during screening (e.g., fever, cough, night sweats, weight loss), or evidence of current or active pulmonary TB on chest imaging (X-ray or CT) during screening or within 6 months prior to screening.\n\nNew York Heart Association (NYHA) class III or IV heart failure, or left ventricular ejection fraction \\\u003C30%.\n\nDiagnosis within 3 months prior to randomization of new-onset myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, or stroke.\n\nType 1 diabetes mellitus, poorly controlled type 2 diabetes mellitus (HbA1c ≥10%), or diabetes with multiple organ comorbidities.\n\nSCORE (Systematic Coronary Risk Evaluation) ≥10%.\n\nDuring screening, uncontrolled hypertension (defined as systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg) or moderate to severe renal impairment, defined as estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m².\n\nOngoing active liver disease or liver function abnormalities, defined as ALT and\u002For AST ≥3× the upper limit of normal (ULN).\n\nPresence of malignancy.\n\nHistory of severe drug allergy, or known hypersensitivity to funakinzumab, ricazinumab, or any of their excipients.\n\nPregnant or breastfeeding women, women planning pregnancy during the study period, or male or female subjects unwilling to use contraception.\n\nReceipt of systemic oral or intravenous treatment prior to screening without completion of the required washout period, as defined below:\n\n1. Use of TNF-α, IL-12\u002F23, IL-17, or IL-23 monoclonal antibodies (e.g., adalimumab, ustekinumab, ixekizumab, secukinumab, guselkumab) within 3 months prior to screening;\n2. Use of systemic psoriasis treatments (including but not limited to methotrexate, JAK inhibitors, acitretin, cyclosporine, oral or injectable corticosteroids) within 4 weeks prior to screening;\n3. Use of topical psoriasis treatments (including but not limited to corticosteroids, vitamin D₃ analogues, calcineurin inhibitors, tapinarof) within 2 weeks prior to screening;\n4. Receipt of phototherapy (including oral or topical PUVA, UVB, tanning beds, or therapeutic sun exposure) within 4 weeks prior to screening;\n5. Use of statins, cholesterol absorption inhibitors, or fibrates within 4 weeks prior to screening.\n\nLaboratory abnormalities at screening meeting any of the following criteria:\n\n1. Absolute white blood cell count \\\u003C3,000\u002Fmm³;\n2. Absolute lymphocyte count \\\u003C500\u002Fmm³;\n3. Absolute neutrophil count \\\u003C1,000\u002Fmm³;\n4. Platelet count \\\u003C100,000\u002Fmm³;\n5. Hemoglobin \\\u003C9 g\u002FdL;\n6. ALT and\u002For AST \\>3× ULN;\n7. Total unconjugated and\u002For conjugated bilirubin \\>2× ULN;\n8. Clinically significant electrocardiogram (ECG) abnormalities;\n9. Any other laboratory abnormality deemed by the investigator to interfere with study completion or interpretation of study results.",{"count":150,"type":21},[335],"The aim is to evaluate the safety and efficacy of vunakizumab combined with recaticimab versus vunakizumab combined with placebo in the treatment of plaque psoriasis with dyslipidemia.",[27],"2026-01-22",{"date":391,"type":37},"2026-01-28",{"date":393,"type":21},"2026-01-20",{"date":395,"type":21},"2027-08-30",{"name":397,"class":323},"Xiangya Hospital of Central South University",{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":283,"enrollmentInfo":405,"targetDuration":4,"studyType":22,"phases":407,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":222},"100612316","phase-2-efficacy-and-safety-of-icp-332-versus-placebo-in-participants-with-moderate-to-severe-plaque-psoriasis-100612316","NCT07251998","Efficacy and Safety of ICP-332 Versus Placebo in Participants With Moderate to Severe Plaque Psoriasis","A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ICP-332 in Patients With Moderate to Severe Plaque Psoriasis","Inclusion Criteria:\n\n1. Subjects voluntarily participate in this study and have signed the Informed Consent Form (ICF).\n2. Male or female subjects aged ≥ 18 years and ≤ 70 years\n3. A history of plaque psoriasis for ≥6 months at baseline\n4. Meet the following three criteria:\n\n   1. Psoriasis Area and Severity Index (PASI) score ≥12\n   2. Static Physician's Global Assessment (sPGA) score ≥3\n   3. Psoriasis affected Body Surface Area (BSA) ≥10%\n5. The subject requires systemic treatment and\u002For phototherapy.\n\nExclusion Criteria:\n\n1. Diagnosed with non-plaque psoriasis.\n2. Subject had laboratory values meeting any of the protocol-specified criteria at Screening.\n3. Presence of clinically serious, progressive, or uncontrolled disease.\n4. Previous history of alcoholism or drug abuse (except for those who have been completely abstinent for more than 6 months before randomization).\n5. Pregnant or lactating women.\n6. The investigator accepts ICP-332 for any reason that the subject is not suitable for this study.",{"count":406,"type":21},172,[24],"The purpose of this study is to compare the efficacy and safety of ICP-332 to placebo in participants with moderate-to-severe plaque psoriasis.",[27],"2025-12-24",{"date":412,"type":37},"2025-12-31",{"date":414,"type":37},"2025-12-22",{"date":416,"type":21},"2027-05",{"name":418,"class":44},"Beijing InnoCare Pharma Tech Co., Ltd.",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":283,"enrollmentInfo":426,"targetDuration":4,"studyType":22,"phases":428,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":222},"100602983","phase-3-evaluate-the-efficacy-and-safety-of-d-2570-in-subjects-with-moderate-to-severe-plaque-psoriasis-100602983","NCT07130604","Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis","Inclusion Criteria:\n\n1. Subject voluntarily takes part in the study after being fully informed,signs a written ICF, and agrees to follow procedures specified in the study protocol;\n2. Plaque psoriasis assessed by the investigator as suitable for systemic treatment and stable (defined as stable as no significant outbreak of morphological change or disease activity assessed by the investigator) for at least 6 months prior to signing informed consent;\n3. During the screening period and before taking the investigational drug for the first time, psoriatic surface area (BSA) ≥10%, PGA score ≥ 3, PASI score ≥ 12;\n4. Hematology, Blood chemistry and Urinalysis examination were basically normal.