- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03447704
International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis
February 17, 2023 updated by: Biocad
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
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
228
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Chelyabinsk, Russian Federation, 355047
- Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways"
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Chelyabinsk, Russian Federation
- Chelyabinsk Regional Clinical Hospital
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Kazan, Russian Federation
- Kazan State Medical University
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Moscow, Russian Federation
- State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
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Omsk, Russian Federation
- Omsk Regional Clinical Hospital
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Saint-Petersburg, Russian Federation
- LLC BioEk
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St.Petersburg, Russian Federation
- North-Western State Medical University n.a. I.I.Mechnikov
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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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
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Experimental: BCD-085 (netakimab)
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120 mg of BCD-085 subcutaneously at week 0,1 and 2 every other week
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ASAS40 rate at Week 16
Time Frame: 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%)
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Week 16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ASAS20 rate
Time Frame: Week 4, 8, 12, 16, 24, 36, 52
|
Percentage of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20%
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Week 4, 8, 12, 16, 24, 36, 52
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Change from baseline in BASDAI
Time Frame: Week 4, 8, 12, 16, 24, 36, 52
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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
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Week 4, 8, 12, 16, 24, 36, 52
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Change from baseline in ASDAS-CRP
Time Frame: Week 4, 8, 12, 16, 24, 36, 52
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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
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Week 4, 8, 12, 16, 24, 36, 52
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Change from baseline in SF-36
Time Frame: Week 16, 36, 52
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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
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Week 16, 36, 52
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Frequency of AE/SAE
Time Frame: Week 60
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Percentage of patients with AE (adverse events) /SAE (serious adverse events)
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Week 60
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 9, 2018
Primary Completion (Actual)
December 24, 2018
Study Completion (Anticipated)
April 5, 2023
Study Registration Dates
First Submitted
February 21, 2018
First Submitted That Met QC Criteria
February 21, 2018
First Posted (Actual)
February 27, 2018
Study Record Updates
Last Update Posted (Estimate)
February 20, 2023
Last Update Submitted That Met QC Criteria
February 17, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCD-085-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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