International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis
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ClinicalTrials.gov Identifier: NCT03447704 |
Recruitment Status :
Active, not recruiting
First Posted : February 27, 2018
Last Update Posted : May 4, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ankylosing Spondylitis | Drug: BCD-085 Other: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 228 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official 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 |
Actual Study Start Date : | February 9, 2018 |
Actual Primary Completion Date : | December 24, 2018 |
Estimated Study Completion Date : | March 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: BCD-085 (netakimab) |
Drug: BCD-085
120 mg of BCD-085 subcutaneously at week 0,1 and 2 every other week
Other Name: netakimab |
Placebo Comparator: Placebo |
Other: placebo
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 [ 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%)
- 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%
- 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
- 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
- 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
- Frequency of AE/SAE [ Time Frame: Week 60 ]Percentage of patients with AE (adverse events) /SAE (serious adverse events)

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447704
Russian Federation | |
Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways" | |
Chelyabinsk, Russian Federation, 355047 | |
Chelyabinsk Regional Clinical hospital | |
Chelyabinsk, Russian Federation | |
Kazan State Medical University | |
Kazan, Russian Federation | |
State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University | |
Moscow, Russian Federation | |
Omsk Regional Clinical Hospital | |
Omsk, Russian Federation | |
LLC BioEk | |
Saint-Petersburg, Russian Federation | |
North-Western State Medical University n.a. I.I.Mechnikov | |
St.Petersburg, Russian Federation |
Study Chair: | Roman Ivanov, PhD | JSC BIOCAD |
Responsible Party: | Biocad |
ClinicalTrials.gov Identifier: | NCT03447704 |
Other Study ID Numbers: |
BCD-085-5 |
First Posted: | February 27, 2018 Key Record Dates |
Last Update Posted: | May 4, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ankylosing Spondylitis interleukin 17 monoclonal antibody netakimab |
Spondylitis Spondylitis, Ankylosing Bone Diseases, Infectious Infections Bone Diseases Musculoskeletal Diseases |
Spinal Diseases Spondylarthropathies Spondylarthritis Ankylosis Joint Diseases Arthritis |