nctId: NCT06333210 id: BCD-180-3 briefTitle: Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA) overallStatus: RECRUITING date: 2023-12-25 date: 2024-12 date: 2028-02 date: 2024-03-27 date: 2024-03-27 name: Biocad class: INDUSTRY briefSummary: The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of a fixed dose of study drug (BCD-180) in comparison with placebo in patients with active axial spondyloarthritis (axSpA). The study will include HLA-B27+ patients with radiographic (r-axSpA) and non-radiographic (nr-axSpA) who had no response to prior therapy with non-steroidal anti-rheumatic drugs (NSAIDs), have not received biologic disease-modifying anti-rheumatic drugs (bDMARDs) or targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), and subjects with insufficient efficacy and/or loss of efficacy on bDMARDs and/or tsDMARDs. conditions: Axial Spondyloarthritis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 421 type: ESTIMATED name: anti-TRBV9 monoclonal antibody infusions name: Placebo infusions name: Adalimumab subcutaneous injection name: Placebo subcutaneous injection measure: Proportion of subjects who achieved ASAS40 among bDMARDs and tsDMARD-naive subjects measure: Proportion of subjects who achieved ASAS40 among bDMARDs and/or tsDMARD-experienced subjects measure: Proportion of subjects who achieved ASAS40 among subjects with r-axSpA measure: Proportion of subjects who achieved ASAS40 among subjects with nr-axSpA measure: Proportion of subjects with the ASDAS-CRP <1.3 measure: Proportion of subjects with the ASDAS-CRP ≥1.3 - <2.1 measure: Proportion of subjects with the ASDAS-CRP ≥2.1 - ≤3.5 measure: Proportion of subjects with the ASDAS-CRP >3.5 measure: Proportion of subjects who achieved ASDAS-CII (clinically important improvement) measure: Proportion of subjects who achieved ASDAS-MI (Major improvement) measure: ASDAS-CRP change from baseline measure: Proportion of patients who achieved clinical response defined as an improvement of BASDAI by at least 50% compared to baseline measure: Change from baseline in BASDAI measure: Proportion of subjects who achieved ASAS40 measure: Proportion of subjects who achieved ASAS20 measure: Proportion of subjects who achieved ASAS5/6 measure: Proportion of subjects who achieved ASAS partial remission measure: Change from baseline in BASMI measure: Change from baseline in BASFI measure: Change from baseline in the swollen joint count (44 joints) measure: Change from baseline in MASES measure: Change from baseline in overall back pain severity (BASDAI No. 2) measure: Change from baseline in nocturnal back pain severity measure: Change in the patient global assessment of disease activity from baseline measure: Change in the quality of life score assessed with EQ-5D-3L questionnaire from baseline measure: Change from baseline in SF-36 Physical Functioning compared to baseline measure: Change from baseline in SF-36 Mental Health compared to baseline measure: Change in the WPAI score from baseline measure: Change in the ASAS HI score from baseline measure: Change in the concentration of hsCRP from baseline measure: Change in ESR from baseline measure: Changes in the SPARCC score (spine, SIJ) from baseline measure: Changes in mSASSS scores from baseline measure: Proportion of subjects with adverse events measure: Proportion of subjects with serious adverse events measure: Proportion of subjects with grade 3 or higher adverse events according to CTCAE 5.0 measure: Proportion of subjects prematurely withdrawn from the study due to adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chelyabinsk Regional Clinical hospital status: RECRUITING city: Chelyabinsk country: Russian Federation name: Olga Nesmeianova, PhD role: CONTACT phone: +73517493727 email: chelokb@mail.ru lat: 55.15402 lon: 61.42915 facility: State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University status: RECRUITING city: Moscow country: Russian Federation name: Sergey Moiseev, PhD, Doc Med Sci role: CONTACT phone: +7 499 248 25 44 email: clinpharm@mtu-net.ru lat: 55.75222 lon: 37.61556 facility: Clinical Rheumatology Hospital №25 status: RECRUITING city: Saint Petersburg country: Russian Federation name: Inna Gaidukova role: CONTACT phone: +7 (812) 670 30 90 email: b25@zdrav.spb.ru lat: 59.93863 lon: 30.31413 facility: North-Western State Medical University n.a. I.I.Mechnikov status: RECRUITING city: Saint-Petersburg country: Russian Federation name: Vadim Mazurov, PhD role: CONTACT lat: 59.93863 lon: 30.31413 hasResults: False