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

NCT02762994 | Completed Phase 2 Results

• 1 other identifier: BCD-085-2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

interleukin 17; monoclonal antibody; psoriasis

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (13)

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

  Week 4, Week 8

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

  Week 4, Week 8, Week 12

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

  Week 4, Week 8, Week 12

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

  Week 4, Week 8, Week 12

• Relative Change in NAPSI Score After 12 Weeks of Therapy With BCD-085

  Week 12

Study Arms (4)

BCD-085, 40 mg

EXPERIMENTAL

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

Drug: BCD-085

BCD-085, 80 mg

EXPERIMENTAL

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

Drug: BCD-085

BCD-085, 120 mg

EXPERIMENTAL

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

Drug: BCD-085

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

BCD-085 DRUG

Also known as: monoclonal antibody to interleukin 17

BCD-085, 120 mg; BCD-085, 40 mg; BCD-085, 80 mg

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

BIOCAD

Saint Petersburg, Strelna, 198515, Russia

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Nikiforova Aleksandra
• Organization: BIOCAD

nikiforovaan@biocad.ru

+7(812) 380 49 33

Study Officials

• Roman Ivanov, PhD

  JCS BIOCAD

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: May 5, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: March 23, 2021
• Results First Posted: March 23, 2021

Record last verified: 2021-02

Locations

RU (1)