Ankylosing SpondylitisPhase 3NCT03447704
International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis
A Phase 3 study testing BCD-085 in people with Ankylosing Spondylitis, run by Biocad at 7 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- BCD-085
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 7 sitesRussia
- Study dates
- 9 Feb 2018to 31 Mar 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Russia7 sites
Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways"
Chelyabinsk, 355047
Chelyabinsk Regional Clinical hospital
Chelyabinsk
Kazan State Medical University
Kazan'
State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
Moscow
Omsk Regional Clinical Hospital
Omsk
LLC BioEk
Saint Petersburg
North-Western State Medical University n.a. I.I.Mechnikov
Saint Petersburg
About this study
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
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.
- Conditions
- Ankylosing Spondylitis
- Being tested
- BCD-085, placebo
- Keywords
- Ankylosing Spondylitis, interleukin 17, monoclonal antibody, netakimab
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-085Drug
Also called netakimab
120 mg of BCD-085 subcutaneously at week 0,1 and 2 every other week
placeboOther
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
| Study group | Role | What they receive |
|---|---|---|
| BCD-085 (netakimab) | Experimental | Not described Receives: Drug: BCD-085 |
| Placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Measured: Week 16
Secondary outcomes (5)
ASAS20 rate
Percentage of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20%
Measured: 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
Measured: 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
Measured: 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
Measured: Week 16, 36, 52
Frequency of AE/SAE
Percentage of patients with AE (adverse events) /SAE (serious adverse events)
Measured: Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start9 Feb 2018
- Primary completion24 Dec 2018
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman Ivanov, PhD, Study chair, JSC BIOCAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447704
- Sponsor's protocol ID
- BCD-085-5
- Status last verified
- Jul 2025
- First submitted
- 21 Feb 2018
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mazurov VI, Dubinina TV, Erdes S, Lapshina SA, Soroka NF, Kunder EV, Smirnov AV, Eremeeva AV, Zinkina-Orikhan AV, Morozova MA, Gaydukova IZ. Response to netakimab in radiographic axial spondyloarthritis patients with different baseline C-reactive protein, sacroiliitis evaluated by MRI and peripheral joint involvement status: a post-hoc analysis of the ASTERA study. Clin Exp Rheumatol. 2023 Mar;41(3):718-726. doi: 10.55563/clinexprheumatol/ljpqqe. Epub 2022 Aug 31.
PubMed 36062743
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03447704
- Acronym / sponsor ID
- BCD-085-5
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis, interleukin 17, monoclonal antibody, netakimab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 24 Dec 2018 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCD-085 (netakimab) | Experimental | Drug: BCD-085 |
| Placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCD-085Also: netakimab120 mg of BCD-085 subcutaneously at week 0,1 and 2 every other week | Drug | BCD-085 (netakimab) |
| placebo2 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 | Other | Placebo |
Primary outcome
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%)
5 secondary outcomes
ASAS20 rate
Time frame: Week 4, 8, 12, 16, 24, 36, 52
Change from baseline in BASDAI
Time frame: Week 4, 8, 12, 16, 24, 36, 52
Change from baseline in ASDAS-CRP
Time frame: Week 4, 8, 12, 16, 24, 36, 52
Change from baseline in SF-36
Time frame: Week 16, 36, 52
Frequency of AE/SAE
Time frame: Week 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Results publication: PubMed 36062743Mazurov VI, Dubinina TV, Erdes S, Lapshina SA, Soroka NF, Kunder EV, Smirnov AV, Eremeeva AV, Zinkina-Orikhan AV, Morozova MA, Gaydukova IZ. Response to netakimab in radiographic axial spondyloarthritis patients with different baseline C-reactive protein, sacroiliitis evaluated by MRI and peripheral joint involvement status: a post-hoc analysis of the ASTERA study. Clin Exp Rheumatol. 2023 Mar;41(3):718-726. doi: 10.55563/clinexprheumatol/ljpqqe. Epub 2022 Aug 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Ivanov, PhD study chair
JSC BIOCAD
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BCD-085 in people with Ankylosing Spondylitis, run by Biocad at 7 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASAS40 rate at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03447704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.