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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 February 2023
• Main ID: NCT03447704
• Date of registration: 21/02/2018
• Prospective Registration: No
• Primary sponsor: Biocad
• Public title: International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis
• Scientific 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
• Date of first enrolment: February 9, 2018
• Target sample size: 228
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03447704
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Russian Federation

Contacts

• Name: Roman Ivanov, PhD
• Affiliation: JSC BIOCAD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Other: placebo

Drug: BCD-085

Primary Outcome(s)

ASAS40 rate at Week 16 [Time Frame: Week 16]

Secondary Outcome(s)

Frequency of AE/SAE [Time Frame: Week 60]

Change from baseline in BASDAI [Time Frame: Week 4, 8, 12, 16, 24, 36, 52]

Change from baseline in SF-36 [Time Frame: Week 16, 36, 52]

Change from baseline in ASDAS-CRP [Time Frame: Week 4, 8, 12, 16, 24, 36, 52]

ASAS20 rate [Time Frame: Week 4, 8, 12, 16, 24, 36, 52]

Secondary ID(s)

BCD-085-5

Source(s) of Monetary Support

Please refer to primary and secondary sponsors