Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA)

Sponsor
Biocad
Study ID
NCT06333210
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • anti-TRBV9 monoclonal antibody infusions — BIOLOGICAL
    infusions
  • Placebo infusions — OTHER
    infusions
  • Adalimumab subcutaneous injection — DRUG
    subcutaneous injection
  • Placebo subcutaneous injection — OTHER
    subcutaneous injection

Study Details

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.

Key Dates

Start date
Dec 25, 2023
Status verified
May 2024
Primary completion
Dec 31, 2024
Completion
Feb 29, 2028

Study Design

Enrollment
421 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: bDMARDs and/or tsDMARD experienced subjects, BCD-180 group
    Subjects in this arm will receive a fixed dose of BCD-180 infusions
  • Placebo Comparator: bDMARDs and/or tsDMARD experienced subjects, Placebo group
    Subjects in this arm will receive Placebo infusions till the assessment of the primary endpoint and then will be switched to BCD-180 infusions
  • Experimental: bDMARDs and tsDMARD-naive subjects, BCD-180 group
    Subjects in this arm will receive a fixed dose of BCD-180 infusions and subcutaneous injections of placebo to maintain blindness of adalimumab therapy till the assessment of the primary endpoint, thereafter subjects will receive only BCD-180 infusions
  • Placebo Comparator: bDMARDs and tsDMARD-naive subjects, Placebo group
    Subjects in this arm will receive Placebo infusions and subcutaneous injections of placebo to maintain blindness of adalimumab therapy till the assessment of the primary endpoint, thereafter subjects will be switched to BCD-180 infusions
  • Active Comparator: bDMARDs and tsDMARD-naive subjects, Adalimumab group
    Subjects in this arm will receive subcutaneous injections of adalimumab and infusions of placebo till the assessment of the primary endpoint, thereafter subjects will be switched to BCD-180 infusions

Primary Outcome Measure

Proportion of subjects who achieved ASAS40 among bDMARDs and tsDMARD-naive subjects [ Time Frame: [Time Frame: week 24] ]

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