[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567761":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":70,"studyPopulation":19,"armGroups":71,"interventions":84,"overallOfficials":19,"centralContacts":94,"locations":100,"responsibleParty":113,"collaborators":19,"id":115,"slug":19,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":19,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":19,"enrollmentInfo":123,"targetDuration":19,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":19,"overallStatus":132,"whyStopped":19,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Hansoh BioMedical R&D Company","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":19},[9,13],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients achieving PASI 75 response at Week 16","Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 response is defined as 75% or greater improvement in PASI score from baseline.","Baseline to Week 16",{"measure":14,"description":15,"timeFrame":12},"Proportion of patients achieving sPGA 0\u002F1 with at least 2 points improvement from baseline at Week 16","Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means \"clear\" or \"almost clear\" respectively.",[17,21,24,27,30,33,35,38,41,43,46,49,52,55,58],{"measure":18,"description":19,"timeFrame":20},"Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation",null,"Baseline to Week 56",{"measure":22,"description":23,"timeFrame":20},"Number of participants with clinical laboratory abnormalities","Clinical laboratory tests include hematology, coagulation testing, blood chemistry, urinalysis, stool analysis, high-sensitivity C-reactive protein, etc.",{"measure":25,"description":26,"timeFrame":20},"Incidence of clinically significant changes in electrocardiogram (ECG)","ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.",{"measure":28,"description":29,"timeFrame":20},"Number of participants with abnormalities of physical examination","Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.",{"measure":31,"description":32,"timeFrame":20},"Number of participants with abnormalities of vital signs","Vital signs measured include blood pressure, pulse rate, and temperature.",{"measure":34,"description":11,"timeFrame":20},"PASI 75 response rates at specified time points",{"measure":36,"description":37,"timeFrame":20},"PASI 90 response rates at specified time points","Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 response is defined as 90% or greater improvement in PASI score from baseline.",{"measure":39,"description":40,"timeFrame":20},"PASI 100 response rates at specified time points","Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 response is defined as 100% improvement in PASI score from baseline.",{"measure":42,"description":15,"timeFrame":20},"Proportion of patients with sPGA 0\u002F1 at specified time points",{"measure":44,"description":45,"timeFrame":20},"Proportion of patients with sPGA 0 at specified time points","Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 means \"clear\".",{"measure":47,"description":48,"timeFrame":20},"Proportion of patients achieving PSSD symptom score of 0 at specified time points among patients with a baseline symptom score ≥1","Psoriasis symptoms and signs diary (PSSD) is an 11-item patient-reported instrument. It assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 subject-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding). The severity of each item is rated from 0 (absent) to 10 (worst imaginable). Two subscores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.",{"measure":50,"description":51,"timeFrame":20},"Proportion of patients achieving DLQI 0\u002F1 at specified time points among patients with a baseline DLQI score ≥2","The dermatology life quality index (DLQI) is a patient reported outcome measurement. It's a questionnaire consisting of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. Each question is scored on a scale of 0 to 3, and the sum of each scores range from 0 (no impairment of life quality) to 30 (maximum impairment).",{"measure":53,"description":54,"timeFrame":12},"Proportion of patients achieving ss-PGA 0\u002F1 at Week 16 among patients with a baseline ss-PGA score ≥3","Scalp specific physician's global assessment (sPGA) of psoriasis is an assessment of the disease severity of scalp psoriasis based on erythema, thickness, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means \"absence of disease\" or \"very mild disease\" respectively.",{"measure":56,"description":57,"timeFrame":12},"Proportion of patients achieving PGA-F 0\u002F1 at Week 16 among patients with a baseline PGA-F score ≥3","Physician's global assessment of fingernails (PGA-F) is a scale used to assess a patient's fingernail psoriasis. Ten fingernails on the hand will be globally evaluated separately for nail bed and nail matrix disease on a scale of 0 to 4. The overall global assessment of nails is the worse of the nail bed and nail matrix assessment. A PGA-F score of 0 or 1 means \"clear\" or \"minimal\" respectively.",{"measure":59,"description":60,"timeFrame":12},"Proportion of patients achieving pp-PGA 0\u002F1 at Week 16 among patients with a baseline pp-PGA score ≥3","Palmoplantar PGA (pp-PGA) is a scale performed by investigators to assess a patient's palmoplantar psoriasis lesions on a scale of 0 to 4. A pp-PGA score of 0 or 1 means \"clear\" or \"almost clear\" respectively.",{"allocation":62,"interventionModel":63,"interventionModelDescription":19,"primaryPurpose":64,"observationalModel":19,"timePerspective":19,"maskingInfo":65},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":66,"maskingDescription":19,"whoMasked":67},"DOUBLE",[68,69],"PARTICIPANT","INVESTIGATOR","This is a 52-week, multi-center, randomized, double-blind, placebo-controlled, Phase 3 study. The study duration includes a 4-week screening period, a 16-week placebo-controlled treatment period, a 36-week study drug treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:1 ratio to receive HS-10374 or placebo QD. At Week 16, subjects receiving placebo will be switched to HS-10374 QD.",[72,78],{"label":73,"type":74,"description":75,"interventionNames":76},"HS-10374","EXPERIMENTAL","Subjects will receive HS-10374 from Week 0 through Week 52.",[77],"Drug: HS-10374 6mg tablets",{"label":79,"type":80,"description":81,"interventionNames":82},"Placebo","PLACEBO_COMPARATOR","Subjects will receive HS-10374 matching placebo from Week 0 through Week 16, and HS-10374 from Week 16 through Week 52.",[77,83],"Drug: HS-10374-matched placebo tablets",[85,90],{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":19},"DRUG","HS-10374 6mg tablets","Specified dose of HS-10374 tablets administered orally QD on specified days",[73,79],{"type":86,"name":91,"description":92,"armGroupLabels":93,"otherNames":19},"HS-10374-matched placebo tablets","Specified dose of HS-10374-matched placebo tablets administered orally QD on specified days",[79],[95],{"name":96,"role":97,"phone":98,"phoneExt":19,"email":99},"Jinhua Xu, MD","CONTACT","(+86)13818978539","xjhhsyy@163.com",[101],{"facility":102,"status":19,"city":103,"state":104,"zip":19,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":19},"Huashan Hospital affiliated to Fudan University","Shanghai","Shanghai Municipality","China","CN",{"type":108,"coordinates":109},"Point",[110,111],121.45806,31.22222,{"lat":111,"lon":110},{"type":114,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100567761",false,"NCT06672393","A Study to Confirm Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis","A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis","Inclusion Criteria:\n\n* Male or female subjects aged 18 years and older\n* Diagnosis of plaque psoriasis for at least 6 months\n* Eligible for phototherapy or systemic therapy\n* Plaque covering ≥ 10% of BSA\n* PASI ≥ 12, sPGA ≥3\n\nExclusion Criteria:\n\n* Diagnosis of non-plaque psoriasis or drug-induced psoriasis\n* Recent history of infection, history or risk of serious infection\n* Any major illness or evidence of unstable condition of major organ systems including psychiatric disease\n* Any condition possibly affecting the PK process of the study drug\n* Evidence of other skin conditions that would interfere with the evaluation of psoriasis\n* History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis\n* Prior exposure to TYK2 inhibitors\n* Have received the prohibited treatment during the protocol required washout period\n* Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period","ALL","18 Years",{"count":124,"type":125},375,"ESTIMATED","INTERVENTIONAL",[128],"PHASE3","This study has been designed to confirm the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis.",[131],"Psoriasis","NOT_YET_RECRUITING","2024-10-31",{"date":135,"type":136},"2024-11-04","ACTUAL",{"date":135,"type":125},{"date":139,"type":125},"2026-06-29",{"name":5,"class":6},1]