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Clinical Trial
. 2025 Jun;522(1):387-403.
doi: 10.1134/S1607672925700140. Epub 2025 May 11.

The Efficacy and Safety of BCD-180, an Anti-TRBV9+ T cell Monoclonal Antibody, in Patients with Active Radiographic Axial Spondyloarthritis: 36-week Results from the Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study ELEFTA

E L Nasonov  1   2 , V I Mazurov  3 , A M Lila  1   4 , T V Dubinina  1 , I Z Gaidukova  3   5 , S A Lapshina  6   7 , A A Klimenko  8   9 , D V Somov  9 , S A Lukyanov  9 , D M Chudakov  9 , I V Zvyagin  9 , O V Britanova  9 , M A Korolev  10 , D I Abdulganieva  6   7 , D G Krechikova  11 , A A Kastanayan  12 , L V Eliseeva  13 , R R Samigullina  2 , T V Povarova  14 , O V Antipova  15 , S A Smakotina  16   17 , V N Soboleva  18 , O B Nesmeyanova  19 , T V Plaksina  20 , N F Soroka  21 , I B Vinogradova  22 , A P Rebrov  23 , T V Kropotina  24 , A L Maslyansky  25 , A V Zinkina-Orikhan  26 , Yu N Linkova  26 , P S Pukhtinskaya  27 , M A Morozova  26 , G A Vinderskaya  26
Affiliations
Clinical Trial

The Efficacy and Safety of BCD-180, an Anti-TRBV9+ T cell Monoclonal Antibody, in Patients with Active Radiographic Axial Spondyloarthritis: 36-week Results from the Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study ELEFTA

E L Nasonov et al. Dokl Biochem Biophys. 2025 Jun.

Abstract

The study aims to evaluate the clinical efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of seniprutug (BCD-180) in patients with active radiographic axial spondyloarthritis (r-axSpA, or ankylosing spondylitis).

Materials and methods: Two hundred sixty patients with active r-axSpA and inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) were randomized into three groups to receive either seniprutug (BCD-180) 5 or 7 mg/kg, or placebo. BCD-180 was administered in the respective group dose using a 0-12-36 week regimen. The placebo group patients were switched to BCD-180 5 mg/kg at Week 24, with therapy continued at Week 36. The primary endpoint was the proportion of patients achieving 40% improvement in the Assessment in Spondyloarthritis International Society (ASAS40) score at Week 24. The secondary endpoints included the proportion of patients achieving an ASAS20/40 response, improvement in 5 of 6 ASAS criteria (ASAS5/6), partial remission according to ASAS, ASDAS-CRP clinically important improvement in (Ankylosing Spondylitis Disease Activity Score with C-reactive protein level, ASDAS-CII) and ASDAS-CRP major improvement (ASDAS-MI). An analysis of changes over time in the disease activity status according to ASDAS-CRP, BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and BASFI (Bath Ankylosing Spondylitis Functional Index) scores, as well as changes over time in laboratory markers (CRP and erythrocyte sedimentation rate (ESR)) was also conducted. Safety was assessed based on the frequency and profile of adverse events (AE) and adverse reactions (AR).

Results: The proportion of patients who achieved an ASAS40 response at Week 24 on seniprutug (BCD-180) at doses of 7 and 5 mg/kg was 51.4 and 40.8%, respectively, compared with 24% in the Placebo group (p = 0.0012 and p = 0.0417, respectively). Analysis of secondary endpoints showed that the efficacy of BCD-180 at both study doses was statistically significantly superior to placebo in patients with r-axSpA at Week 24 in the following respects: reduction in the proportion of subjects with very high disease activity (ASDAS-CRP > 3.5), achieving ASDAS-CII, ASAS20, ASAS5/6 response. A statistically significant decrease in the ASDAS-CRP, BASDAI, BASFI score, as well as CRP and ESR levels was demonstrated. Tolerability of seniprutug therapy was assessed as acceptable. The most common AEs were infusion-related reactions, most of which were mild to moderate according to CTCAE 5.0 (Common Terminology Criteria for Adverse Events) and developed mainly during the first administration. The proportion of patients with detected binding antibodies was 5.1%. No neutralizing antibodies were detected.

Conclusions: Seniprutug (BCD-180) as a therapy for r-axSpA has demonstrated superiority over placebo in the clinical efficacy, a good safety profile and low immunogenicity.

Keywords: radiographic axial spondyloarthritis; Bechterew’s disease; ankylosing spondylitis; anti-TRBV9 monoclonal antibody; seniprutug.

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Conflict of interest statement

ETHICS APPROVAL AND CONSENT TO PARTICIPATE: The ELEFTA study was conducted according to the protocol, International Conference on Harmonisation guidelines and the principles of the Declaration of Helsinki. Before included in the study, all patients provided written informed consent. The trial protocol, protocol amendments, as well as Patient Information Sheet and Informed Consent Form were approved by Independent Ethics Council under the Ministry of Health of the Russian Federation (2022/03/01, no. 303) and by the Ethics Committee in each study center before the study initiation. CONFLICT OF INTEREST: The study was sponsored by JSC BIOCAD. The sponsor participated in the development of the study project, study program support, and the decision to submit the article for publication. The conflict of interest did not affect the results of the study. Authors A.V. Zinkina-Orikhan, Yu.N. Linkova, P.S. Pukhtinskaya, M.A. Morozova, G.A. Vinderskaya are employees of JSC BIOCAD.

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