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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 : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Biocad

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: BCD-085 Other: placebo Phase 3

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: BCD-085 Drug: BCD-085
120 mg of BCD-085 subcutaneously at week 0,1 and 2 every other week
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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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:

  • 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 two or more 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.
Contacts and Locations
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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): NCT03447704


Locations
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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
Sponsors and Collaborators
Biocad
Investigators
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Study Chair: Roman Ivanov, PhD JSC BIOCAD
More Information
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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: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: 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