[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593792":3},{"organization":4,"outcomesModule":7,"designInfo":96,"detailedDescription":104,"studyPopulation":101,"armGroups":105,"interventions":120,"overallOfficials":128,"centralContacts":132,"locations":138,"responsibleParty":305,"collaborators":101,"id":307,"slug":101,"hasResults":308,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":101,"eligibilityCriteria":312,"healthyVolunteers":308,"sex":313,"minAge":314,"maxAge":315,"enrollmentInfo":316,"targetDuration":101,"studyType":319,"phases":320,"briefSummary":322,"conditions":323,"keywords":325,"overallStatus":141,"whyStopped":101,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":341},{"fullName":5,"class":6},"Climb Bio, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":43,"otherOutcomes":71},[9,13,16,19,22,25,28,31,34,37,40],{"measure":10,"description":11,"timeFrame":12},"Incidence of Treatment-Emergent Adverse Events (TEAEs)","Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.","Up to Week 24",{"measure":14,"description":15,"timeFrame":12},"Incidence of Clinical Laboratory Abnormalities","Number of participants with clinically significant laboratory abnormalities.",{"measure":17,"description":18,"timeFrame":12},"Change from Baseline in Systolic Blood Pressure","Mean change from baseline in systolic blood pressure (mmHg).",{"measure":20,"description":21,"timeFrame":12},"Change from Baseline in Diastolic Blood Pressure","Mean change from baseline in diastolic blood pressure (mmHg).",{"measure":23,"description":24,"timeFrame":12},"Change from Baseline in Heart Rate","Mean change from baseline in heart rate (bpm).",{"measure":26,"description":27,"timeFrame":12},"Change from Baseline in Respiratory Rate","Mean change from baseline in respiratory rate.",{"measure":29,"description":30,"timeFrame":12},"Change from Baseline in Body Temperature","Mean change from baseline in body temperature (°C).",{"measure":32,"description":33,"timeFrame":12},"Change from Baseline in PR Interval","Mean change from baseline in PR interval (ms).",{"measure":35,"description":36,"timeFrame":12},"Change from Baseline in QRS Duration","Mean change from baseline in QRS duration (ms).",{"measure":38,"description":39,"timeFrame":12},"Change from Baseline in QT Interval","Mean change from baseline in QT interval (ms).",{"measure":41,"description":42,"timeFrame":12},"Change from Baseline in QTc Interval","Mean change from baseline in corrected QT interval (QTc).",[44,47,50,53,56,59,62,65,68],{"measure":45,"description":46,"timeFrame":12},"Area Under the Curve (AUC) of Budoprutug","Measurement of the area under the drug concentration-time curve.",{"measure":48,"description":49,"timeFrame":12},"Maximum Observed Plasma Concentration (Cmax)","Measurement of the maximum observed plasma concentration.",{"measure":51,"description":52,"timeFrame":12},"Time to Maximum Observed Concentration (Tmax)","Measurement of the time to maximum observed concentration.",{"measure":54,"description":55,"timeFrame":12},"Terminal Half-Life (T1\u002F2)","Measurement of the terminal half-life in days.",{"measure":57,"description":58,"timeFrame":12},"Apparent Clearance (CL\u002FF) of budoprutug","Measurement of the apparent clearance in L\u002Fhour.",{"measure":60,"description":61,"timeFrame":12},"Volume of Distribution (Vd)","Measurement of the volume of distribution in liters.",{"measure":63,"description":64,"timeFrame":12},"Change from Baseline in Circulating B Cell Count","Change in absolute number of CD19+ B cells in peripheral blood.",{"measure":66,"description":67,"timeFrame":12},"Incidence of Anti-Drug Antibodies (ADAs)","Number of participants with detectable ADAs.",{"measure":69,"description":70,"timeFrame":12},"ADA Titer Over Time","Measurement of ADA titer over time.",[72,75,78,81,84,87,90,93],{"measure":73,"description":74,"timeFrame":12},"Change from Baseline in BILAG-2004 Score","Measurement of change in BILAG-2004 score from baseline.",{"measure":76,"description":77,"timeFrame":12},"Change from Baseline in SLEDAI-2K Score","Measurement of change in SLEDAI-2K score from baseline.",{"measure":79,"description":80,"timeFrame":12},"Change from Baseline in Physician's Global Assessment","Measurement of change in Physician's Global Assessment score from baseline.",{"measure":82,"description":83,"timeFrame":12},"Proportion of Participants Achieving SRI-4 Response","Percentage of participants achieving SRI-4 response.",{"measure":85,"description":86,"timeFrame":12},"Change from Baseline in Urine Protein Creatinine Ratio (UPCR)","Measurement of change in UPCR from baseline.",{"measure":88,"description":89,"timeFrame":12},"Time to Renal Response","Measurement of time to renal response in weeks.",{"measure":91,"description":92,"timeFrame":12},"Proportion of