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

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: Ankylosing Spondylitis
• Intervention / Treatment: Drug: BCD-085; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Chelyabinsk, Russian Federation, 355047
    • Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways"
  • Chelyabinsk, Russian Federation
    • Chelyabinsk Regional Clinical Hospital
  • Kazan, Russian Federation
    • Kazan State Medical University
  • Moscow, Russian Federation
    • State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
  • Omsk, Russian Federation
    • Omsk Regional Clinical Hospital
  • Saint-Petersburg, Russian Federation
    • LLC BioEk
  • St.Petersburg, Russian Federation
    • North-Western State Medical University n.a. I.I.Mechnikov

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: 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
Experimental: BCD-085 (netakimab)	Drug: BCD-085; 120 mg of BCD-085 subcutaneously at week 0,1 and 2 every other week; Other Names: netakimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%)	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASAS20 rate	Percentage of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20%	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	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	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	Week 16, 36, 52
Frequency of AE/SAE	Percentage of patients with AE (adverse events) /SAE (serious adverse events)	Week 60

Collaborators and Investigators

• Sponsor: Biocad

Publications and helpful links

General Publications

• 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. 2022 Aug 31. doi: 10.55563/clinexprheumatol/ljpqqe. Online ahead of print.

Study record dates

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

• Keywords: monoclonal antibody; Ankylosing Spondylitis; interleukin 17; netakimab
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• 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