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

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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

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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