[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561247":3},{"organization":4,"outcomesModule":7,"designInfo":93,"detailedDescription":104,"studyPopulation":92,"armGroups":105,"interventions":118,"overallOfficials":131,"centralContacts":191,"locations":200,"responsibleParty":218,"collaborators":92,"id":220,"slug":92,"hasResults":221,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":92,"eligibilityCriteria":225,"healthyVolunteers":221,"sex":226,"minAge":227,"maxAge":228,"enrollmentInfo":229,"targetDuration":92,"studyType":232,"phases":233,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":203,"whyStopped":92,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":252},{"fullName":5,"class":6},"Prime Gene Therapeutics Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":92},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of participants who achieved Eczema Area and Severity Index (EASI 75) at Week 8","Defined as ≥ 75% improvement in Eczema Area and Severity Index score. The EASI score ranges from 0 to 72, higher score indicates greater severity.","8-week",[14,17,21,24,28,31,33,36,39,42,45,47,50,52,55,58,61,63,66,68,71,73,76,78,80,83,86,89],{"measure":15,"description":16,"timeFrame":12},"Key Secondary Outcome: Investigators Global Assessment (IGA) score of 0\u002F1 at Week 8","Proportion of participants achieving Investigators Global Assessment (IGA) score of clear (0) or almost clear (1) with at least a 2-point decrease from baseline at Week 8.",{"measure":18,"description":19,"timeFrame":20},"Proportion change of eczema area and severity index (EASI) at each scheduled visit","Proportion change in the eczema area and severity index (EASI) total score from baseline at each scheduled visit. The EASI score ranges from 0 to 72, higher score indicates greater severity.","Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52",{"measure":22,"description":23,"timeFrame":20},"Change of eczema area and severity index (EASI) score at each scheduled visit","Value change in the eczema area and severity index (EASI) total score from baseline at each scheduled visit. The EASI score ranges from 0 to 72, higher score indicates greater severity.",{"measure":25,"description":26,"timeFrame":27},"Change from baseline of Itch Numeric Rating Scale (NRS) at each scheduled visit","The Itch NRS is an assessment tool that participants used to report the intensity of their itch during a 24-hour recall period. The NRS score ranges from 0 to 10 points, higher score indicates greater intensity.","Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52",{"measure":29,"description":30,"timeFrame":27},"Proportion change from baseline of Child Dermatology Life Quality Index (CDLQI) score at each scheduled visit","Child Dermatology Life Quality Index (CDLQI) are designed to measure the impact of any skin disease on the lives of children. The CDLQI score ranges from 0 to 30 points, higher score indicates greater severity.",{"measure":32,"description":30,"timeFrame":27},"Change from baseline of Child Dermatology Life Quality Index (CDLQI) score at each scheduled visit",{"measure":34,"description":35,"timeFrame":27},"Change from baseline of the Patient-oriented eczama Measure (POEM) score at each scheduled visit.","The Patient-oriented eczama Measure (POEM) is a comprehensive assessment of the patient own assessment of clinical symptoms in the past week. The POEM score ranges from 0 to 28 points, higher score indicate greater severity.",{"measure":37,"description":38,"timeFrame":27},"Proportion change from baseline of affected body surface area (BSA) at each scheduled visit","Total body surface area(BSA) is 100%, and the proportion of affected body surface area(BSA) is ranged from 0 to100%, higher value indicates greater severity.",{"measure":40,"description":41,"timeFrame":27},"Proportion change from baseline of the Patient-oriented Eczama Measure (POEM) score at each scheduled visit.","The Patient-oriented Eczama Measure (POEM) is a comprehensive assessment of the patient own assessment of clinical symptoms in the past week. The POEM score ranges from 0 to 28 points, higher score indicate greater severity.",{"measure":43,"description":44,"timeFrame":27},"Proportion change from baseline in Scoring Atopic Dermatitis (SCORAD) score at each scheduled visit.","Scoring Atopic Dermatitis(SCORAD) is a tool to assess the extent and severity of eczema and will be completed before, during, and after treatment has begun to determine whether the treatment has been effective. The SCORAD score ranges from 0 to 103, and higher score indicates greater severity.",{"measure":46,"description":44,"timeFrame":27},"Change from baseline in Scoring Atopic Dermatitis (SCORAD) score at each scheduled visit.",{"measure":48,"description":49,"timeFrame":27},"Change from baseline of Dermatology Life Quality Index (DLQI) score at each scheduled visit.","Dermatology Life Quality Index (DLQI) is designed to measure the impact of any skin disease on the lives of adults.The DLQI score ranges from 0 to 30 points, higher score indicates greater severity.",{"measure":51,"description":49,"timeFrame":27},"Proportion change from baseline of Dermatology Life Quality Index (DLQI) score at each scheduled visit.",{"measure":53,"description":54,"timeFrame":27},"The average time of the sites achieving Investigators Global Assessment(IGA) 0\u002F1 from baseline","Average time to achieve Investigators Global Assessment (IGA) score of clear (0) or almost clear (1) by using PG-011gel or a placebo. The IGA score ranges from 0 to 4 points, higher score indicates greater severity.",{"measure":56,"description":57,"timeFrame":27},"The average time of the sites achieving Investigators Global Assessment (IGA) 0\u002F1 with at least a 2-point decrease from baseline","Average time to achieve Investigators Global Assessment (IGA) score of clear (0) or almost clear (1) with at least a 2-point decrease from baseline by using PG-011gel or a placebo. The IGA score ranges from 0 to 4 points, higher score indicates greater severity.",{"measure":59,"description":60,"timeFrame":20},"Proportion of achieving Investigators Global Assessment (IGA) 0\u002F1 at each scheduled visit","The IGA score ranges from 0 to 4 points, higher score indicates greater severity.",{"measure":62,"description":60,"timeFrame":20},"Proportion of achieving Investigators Global Assessment (IGA) 0\u002F1 with at least a 2-point decrease from baseline at each scheduled visit",{"measure":64,"description":65,"timeFrame":27},"The average time of achieving Investigators Global Assessment (IGA) 0\u002F1 at the atopic dermatitis (AD) target site","The target site is a representative site of atopic dermatitis skin lesions selected by the investigator. The Investigators Global Assessment (IGA) score ranges from 0 to 4 points, higher score indicates greater severity. The IGA score 0 means clear and IGA score 1 means almost clear.",{"measure":67,"description":65,"timeFrame":20},"The average time of achieving Investigators Global Assessment (IGA) 0\u002F1 with at least a 2-point decrease from baseline at the atopic dermatitis (AD) target site",{"measure":69,"description":70,"timeFrame":27},"Proportion of participants achieving at least a 3-point decrease of Itch Numeric Rating Scale (NRS) from baseline at each scheduled visit","The Itch NRS is an assessment tool that participants used to report the intensity of their itch during a 24-hour recall period. The Itch Numeric Rating Scale(NRS) score ranges from 0 to 10 points, higher score indicates greater intensity.",{"measure":72,"description":70,"timeFrame":20},"Proportion of participants achieving at least a 4-point decrease of Itch Numeric Rating Scale (NRS) from baseline at each scheduled visit",{"measure":74,"description":75,"timeFrame":27},"Change from baseline of affected Body Surface Area (BSA) at each scheduled visit","Total Body Surface Area(BSA) is 100%, and the proportion of affected BSA is ranged from 0 to100%, higher value indicates greater severity.",{"measure":77,"description":65,"timeFrame":27},"Proportion of achieving Investigators Global Assessment (IGA) 0\u002F1 in Atopic Dermatitis (AD) target site at each scheduled visit",{"measure":79,"description":65,"timeFrame":20},"Proportion of Investigators Global Assessment (IGA) 0\u002F1 with at least a 2-point decrease from baseline in Atopic Dermatitis (AD) target site at each scheduled visit",{"measure":81,"description":82,"timeFrame":20},"Proportion of participants achieving Eczema Area and Severity Index(EASI) 50 at each scheduled visit","Defined as at least 50% improvement from baseline in Eczema Area and Severity Index(EASI) score at each scheduled visit.The EASI score ranges from 0 to 72, higher score indicates greater severity.",{"measure":84,"description":85,"timeFrame":20},"Proportion of participants achieving Eczema Area and Severity Index(EASI) 75 at each scheduled visit","Defined as at least 75% improvement from baseline in Eczema Area and Severity Index(EASI) score at each scheduled visit. The EASI score ranges from 0 to 72, higher score indicates greater severity.",{"measure":87,"description":88,"timeFrame":20},"Proportion of participants achieving Eczema Area and Severity Index(EASI) 90 at each scheduled visit","Defined as at least 90% improvement from baseline in Eczema Area and Severity Index(EASI) score at each scheduled visit.The EASI score ranges from 0 to 72, higher score indicates greater severity.",{"measure":90,"description":91,"timeFrame":20},"Proportion of participants achieving Eczema Area and Severity Index(EASI) 100 at each scheduled visit","Defined as at least 100% improvement from baseline in Eczema Area and Severity