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

Primary Purpose

Ankylosing Spondylitis

Status
Active
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
BCD-085
placebo
Sponsored by
Biocad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Ankylosing Spondylitis, interleukin 17, monoclonal antibody, netakimab

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways"
  • Chelyabinsk Regional Clinical hospital
  • Kazan State Medical University
  • State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
  • Omsk Regional Clinical Hospital
  • LLC BioEk
  • North-Western State Medical University n.a. I.I.Mechnikov

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BCD-085 (netakimab)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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%)

Secondary Outcome Measures

ASAS20 rate
Percentage of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20%
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
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
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
Frequency of AE/SAE
Percentage of patients with AE (adverse events) /SAE (serious adverse events)

Full Information

First Posted
February 21, 2018
Last Updated
February 17, 2023
Sponsor
Biocad
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1. Study Identification

Unique Protocol Identification Number
NCT03447704
Brief Title
International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 9, 2018 (Actual)
Primary Completion Date
December 24, 2018 (Actual)
Study Completion Date
April 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Ankylosing Spondylitis, interleukin 17, monoclonal antibody, netakimab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BCD-085 (netakimab)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BCD-085
Other Intervention Name(s)
netakimab
Intervention Description
120 mg of BCD-085 subcutaneously at week 0,1 and 2 every other week
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
ASAS40 rate at Week 16
Description
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 Outcome Measure Information:
Title
ASAS20 rate
Description
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
Title
Change from baseline in BASDAI
Description
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
Title
Change from baseline in ASDAS-CRP
Description
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
Title
Change from baseline in SF-36
Description
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
Title
Frequency of AE/SAE
Description
Percentage of patients with AE (adverse events) /SAE (serious adverse events)
Time Frame
Week 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Ivanov, PhD
Organizational Affiliation
JSC BIOCAD
Official's Role
Study Chair
Facility Information:
Facility Name
Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways"
City
Chelyabinsk
ZIP/Postal Code
355047
Country
Russian Federation
Facility Name
Chelyabinsk Regional Clinical hospital
City
Chelyabinsk
Country
Russian Federation
Facility Name
Kazan State Medical University
City
Kazan
Country
Russian Federation
Facility Name
State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
City
Moscow
Country
Russian Federation
Facility Name
Omsk Regional Clinical Hospital
City
Omsk
Country
Russian Federation
Facility Name
LLC BioEk
City
Saint-Petersburg
Country
Russian Federation
Facility Name
North-Western State Medical University n.a. I.I.Mechnikov
City
St.Petersburg
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36062743
Citation
Mazurov VI, Dubinina TV, Erdes S, Lapshina SA, Soroka NF, Kunder EV, Smirnov AV, Eremeeva AV, Zinkina-Orikhan AV, Morozova MA, Gaydukova IZ. Response to netakimab in radiographic axial spondyloarthritis patients with different baseline C-reactive protein, sacroiliitis evaluated by MRI and peripheral joint involvement status: a post-hoc analysis of the ASTERA study. Clin Exp Rheumatol. 2023 Mar;41(3):718-726. doi: 10.55563/clinexprheumatol/ljpqqe. Epub 2022 Aug 31.
Results Reference
result

Learn more about this trial

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

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