International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biocad

Criteria

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.