Index(EASI) score at each scheduled visit.The EASI score ranges from 0 to 72, higher score indicates greater severity.",null,{"allocation":94,"interventionModel":95,"interventionModelDescription":92,"primaryPurpose":96,"observationalModel":92,"timePerspective":92,"maskingInfo":97},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":98,"maskingDescription":92,"whoMasked":99},"QUADRUPLE",[100,101,102,103],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in adolescent and adult participants aged from 12 to 75 years old (including threshold) with mild to moderate Atopic Dermatitis. Approximately 472 participants will be randomized 3:1 to PG-011 gel 3% BID, or placebo gel. In addition, approximately 10% of the overall study population will consist of adolescents. Participants with AD involvement of 3% to 20% BSA and IGA score of 2 to 3 will receive blinded study treatment for 8 weeks followed by an open-label treatment for 44 weeks, at last the safety follow-up for 2 weeks.\n\nThe study is to evaluate the efficacy and long-term safety of PG-011 gel 3% in the treatment of mild to moderate Atopic Dermatitis and the PK characteristics by sparse sampling.",[106,112],{"label":107,"type":108,"description":109,"interventionNames":110},"PG-011Gel 3%","EXPERIMENTAL","Topically administered Pumecitinib Gel 3% to the skin twice daily for 52 or 44 weeks",[111],"Drug: PG-011Gel",{"label":113,"type":114,"description":115,"interventionNames":116},"Vehicle Gel","PLACEBO_COMPARATOR","Topically administered the Vehicle Gel to the skin twice daily for 8 weeks",[117],"Drug: Vehicle",[119,125],{"type":120,"name":121,"description":122,"armGroupLabels":123,"otherNames":124},"DRUG","PG-011Gel","Twice daily for 52 weeks or 44 weeks",[107],[107],{"type":120,"name":126,"description":127,"armGroupLabels":128,"otherNames":129},"Vehicle","Vehicle Gel twice daily for 8 weeks",[113],[130],"placebo",[132,136,140,143,146,149,152,155,158,161,164,167,170,173,176,179,182,185,188],{"name":133,"affiliation":134,"role":135},"Xinghua Gao","First Hospital of China Medical University","STUDY_CHAIR",{"name":137,"affiliation":138,"role":139},"ZhiQiang Xie, Professor","Beijing Hospital","PRINCIPAL_INVESTIGATOR",{"name":141,"affiliation":142,"role":139},"Litao Zhang","Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital",{"name":144,"affiliation":145,"role":139},"Yunsheng Liang","Dermatology Hospital of Southern Medical University",{"name":147,"affiliation":148,"role":139},"Wenli Feng","Second Hospital of Shanxi Medical University",{"name":150,"affiliation":151,"role":139},"Chao Ji","First Affiliated Hospital of Fujian Medical University",{"name":153,"affiliation":154,"role":139},"Aie Xu","Hangzhou Third People's Hospital",{"name":156,"affiliation":157,"role":139},"Bingjiang Lin","First Affiliated Hospital of Ningbo University",{"name":159,"affiliation":160,"role":139},"Lei Cao","Brief Introduction of Wuxi No.2 People's Hospital",{"name":162,"affiliation":163,"role":139},"Rixin Chen","NANYANG FIRST PEOPLE'S HOSPITAL NATIONAL THIRD CLASS A HOSPITAL",{"name":165,"affiliation":166,"role":139},"Liming Wu","Affiliated Hangzhou First People's Hospital， School of Medicine，WestLake University",{"name":168,"affiliation":169,"role":139},"Yanyan Fen","Chengdu Second People's Hospital",{"name":171,"affiliation":172,"role":139},"Yingxia He","GENERTEC LIAOYOUGEM FLOWER HOSPITAL",{"name":174,"affiliation":175,"role":139},"Guoqiang Zhang","The First Hospital of Hebei Medical University",{"name":177,"affiliation":178,"role":139},"Meiying Jiang","Second Affiliated Hospital of Nanchang University",{"name":180,"affiliation":181,"role":139},"Linfeng Li","Beijing Friendship Hospital",{"name":183,"affiliation":184,"role":139},"Wenli Yang","Second Affiliated Hospital of Guangzhou Medical University",{"name":186,"affiliation":187,"role":139},"Zudong Meng","Shiyan Renmin Hospital",{"name":189,"affiliation":190,"role":139},"Kunpeng Bian","Nanyang Central Hospital",[192,197],{"name":193,"role":194,"phone":195,"phoneExt":92,"email":196},"Xinghua Gao, Professor","CONTACT","+86-13940152467","barrygao@hotmail.com",{"name":198,"role":194,"phone":92,"phoneExt":92,"email":199},"Li Zhang, Professor","lizhang_100l@126.com",[201],{"facility":202,"status":203,"city":204,"state":205,"zip":92,"country":206,"countryCode":207,"cosmosGeoPoint":208,"geoPoint":213,"contacts":214},"The First Hospital of China Medical University","RECRUITING","Shenyang","Liaoning","China","CN",{"type":209,"coordinates":210},"Point",[211,212],123.43278,41.79222,{"lat":212,"lon":211},[215],{"name":216,"role":194,"phone":217,"phoneExt":92,"email":196},"Xin Hua GAO","+86 13940152467",{"type":219,"investigatorFullName":92,"investigatorTitle":92,"investigatorAffiliation":92,"oldNameTitle":92,"oldOrganization":92},"SPONSOR","100561247",false,"NCT06587685","A Study to Assess the Efficacy and Safety of PG-011 Gel in Adolescents and Adults With Atopic Dermatitis","A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study to Assess the Efficacy and Safety of PG-011 Gel With 8 Weeks Treatment and Extension Safety Study to 52 Weeks in Adolescents and Adults With Atopic Dermatitis","Inclusion Criteria:\n\n1. 