\n\nExclusion Criteria:\n\n1. Erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, reverse psoriasis, drug-induced psoriasis;\n2. Have other skin lesions that affect the evaluation of treatment outcomes, such as eczema;\n3. History of herpes zoster\u002Fherpes simplex, or presence of herpes zoster\u002Fherpes simplex infection during the screening period;\n4. Have a history of tuberculosis, or active tuberculosis, or latent tuberculosis, or suspected clinical manifestations of tuberculosis infection;\n5. Other conditions that the investigator considers inappropriate for participation in the study.",{"count":427,"type":21},390,[107],"This study is a randomized, double-blind, placebo-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis.",[27],"2025-12-07",{"date":433,"type":37},"2025-12-09",{"date":435,"type":37},"2025-09-18",{"date":437,"type":21},"2027-07-28",{"name":297,"class":44},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":283,"enrollmentInfo":446,"targetDuration":4,"studyType":22,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":222},"100610977","a-study-to-evaluate-effectiveness-and-safety-of-a-tyk2-inhibitor-in-subjects-with-moderate-to-severe-plaque-psoriasis-100610977","NCT07234591","A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis","A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis","Inclusion Criteria:\n\n* Male and female, ages 18 to 70 years\n* Body weight \\>40 kg, body mass index (BMI) of 18 to 40 kg\u002Fm2\n* Clinical diagnosis of plaque psoriasis for ≥6 months before the Baseline visit\n* Women of childbearing potential (WOCBP) and males who are sexucally active must agree to follow instructions for method(s) of contraception.\n\nExclusion Criteria:\n\n* Diagnosed with non-plaque psoriasis\n* Previously received tyrosine kinase 2 (TYK2) inhibitors\n* Previously received other psoriasis treatments such as biological agents, immunoregulators, or hormonal drugs within a specific period before administration, and the investigator deems it may affect the immunity of the subjects\n* Has participated in any clinical trials within 30 days or 5 half-lives of the drug before the first administration, or currently undergoing visits for other clinical trials;\n* Has history of chronic disease that may affect the study, or acute or chronic severe infectious diseases, such as a history of active or inadequately treated latent tuberculosis infection, severe bone or joint infections within 6 months before screening, and other acute infectious diseases.\n* Has known or suspected skin or systemic autoimmune diseases other than psoriasis and psoriatic arthritis;\n* Other conditions that the investigator deems unsuitable for participation in this study.\n\nOther protocol defined inclusion\u002Fexclusion criteria could apply",{"count":447,"type":21},140,[235],"A Study to evaluate efficacy and safety in subjects with moderate to severe Plaque Psoriasis treated with a TYK2 Inhibitor for 12 weeks",[27,82],"2025-11-14",{"date":453,"type":37},"2025-11-18",{"date":455,"type":37},"2025-10-21",{"date":457,"type":21},"2026-05-30",{"name":459,"class":44},"Usynova Pharmaceuticals Ltd.",{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":231,"sex":17,"minAge":18,"maxAge":467,"enrollmentInfo":468,"targetDuration":4,"studyType":22,"phases":470,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":222},"100595920","phase-1-a-study-of-ua026-tablets-in-healthy-adult-subjects-and-adult-subjects-with-moderate-to-severe-plaque-psoriasis-100595920","NCT07038720","A Study of UA026 Tablets in Healthy Adult Subjects and Adult Subjects With Moderate to Severe Plaque Psoriasis","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Food Effect of UA026 Tablets in Healthy Adult Subjects and Adult Subjects With Moderate to Severe Plaque Psoriasis","For Healthy Subject:\n\nInclusion Criteria\n\n1. Men and women aged 18-55 at the time of screening visit;\n2. Body mass index (BMI) 18.5-28 kg\u002Fm2, inclusive, and total body weight ≥50 kg for male or ≥45 kg for female;\n3. Voluntarily participate in the study and provide the signed and dated informed consent;\n4. For female subjects:\n\n   1. With no childbearing potential, including those who has surgical sterilization (documented tubal ligation, hysterectomy, or bilateral oophorectomy) at least 6 weeks before the screening visit, and who menopause ≥12 months before the screening visit (confirmed by a follicle stimulating hormone (FSH) level ≥40IU\u002FL), or\n   2. With childbearing potential (WOCBP), must not be pregnant nor lactating, and must have used nonpharmacologic contraception 30 days before administration, during the study, and for 3 months after dose, and must have tested negative for human chorionic gonadotropin (hCG) at the screening visit and D-1; female subjects must refrain from egg donation during this period.\n5. Males who are sexually active with WOCBP must have used nonpharmacologic contraception 14 days before administration, during the study, and for 3 months after administration. Male subjects must refrain from sperm donation during this time.\n6. Subject is willing to comply with protocol-specified visits, treatments, laboratory tests, and other study-related procedures and requirements.\n\nExclusion Criteria\n\n1. Allergy to the investigational drugs or the excipients, or a history of severe allergy (including any food allergy or drug allergy);\n2. Has received IL-17 small molecule inhibitors in the past;\n3. Medical history or family history of psychiatric disorders or genetic immunodeficiency;\n4. Has received hematopoietic stem cell transplantation, or organ transplantation in the past;\n5. History of chronic or recurrent infectious diseases, or systemic infection caused by fungal, parasitic or mycotic pathogens, or other opportunistic infections;\n6. History of active or latent tuberculosis (TB), or inadequately treated latent TB infection, or contact history of patients with TB;\n7. Has serious bone or joint infection within 6 months before screening, serious infection (e.g., hospitalization for infection or parenteral antibiotic treatment for infection), or herpes zoster virus infection within 3 months before screening;\n8. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or treponema pallidum antibody (TP-Ab);\n9. Subject with any acute infection, or any symptoms or signs of infection;\n10. Has presence of a surgical site, trauma site, severe mucosal ulceration, or incomplete fracture healing, or risk of gastrointestinal bleeding\u002Fperforation (e.g., active gastroduodenal ulcer, intestinal obstruction, ulcerative colitis, esophagogastric varices, gastrointestinal perforation within 6 months prior to screening), and risk of infection as assessed by the investigator;\n11. Abnormal liver function within 3 months prior to administration, or higher than the upper limit of normal ALT, AST, ALP, or TBL detected during screening period, and is clinically significant;\n12. Has abnormal coagulation parameters (including prothrombin time and international normalized ratio) and is clinically significant;\n13. Known or suspected history of drug abuse (e.g., morphine, methamphetamine, ketamine, dimethylene dioxyamphetamine, THC, cocaine, etc.), or positive at baseline screening for drug abuse;\n14. Alcohol abuse within 1 year prior to screening (drinking more than 14 standard units per week, with 1 standard unit containing 14g of alcohol, such as 360 ml of 5% beer, 45ml of 40% liquor, 120 ml of 12% wine), or positive breath test for alcohol during screening\u002Fbaseline period;\n15. Smokes more than 5 cigarettes per day or the equivalent of 5 cigarettes per day of nicotine-containing products within 3 months before screening, or inability to comply with the smoking ban during the study;\n16. Has received vaccines within 3 months prior to screening, or plan to receive vaccines during the study;\n17. Has received any experimental drug or participated in any drug\u002Finvestigational device trial within 3 months before dosing;\n18. Has undergone any surgery in the 3 months prior to screening, or planned to undergo surgery during the study period;\n19. Subject with previous severe or current chronic diseases of the central nervous system, cardiovascular, liver, kidney, lung, digestive tract, metabolic, hematological, skeletal, immune and other systems of clinical significance, or any other diseases or medical conditions that may affect the study or pose an unacceptable risk to the subject in the judgment of the investigator;\n20. History of abdominal surgery affecting the structure and function of the digestive tract;\n21. Subject with structural abnormalities of the digestive tract, or previous history of gastrointestinal disease (such as gastrointestinal bleeding, gastrointestinal perforation, gastroesophageal reflux disease, and inflammatory bowel disease) or current clinically significant gastrointestinal disease (such as gallstones) or symptoms (such as nausea, vomiting, and diarrhea), or patients who had undergone gastrointestinal surgery;\n22. Subject with symptoms of uninduced diarrhea within 3 months prior to screening;\n23. Any clinically significant abnormal results in vital signs, physical examination, or protocol-specified laboratory tests;\n24. Any clinically significant abnormal result in 12-lead ECGs, such as QTcF interval (Fridericia correction) \\> 450 ms for males and \\> 470 ms for females;\n25. Serum creatinine clearance (Ccr) \\\u003C 90 mL\u002Fmin, calculated according to Cockcroft-Gault formula: Creatinine clearance (mL\u002Fmin) =(140-age) × body weight (kg) ×(0.85 \\[women only\\])\u002F 72 × serum creatinine (mg\u002FdL), Or creatinine clearance (mL\u002Fmin) =(140-age) × body weight (kg) ×(0.85 \\[women only\\])\u002F 0.81 × serum creatinine (μmol\u002FL);\n26. Has received any drugs that may interact with the investigational drug within 7 days before administration, such as CYP3A4 inhibitors and inducers, or P-gp inhibitors (refer to Appendix 12.6 for details);\n27. Has received any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 7 days before screening; Ingestion of foods or beverages that induce or inhibit liver metabolism enzymes (e.g., grapefruit, etc.) within 48 hours before administration; Inability to comply with the prohibition of ingestion of any foods or beverages containing or metabolically producing caffeine or xanthine (e.g., coffee, tea, chocolate) within 48 hours before the first administration until the completion of the last PK blood sample;\n28. Inability to comply with the prohibition of the use of any medications, other than those permitted by the investigator, including prescription and over-the-counter medications (excluding topical eye\u002Fnose drops and creams without systemic exposure risk), vitamins (excluding conventional vitamins), health supplements, or Chinese herbal medicine within 14 days or 5 half-lives (whichever is longer) before administration until the last visit.\n29. Has donated or lost ≥400 ml of blood within the 3 months prior to screening, or planned to donate blood during the study period;\n30. Inability to be venipunctured for blood collection and\u002For has a history of fainting blood and fainting needles; Subject with any other serious systemic diseases, significant laboratory or procedure abnormalities, or other reasons that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study.\n\nFor Psoriasis Patient:\n\nInclusion Criteria\n\n1. Men and women aged 18-70 at the time of screening visit;\n2. Body mass index (BMI) 18-35 kg\u002Fm2, inclusive, and total body weight ≥ 40 kg;\n3. Patients with plaque psoriasis who meet the following criteria during screening:\n\n   1. Diagnosis of plaque psoriasis for at least 6 months before the first administration, and, in the opinion of the Investigator, have stable psoriasis with no significant progression or morphological changes.\n   2. Psoriasis Area and Severity Index (PASI) score 12\n   3. Static physician's global assessment (sPGA) ≥3\n   4. Psoriatic plaques must cover 10% of body surface area (BSA)\n   5. Deemed by Investigator to be eligible for phototherapy or systemic therapy\n   6. Subject is willing to discontinue topical and\u002For systemic therapies other than the investigational drugs, with the exception of topical moisturizer and low-intensity topical steroids used for salvage therapy.\n4. Voluntarily participate in the study and provide the signed and dated informed consent；\n5. For female subjects:\n\n   1. With no childbearing potential, including those who has surgical sterilization (documented tubal ligation, hysterectomy, or bilateral oophorectomy) at least 6 weeks before the screening visit, and who menopause ≥12 months before the screening visit (confirmed by a follicle stimulating hormone (FSH) level ≥40IU\u002FL), or\n   2. With childbearing potential (WOCBP), must not be pregnant nor lactating, and must have used nonpharmacologic contraception 30 days before administration, during the study, and for 3 months after dose, and must have tested negative for human chorionic gonadotropin (hCG) at the screening visit and D-1; female subjects must refrain from egg donation during this period;\n6. Males who are sexually active with WOCBP must have used nonpharmacologic contraception 14 days before administration, during the study, and for 3 months after administration. Male subjects must refrain from sperm donation during this time;\n7. Subject is willing to comply with protocol-specified visits, treatments, laboratory tests, and other study-related procedures and requirements.