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

Biocad

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Other: Placebo; Drug: BCD-085

Study type: Interventional

Funder types: Industry

Identifiers

NCT02762994

BCD-085-2

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 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.

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.

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.

Treatment:

Drug: BCD-085

Placebo

Placebo Comparator group

Description:

Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.

Treatment:

Other: Placebo