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Ankylosing SpondylitisPhase 2NCT02763111

Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis

A Phase 2 study testing BCD-085 in people with Ankylosing Spondylitis, run by Biocad.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

BCD-085-3 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During the trial patients with active ankylosing spondylitis will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12. Efficacy and safety parameters will be evaluated. 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
88 participants
Where
No sites listed yet
Study dates
Sep 2016to Jun 2017
Phase
Phase 2
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

  • Written informed consent
  • Age between 18 and 65 years
  • 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.
  • If patient have had biologic therapy to treat ankylosing spondylitis for at least 3 months, there was no positive results of such treatment or patient revealed intolerance to the drug. This therapy must be discontinued at least 12 weeks before enrollment in the study.
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  • Female patients have negative urine pregnancy test.
  • Patient has no history of tuberculosis.
  • Patients have negative results of Diaskintest.
  • Patient has no history of alcohol or drug abuse.

Who cannot join

  • Total spinal ankylosis.
  • Allergy or intolerance of monoclonal antibodies or any excipients of study drugs.
  • Previous receipt of anti-interleukin 17 drugs or anti-interleukin 17 receptor drugs.
  • Prior use of two or more biologics to tumor necrosis factor alfa.
  • Prior use of two or more biologics to other targets. Previous receipt of monoclonal antibodies if they were cancelled less that in 12 weeks before signing informed consent.
  • Patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent and during screening, or in a dose less than 10 mg (recalculated to prednisolone) if it was not stable.
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  • Prior use of disease-modifying antirheumatic drugs including methotrexate, sulfasalazin, chloroquine or hydroxychloroquine for up to 4 weeks before randomization, if their dose was not stable for up to 4 weeks before signing informed consent and during screening.
  • 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.
  • Intraarticular use of corticosteroids for up to 4 weeks before randomization.

About this study

Official title: International Multi-center Comparative Randomized Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Active Ankylosing Spondylitis

BCD-085-3 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During the trial patients with active ankylosing spondylitis will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12. Efficacy and safety parameters will be evaluated.

Being tested
BCD-085, Placebo
Keywords
ankylosing spondylitis, interleukin 17, monoclonal antibody
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

  • PlaceboOther

Study groups in NCT02763111
Study groupRoleWhat they receive
BCD-085, 40 mgExperimentalPatient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
Receives: Drug: BCD-085
BCD-085, 80 mgExperimentalPatient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
Receives: Drug: BCD-085
BCD-085, 120 mgExperimentalPatient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
Receives: Drug: BCD-085
PlaceboPlacebo comparatorPatient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ratio of patients with ASAS20 response after 16 weeks of therapy

    Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% or more after 16 weeks of therapy with BCD-085.

    Measured: Week 16

Secondary outcomes (26)

  1. Ratio of patients with ASAS20 response after 4, 8, 12 weeks of therapy

    Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% or more after 4, 8, 12 weeks of therapy with BCD-085.

    Measured: Week 4, Week 8, Week 12

  2. Ratio of patients with ASAS40 response after 4, 8, 12, 16 weeks of therapy

    Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 40% or more after 4, 8, 12, 16 weeks of therapy with BCD-085.

    Measured: Week 4, Week 8, Week 12, Week 16

  3. Ratio of patients with ASAS5/6 response after 4, 8, 12, 16 weeks of therapy

    Ratio of patients who developed a response in at least 5 of 6 criteria of ankylosing spondylitis assessment score (ASAS) after 4, 8, 12, 16 weeks of therapy with BCD-085.

    Measured: Week 4, Week 8, Week 12, Week 16

  4. Mean BASDAI score at screening and after 4, 8, 12, 16 weeks of therapy

    Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score at screening and after 4, 8, 12, 16 weeks of therapy

    Measured: Screening, Week 4, Week 8, Week 12, Week 16

  5. Mean BASMI score at screening and after 4, 8, 12, 16 weeks of therapy

    Mean Bath Ankylosing Spondylitis Metrology Index (BASMI) score at screening and after 4, 8, 12, 16 weeks of therapy

    Measured: Screening, Week 4, Week 8, Week 12, Week 16

  6. Mean MASES score at screening and after 4, 8, 12, 16 weeks of therapy

    Mean Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at screening and after 4, 8, 12, 16 weeks of therapy

    Measured: Screening, Week 4, Week 8, Week 12, Week 16

  7. Mean chest excursion at screening and after 4, 8, 12, 16 weeks of therapy

    Mean chest excursion at screening and after 4, 8, 12, 16 weeks of therapy measured by Cloth Tape Measure Technique

    Measured: Screening, Week 4, Week 8, Week 12, Week 16

  8. Mean BASFI score at screening and after 4, 8, 12, 16 weeks of therapy

    Mean Bath Ankylosing Spondylitis Functional Index (BASFI) score at screening and after 4, 8, 12, 16 weeks of therapy

    Measured: Screening, Week 4, Week 8, Week 12, Week 16

  9. Mean ASDAS-CRP score at screening and after 4, 8, 12, 16 weeks of therapy

    Mean Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) score at screening and after 4, 8, 12, 16 weeks of therapy

    Measured: Screening, Week 4, Week 8, Week 12, Week 16

  10. Mean SF-36 score at screening and after 8 and 16 weeks of therapy

    Mean Short Form-36 (SF36) score at screening and after 8, 16 weeks of therapy

    Measured: Screening, Week 8, Week 16

  11. Mean pain score during a day at screening and after 1, 2, 4, 8, 12, 16 weeks of therapy

    Mean pain score during a day at screening and after 1, 2, 4, 8, 12, 16 weeks of therapy measured by Visual Analog Scale for Pain

    Measured: Screening, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16

  12. Proportion of patients with deterioration of roentgenologic signs of sacroileitis after 16 weeks of treatment

    Measured: Week 16

  13. Mean C-reactive protein concentration at screening and after 4, 8, 12 and 16 weeks of treatment.

    Measured: Screening, Week 4, Week 8, Week 12, Week 16

  14. Frequency of AE/SAE

    Measured: 16 weeks

  15. Frequency of local reactions

    Measured: 16 weeks

  16. Frequency of AE/SAE 3-4 grade CTCAE 4.03

    Measured: 16 weeks

  17. Frequency of withdrawals due to AE/SAE

    Measured: 16 weeks

  18. Cmin

    Minimal concentration of BCD-085 in blood after drug injection

    Measured: 0 to 168 hours post-dose

  19. AUC (0-168h)

    Area under curve from 0 to 168 hours of BCD-085 in blood after drug injection

    Measured: 0 to 168 hours post-dose

  20. AUC0-∞

    Area under curve from 0 to infinity of BCD-085 in blood after drug injection

    Measured: 0 to 168 hours post-dose

  21. Cmax

    Maximal concentration of BCD-085 in blood after drug injection

    Measured: 0 to 168 hours post-dose

  22. Тmax

    Time before Cmax of BCD-085 is reached in blood after drug injection

    Measured: 0 to 168 hours post-dose

  23. Т½

    Half-life of BCD-085 in blood after drug injection

    Measured: 0 to 168 hours post-dose

  24. Кel

    Elimination rate constant of BCD-085 in blood after drug injection

    Measured: 0 to 168 hours post-dose

  25. Cl

    Clearance of BCD-085 in blood after drug injection

    Measured: 0 to 168 hours post-dose

  26. Proportion of patients who developed binding and neutralizing antibodies to BCD-085

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionJun 2017
  4. Study completionJun 2017

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02763111
Sponsor's protocol ID
BCD-085-3
Status last verified
Oct 2021
First submitted
3 Apr 2016
Last updated
1 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Erdes S, Nasonov E, Kunder E, Pristrom A, Soroka N, Shesternya P, Dubinina T, Smakotina S, Raskina T, Krechikova D, Povarova T, Plaksina T, Gordeev I, Mazurov V, Reshetko O, Zonova E, Eremeeva A, Chernyaeva E, Makulova T, Ivanov R. Primary efficacy of netakimab, a novel interleukin-17 inhibitor, in the treatment of active ankylosing spondylitis in adults. Clin Exp Rheumatol. 2020 Jan-Feb;38(1):27-34. Epub 2019 Apr 16.

    PubMed 31025924

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BCD-085 in people with Ankylosing Spondylitis, run by Biocad.

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 10 inclusion and 10 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Ratio of patients with ASAS20 response after 16 weeks of therapy (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 NCT02763111, 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 1 Nov 2021.

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