\n\nExclusion Criteria\n\n1. Allergy to the investigational drugs or the excipients, or a history of severe allergy (including any food allergy or drug allergy);\n2. Has received IL-17 small molecule inhibitors in the past;\n3. Diagnosis of non-plaque psoriasis (guttate, inverse, pustular, erythrodermic);\n4. Diagnosis of or at risk for drug-induced psoriasis (including, but not limited to, new-onset psoriasis or exacerbation of psoriasis caused by β receptor blockers, calcium channel inhibitors, or lithium, and newly use of β receptor blockers or calcium channel inhibitors within 2 years prior to enrollment);\n5. Has or suspected to have other skin or systemic autoimmune diseases other than psoriasis and psoriatic arthritis;\n6. History of lack of response to Ustekinumab, Guselkumab, Tildrakizumab, Secukinumab, Ixekizumab, or Brodalumab (any therapeutic agent targeted to IL-12, IL-17 or IL-23) at approved doses after at least 3 months of therapy;\n7. Has received Ustekinumab, Guselkumab, Tildrakizumab, Secukinumab, Ixekizumab, or Brodalumab (any therapeutic agent targeted to IL-12, IL-17 or IL-23) within 3 months of first administration of investigational drugs;\n8. Has received TNF-α inhibitor(s) (Etanercept, Infliximab, Adalimumab, or Sacituzumab) within 2 months of first administration of investigational drugs;\n9. Has received phototherapy or any systemic medications\u002Ftreatments for psoriasis, (including, but not limited to, Chinese medicines, JAK inhibitors, PDE4 inhibitors, TYK2 inhibitors, methotrexate, cyclosporin, retinoids) within 1 month of the first administration;\n10. Has used topical medications\u002Ftreatments for psoriasis (including, but not limited to, glucocorticoids, vitamin D derivatives, retinoids, calcineurin inhibitors, aryl hydrocarbon receptor agonists, combination preparation for external use, Chinese medicines, JAK inhibitors, PDE4 inhibitors) within 2 weeks of the first administration;\n11. Has received any other monoclonal antibodies that the Investigator determined could affect the evaluation of the investigational drugs. For example, has received natalizumab, efalizumab, or agents that modulate B cells or T cells (eg, alemtuzumab, abatacept, alefacept, or visilizumab) within 3 months of the first administration; or has received rituximab within 6 months of the first administration;\n12. Medical history or family history of psychiatric disorders or genetic immunodeficiency;\n13. Has received hematopoietic stem cell transplantation, or organ transplantation in the past;\n14. History of chronic or recurrent infectious diseases, or systemic infection caused by fungal, parasitic or mycotic pathogens, or other opportunistic infections;\n15. History of active or latent TB, or inadequately treated latent TB infection, or contact history of patients with TB;\n16. Has serious bone or joint infection within 6 months before screening, serious infection (e.g., hospitalization for infection or parenteral antibiotic treatment for infection), or herpes zoster virus infection within 3 months before screening;\n17. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or treponema pallidum antibody (TP-Ab);\n18. Subject with any acute infection, or any symptoms or signs of infection;\n19. Has presence of a surgical site, trauma site, severe mucosal ulceration, or incomplete fracture healing, or risk of gastrointestinal bleeding\u002Fperforation (e.g., active gastroduodenal ulcer, intestinal obstruction, ulcerative colitis, esophagogastric varices, gastrointestinal perforation within 6 months prior to screening), and risk of infection as assessed by the Investigator;\n20. History of malignant tumor or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma, or carcinoma in situ of cervix that has been treated with no evidence of recurrence within the previous 3 years);\n21. Class III or IV congestive heart failure by New York Heart Association Criteria; Or has unstable cardiovascular disease, defined as a recent clinical deterioration (e.g., unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months;\n22. Absolute WBC count, lymphocyte count, or neutrophil count is below the lower limit of normal and is clinically significant;\n23. Abnormal liver function within 3 months before the first administration, or higher than the upper limit of normal ALT, AST, ALP, or TBL detected during screening period, and is clinically significant；\n24. Serum creatinine clearance (Ccr) \\\u003C 60 mL\u002Fmin, calculated according to Cockcroft-Gault formula;\n25. Has abnormal coagulation parameters (including prothrombin time and international normalized ratio) and is clinically significant;\n26. Known or suspected history of drug abuse (e.g., morphine, methamphetamine, ketamine, dimethylene dioxyamphetamine, THC, cocaine, etc.), or positive at baseline screening for drug abuse;\n27. Alcohol abuse within 1 year prior to screening (drinking more than 14 standard units per week, with 1 standard unit containing 14g of alcohol, such as 360 ml of 5% beer, 45ml of 40% liquor, 120 ml of 12% wine), or positive breath test for alcohol during screening\u002Fbaseline period;\n28. Smokes more than 5 cigarettes per day or the equivalent of 5 cigarettes per day of nicotine-containing products within 3 months before screening, or inability to comply with the smoking ban during the study;\n29. Has received vaccines within 3 months prior to screening, or plan to receive vaccines during the study;\n30. Has received an experimental antibody or biologic therapy within the previous 6 months, or received any other experimental therapy or new investigational agent within 30 days or 5 half-lives (whichever is longer) of any study medication administration;\n31. Has undergone any surgery in the 3 months prior to screening, or planned to undergo surgery during the study period;\n32. Has donated or lost ≥400 ml of blood within the 3 months prior to screening, or planned to donate blood during the study period;\n33. Inability to be venipunctured for blood collection and\u002For has a history of fainting blood and fainting needles;\n34. Subject with any other serious systemic diseases, significant laboratory or procedure abnormalities, or other reasons that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study.","55 Years",{"count":469,"type":21},124,[471],"PHASE1","This study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetic profile, and food effect of UA026 tablets.\n\nThe study consists of four parts: Part A is a single ascending dose (SAD) study, Part B is a multiple ascending dose (MAD) study, Part C is a food effect (FE) study, and Part D is a multi-dose parallel control study. Part A, B, and C will be conducted in healthy subject, and Part D will be conducted in subjects with moderate to severe plaque psoriasis.",[27,474],"Healthy Volunteer",{"date":476,"type":37},"2025-11-17",{"date":478,"type":37},"2025-05-08",{"date":480,"type":21},"2026-06-01",{"name":459,"class":44},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":283,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":492,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":499,"leadSponsor":501,"locationsCount":503},"100602889","phase-1-a-study-to-evaluate-the-efficacy-and-safety-of-cs32582-in-participants-with-moderate-to-severe-plaque-psoriasis-100602889","NCT07129382","A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis","A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ib\u002FII Study to Evaluate the Efficacy and Safety of CS32582 Capsule in Adult Patients With Moderate to Severe Plaque Psoriasis","MECAP","Inclusion Criteria:\n\n* Voluntarily sign the informed consent form (ICF) after fully understanding the trial.\n* Age 18-70 years (inclusive) at consent, any gender\n* Clinically diagnosed with chronic plaque psoriasis, defined as disease duration ≥ 6 months at screening.\n* Stable plaque psoriasis at screening, defined as no significant flare-ups or morphological changes during the 6 months prior to screening (investigator-assessed).\n* Moderate-to-severe disease at screening\u002Frandomization: PASI≥12, sPGA≥3, and BSA≥10%;\n* Candidate for phototherapy or systemic therapy per investigator's judgment.\n* Women of childbearing potential and males: Agreement to use highly effective contraception from consent until 30 days post-last dose.\n\nExclusion Criteria:\n\n* Forms of psoriasis other than plaque-type (e.g., erythrodermic, pustular, guttate, or drug-induced psoriasis) .\n* Presence of other skin conditions that in the judgement of the Investigator could interfere with study assessment.\n* Immune-mediated diseases requiring systemic therapy (e.g., inflammatory bowel disease), except NSAIDs.\n* History of severe drug allergies.\n* Major surgery within 2 months before randomization or planned during the study.\n* Drug\u002Falcohol abuse within 6 months before screening.\n* Uncontrolled hypertension at screening (SBP \\>160 mmHg or DBP \\>100 mmHg).\n* Myocardial infarction, unstable angina, TIA, stroke, PCI, or CABG within 6 months before screening.\n* NYHA Class III\u002FIV heart failure at screening.\n* History of malignancy or lymphoproliferative disorders within 5 years (exceptions: basal cell carcinoma, localized squamous cell carcinoma, or cervical carcinoma in situ cured ≥1 year).\n* Prosthetic joint infection (unless prosthesis removed\u002Freplaced ≥2 months before randomization).\n* History of opportunistic infections (e.g., PJP, histoplasmosis, coccidioidomycosis).\n* Active\u002Flatent TB infection (positive IGRA without clinical manifestations).\n* Herpes infection:a) Active herpes zoster\u002Fsimplex (HSV-1\u002F2) at screening;b) History of severe herpes (disseminated disease, multidermatomal HSV, encephalitis, ophthalmic herpes, or recurrent zoster \\[≥2 episodes in 2 years\\]).\n* History of severe bacterial, fungal, or viral infection requiring hospitalization for IV antibiotic or antiviral administration within 2 months before randomization.\n* History of live vaccine administration within 2 months before randomization or plans to receive a live vaccine during the study period.\n* Evidence of active infection and\u002For febrile illness requiring systemic anti-infective therapy within 2 weeks before randomization.\n* Abnormal virology at screening:\n\n  * HBsAg(+) or HBcAb(+) with detectable HBV-DNA\n  * HCV Ab(+) with detectable HCV-RNA\n  * History of HIV infection or HIV Ab(+)\n  * Treponema pallidum Ab(+) with positive RPR\u002FTRUST\n* Prior use of TYK2 inhibitors (e.g., deucravacitinib).\n* Use of any of the following therapeutic agents within 6 months before randomization:\n\n  * IL-12\u002F23, IL-17, or IL-23 inhibitors (ustekinumab, secukinumab, tildrakizumab, ixekizumab, guselkumab)\n  * Rituximab or other B-cell depleting agents\n  * Leflunomide\n* Use of any of the following therapeutic agents within 3 months before randomization: Integrin pathway modulators (natalizumab) or B\u002FT-cell modulators (alemtuzumab, abatacept, vedolizumab).\n* Use of TNF inhibitors (etanercept, adalimumab, infliximab, certolizumab) within 2 months before randomization.\n* Any biologic psoriasis therapy within 3 months or 5 half-lives (whichever longer) before randomization.\n* Use of systemic non-biologic psoriasis agents and\u002For any systemic immunosuppressants within 4 weeks before randomization, including but not limited to: apremilast, methotrexate, azathioprine, cyclosporine, JAK inhibitors, 6-thioguanine, mercaptopurine, mycophenolate, hydroxyurea, tacrolimus, oral\u002Finjectable corticosteroids, retinoids, calcitriol\u002Fanalogs, psoralen, sulfasalazine, fumarates).\n* Use of Lithium, antimalarials, or intramuscular gold preparations within 4 weeks before randomization.\n* Use of any botanical agents for the treatment of psoriasis or other immune disorders within 4 weeks before randomization, including herbal supplements or traditional Chinese medicines derived from plants, minerals, or animals.\n* Received phototherapy within 4 weeks before randomization.\n* Use of medicated shampoos and\u002For body washes within 2 weeks before randomization, including but not limited to products containing: corticosteroids, coal tar, \\>3% salicylic acid, vitamin D3 analogs.\n* Use of any topical agents that may affect psoriasis symptoms within 2 weeks before randomization.\n* Received any investigational therapy within 30 days or 5 half-lives (whichever is longer) before randomization, OR current participation in other trial.\n* Laboratory values meeting any of the following criteria during screening or before randomization:\n\n  * Liver: ALT\u002FAST ≥3×ULN; total bilirubin \\>2×ULN\n  * Hematology: WBC \\\u003C3.0×10⁹\u002FL (3000\u002Fmm³); ANC \\\u003C1.0×10⁹\u002FL (1000\u002Fmm³); lymphocyte count \\\u003C0.5×10⁹\u002FL (500\u002Fmm³); platelets \\\u003C100×10⁹\u002FL (100,000\u002Fmm³); hemoglobin \\\u003C9.0 g\u002FdL (90 g\u002FL)\n  * Renal: eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² (CKD-EPI equation)\n* Pregnant or lactating women.\n* Any condition deemed unsuitable by the investigator.",{"count":491,"type":21},220,[471,24],"\" This study consists of two parts: Part 1 (Dose Escalation): A randomized, double-blind, placebo-controlled phase in which approximately 20 to 30 adult patients with plaque psoriasis will receive the investigational treatment for 4 weeks.\n\nPart 2 (Efficacy and Safety Assessment): A randomized, double-blind, placebo-controlled evaluation where approximately 200 adult patients with plaque psoriasis will undergo 12 weeks of treatment.\n\nThe resulting data will provide preliminary evidence on the safety and efficacy profile of CS32582, informing its subsequent development strategy.",[27],"2025-09-08",{"date":497,"type":37},"2025-09-10",{"date":495,"type":37},{"date":500,"type":21},"2027-09-18",{"name":502,"class":44},"Chipscreen Biosciences, Ltd.",11,{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":22,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":348,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":4},"100605111","phase-2-a-phase-2-study-of-hsk47388-tablets-to-evaluate-the-efficacy-and-safety-in-patients-with-moderate-to-severe-plaque-psoriasis-100605111","NCT07158268","A Phase 2 Study of HSK47388 Tablets to Evaluate the Efficacy and Safety in Patients With Moderate-to-Severe Plaque Psoriasis","A Phase 2 Multicenter, Randomized, Double-blind and Two-Stage Study to Evaluate the Efficacy and Safety of HSK47388 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis","Inclusion Criteria:\n\n1. Confirmed diagnosis of plaque psoriasis with a disease duration of at least 26 weeks before the first administration of the study intervention\n2. Total Body Surface Area (BSA) involvement ≥ 10% at both screening and baseline visits\n3. Psoriasis Area and Severity Index (PASI) total score ≥ 12 at both screening and baseline visits\n4. Investigator Global Assessment (IGA) for plaque psoriasis total score ≥ 3 (moderate or severe disease) at both screening and baseline visits\n5. Participants deemed appropriate candidates for systemic therapy for plaque psoriasis\n\nExclusion Criteria:\n\n1. Non-plaque psoriasis (e.g., erythrodermic, guttate, or pustular psoriasis)\n2. Current drug-induced psoriasis\n3. Current diagnosis, signs, or symptoms of severe, progressive, or uncontrolled disease involving the renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic systems\n4. Known allergy, hypersensitivity, or intolerance to HSK47388。\n5. A history of malignant tumor before screening;\n6. Subjects deemed unsuitable for participation due to other factors as determined by the investigator",{"count":491,"type":21},[24],"The primary objective of this study is to evaluate the efficacy of multiple-dose HSK47388 versus placebo in participants with moderate-to-severe plaque psoriasis.",[27],"2025-08-28",{"date":517,"type":37},"2025-09-05",{"date":519,"type":21},"2025-09-01",{"date":521,"type":21},"2027-01-17",{"name":523,"class":44},"Haisco Pharmaceutical Group Co., Ltd.",{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":22,"phases":533,"briefSummary":534,"conditions":535,"keywords":4,"overallStatus":348,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":540,"leadSponsor":542,"locationsCount":4},"100601689","new-topical-treatment-in-plaque-psoriasis-100601689","NCT07113756","New Topical Treatment in Plaque Psoriasis","Efficacy of Topical Metformin 30% Cream Versus Betamethasone Valerate 0.1% Cream in Treatment of Adult Patients With Plaque Psoriasis","* Inclusion Criteria:\n\n  * Patients of both sexes aged ≥ 18 years, having clinical and dermoscopic finding of mild and moderate plaque psoriasis and did not receive any topical, phototherapy or systemic treatment in the last 3 months for psoriasis.\n* Exclusion Criteria:\n\n  * Other types of psoriasis\n  * Patient refusal.\n  * Pregnant and lactating women.\n  * Patients with other inflammatory or autoimmune skin diseases (atopic dermatitis, lichen planus, alopecia areata, cutaneous lupus erythromatosis, systemic sclerosis, rheumatoid arthritis, acne vulgaris, hidradinitis supprativa\n  * Hypersensitivity to topical treatment.",{"count":532,"type":21},70,[235],"Psoriasis is a chronic, recurring, immune-mediated papulosquamous condition The etiology of psoriasis is complex and not fully understood Though many treatment options are available for plaque psoriasis, each has its limitations and side effects. Therefore, the need for an effective topical agent that delivers the drug efficiently into the target site with minimal systemic side effects remains an aim in itself.Metformin is a derivative of biguanide that is the most widely used as an oral antihyperglycemic agent for the control of diabetes mellitus. In addition to its hypoglycaemic effect, metformin can serve as an anti-inflammatory agent. Metformin has been demonstrated to suppress proliferation in keratinocytes by blocking the mitogen-activated protein kinase pathway (MAPK) (25). Hence, metformin may play an important role in the reducing pathogenesis of psoriasis by anti-inflammatory, anti-proliferative, and anti- angiogenic effects .The topical form of metformin has been used in regenerative medicine (33), treatment of acne (34), adjuvant treatment for psoriasis (35), neo-adjuvant therapy for squamous cell carcinoma (36), and treatment of pigmentary disorders as an alternative to hydroquinone (37). The aim of the study is to:\n\n* Assess the efficacy and the safety of topical metformin 30% cream compared with betamethasone valerate 0.1 % cream in the treatment of adult patients with mild and moderate plaque psoriasis.\n* Compare the efficacy of topical metformin 30% cream versus betamethasone valerate 0.1 % cream clinically, dermoscopically, histopathologically and immunohistochemically by measuring tissue level of IL17 in psoriatic skin lesions before and after treatment in all patients.",[27],"2025-08-02",{"date":538,"type":37},"2025-08-11",{"date":519,"type":21},{"date":541,"type":21},"2026-09-01",{"name":543,"class":323},"Sohag University",{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":231,"sex":17,"minAge":18,"maxAge":551,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":557,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":565,"locationsCount":222},"100594834","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-pharmacodynamics-and-efficacy-of-asc50-tables-in-healthy-participants-and-participants-with-plaque-psoriasis-100594834","NCT07024602","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 Tables in Healthy Participants and Participants With Plaque Psoriasis","A Phase I, Randomized, Double-blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of ASC50 Tablets in Healthy Adult Participants and Adult Participants With Mild to Moderate Plaque Psoriasis","Inclusion Criteria:\n\n1. Male and female participants between 18 to 65 years of age inclusive, at the time of screening.\n2. Willing and able to give informed consent prior to any study specific procedures being performed.\n3. Have venous access sufficient to allow for blood sampling\n\nExclusion Criteria:\n\n1. Female participants who are pregnant, breastfeeding or plan to be pregnant during the study period and 3 months after last dose.\n2. History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety during the clinical study or expose the subject to undue risk as judged by the Investigator.\n3. Have received systemic immunosuppressive therapy (MTX, apremilast, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of first administration of study drug.\n4. Have any other conditions, which, in the opinion of the investigator or sponsor, would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.","65 Years",{"count":553,"type":21},94,[471],"This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, food effect of ASC50 tablets in healthy adult participants and adult participants with mild to moderate plaque psoriasis.",[27],[558,27],"ASC50","2025-06-09",{"date":561,"type":37},"2025-06-17",{"date":563,"type":21},"2025-06",{"date":352,"type":21},{"name":566,"class":44},"Ascletis Pharma (China) Co., Limited",{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":573,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":577,"conditions":578,"keywords":580,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":222},"100592717","rollyn-ust-an-observational-study-in-patients-treated-by-steqeyma-an-ustekinumab-biosimilar-100592717","NCT06997055","ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar","ROLL'YN-UST: Etude Observationnelle de Cohorte Pour la Prise en Charge Des Patients Atteints de Pathologies Inflammatoires Chroniques traités Par Steqeyma®, un Biosimilaire de l'ustékinumab","ROLL'YN-UST","Inclusion Criteria:\n\n* Be an adult (18 years of age or older at the time of inclusion) followed in specialty care and diagnosed with of one of the following conditions: Crohn's disease, Plaque psoriasis\n* Treated for at least 6 months prior to inclusion with the reference Ustekinumab for the pathology in question: Crohn's disease, Plaque psoriasis\n* Stable for at least 3 months according to the prescribing physician and in clinical remission according to the specific disease activity score.\n* For whom the specialist has decided to switch to the biosimilar treatment developed and marketed by Celltrion on the day of inclusion (shared medical decision independent of the study)\n* Have an email address.\n* Have a mobile phone number.\n* Be able to understand and complete questionnaires in French.\n* Not opposed to participating in the study.\n* Be affiliated to a French Social Security scheme or be a beneficiary of such a scheme.\n\nExclusion Criteria:\n\n* Patients under guardianship or otherwise deprived of their freedom.\n* Pregnant women or women of childbearing potential who wish to become pregnant while taking one of the study treatments.\n* Patients participating at the time of inclusion in a clinical trial or other clinical study that prohibits simultaneous participation in other studies.\n* Contraindication to study products.",{"count":576,"type":21},225,"ROLL'YN-UST is a real-life study, which includes patients in clinical remission for at least 3 months and who have been treated with a reference biotherapy for at least 6 months, and for whom the physician has decided, independently of the study and as part of a shared medical decision, to switch them to STEQEYMA®. The main aim of this study is to the maintenance of clinical remission 12 months after initiation of a biosimilar as well as patient satisfaction 6 and 12 months after initiation of a biosimilar.",[579,27],"Crohn Disease",[581,582],"Biosimilar","ustekinumab","2025-05-21",{"date":585,"type":37},"2025-05-30",{"date":587,"type":37},"2025-03-17",{"date":589,"type":21},"2027-12-31",{"name":591,"class":44},"Celltrion HealthCare France",{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":17,"minAge":599,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":22,"phases":602,"briefSummary":603,"conditions":604,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":275},"100565945","phase-3-efficacy-and-safety-of-roflumilast-cream-03-in-subjects-with-plaque-psoriasis-a-phase-3-study-100565945","NCT06648772","Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study","A Multicenter, Randomized, Double-blind, Vehicle-controlled Phase 3 Clinical Study To Evaluate The Efficacy and Safety Of Roflumilast Cream 0.3% (Zoryve®) in the Treatment of Plaque Psoriasis In China","Inclusion Criteria:\n\n1. Fully understand the objectives and requirements of this study, voluntarily participate in the clinical trial and sign the informed consent form (ICF), and be able to complete all visits as required by the protocol.\n2. Aged ≥ 6 years at the time of signing the ICF, male or female.\n3. Clinical diagnosis of plaque psoriasis before the first dose in this study, with a disease duration of ≥ 6 months (for those aged ≥ 12 years) or ≥ 3 months (for those aged 6-11 years) and stable for the last 4 weeks.\n4. Patients are required to meet the following requirements at screening and baseline:\n\n   * Psoriasis involving 2%-20% BSA (excluding the scalp, palms, and soles);\n   * IGA score of ≥ 2 points;\n   * PASI score of ≥ 2 points (excluding the scalp, palms, and soles).\n5. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline. FOCBP must agree to take at least one reliable form of birth control, including oral\u002Fimplantable\u002Finjectable\u002Ftransdermal contraceptive, intrauterine device, bilateral tubal ligation\u002Focclusion, partner's vasectomy, and barrier contraception (used correctly throughout sexual intercourse), from 4 weeks before the first dose of the IMP until 2 months after the last dose. If the subject is routinely abstinent, the subject may use this form of contraception, but should choose a reliable form of contraception as mentioned above if the subject is no longer abstinent. Male subjects will be required to have no plans to have children, no plans to donate sperm, and agree to use highly effective contraception. from the first dose of the investigational medicinal product until 4 months after the last dose.\n\n   Note: FOCBP are defined as female subjects who have experienced menarche, have not reached a postmenopausal state (amenorrhea for at least 12 consecutive months, with no clear cause other than menopause and confirmd by FSH), and have no surgical (i.e., bilateral oophorectomy and\u002For bilateral salpingectomy and\u002For hysterectomy) or investigator-determined causes of permanent infertility (e.g., mullerian agenesis, etc.).\n6. Subjects were assessed by the investigator to be free of other medical conditions that would interfere with the assessment of safety and efficacy based on medical history, physical examination, routine blood, blood biochemistry, urine, and other laboratory tests.\n\nExclusion Criteria:\n\n1. Non-plaque psoriasis (e.g., guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, and arthropathic psoriasis) or drug-induced psoriasis.\n2. Skin disorders or other conditions that, in the judgment of the investigator, may interfere with the assessment of endpoints relevant to this study, including but not limited to: viral lesions, fungal and bacterial skin infections, parasitic infections, syphilis or tuberculosis-related skin manifestations, etc.\n3. Prior use of etanercept within 4 weeks before the first dose of this study, or use of adalimumab and\u002For infliximab within 8 weeks before the first dose of this study, or prior use of another biologic within 12 weeks before the first dose of this study (or within 5 half-lives of the biologic at the time of the first dose of this study, whichever is longer).