Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis
NCT02763111 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2021-11-01
Summary
BCD-085-3 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During the trial patients with active ankylosing spondylitis will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12. Efficacy and safety parameters will be evaluated.
Conditions
Interventions
- DRUG
-
BCD-085
- OTHER
-
Placebo
Sponsors & Collaborators
-
Biocad
lead INDUSTRY
Principal Investigators
-
Roman Ivanov, PhD · JCS BIOCAD
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-30
- Primary Completion
- 2017-06-30
- Completion
- 2017-06-30
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