[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641531":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":34,"armGroups":41,"interventions":61,"overallOfficials":70,"centralContacts":74,"locations":80,"responsibleParty":207,"collaborators":34,"id":209,"slug":210,"hasResults":211,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":34,"eligibilityCriteria":215,"healthyVolunteers":211,"sex":216,"minAge":217,"maxAge":218,"enrollmentInfo":219,"targetDuration":34,"studyType":222,"phases":223,"briefSummary":225,"conditions":226,"keywords":229,"overallStatus":83,"whyStopped":34,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},{"fullName":5,"class":6},"AbbVie","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":34,"otherOutcomes":34},[9,13,17,20,23,26,30],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline in B Cells in Blood","Change from baseline in B cells in blood.","Up to 365 Days",{"measure":14,"description":15,"timeFrame":16},"Maximum Plasma Concentration (Cmax) of ABBV-519.","Cmax of ABBV-519","Up to 85 Days",{"measure":18,"description":19,"timeFrame":16},"Time to Cmax (Tmax) of ABBV-519","Tmax of ABBV-519",{"measure":21,"description":22,"timeFrame":16},"Terminal Phase Elimination Half-Life (t1\u002F2) of ABBV-519","t1\u002F2 of ABBV-519",{"measure":24,"description":25,"timeFrame":16},"Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-519","AUCt of ABBV-519",{"measure":27,"description":28,"timeFrame":29},"Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-519","Percentage of participants with detection of ADAs for ABBV-519","Up to 169 Days",{"measure":31,"description":32,"timeFrame":33},"Number of Participants with Adverse Events (AEs)","An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.","Up to 425 Days",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"NON_RANDOMIZED","SEQUENTIAL","BASIC_SCIENCE",{"masking":40,"maskingDescription":34,"whoMasked":34},"NONE",[42,48,51,54,58],{"label":43,"type":44,"description":45,"interventionNames":46},"Group 1: Dose A","EXPERIMENTAL","Participants will receive a single intravenous (IV) dose of ABBV-519",[47],"Drug: ABBV-519",{"label":49,"type":44,"description":45,"interventionNames":50},"Group 2: Dose B",[47],{"label":52,"type":44,"description":45,"interventionNames":53},"Group 3: Dose C",[47],{"label":55,"type":44,"description":56,"interventionNames":57},"Group 4: Dose D","Participants will receive a single subcutaneous (SC) dose of ABBV-519",[47],{"label":59,"type":44,"description":56,"interventionNames":60},"Group 5: Dose E",[47],[62,67],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":34},"DRUG","ABBV-519","Intravenous (IV) Infusion",[43,49,52],{"type":63,"name":64,"description":68,"armGroupLabels":69,"otherNames":34},"Subcutaneous (SC) Injection",[55,59],[71],{"name":72,"affiliation":5,"role":73},"ABBVIE INC.","STUDY_DIRECTOR",[75],{"name":76,"role":77,"phone":78,"phoneExt":34,"email":79},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",[81,95,105,115,124,133,142,151,160,170,180,190,202],{"facility":82,"status":83,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":34},"Pinnacle Research Group \u002FID# 278677","RECRUITING","Anniston","Alabama","36207","United States","US",{"type":90,"coordinates":91},"Point",[92,93],-85.83163,33.65983,{"lat":93,"lon":92},{"facility":96,"status":83,"city":97,"state":98,"zip":99,"country":87,"countryCode":88,"cosmosGeoPoint":100,"geoPoint":104,"contacts":34},"Solace Research \u002FID# 279155","Tustin","California","92780",{"type":90,"coordinates":101},[102,103],-117.82617,33.74585,{"lat":103,"lon":102},{"facility":106,"status":83,"city":107,"state":108,"zip":109,"country":87,"countryCode":88,"cosmosGeoPoint":110,"geoPoint":114,"contacts":34},"Clinical Research Of West Florida - Phase I Unit \u002FID# 279292","Clearwater","Florida","33765",{"type":90,"coordinates":111},[112,113],-82.8001,27.96585,{"lat":113,"lon":112},{"facility":116,"status":83,"city":117,"state":108,"zip":118,"country":87,"countryCode":88,"cosmosGeoPoint":119,"geoPoint":123,"contacts":34},"Finlay Medical Research - Greenacres \u002FID# 278380","Greenacres City","33467",{"type":90,"coordinates":120},[121,122],-80.12532,26.62368,{"lat":122,"lon":121},{"facility":125,"status":83,"city":126,"state":108,"zip":127,"country":87,"countryCode":88,"cosmosGeoPoint":128,"geoPoint":132,"contacts":34},"Clinical Research of Osceola \u002FID# 278374","Kissimmee","34741",{"type":90,"coordinates":129},[130,131],-81.41667,28.30468,{"lat":131,"lon":130},{"facility":134,"status":83,"city":135,"state":108,"zip":136,"country":87,"countryCode":88,"cosmosGeoPoint":137,"geoPoint":141,"contacts":34},"Allied Biomedical Research Institute \u002FID# 284408","Miami","33155",{"type":90,"coordinates":138},[139,140],-80.19366,25.77427,{"lat":140,"lon":139},{"facility":143,"status":83,"city":144,"state":108,"zip":145,"country":87,"countryCode":88,"cosmosGeoPoint":146,"geoPoint":150,"contacts":34},"Discovery Health Research Center \u002FID# 279691","Plantation","33317",{"type":90,"coordinates":147},[148,149],-80.23184,26.13421,{"lat":149,"lon":148},{"facility":152,"status":83,"city":153,"state":108,"zip":154,"country":87,"countryCode":88,"cosmosGeoPoint":155,"geoPoint":159,"contacts":34},"Clinical Research Of West Florida - Tampa - North Howard Avenue \u002FID# 279130","Tampa","33606",{"type":90,"coordinates":156},[157,158],-82.45843,27.94752,{"lat":158,"lon":157},{"facility":161,"status":83,"city":162,"state":163,"zip":164,"country":87,"countryCode":88,"cosmosGeoPoint":165,"geoPoint":169,"contacts":34},"Advanced Quality Medical Research \u002FID# 279147","Orland Park","Illinois","60462",{"type":90,"coordinates":166},[167,168],-87.85394,41.63031,{"lat":168,"lon":167},{"facility":171,"status":83,"city":172,"state":173,"zip":174,"country":87,"countryCode":88,"cosmosGeoPoint":175,"geoPoint":179,"contacts":34},"West Tennessee Research Institute - Jackson \u002FID# 284561","Jackson","Tennessee","38305",{"type":90,"coordinates":176},[177,178],-88.81395,35.61452,{"lat":178,"lon":177},{"facility":181,"status":83,"city":182,"state":183,"zip":184,"country":87,"countryCode":88,"cosmosGeoPoint":185,"geoPoint":189,"contacts":34},"Epic Medical Research \u002FID# 279180","Red Oak","Texas","75154",{"type":90,"coordinates":186},[187,188],-96.80444,32.51764,{"lat":188,"lon":187},{"facility":191,"status":83,"city":192,"state":193,"zip":194,"country":195,"countryCode":196,"cosmosGeoPoint":197,"geoPoint":201,"contacts":34},"Japan Community Healthcare Organization Chukyo Hospital \u002FID# 279611","Nagoya","Aichi-ken","457-8510","Japan","JP",{"type":90,"coordinates":198},[199,200],136.90641,35.18147,{"lat":200,"lon":199},{"facility":203,"status":83,"city":204,"state":205,"zip":206,"country":195,"countryCode":196,"cosmosGeoPoint":34,"geoPoint":34,"contacts":34},"Institute of Science Tokyo Hospital \u002FID# 279648","Bunkyo-ku","Tokyo","113-8519",{"type":208,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100641531","phase-1-a-study-to-assess-adverse-events-how-the-drug-moves-through-the-body-and-effectiveness-of-intravenous-infusions-and-subcutaneous-injections-of-abbv-519-in-adult-participants-with-systemic-lupus-erythematosus-sle-or-rheumatoid-arthritis-ra-100641531",false,"NCT07607964","A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)","A Phase 1, First-in-Human, Single Ascending Dose, Open-label, Non-randomized Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of ABBV-519 in Subjects With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n* Individuals between 18 and 75 years of age inclusive at the time of Screening.\n* Minimum baseline B-cell count of 50 cells\u002FmcL.\n\nInclusion Criteria for SLE Participants:\n\n* Clinical diagnosis of SLE and fulfilling the 2019 EULAR\u002FACR classification criteria.\n* Positive ANA ≥ 1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double-stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome antigen A (SSA).\n* Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score of ≥ 4 (excluding anti-dsDNA and C3\u002FC4). Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility.\n* Participants must have an inadequate response to ≥ 1 immunosuppressant therapies, used for at least 3 months.\n\nInclusion Criteria for RA Participants:\n\n* Clinical diagnosis of RA and fulfilling the 2010 ACR\u002FEULAR classification criteria for RA.\n* Presence of rheumatoid factor (RF) or anti-citrullinated peptide antibodies (ACPA) above the ULN.\n* Presence of at least 6 swollen and 6 tender joints\n* High-sensitivity C-reactive protein (hs-CRP) ≥ 3 mg\u002FL.\n* Failed at least 1 conventional synthetic disease-modifying antirheumatic drug (DMARD) and ≥ 1 biological or targeted DMARDs of different classes.\n\nExclusion Criteria:\n\nKey Exclusion Criteria:\n\n* Participants with a history of infection.\n* Participants with uncontrolled hypertension\n\nExclusion for SLE Participants:\n\n* Active neuropsychiatric SLE, or signs or symptoms of neuropsychiatric SLE within the 6 months prior to Screening (lupus headache permissible).\n\n  \\- Unstable or progressive glomerulonephritis (active class III or IV).\n* SLE overlap syndromes including, but not limited to RA, Sjogren's disease (SjD), SSc, polymyositis, dermatomyositis, or mixed connective tissue disease.\n\nExclusion for RA Participants:\n\n\\-- History of RA overlap syndromes, including but not limited to SLE, SjD, scleroderma, mixed connective tissue disorder or polymyositis.","ALL","18 Years","75 Years",{"count":220,"type":221},30,"ESTIMATED","INTERVENTIONAL",[224],"PHASE1","Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity.\n\nRheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety of ABBV-519 in adult participants with SLE or RA.\n\nThis is a single ascending dose study in an estimated 30 adult participants with moderate SLE or RA. The total duration of the study will be approximately 425 days (60-day Screening Period, 1-day Treatment Period, and a 52 week Follow-up Period) at approximately 15 to 20 sites globally.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[227,228],"Systemic Lupus Erythematosus","Rheumatoid Arthritis",[227,228],"2026-10-09",{"date":232,"type":233},"2026-10-13","ACTUAL",{"date":235,"type":233},"2026-05-28",{"date":237,"type":221},"2029-01",{"name":5,"class":6},13]