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Trial record 6 of 7 for:    BCD-085

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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ClinicalTrials.gov Identifier: NCT02762994
Recruitment Status : Completed
First Posted : May 5, 2016
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Biocad

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: BCD-085 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: International Multi-center Comparative Randomized 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
Study Start Date : June 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: BCD-085, 40 mg
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Drug: BCD-085
Other Name: monoclonal antibody to interleukin 17

Experimental: BCD-085, 80 mg
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Drug: BCD-085
Other Name: monoclonal antibody to interleukin 17

Experimental: BCD-085, 120 mg
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Drug: BCD-085
Other Name: monoclonal antibody to interleukin 17

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



Primary Outcome Measures :
  1. Ratio of patients with PASI75 response after 12 weeks of therapy [ Time Frame: Week 12 ]
    Ratio of patients who developed a decrease in Psoriasis Area Severity Index (PASI) score by 75% or more after 12 weeks of therapy with BCD-085.


Secondary Outcome Measures :
  1. Ratio of patients with PASI75 response after 4 and 8 weeks of therapy [ Time Frame: Week 4, Week 8 ]
    Ratio of patients who developed a decrease in Psoriasis Area Severity Index (PASI) score by 75% or more after 4 and 8 weeks of therapy with BCD-085.

  2. Ratio of patients with PASI50 and PASI90 response after 4, 8 and 12 weeks of therapy [ Time Frame: Week 4, Week 8, Week 12 ]
    Ratio of patients who developed a decrease in Psoriasis Area Severity Index (PASI) score by 50% or more and by 90% or more after 4, 8 and 12 weeks of therapy with BCD-085.

  3. Relative decrease in PASI score after 4, 8 and 12 weeks of therapy with BCD-085 [ Time Frame: Week 4, Week 8, Week 12 ]
  4. Relative decrease in BSA after 4, 8 and 12 weeks of therapy with BCD-085 [ Time Frame: Week 4, Week 8, Week 12 ]
    Relative decrease in percent of body surface area (BSA), affected by psoriasis (as measured by physician during physical examination of patient), after 4, 8, 12 weeks of therapy with BCD-085.

  5. Relative decrease in NAPSI score after 12 weeks of therapy with BCD-085 [ Time Frame: Week 12 ]
    Relative decrease in Nail Psoriasis Severity Index (NAPSI) score after 12 weeks of therapy with BCD-085.

  6. Mean change in severity of pruritus assessed by visual analog scale after 1, 4, 8 and 12 weeks of treatment with BCD-085 [ Time Frame: Week 1, Week 4, Week 8, Week 12 ]
    Mean change in severity of pruritus assessed by visual analog scale (0 to 100 mm) after 1, 4, 8 and 12 weeks of treatment with BCD-085

  7. Ratio of patients with sPGA response after 4, 8, 12 weeks of treatment with BCD-085 [ Time Frame: Week 4, Week 8, Week 12 ]
    Ratio of patients who have static Physicians Global Assessment (sPGA) score 0 or 1 after 4, 8, 12 weeks of therapy with BCD-085.

  8. Mean change in quality of life assessed by SF-36 after 4, 8 and 12 weeks of treatment with BCD-085 [ Time Frame: Week 4, Week 8, Week 12 ]
    Mean change in quality of life assessed by Short Form-36 (SF-36) questionnaire after 4, 8 and 12 weeks of treatment with BCD-085

  9. Mean change in quality of life assessed by DLQI after 4, 8 and 12 weeks of treatment with BCD-085 [ Time Frame: Week 4, Week 8, Week 12 ]
    Mean change in quality of life assessed by Dermatology Life Quality Index (DLQI) questionnaire after 4, 8 and 12 weeks of treatment with BCD-085

  10. Frequency of AE/SAE [ Time Frame: 14 weeks ]
  11. Frequency of local reactions [ Time Frame: 14 weeks ]
  12. Frequency of AE/SAE grade 4 CTCAE 4.03 [ Time Frame: 14 weeks ]
  13. Frequency of withdrawal due to AE/SAE [ Time Frame: 14 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762994


Locations
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Russian Federation
BIOCAD
Saint Petersburg, Strelna, Russian Federation, 198515
Sponsors and Collaborators
Biocad
Investigators
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Study Chair: Roman Ivanov, PhD JCS BIOCAD

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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT02762994     History of Changes
Other Study ID Numbers: BCD-085-2
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biocad:
interleukin 17
monoclonal antibody
psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs