Tribuvia (seniprutug) / Biocad - LARVOL DELTA

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. (PubMed, Dokl Biochem Biophys) - "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."

Clinical • Journal • P2 data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • CRP

Clinical Efficacy of Seniprutug (BCD-180), anti-TRBV9 therapy for radiographic Axial Spondyloarthritis (APLAR 2024) - No abstract available

Clinical • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis

Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA) (clinicaltrials.gov) - P3 | N=421 | Active, not recruiting | Sponsor: Biocad | Recruiting ➔ Active, not recruiting

Enrollment closed • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis

Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA) (clinicaltrials.gov) - P3 | N=421 | Recruiting | Sponsor: Biocad

New P3 trial • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis

Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of Single Escalating Doses of BCD-180 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=39 | Completed | Sponsor: Biocad | Active, not recruiting ➔ Completed

Trial completion

Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of Single Escalating Doses of BCD-180 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=39 | Active, not recruiting | Sponsor: Biocad | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2022 ➔ Sep 2023 | Trial primary completion date: Sep 2022 ➔ Sep 2023

Enrollment closed • Trial completion date • Trial primary completion date

ELEFTA: Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (clinicaltrials.gov) - P2 | N=250 | Active, not recruiting | Sponsor: Biocad | Recruiting ➔ Active, not recruiting

Enrollment closed • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis • CRP

ELEFTA: Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (clinicaltrials.gov) - P2 | N=250 | Recruiting | Sponsor: Biocad

New P2 trial • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis • CRP

Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of Single Escalating Doses of BCD-180 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=39 | Recruiting | Sponsor: Biocad

New P1 trial