International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis
- Conditions
- Ankylosing Spondylitis
- Interventions
- Other: placebo
- Registration Number
- NCT03447704
- Lead Sponsor
- Biocad
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 228
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BCD-085 (netakimab) BCD-085 - Placebo placebo -
- Primary Outcome Measures
Name Time Method ASAS40 rate at Week 16 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
Name Time Method ASAS20 rate Week 4, 8, 12, 16, 24, 36, 52 Percentage of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20%
Change from baseline in BASDAI 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
Change from baseline in ASDAS-CRP 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
Change from baseline in SF-36 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
Frequency of AE/SAE Week 60 Percentage of patients with AE (adverse events) /SAE (serious adverse events)
Trial Locations
- Locations (7)
Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways"
🇷🇺Chelyabinsk, Russian Federation
LLC BioEk
🇷🇺Saint-Petersburg, Russian Federation
Kazan State Medical University
🇷🇺Kazan, Russian Federation
North-Western State Medical University n.a. I.I.Mechnikov
🇷🇺St.Petersburg, Russian Federation
Chelyabinsk Regional Clinical hospital
🇷🇺Chelyabinsk, 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