Clinical trial NCT03447704: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
interleukin 17
monoclonal antibody
netakimab
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2018-02-27
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: ASAS40 rate at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: ASAS20 rate
timeFrame: Week 4, 8, 12, 16, 24, 36, 52
measure: Change from baseline in BASDAI
timeFrame: Week 4, 8, 12, 16, 24, 36, 52
measure: Change from baseline in ASDAS-CRP
timeFrame: Week 4, 8, 12, 16, 24, 36, 52
measure: Change from baseline in SF-36
timeFrame: Week 16, 36, 52
measure: Frequency of AE/SAE
timeFrame: Week 60
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways"
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical hospital
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Moscow
country: Russian Federation
facility: State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
city: Omsk
country: Russian Federation
facility: Omsk Regional Clinical Hospital
city: Saint-Petersburg
country: Russian Federation
facility: LLC BioEk
city: St.Petersburg
country: Russian Federation
facility: North-Western State Medical University n.a. I.I.Mechnikov
Study officials:
affiliation: JSC BIOCAD
name: Roman Ivanov, PhD
role: STUDY_CHAIR
References:
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.