Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis

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Status and phase

Completed
Phase 2

Conditions

Ankylosing Spondylitis

Treatments

Other: Placebo
Drug: BCD-085

Study type

Interventional

Funder types

Industry

Identifiers

NCT02763111
BCD-085-3

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Written informed consent
  • Age between 18 and 65 years
  • 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.
  • If patient have had biologic therapy to treat ankylosing spondylitis for at least 3 months, there was no positive results of such treatment or patient revealed intolerance to the drug. This therapy must be discontinued at least 12 weeks before enrollment in the study.
  • Female patients have negative urine pregnancy test.
  • Patient has no history of tuberculosis.
  • Patients have negative results of Diaskintest.
  • Patient has no history of alcohol or drug abuse.

Exclusion criteria

  • Total spinal ankylosis.
  • Allergy or intolerance of monoclonal antibodies or any excipients of study drugs.
  • Previous receipt of anti-interleukin 17 drugs or anti-interleukin 17 receptor drugs.
  • Prior use of two or more biologics to tumor necrosis factor alfa.
  • Prior use of two or more biologics to other targets. Previous receipt of monoclonal antibodies if they were cancelled less that in 12 weeks before signing informed consent.
  • Patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent and during screening, or in a dose less than 10 mg (recalculated to prednisolone) if it was not stable.
  • Prior use of disease-modifying antirheumatic drugs including methotrexate, sulfasalazin, chloroquine or hydroxychloroquine for up to 4 weeks before randomization, if their dose was not stable for up to 4 weeks before signing informed consent and during screening.
  • 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.
  • Intraarticular use of corticosteroids for up to 4 weeks before randomization.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

88 participants in 4 patient groups, including a placebo group

BCD-085, 40 mg
Experimental group
Description:
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
Treatment:
Drug: BCD-085
BCD-085, 80 mg
Experimental group
Description:
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
Treatment:
Drug: BCD-085
BCD-085, 120 mg
Experimental group
Description:
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
Treatment:
Drug: BCD-085
Placebo
Placebo Comparator group
Description:
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
Treatment:
Other: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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