Status:
COMPLETED
International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis
Lead Sponsor:
Biocad
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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. Durin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT03447704
Start Date
February 9 2018
End Date
March 31 2022
Last Update
July 8 2025
Active Locations (7)
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1
Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways"
Chelyabinsk, Russia, 355047
2
Chelyabinsk Regional Clinical hospital
Chelyabinsk, Russia
3
Kazan State Medical University
Kazan', Russia
4
State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
Moscow, Russia