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.

Start Date25 Dec 2023

Sponsor / Collaborator

Biocad CJSC

NCT05445076

/ Active, not recruitingPhase 2

An International, Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis

The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of two doses of study drug (BCD-180) in comparison with placebo in patients with active radiographic axial spondyloarthritis (axSpA). The study will include HLA-B27+ patients with radiographic axSpA who had no response to prior therapy with Non-steroidal anti-inflammatory drugs (NSAIDs), have not received biologic therapy or targeted Disease-modifying antirheumatic drugs (DMARDs).

Start Date19 Apr 2022

Sponsor / Collaborator

Biocad CJSC

NCT05407779

/ CompletedPhase 1

An Open-Label, Non-controlled Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of Single Escalating Doses of BCD-180 (JSC BIOCAD, Russia) in Healthy Volunteers

The aim of the study is to investigate the pharmacodynamics, pharmacokinetics, safety, and immunogenicity of BCD-180 after a single intravenous administration in escalating doses to healthy volunteers.

Start Date22 Jan 2021

Sponsor / Collaborator

Biocad CJSC

100 Clinical Results associated with Seniprutug

100 Translational Medicine associated with Seniprutug

100 Patents (Medical) associated with Seniprutug

100 Deals associated with Seniprutug

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Axial Spondyloarthritis	Phase 3	Russia	Biocad CJSC	25 Dec 2023
Axial Spondyloarthritis	Phase 3	Belarus	Biocad CJSC	25 Dec 2023

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