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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-09

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02763111

Ankylosing Spondylitis

COMPLETED PHASE2

Clinical Study of Efficacy and Safety of BCD-085 (Monoclonal Anti-IL-17 Antibody) in Psoriatic Arthritis

NCT03598751

Psoriatic Arthritis

COMPLETED PHASE3

A Study of the Efficacy and Tolerance of Remicade in the Treatment of Active Ankylosing Spondylitis (Study P04042)(COMPLETED)

NCT00779012

Spondylitis, Ankylosing

COMPLETED PHASE4

The BCD-089 (aIL6R) in Patients With Active Rheumatoid Arthritis

NCT03455842

Seropositive RA

COMPLETED PHASE2

A Clinical Study of JS005 in Patients With Ankylosing Spondylitis

NCT06250062

Ankylosing Spondylitis

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ankylosing Spondylitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BCD-085 (netakimab)

Group Type EXPERIMENTAL

BCD-085

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BCD-085

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

Intervention Type DRUG

placebo

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

netakimab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No