Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis

Biocad88 enrolled

Overview

BCD-085-3 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During the trial patients with active ankylosing spondylitis will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12. Efficacy and safety parameters will be evaluated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Ankylosing Spondylitis

Interventions

BCD-085DRUG

PlaceboOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent * Age between 18 and 65 years * 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. * If patient have had biologic therapy to treat ankylosing spondylitis for at least 3 months, there was no positive results of such treatment or patient revealed intolerance to the drug. This therapy must be discontinued at least 12 weeks before enrollment in the study. * Female patients have negative urine pregnancy test. * Patient has no history of tuberculosis. * Patients have negative results of Diaskintest. * Patient has no history of alcohol or drug abuse. Exclusion Criteria: * Total spinal ankylosis. * Allergy or intolerance of monoclonal antibodies or any excipients of study drugs. * Previous receipt of anti-interleukin 17 drugs or anti-interleukin 17 receptor drugs. * Prior use of two or more biologics to tumor necrosis factor alfa. * Prior use of two or more biologics to other targets. Previous receipt of monoclonal antibodies if they were cancelled less that in 12 weeks before signing informed consent. * Patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent and during screening, or in a dose less than 10 mg (recalculated to prednisolone) if it was not stable. * Prior use of disease-modifying antirheumatic drugs including methotrexate, sulfasalazin, chloroquine or hydroxychloroquine for up to 4 weeks before randomization, if their dose was not stable for up to 4 weeks before signing informed consent and during screening. * 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. * Intraarticular use of corticosteroids for up to 4 weeks before randomization.

Outcomes

Primary Outcomes

Ratio of patients with ASAS20 response after 16 weeks of therapy

Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% or more after 16 weeks of therapy with BCD-085.

Time frame: Week 16

Secondary Outcomes

Ratio of patients with ASAS20 response after 4, 8, 12 weeks of therapy

Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% or more after 4, 8, 12 weeks of therapy with BCD-085.

Time frame: Week 4, Week 8, Week 12

Ratio of patients with ASAS40 response after 4, 8, 12, 16 weeks of therapy

Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 40% or more after 4, 8, 12, 16 weeks of therapy with BCD-085.

Time frame: Week 4, Week 8, Week 12, Week 16

Ratio of patients with ASAS5/6 response after 4, 8, 12, 16 weeks of therapy

Ratio of patients who developed a response in at least 5 of 6 criteria of ankylosing spondylitis assessment score (ASAS) after 4, 8, 12, 16 weeks of therapy with BCD-085.

Time frame: Week 4, Week 8, Week 12, Week 16

Mean BASDAI score at screening and after 4, 8, 12, 16 weeks of therapy

Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score at screening and after 4, 8, 12, 16 weeks of therapy

Time frame: Screening, Week 4, Week 8, Week 12, Week 16

Mean BASMI score at screening and after 4, 8, 12, 16 weeks of therapy

Mean Bath Ankylosing Spondylitis Metrology Index (BASMI) score at screening and after 4, 8, 12, 16 weeks of therapy

Time frame: Screening, Week 4, Week 8, Week 12, Week 16

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.