An International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-085 (JSC BIOCAD, Russia) in Patients With Active Ankylosing Spondylitis

BCD-085-5

BCD-085-5 is an International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During BCD-085-5 trial patients with active ankylosing spondylitis will receive 120 mg of BCD-085 subcutaneously every other week or placebo up to Week 16. Starting from week 16 all patients will receive BCD-085. Efficacy, PK and safety parameters will be evaluated.

2018-02-09

2018-12-24

2023-04-05

Active (not recruiting)

Early phase I

228

Inclusion Criteria: * Active ankylosing spondylitis according to modified criteria of New York classification (1984), that was diagnosed at least 3 months prior to screening. * Active disease according to BASDAI (score 4 or more) if nonsteroidal antiinflammatory drugs were used in the last 3 month prior to screening. * Mean backache intensity equals 4 points or more. Exclusion Criteria: * Total spinal ankylosis. * Previous treatment with anti-interleukin 17 drugs or anti-interleukin 17 receptor drugs. * Prior use of \>2 biologics to tumor necrosis factor alfa. * Prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent. * Prior use of alkylating agents for up to 12 months prior to signing informed consent.

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2023-02-21