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

NCT06333210 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2024-06-03

No results posted yet for this study

Summary

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

Interventions

BIOLOGICAL

anti-TRBV9 monoclonal antibody infusions

infusions

OTHER

Placebo infusions

infusions

DRUG

Adalimumab subcutaneous injection

subcutaneous injection

OTHER

Placebo subcutaneous injection

subcutaneous injection

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Arina Zinkina-Orikhan, PhD, MD · Director of Clinical Development Department, BIOCAD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-25
Primary Completion
2024-12-31
Completion
2028-02-29

Countries

  • Belarus
  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06333210 on ClinicalTrials.gov