NCT03447704

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2018

Typical duration for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 9, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2018

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

February 21, 2018

Last Update Submit

July 7, 2025

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitisinterleukin 17monoclonal antibodynetakimab

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • ASAS20 rate

    Week 4, 8, 12, 16, 24, 36, 52

  • Change from baseline in BASDAI

    Week 4, 8, 12, 16, 24, 36, 52

  • Change from baseline in ASDAS-CRP

    Week 4, 8, 12, 16, 24, 36, 52

  • Change from baseline in SF-36

    Week 16, 36, 52

  • Frequency of AE/SAE

    Week 60

Study Arms (2)

BCD-085 (netakimab)

EXPERIMENTAL
Drug: BCD-085

Placebo

PLACEBO COMPARATOR
Other: placebo

Interventions

BCD-085DRUG

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

Also known as: netakimab
BCD-085 (netakimab)
placeboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways"

Chelyabinsk, 355047, Russia

Location

Chelyabinsk Regional Clinical hospital

Chelyabinsk, Russia

Location

Kazan State Medical University

Kazan', Russia

Location

State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University

Moscow, Russia

Location

Omsk Regional Clinical Hospital

Omsk, Russia

Location

LLC BioEk

Saint Petersburg, Russia

Location

North-Western State Medical University n.a. I.I.Mechnikov

Saint Petersburg, Russia

Location

Related Publications (1)

  • 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.

    PMID: 36062743RESULT

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

netakimab

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Officials

  • Roman Ivanov, PhD

    JSC BIOCAD

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2018

First Posted

February 27, 2018

Study Start

February 9, 2018

Primary Completion

December 24, 2018

Study Completion

March 31, 2022

Last Updated

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

RU(7)