Participants with Complete or Partial Renal Response","Percentage of participants with complete or partial renal response.",{"measure":94,"description":95,"timeFrame":12},"Change from Baseline in FACIT-Fatigue Score","Measurement of change in FACIT-Fatigue score from baseline.",{"allocation":97,"interventionModel":98,"interventionModelDescription":99,"primaryPurpose":100,"observationalModel":101,"timePerspective":101,"maskingInfo":102},"NON_RANDOMIZED","SEQUENTIAL","This is an open-label study in which subjects will be enrolled into four single-dose ascending cohorts. Each subject's participation will last approximately 198 days, including a 30-day screening period, a 1-day treatment period, and follow-up through Week 24.","TREATMENT",null,{"masking":103,"maskingDescription":101,"whoMasked":101},"NONE","Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1b, open-label study will evaluate budoprutug administered as a single intravenous infusion in ascending dose cohorts of patients aged 18 years and above with active, seropositive SLE and inadequate response to standard therapy. The study will also assess the pharmacokinetics, pharmacodynamics and early indications of efficacy of budoprutug in SLE, where pharmacodynamics will be evaluated as the change in the number of B cells and immunoglobulins (antibodies) in the blood over time following a single infusion.",[106,111,114,117],{"label":107,"type":108,"description":101,"interventionNames":109},"Cohort 1: Dose Level A","EXPERIMENTAL",[110],"Drug: Budoprutug",{"label":112,"type":108,"description":101,"interventionNames":113},"Cohort 2: Dose Level B",[110],{"label":115,"type":108,"description":101,"interventionNames":116},"Cohort 3: Dose Level C",[110],{"label":118,"type":108,"description":101,"interventionNames":119},"Cohort 4: Dose Level D",[110],[121],{"type":122,"name":123,"description":124,"armGroupLabels":125,"otherNames":126},"DRUG","Budoprutug","Single IV dose of study product on Day 1 of study",[107,112,115,118],[127],"TNT119",[129],{"name":130,"affiliation":5,"role":131},"Study 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#380103","Kyiv",{"type":148,"coordinates":275},[276,277],30.5238,50.45466,{"lat":277,"lon":276},{"facility":280,"status":141,"city":273,"state":101,"zip":101,"country":264,"countryCode":265,"cosmosGeoPoint":281,"geoPoint":283,"contacts":101},"Climb Bio Investigative Site #380106",{"type":148,"coordinates":282},[276,277],{"lat":277,"lon":276},{"facility":285,"status":141,"city":286,"state":101,"zip":101,"country":264,"countryCode":265,"cosmosGeoPoint":287,"geoPoint":291,"contacts":101},"Climb Bio Investigative Site #380101","Ternopil",{"type":148,"coordinates":288},[289,290],25.59067,49.55404,{"lat":290,"lon":289},{"facility":293,"status":141,"city":294,"state":101,"zip":101,"country":264,"countryCode":265,"cosmosGeoPoint":295,"geoPoint":299,"contacts":101},"Climb Bio Investigative Site #380104","Vinnytsia",{"type":148,"coordinates":296},[297,298],28.46871,49.2322,{"lat":298,"lon":297},{"facility":301,"status":141,"city":294,"state":101,"zip":101,"country":264,"countryCode":265,"cosmosGeoPoint":302,"geoPoint":304,"contacts":101},"Climb Bio Investigative Site #380105",{"type":148,"coordinates":303},[297,298],{"lat":298,"lon":297},{"type":306,"investigatorFullName":101,"investigatorTitle":101,"investigatorAffiliation":101,"oldNameTitle":101,"oldOrganization":101},"SPONSOR","100593792",false,"NCT07011043","A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)","A Phase 1b Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Budoprutug (TNT119) in Adult Subjects With Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n1. Aged 18 to 65 years at the time of consent.\n2. Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria.\n3. Active, seropositive disease, with SLEDAI 2K \\>=8.\n4. Inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic standard-of care therapy.\n\nExclusion Criteria:\n\n1. Active neuropsychiatric SLE.\n2. History of inflammatory or autoimmune diseases including, but not limited to, rheumatoid arthritis, scleroderma, myositis, vasculitis, inflammatory bowel disease, or other conditions that require immune suppressive therapy. Subjects with stable concurrent Sjogren's, asthma, or autoimmune thyroid disease may be considered for participation.\n3. Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.","ALL","18 Years","65 Years",{"count":317,"type":318},30,"ESTIMATED","INTERVENTIONAL",[321],"PHASE1","The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.",[324],"Systemic Lupus Erythematosus",[326,327,328,329,330,331],"Lupus","SLE","Biologics","Open-label","Monoclonal","Anti-CD19","2026-03-24",{"date":334,"type":335},"2026-03-27","ACTUAL",{"date":337,"type":335},"2025-07-10",{"date":339,"type":318},"2027-04",{"name":5,"class":6},18]