International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis

Study Overview
=================
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.

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

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Drug: BCD-085
* Other: placebo


Participation Criteria
=================
Eligibility 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 >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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCD-085 (netakimab)<br> | Drug: BCD-085<br>* 120 mg of BCD-085 subcutaneously at week 0,1 and 2 every other week<br>* Other names: netakimab;|
| Placebo Comparator: Placebo<br> | Other: placebo<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASAS40 rate at 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%) | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASAS20 rate | Percentage of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% | Week 4, 8, 12, 16, 24, 36, 52 | 
| Change from baseline in BASDAI | 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 | Week 4, 8, 12, 16, 24, 36, 52 | 
| Change from baseline in ASDAS-CRP | 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 | Week 4, 8, 12, 16, 24, 36, 52 | 
| Change from baseline in SF-36 | 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 | Week 16, 36, 52 | 
| Frequency of AE/SAE | Percentage of patients with AE (adverse events) /SAE (serious adverse events) | Week 60 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankylosing Spondylitis, interleukin 17, monoclonal antibody, netakimab