Ankylosing Spondylitis
Conditions
Keywords
Ankylosing Spondylitis, interleukin 17, monoclonal antibody, netakimab
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.
Interventions
DRUGBCD-085
120 mg of BCD-085 subcutaneously at week 0,1 and 2 every other week
OTHERplacebo
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
Sponsors
Biocad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 \>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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Russia
Outcome results
None listed