protocolSection identificationModule nctId: NCT06333210, orgStudyIdInfo id: BCD-180-3, briefTitle: Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-25, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Biocad, class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Axial Spondyloarthritis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 421, type: ESTIMATED, armsInterventionsModule interventions name: anti-TRBV9 monoclonal antibody infusions, interventions name: Placebo infusions, interventions name: Adalimumab subcutaneous injection, interventions name: Placebo subcutaneous injection, outcomesModule primaryOutcomes measure: Proportion of subjects who achieved ASAS40 among bDMARDs and tsDMARD-naive subjects, primaryOutcomes measure: Proportion of subjects who achieved ASAS40 among bDMARDs and/or tsDMARD-experienced subjects, secondaryOutcomes measure: Proportion of subjects who achieved ASAS40 among subjects with r-axSpA, secondaryOutcomes measure: Proportion of subjects who achieved ASAS40 among subjects with nr-axSpA, secondaryOutcomes measure: Proportion of subjects with the ASDAS-CRP <1.3, secondaryOutcomes measure: Proportion of subjects with the ASDAS-CRP ≥1.3 - <2.1, secondaryOutcomes measure: Proportion of subjects with the ASDAS-CRP ≥2.1 - ≤3.5, secondaryOutcomes measure: Proportion of subjects with the ASDAS-CRP >3.5, secondaryOutcomes measure: Proportion of subjects who achieved ASDAS-CII (clinically important improvement), secondaryOutcomes measure: Proportion of subjects who achieved ASDAS-MI (Major improvement), secondaryOutcomes measure: ASDAS-CRP change from baseline, secondaryOutcomes measure: Proportion of patients who achieved clinical response defined as an improvement of BASDAI by at least 50% compared to baseline, secondaryOutcomes measure: Change from baseline in BASDAI, secondaryOutcomes measure: Proportion of subjects who achieved ASAS40, secondaryOutcomes measure: Proportion of subjects who achieved ASAS20, secondaryOutcomes measure: Proportion of subjects who achieved ASAS5/6, secondaryOutcomes measure: Proportion of subjects who achieved ASAS partial remission, secondaryOutcomes measure: Change from baseline in BASMI, secondaryOutcomes measure: Change from baseline in BASFI, secondaryOutcomes measure: Change from baseline in the swollen joint count (44 joints), secondaryOutcomes measure: Change from baseline in MASES, secondaryOutcomes measure: Change from baseline in overall back pain severity (BASDAI No. 2), secondaryOutcomes measure: Change from baseline in nocturnal back pain severity, secondaryOutcomes measure: Change in the patient global assessment of disease activity from baseline, secondaryOutcomes measure: Change in the quality of life score assessed with EQ-5D-3L questionnaire from baseline, secondaryOutcomes measure: Change from baseline in SF-36 Physical Functioning compared to baseline, secondaryOutcomes measure: Change from baseline in SF-36 Mental Health compared to baseline, secondaryOutcomes measure: Change in the WPAI score from baseline, secondaryOutcomes measure: Change in the ASAS HI score from baseline, secondaryOutcomes measure: Change in the concentration of hsCRP from baseline, secondaryOutcomes measure: Change in ESR from baseline, secondaryOutcomes measure: Changes in the SPARCC score (spine, SIJ) from baseline, secondaryOutcomes measure: Changes in mSASSS scores from baseline, secondaryOutcomes measure: Proportion of subjects with adverse events, secondaryOutcomes measure: Proportion of subjects with serious adverse events, secondaryOutcomes measure: Proportion of subjects with grade 3 or higher adverse events according to CTCAE 5.0, secondaryOutcomes measure: Proportion of subjects prematurely withdrawn from the study due to adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chelyabinsk Regional Clinical hospital, status: RECRUITING, city: Chelyabinsk, country: Russian Federation, contacts name: Olga Nesmeianova, PhD, role: CONTACT, phone: +73517493727, email: chelokb@mail.ru, geoPoint lat: 55.15402, lon: 61.42915, locations facility: State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University, status: RECRUITING, city: Moscow, country: Russian Federation, contacts name: Sergey Moiseev, PhD, Doc Med Sci, role: CONTACT, phone: +7 499 248 25 44, email: clinpharm@mtu-net.ru, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Clinical Rheumatology Hospital №25, status: RECRUITING, city: Saint Petersburg, country: Russian Federation, contacts name: Inna Gaidukova, role: CONTACT, phone: +7 (812) 670 30 90, email: b25@zdrav.spb.ru, geoPoint lat: 59.93863, lon: 30.31413, locations facility: North-Western State Medical University n.a. I.I.Mechnikov, status: RECRUITING, city: Saint-Petersburg, country: Russian Federation, contacts name: Vadim Mazurov, PhD, role: CONTACT, geoPoint lat: 59.93863, lon: 30.31413, hasResults: False