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Completed

NCT Number: NCT03447704

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

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.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chelyabinsk Regional Clinical hospital, Chelyabinsk, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BCD-085

Drug

120 mg of BCD-085 subcutaneously at week 0,1 and 2 every other week

Other names: netakimab

Placebo

Other

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

Primary outcomes

  1. ASAS40 rate at Week 16

    Time frame: 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%)

Secondary outcomes

  1. ASAS20 rate

    Time frame: Week 4, 8, 12, 16, 24, 36, 52

    Percentage of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20%

  2. Change from baseline in BASDAI

    Time frame: Week 4, 8, 12, 16, 24, 36, 52

    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

  3. Change from baseline in ASDAS-CRP

    Time frame: Week 4, 8, 12, 16, 24, 36, 52

    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

  4. Change from baseline in SF-36

    Time frame: Week 16, 36, 52

    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

  5. Frequency of AE/SAE

    Time frame: Week 60

    Percentage of patients with AE (adverse events) /SAE (serious adverse events)

Sponsors and collaborators

Lead sponsor

Biocad

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2022
First posted
Feb 27, 2018
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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