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

NCT ID: NCT02762994

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-05-31

Brief 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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

BCD-085, 40 mg

Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.

Group Type: EXPERIMENTAL

BCD-085

Intervention Type: DRUG

BCD-085, 80 mg

Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.

Group Type: EXPERIMENTAL

BCD-085

Intervention Type: DRUG

BCD-085, 120 mg

Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.

Group Type: EXPERIMENTAL

BCD-085

Intervention Type: DRUG

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

BCD-085

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Other Intervention Names

monoclonal antibody to interleukin 17

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocad

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roman Ivanov, PhD

Role: STUDY_CHAIR

JCS BIOCAD

Locations

BIOCAD

Saint Petersburg, Strelna, Russia

Countries

Russia

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

BCD-085-2

Identifier Type: -

Identifier Source: org_study_id