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

Biocad120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Psoriasis

Interventions

BCD-085DRUG

PlaceboOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

BIOCAD

Saint Petersburg, Strelna, Russia

Outcomes

Primary Outcomes

Number of Patients With PASI 75 Response After 12 Weeks of Therapy

The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI: 0 (no disease) to 72 (maximal disease). The proportion of patients with PASI 75 was defined as patients achieving 75% or more improvement at Week 12 of therapy with BCD-085 from baseline.

Time frame: 12 weeks

Secondary Outcomes

Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy

Time frame: Week 4, Week 8

Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy

The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI: 0 (no disease) to 72 (maximal disease). The proportion of patients with PASI 50 and PASI 90 was defined as patients achieving 50% or more and 90% or more improvement from baseline, respectively.

Time frame: Week 4, Week 8, Week 12

Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085

The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI: 0 (no disease) to 72 (maximal disease). Relative (percentage) change in PASI score from baseline (screening) is calculated as 100 x (baseline value - time point t value) / (baseline value)

Data from ClinicalTrials.gov

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