[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593382":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":19,"studyPopulation":19,"armGroups":71,"interventions":88,"overallOfficials":99,"centralContacts":103,"locations":108,"responsibleParty":202,"collaborators":19,"id":204,"slug":205,"hasResults":206,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":19,"eligibilityCriteria":210,"healthyVolunteers":211,"sex":212,"minAge":213,"maxAge":214,"enrollmentInfo":215,"targetDuration":19,"studyType":218,"phases":219,"briefSummary":221,"conditions":222,"keywords":19,"overallStatus":164,"whyStopped":19,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},{"fullName":5,"class":6},"BeOne Medicines","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":37,"otherOutcomes":19},[9,13,17,21,23,25,27,29,31,33,35],{"measure":10,"description":11,"timeFrame":12},"Part A: Number of participants with adverse events (AEs)","Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including findings from laboratory tests and electrocardiogram results.","Up to approximately 4 months",{"measure":14,"description":15,"timeFrame":16},"Part B: Number of participants with adverse events (AEs)","Number of participants with TEAEs and SAEs, including findings from laboratory tests and electrocardiogram results.","Up to approximately 6 weeks",{"measure":18,"description":19,"timeFrame":20},"Part A: Maximum observed plasma concentration (Cmax) of tacabrutideg",null,"Up to approximately 10 weeks",{"measure":22,"description":19,"timeFrame":20},"Part A: Minimum observed plasma concentration (Cmin) of tacabrutideg",{"measure":24,"description":19,"timeFrame":20},"Part A: Time to reach maximum observed plasma concentration (Tmax) of tacabrutideg",{"measure":26,"description":19,"timeFrame":20},"Part A: Apparent terminal elimination half life (t1\u002F2) of tacabrutideg",{"measure":28,"description":19,"timeFrame":20},"Part A: Area under the curve (AUC) of tacabrutideg",{"measure":30,"description":19,"timeFrame":20},"Part A: Apparent oral clearance (CL\u002FF) of tacabrutideg",{"measure":32,"description":19,"timeFrame":20},"Part A: Apparent volume of distribution (Vz\u002FF) of tacabrutideg",{"measure":34,"description":19,"timeFrame":20},"Part A: Accumulation Ratio of AUC for tacabrutideg",{"measure":36,"description":19,"timeFrame":20},"Part A: Accumulation Ratio of Cmax for tacabrutideg",[38,42,45,48,51,54,57,59],{"measure":39,"description":40,"timeFrame":41},"Part A: Change from Baseline in Weekly Urticaria Activity Score (UAS7)","The UAS7 consists of an assessment of both hives and itch severity to provide a measure of disease activity. The UAS7 is the sum of the weekly Hives Severity Score (HSS7) and the weekly Itch Severity Score (ISS7) and ranges between 0 and 42. A UAS7 score of 0 signifies that the patient is symptom free, and high UAS7 scores indicate severe symptoms.","Baseline and up to approximately 3 months",{"measure":43,"description":44,"timeFrame":41},"Part A: Change from baseline in weekly Itch Severity Score (ISS7)","The Itch Severity Score (ISS) is a measure of itching. Daily scores range from 0 (no itching) to 3 (intense itching). The ISS7 is a weekly score derived by adding up the daily ISS scores of the past 7 days and ranges from 0 to 21.",{"measure":46,"description":47,"timeFrame":41},"Part A: Change from baseline in weekly Hives Severity Score (HSS7)","The Hives Severity Score (HSS) is a measure of the number of hives present recorded by the participant. Daily scores range from 0 (no hives) to 3 (intense\u002Fsevere hives). HSS7 is the sum of the daily HSS scores over the past 7 days and ranges from 0 to 21.",{"measure":49,"description":50,"timeFrame":41},"Part A: Change from baseline in weekly Angioedema Activity Score (AAS7)","The Angioedema Activity Score (AAS) is a validated tool designed and verified to measure disease activity, assess response to treatment, and optimize the treatment plan for patients with recurrent angioedema. Responses are filled out prospectively and daily, evaluating five main factors related to angioedema: duration, physical discomfort caused, impact on daily activities, effect on appearance, and overall severity, each scored between 0 and 3. Daily AAS scores can range daily from 0 to 15, and weekly (AAS7) from 0 to 105. Higher AAS scores indicate frequent and severe attacks. Lower scores indicate well-controlled symptoms.",{"measure":52,"description":53,"timeFrame":41},"Part A: Change from baseline in 7-day recall period version of the Urticaria Control Test (UCT7)","UCT7 is a validated questionnaire used to measure the quality of life of patients with chronic urticaria and angioedema. It contains 4 questions, each of which inquires about the extent of impairment in the previous 7 days, with 5 options for answers ranging from \"not at all\" to \"very much.