International Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: BCD-085; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: interleukin 17; monoclonal antibody; psoriasis

Summary:

      BCD-085-2 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal
      antibody to interleukin 17. During BCD-085-2 trial patients with moderate to severe plaque
      psoriasis, in whom poor response to previous treatment including UV-therapy and biologic
      drugs was registered, will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1,
      2, 4, 6, 8, 10. Efficacy and safety parameters will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Age between 18 and 65 years

          -  Diagnosis of plaque psoriasis with stable course of the disease during last 6 months
             prior to enrollment in the study.

          -  Patient have had at least 1 course of phototherapy or systemic therapy of psoriasis or
             are candidates for such treatment.

          -  BSA affected by psoriasis ≥ 10%, PASI score ≥ 12, sPGA score ≥ 3.

          -  If patient have had biologic therapy 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.

          -  Patients are able to perform all procedures planed by protocol.

          -  Patients are ready for contraception with reliable methods starting 2 weeks before
             entering the study, and up to 4 weeks after the last dose of study drug.

        Exclusion Criteria:

          -  Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,
             medication-induced psoriasis, or other skin conditions at the time of the screening
             visit (e.g., eczema) that would interfere with evaluations of the effect of
             investigational product on psoriasis.

          -  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 drugs including methotrexate, sulfasalazin and
             cyclosporin for up to 4 weeks before signing informed consent, 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 phototherapy including selective phototherapy and photochemotherapy for
             up to 4 weeks before signing informed consent.