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

Biocad228 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

228

Conditions

Ankylosing Spondylitis

Interventions

BCD-085DRUG

120 mg of BCD-085 subcutaneously at week 0,1 and 2 every other week

placeboOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (7)

Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways"

Chelyabinsk, Russia

Chelyabinsk Regional Clinical hospital

Chelyabinsk, Russia

Kazan State Medical University

Kazan', Russia

State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University

Outcomes

Primary Outcomes

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%)

Time frame: Week 16

Secondary Outcomes

ASAS20 rate

Percentage of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20%

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Week 16, 36, 52

Frequency of AE/SAE

Percentage of patients with AE (adverse events) /SAE (serious adverse events)

Time frame: Week 60

Data from ClinicalTrials.gov

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