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

Ankylosing Spondylitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03447704
• Other study ID #: BCD-085-5
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 9, 2018
• Est. completion date: April 5, 2023

Study information

• Verified date: February 2023
• Source: Biocad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 228
• Est. completion date: April 5, 2023
• Est. primary completion date: December 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

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

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biocad

Country where clinical trial is conducted

Russian Federation, 

References & 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, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Frequency of AE/SAE	Percentage of patients with AE (adverse events) /SAE (serious adverse events)	Week 60