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

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ClinicalTrials.gov Identifier: NCT02763111
Recruitment Status : Completed
First Posted : May 5, 2016
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Biocad

Brief Summary:
BCD-085-3 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During BCD-085-2 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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: BCD-085 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : September 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BCD-085, 40 mg
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
Drug: BCD-085
Experimental: BCD-085, 80 mg
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
Drug: BCD-085
Experimental: BCD-085, 120 mg
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
Drug: BCD-085
Placebo Comparator: Placebo
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
Other: Placebo



Primary Outcome Measures :
  1. Ratio of patients with ASAS20 response after 16 weeks of therapy [ Time Frame: Week 16 ]
    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.


Secondary Outcome Measures :
  1. Ratio of patients with ASAS20 response after 4, 8, 12 weeks of therapy [ Time Frame: Week 4, Week 8, Week 12 ]
    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.

  2. Ratio of patients with ASAS40 response after 4, 8, 12, 16 weeks of therapy [ Time Frame: Week 4, Week 8, Week 12, Week 16 ]
    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.

  3. Ratio of patients with ASAS5/6 response after 4, 8, 12, 16 weeks of therapy [ Time Frame: Week 4, Week 8, Week 12, Week 16 ]
    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.

  4. Mean BASDAI score at screening and after 4, 8, 12, 16 weeks of therapy [ Time Frame: Screening, Week 4, Week 8, Week 12, Week 16 ]
    Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score at screening and after 4, 8, 12, 16 weeks of therapy

  5. Mean BASMI score at screening and after 4, 8, 12, 16 weeks of therapy [ Time Frame: Screening, Week 4, Week 8, Week 12, Week 16 ]
    Mean Bath Ankylosing Spondylitis Metrology Index (BASMI) score at screening and after 4, 8, 12, 16 weeks of therapy

  6. Mean MASES score at screening and after 4, 8, 12, 16 weeks of therapy [ Time Frame: Screening, Week 4, Week 8, Week 12, Week 16 ]
    Mean Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at screening and after 4, 8, 12, 16 weeks of therapy

  7. Mean chest excursion at screening and after 4, 8, 12, 16 weeks of therapy [ Time Frame: Screening, Week 4, Week 8, Week 12, Week 16 ]
    Mean chest excursion at screening and after 4, 8, 12, 16 weeks of therapy measured by Cloth Tape Measure Technique

  8. Mean BASFI score at screening and after 4, 8, 12, 16 weeks of therapy [ Time Frame: Screening, Week 4, Week 8, Week 12, Week 16 ]
    Mean Bath Ankylosing Spondylitis Functional Index (BASFI) score at screening and after 4, 8, 12, 16 weeks of therapy

  9. Mean ASDAS-CRP score at screening and after 4, 8, 12, 16 weeks of therapy [ Time Frame: Screening, Week 4, Week 8, Week 12, Week 16 ]
    Mean Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) score at screening and after 4, 8, 12, 16 weeks of therapy

  10. Mean SF-36 score at screening and after 8 and 16 weeks of therapy [ Time Frame: Screening, Week 8, Week 16 ]
    Mean Short Form-36 (SF36) score at screening and after 8, 16 weeks of therapy

  11. Mean pain score during a day at screening and after 1, 2, 4, 8, 12, 16 weeks of therapy [ Time Frame: Screening, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16 ]
    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

  12. Proportion of patients with deterioration of roentgenologic signs of sacroileitis after 16 weeks of treatment [ Time Frame: Week 16 ]
  13. Mean C-reactive protein concentration at screening and after 4, 8, 12 and 16 weeks of treatment. [ Time Frame: Screening, Week 4, Week 8, Week 12, Week 16 ]
  14. Frequency of AE/SAE [ Time Frame: 16 weeks ]
  15. Frequency of local reactions [ Time Frame: 16 weeks ]
  16. Frequency of AE/SAE 3-4 grade CTCAE 4.03 [ Time Frame: 16 weeks ]
  17. Frequency of withdrawals due to AE/SAE [ Time Frame: 16 weeks ]
  18. Cmin [ Time Frame: 0 to 168 hours post-dose ]
    Minimal concentration of BCD-085 in blood after drug injection

  19. AUC (0-168h) [ Time Frame: 0 to 168 hours post-dose ]
    Area under curve from 0 to 168 hours of BCD-085 in blood after drug injection

  20. AUC0-∞ [ Time Frame: 0 to 168 hours post-dose ]
    Area under curve from 0 to infinity of BCD-085 in blood after drug injection

  21. Cmax [ Time Frame: 0 to 168 hours post-dose ]
    Maximal concentration of BCD-085 in blood after drug injection

  22. Тmax [ Time Frame: 0 to 168 hours post-dose ]
    Time before Cmax of BCD-085 is reached in blood after drug injection

  23. Т½ [ Time Frame: 0 to 168 hours post-dose ]
    Half-life of BCD-085 in blood after drug injection

  24. Кel [ Time Frame: 0 to 168 hours post-dose ]
    Elimination rate constant of BCD-085 in blood after drug injection

  25. Cl [ Time Frame: 0 to 168 hours post-dose ]
    Clearance of BCD-085 in blood after drug injection

  26. Proportion of patients who developed binding and neutralizing antibodies to BCD-085 [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

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): NCT02763111


Sponsors and Collaborators
Biocad
Investigators
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Study Chair: Roman Ivanov, PhD JCS BIOCAD

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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT02763111     History of Changes
Other Study ID Numbers: BCD-085-3
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Biocad:
ankylosing spondylitis
interleukin 17
monoclonal antibody

Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis