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

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biocad
• Treatments: Antibodies; Antibodies, Monoclonal

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.