12 years old≤ age ≤ 75 years old (including threshold), male or female.\n2. Participants diagnosed of atopic dermatitis (AD) as defined by the Williams diagnostic criteria.\n3. AD\u002Feczema duration of at least 1 year for adults and 6 months for adolescents.\n4. IGA score of 2 (mild) or 3 (moderate) at the screening day and day 1.\n5. %BSA (excluding the scalp) with AD involvement of at least 10% and up to 20%.\n6. Willingness to avoid pregnancy or fathering children based on the criteria as outlined in the protocol.\n\nExclusion Criteria:\n\n1. Participant has unstable course of AD (spontaneously improving or rapidly deteriorating).\n2. Immunocompromised (e.g. lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).\n3. Any other concomitant skin disorder(e.g. generalized erythroderma, Netherton syndrome, acne, psoriasis, urticaria, pigmentation or extensive scarring）, in the opinion of investigator, may interfere with the evaluation of AD lesions or compromise participant safety.\n4. Participant with chronic or acute infection needs to be treated with systemic antibiotics, antiviral drugs, antiparasitic drugs, anti-antigenic animal drugs or antifungal drugs within 2 weeks before randomization.\n5. Participant with active acute\u002Fchronic bacterial, fungal or viral skin infections (such as herpes simplex, herpes zoster, chickenpox, etc.) before randomization, including but not limited to clinically significant secondary infections of AD or other infections associated with AD lesions.\n6. Participant has human immunodeficiency virus (HIV) infection, active hepatitis C virus (HCV) infection (anti-HCV positive), active hepatitis B virus (HBV) infection (HBV-DNA \\> 2000IU\u002Fml) or Treponema pallidum antibody positive and showing active.\n7. Clinically significant or uncontrolled cardiovascular disease (including but not limited to unstable angina, acute myocardial infarction, heart failure, arrhythmia requiring treatment or uncontrolled hypertension).\n8. Participant has serious diseases or complications of the central nervous system, respiratory system, liver, kidney, gastrointestinal tract, urinary system, endocrine system or immune system, blood system, etc., and in the opinion of the investigator, may affect the judgment of efficacy and safety .\n9. Participant has mental illness such as anxiety disorder, depression, or other conditions that affect the compliance and may interfere with the implementation of clinical research.\n10. Participant has a history of malignant tumors before randomization.\n11. Participant has severe and uncontrolled disease that may affect safety, trial compliance, affect the evaluation of endpoints, and require the use of drugs that are not allowed in the protocol.\n12. Female participant who is lactating or pregnant at the time of screening.\n13. Any situation affects the safety and efficacy evaluation of the study drug judged by investigator.\n14. Any other condition that, in the opinion of the investigator or sponsor, makes the subject unsuitable for participation in the study.","ALL","12 Years","75 Years",{"count":230,"type":231},472,"ESTIMATED","INTERVENTIONAL",[234],"PHASE3","This is a Multicenter, Randomized, Double-blind, Placebo-controlled seamless and adaptive-designed phase IIb\u002FIII study to Assess the Efficacy and Safety of topical use of PG-011 Gel in adolescents and Adults With Atopic Dermatitis. It consists of phase IIb and phase III parts, phase IIb is a dose-ranging part and has been done, and phase III is a pivotal study part which is registered this time.\n\nThe goal of this phase III clinical trial is to learn if PG-011gel works to treat mild to moderate Atopic Dermatitis in adolescents and adults by topical use. It will also learn about the safety of PG-011gel. Investigators will compare PG-011gel to a placebo (a look-alike substance that contains no drug) to see if PG-011gel works to treat mild to moderate Atopic Dermatitis.\n\nParticipants will:\n\n* Use PG-011gel or a placebo twice daily for initial 8 weeks, and followed by using PG-011 gel for all of the participants till 52-week.\n* Visit the clinic at weeks 1, 2, 4 and 8 for checkups and tests, and followed by visiting the clinic every 4 weeks till 52-week.\n* Keep a diary of their symptoms.",[237],"Atopic Dermatitis",[237,239,240,241,242],"PG-011","Pumecitinib","Atopic","Dermatitis","2025-05-19",{"date":245,"type":246},"2025-05-20","ACTUAL",{"date":248,"type":246},"2024-03-15",{"date":250,"type":231},"2026-01-15",{"name":5,"class":6},1]