A Phase 3 interventional study of BCD-085 and placebo in Ankylosing Spondylitis, sponsored by Biocad. Completed at 7 sites in Russia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Biocad · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
Drug: BCD-085
Other: placebo
120 mg of BCD-085 subcutaneously at week 0,1 and 2 every other week
Also known as: netakimab
2 ml of placebo subcutaneously at week 0,1 2 and every other week, starting from week 16 - 120 mg of BCD-085 subcutaneously at week 16,17 and 18 every other week
ASAS40 rate at Week 16
Percentage of patients with ASAS40 response after 16 weeks of therapy (percentage of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 40%)
Time frame: Week 16
ASAS20 rate
Percentage of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20%
Time frame: Week 4, 8, 12, 16, 24, 36, 52
Change from baseline in BASDAI
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score in comparison with screening (from 0 to 10). The maximum change is considered to be better outcome
Time frame: Week 4, 8, 12, 16, 24, 36, 52
Change from baseline in ASDAS-CRP
Change in ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score Index) score in comparison with screening (from 0 to \> 3.5). The maximum change is considered to be better outcome
Time frame: Week 4, 8, 12, 16, 24, 36, 52
Change from baseline in SF-36
Change in SF-36 (The Short Form-36) score in comparison with screening (physical component) (from 15.9 to 62.1). The maximum change is considered to be better outcome
Time frame: Week 16, 36, 52
Frequency of AE/SAE
Percentage of patients with AE (adverse events) /SAE (serious adverse events)
Time frame: Week 60
Plan to share: No
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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