\n4. Prior use of systemic drugs for psoriasis treatment or any other agents which may impact efficacy assessment of psoriasis, including but not limited to oral or intravenous glucocorticoids, retinoic acids, methotrexate, cyclosporine, and other systemic immunosuppressive agents or a class of drugs (including Chinese herbal formulas, herbs, proprietary Chinese medicines, etc.) containing Chinese medicinal ingredients within 4 weeks of the first dose of this study.\n5. Prior use of topical agents for psoriasis treatment or any other agents which may impact efficacy assessment of psoriasis, including but not limited to topical glucocorticoids, vitamin D analogues, benvitimod and prescription emollients or emollients containing additives (e.g., ceramides, hyaluronic acid, urea, or filamentous proteolytic products) or antipruritic ingredients (e.g., menthol, polyhydroxyethanol, pramoxine, lidocaine, prilocaine, capsaicin, naltrexone, N-palmitoylethanolamine, etc.) or a class of drugs (including Chinese herbal formulas, herbs, proprietary Chinese medicines, etc.) containing Chinese medicinal ingredients for topical use (Note: for the treatment of diseases other than psoriasis, except in cases where the use of such medicines is deemed necessary in the medical judgment of the investigator and\u002For the specialist and would not interfere with the assessment of the study), etc. within 2 weeks.\n6. Prior use of psoralen plus ultraviolet A (PUVA) or ultraviolet B (UVB) phototherapy within 4 weeks before the first dose of this study.\n7. Prior use of ZORYVE® cream or foam; prior use of oral roflumilast or other phosphodiesterase-4 (PDE4) inhibitors (apremilast, etc.) within 4 weeks prior to the first dose of this study.\n8. Prior use of antihistamines, potent cytochrome P (CYP) 450 enzyme inhibitors (such as indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir and telithromycin) or inducers (such as efavirenz, barbiturates, phenytoin sodium, and rifampicin) within 2 weeks before the first dose of this study or these drugs cannot be discontinued during the study.\n9. Prior use of lithium-containing agents or antimalarials within 4 weeks (or 5 half-lives, whichever is longer) prior to the first dose of this study..\n10. Subjects who are expected to have excessive exposure to natural\u002Fartificial light, sunbeds, or other light-emitting diode (LED) irradiation at the treatment area during the treatment period of this study.\n11. Planned initiation or change in the use of an existing medication (e.g., beta-blockers or angiotensin-converting enzyme inhibitors) that, in the opinion of the investigator, can affect the efficacy evaluation for psoriasis.\n12. Known hypersensitivity to roflumilast or any of the excipients of the product (white vaseline, isopropyl palmitate, hydroxybenzyl ester, propyl hydroxybenzoate, diethyleneglycol monoethyl ether, hexanediol, hydrochloric acid dilute, sodium hydroxide, Crodafos CES \\[including cetearyl alcohol, cetyl phosphate, and ceteareth-10 phosphate\\]).\n13. Previous or suspected human immunodeficiency virus (HIV) infection, or HIV antibody-positive at screening; or hepatitis B (hepatitis B virus surface antigen \\[HBsAg\\])-positive or HBsAg-negative but hepatitis B virus core antibody (HBcAb)-positive, in which case DNA quantitation should be detected and the result is higher than the upper limit of normal; or hepatitis C (hepatitis C virus \\[HCV\\]) antibody-positive with HCV-RNA quantification above the upper limit of normal value; or syphilis screening-positive (except for patients with a positive specific antibody test, a negative non-specific antibody test, and confirmed as inactive infection in combination with clinical judgment).\n14. As judged by the investigator, with known or suspected:\n\n    * Moderate to severe hepatic impairment (Child-Pugh B\u002FC) at screening. See Appendix 16.7 for Child-Pugh grading criteria\n    * Total bilirubin and or AST and or ALT \\> 1.5 x ULN at screening\n    * SCr \\> 1.5 x ULN at screening\n    * History of major depressive disorder, suicidality, or suicidal tendency suggested by the C-SSRS at baseline or screening.\n15. PHQ-8 (adults) or modified PHQ-A (aged 12-17 years) ≥ 10 points, for children aged 6-11 years, investigators assessed the presence or risk of depression after communicating with their parents\u002Fguardians at baseline or screening.\n16. Female subjects in the lactating period; or subjects who have a fertility plan during the study.\n17. Alcohol (defined as \\>2 units of alcohol per day\u002F\\>14 units of alcohol per week, with 1 unit of alcohol equivalent to 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) or drug abuse within 6 months before screening in this study.\n18. Have undergone a major surgery within 4 weeks prior to the first dose of this study (for the definition of major surgery, refer to Level 3 and Level 4 surgeries specified in the \"Measures for the Classification of Surgical Procedures in Medical Institutions\" issued by the National Health Commission of the People's Republic of China on Dec. 6, 2022) or plan to undergo a major surgery during the study.\n19. Cancer (except for non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, stage I uterine cancer, cervical carcinoma in situ, or breast carcinoma in situ that have been treated with curative therapy) within 5 years before the first dose of this study.\n20. Prior active infection requiring the use of oral or intravenous antibiotics, antifungal or antiviral agents within 7 days before the first dose of this study.\n21. Any serious disease or medical measure, physical or mental condition that, in the opinion of the investigator, will affect the subject's participation in the trial (including the use of IMP and participation in required study visits), or that, in the opinion of the investigator, will pose a significant risk or effect to the subject.\n22. Family members involving staff from the clinical research organization, contract research organization (CRO, if applicable), or sponsor participated in the design or conduct of this study, or a family member has already been enrolled in this study.\n23. Currently participating in any other interventional clinical trials; or participation in a pharmaceutical clinical trial within 3 months or 5 half-lives (whichever is longer) or any other interventional clinical trial within 3 months prior to the first dose of this study.\n24. Other reasons judged by the investigator as inappropriate for enrollment in this study.","6 Years",{"count":601,"type":21},189,[107],"This study is a multi-center, randomized, double-blind, vehicle-controlled phase III study to evaluate the efficacy, safety, and PK profile of roflumilast cream 0.3% in Chinese subjects ≥6 years of age with plaque psoriasis.",[27],"2025-05-15",{"date":607,"type":37},"2025-05-16",{"date":609,"type":37},"2024-11-14",{"date":611,"type":21},"2025-07-04",{"name":613,"class":44},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd."]