\" The first question asks about the frequency of all symptoms combined (itching, hives, and\u002For swelling). The second question asks about the overall impact on quality of life. The third question asks how often treatment has been insufficient to control symptoms, and the final question asks about how well the disease has been controlled. Answers are scored from 0 to 4 (the total score will range from 0 to 16), with higher scores representing milder and better-controlled urticaria and angioedema. The recall period for this questionnaire is 7 days.",{"measure":55,"description":19,"timeFrame":56},"Part A: Percentage of participants with complete absence of hives and itch, assessed as UAS7 = 0","Up to approximately 3 months",{"measure":58,"description":19,"timeFrame":56},"Part A: Percentage of participants with UAS7 ≤ 6 response",{"measure":60,"description":19,"timeFrame":56},"Part A: Levels of Bruton tyrosine kinase (BTK) protein",{"allocation":62,"interventionModel":63,"interventionModelDescription":64,"primaryPurpose":65,"observationalModel":19,"timePerspective":19,"maskingInfo":66},"RANDOMIZED","SEQUENTIAL","Part A is a double-blinded, placebo-controlled study to evaluate tacabrutideg in adults with moderate to severe CSU. Part B is an open-label study of tacabrutideg in healthy participants.","TREATMENT",{"masking":67,"maskingDescription":19,"whoMasked":68},"DOUBLE",[69,70],"PARTICIPANT","INVESTIGATOR",[72,78,84],{"label":73,"type":74,"description":75,"interventionNames":76},"Part A (CSU): Tacabrutideg","EXPERIMENTAL","Sequential cohorts of increasing dose levels of tacabrutideg will be evaluated in participants with CSU.",[77],"Drug: Tacabrutideg",{"label":79,"type":80,"description":81,"interventionNames":82},"Part A (CSU): Placebo","PLACEBO_COMPARATOR","Participants with CSU will receive matching placebo orally for 28 days and then crossover to receive tacabrutideg.",[77,83],"Drug: Placebo",{"label":85,"type":74,"description":86,"interventionNames":87},"Part B (Healthy Participants): Tacabrutideg","Sequential cohorts of increasing dose levels of tacabrutideg will be evaluated in healthy participants.",[77],[89,96],{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":94},"DRUG","Tacabrutideg","Administered orally",[79,73,85],[95],"BGB-16673",{"type":90,"name":97,"description":92,"armGroupLabels":98,"otherNames":19},"Placebo",[79],[100],{"name":101,"affiliation":5,"role":102},"Study Director","STUDY_DIRECTOR",[104],{"name":101,"role":105,"phone":106,"phoneExt":19,"email":107},"CONTACT","1-877-828-5568","clinicaltrials@beonemed.com",[109,123,133,142,152,162,173,183,193],{"facility":110,"status":111,"city":112,"state":113,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":19},"Peking University Third Hospital","COMPLETED","Beijing","Beijing Municipality","100000","China","CN",{"type":118,"coordinates":119},"Point",[120,121],116.39723,39.9075,{"lat":121,"lon":120},{"facility":124,"status":111,"city":125,"state":126,"zip":127,"country":115,"countryCode":116,"cosmosGeoPoint":128,"geoPoint":132,"contacts":19},"The First Affiliated Hospital of Chongqing Medical University","Chongqing","Chongqing Municipality","630014",{"type":118,"coordinates":129},[130,131],106.55771,29.56026,{"lat":131,"lon":130},{"facility":134,"status":111,"city":135,"state":136,"zip":19,"country":115,"countryCode":116,"cosmosGeoPoint":137,"geoPoint":141,"contacts":19},"Dermatology Hospital of Southern Medical University","Guangzhou","Guangdong",{"type":118,"coordinates":138},[139,140],113.25,23.11667,{"lat":140,"lon":139},{"facility":143,"status":111,"city":144,"state":145,"zip":146,"country":115,"countryCode":116,"cosmosGeoPoint":147,"geoPoint":151,"contacts":19},"Union Hospital of Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430022",{"type":118,"coordinates":148},[149,150],114.26667,30.58333,{"lat":150,"lon":149},{"facility":153,"status":111,"city":154,"state":155,"zip":156,"country":115,"countryCode":116,"cosmosGeoPoint":157,"geoPoint":161,"contacts":19},"Xiangya Hospital of Central South University","Changsha","Hunan","410008",{"type":118,"coordinates":158},[159,160],112.97087,28.19874,{"lat":160,"lon":159},{"facility":163,"status":164,"city":165,"state":166,"zip":167,"country":115,"countryCode":116,"cosmosGeoPoint":168,"geoPoint":172,"contacts":19},"The Affiliated Hospital of Qingdao University Branch West Coast","RECRUITING","Qingdao","Shandong","266555",{"type":118,"coordinates":169},[170,171],120.38042,36.06488,{"lat":171,"lon":170},{"facility":174,"status":111,"city":175,"state":176,"zip":177,"country":115,"countryCode":116,"cosmosGeoPoint":178,"geoPoint":182,"contacts":19},"Chengdu Second Peoples Hospital","Chengdu","Sichuan","610021",{"type":118,"coordinates":179},[180,181],104.06667,30.66667,{"lat":181,"lon":180},{"facility":184,"status":111,"city":185,"state":186,"zip":187,"country":115,"countryCode":116,"cosmosGeoPoint":188,"geoPoint":192,"contacts":19},"Hangzhou First Peoples Hospital","Hangzhou","Zhejiang","310006",{"type":118,"coordinates":189},[190,191],120.16142,30.29365,{"lat":191,"lon":190},{"facility":194,"status":111,"city":195,"state":186,"zip":196,"country":115,"countryCode":116,"cosmosGeoPoint":197,"geoPoint":201,"contacts":19},"The First Affiliated Hospital of Wenzhou Medical University","Wenzhou","325000",{"type":118,"coordinates":198},[199,200],120.66682,27.99942,{"lat":200,"lon":199},{"type":203,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100593382","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-multiple-ascending-doses-of-bgb-16673-in-adults-with-chronic-spontaneous-urticaria-100593382",false,"NCT07005713","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of Tacabrutideg (BGB-16673) in Adults With Chronic Spontaneous Urticaria and in Healthy Participants","A Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple- Ascending Doses of BGB-16673 in Patients With Chronic Spontaneous Urticaria and in Healthy Participants","Inclusion Criteria:\n\nPart A\n\n* Participants must be diagnosed with chronic spontaneous urticaria (CSU) for ≥ 6 months before randomization.\n* The presence of itch and hives for ≥6 consecutive weeks at any time prior to randomization despite the use of second-generation H1-antihistamines\n* UAS7≥16 and HSS7≥8 during the 7 days before randomization\n* Participants must not have had any missing UAS7 entry (ISS7 and HSS7) during the 7 days before randomization\n* Presence of hives must have been documented within 3 months before randomization\n\nPart B\n\n* Participants must be 18 to 55 years of age and healthy, with no clinically relevant abnormalities.\n* Body Mass Index (BMI) of 18 to 32 kg\u002Fm\\^2; and a total body weight \\> 50 kg (110 lbs).\n\nExclusion Criteria:\n\nPart A\n\n* Participants who have a clearly defined, predominating or sole trigger for their chronic urticaria (chronic inducible urticaria), including urticaria factitia (symptomatic dermographism) or cold, heat, solar, pressure, delayed pressure, aquagenic, cholinergic, or contact urticaria.\n* Other diseases with symptoms of urticaria or angioedema\n* Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results, eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or psoriasis.\n\nAll Participants\n\n* Any uncontrolled disease state, including asthma or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids.\n* Significant bleeding risk or coagulopathy.\n* Prior exposure to any BTK inhibitors or protein degraders.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",true,"ALL","18 Years","70 Years",{"count":216,"type":217},58,"ESTIMATED","INTERVENTIONAL",[220],"PHASE1","This is a Phase 1b study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of multiple-ascending doses of tacabrutideg in adults with chronic spontaneous urticaria (CSU) and in healthy participants.",[223],"Chronic Spontaneous Urticaria","2026-09-03",{"date":226,"type":227},"2026-09-09","ACTUAL",{"date":229,"type":227},"2025-07-19",{"date":231,"type":217},"2026-11-30",{"name":5,"class":6},9]