Back to resultsInternational 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
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
BCD-085
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring interleukin 17, monoclonal antibody, psoriasis
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.
Sites / Locations
- BIOCAD
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
BCD-085, 40 mg
BCD-085, 80 mg
BCD-085, 120 mg
Placebo
Arm Description
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Patients With PASI75 Response After 4 and 8 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 from baseline.
Number of Patients With PASI50 and PASI90 Response After 4, 8 and 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 50 and PASI 90 was defined as patients achieving 50% or more and 90% or more improvement from baseline, respectively.
Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085
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).
Relative (percentage) change in PASI score from baseline (screening) is calculated as 100 x (baseline value - time point t value) / (baseline value)
Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085
The area of skin affected by psoriasis (BSA) is estimated with the palm rule. The area of the human palm without fingers corresponds to about 1% of the body surface.
Relative (percentage) from baseline is calculated as "100 x (baseline value - time point t value) / (baseline value)". If the value decreases from baseline it means improvement.
Relative Change in NAPSI Score After 12 Weeks of Therapy With BCD-085
The NAPSI is used to assign a score to each nail involved, which can vary from 0 to 8. In this study, nail involvement will be assessed only for hands, so the total index of all nails can be from 0 to 80 (only hands). A negative change from baseline indicates improvement.
Relative (percentage) change in NAPSI score from baseline (screening) is calculated as 100 x (baseline value - time point t value) / (baseline value)
Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085
Mean change in severity of pruritus assessed by visual analog scale (from 0 (no itch) to 100 mm (unbearable itch)) after 1, 4, 8 and 12 weeks of treatment with BCD-085
Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085
The sPGA scale is used to assess the psoriatic lesions in a certain patient from 0 (clear) to 5 (very severe). Within each area, the severity is estimated by three criteria (induration, desquamation, and erythema).
Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085
SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being with 2 components (physical health score [PH] and mental component score [MH]). Both scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085
The Dermatology Life Quality Index (DLQI) is a 10-item self-reported survey, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was assessed using a 3-point scale, where score 3 means "very much", score 2 means "a lot", score 1 - "a little", and score 0 - "not at all". If more than two questions were left unanswered, the questionnaire was considered invalid. A total score was calculated by summing the score of all items (total maximum score is 30; total minimum score is 0). The higher score representing greater health-related quality of life impairment.
The mean score change was estimated as the difference between the DLQI at baseline and at the assessed visit (the baseline score was subtracted from the visit score).
Frequency of AE/SAE
Number of participants with AEs and SAEs was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.
Frequency of Local Reactions
Number of participants with local reactions was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.
Frequency of AE/SAE Grade 4 CTCAE 4.03
Number of participants with AEs/SAEs grade 4 CTCAE 4.03 was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.
Frequency of Withdrawal Due to AE/SAE
Number of participants who withdrew due to AEs/SAEs was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02762994
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
interleukin 17, monoclonal antibody, psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BCD-085, 40 mg
Arm Type
Experimental
Arm Description
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Arm Title
BCD-085, 80 mg
Arm Type
Experimental
Arm Description
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Arm Title
BCD-085, 120 mg
Arm Type
Experimental
Arm Description
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Intervention Type
Drug
Intervention Name(s)
BCD-085
Other Intervention Name(s)
monoclonal antibody to interleukin 17
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Patients With PASI 75 Response After 12 Weeks of Therapy
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy
Description
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 from baseline.
Time Frame
Week 4, Week 8
Title
Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy
Description
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 50 and PASI 90 was defined as patients achieving 50% or more and 90% or more improvement from baseline, respectively.
Time Frame
Week 4, Week 8, Week 12
Title
Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085
Description
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).
Relative (percentage) change in PASI score from baseline (screening) is calculated as 100 x (baseline value - time point t value) / (baseline value)
Time Frame
Week 4, Week 8, Week 12
Title
Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085
Description
The area of skin affected by psoriasis (BSA) is estimated with the palm rule. The area of the human palm without fingers corresponds to about 1% of the body surface.
Relative (percentage) from baseline is calculated as "100 x (baseline value - time point t value) / (baseline value)". If the value decreases from baseline it means improvement.
Time Frame
Week 4, Week 8, Week 12
Title
Relative Change in NAPSI Score After 12 Weeks of Therapy With BCD-085
Description
The NAPSI is used to assign a score to each nail involved, which can vary from 0 to 8. In this study, nail involvement will be assessed only for hands, so the total index of all nails can be from 0 to 80 (only hands). A negative change from baseline indicates improvement.
Relative (percentage) change in NAPSI score from baseline (screening) is calculated as 100 x (baseline value - time point t value) / (baseline value)
Time Frame
Week 12
Title
Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085
Description
Mean change in severity of pruritus assessed by visual analog scale (from 0 (no itch) to 100 mm (unbearable itch)) after 1, 4, 8 and 12 weeks of treatment with BCD-085
Time Frame
Week 1, Week 4, Week 8, Week 12
Title
Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085
Description
The sPGA scale is used to assess the psoriatic lesions in a certain patient from 0 (clear) to 5 (very severe). Within each area, the severity is estimated by three criteria (induration, desquamation, and erythema).
Time Frame
Week 4, Week 8, Week 12
Title
Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085
Description
SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being with 2 components (physical health score [PH] and mental component score [MH]). Both scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
Time Frame
Week 4, Week 8, Week 12
Title
Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085
Description
The Dermatology Life Quality Index (DLQI) is a 10-item self-reported survey, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was assessed using a 3-point scale, where score 3 means "very much", score 2 means "a lot", score 1 - "a little", and score 0 - "not at all". If more than two questions were left unanswered, the questionnaire was considered invalid. A total score was calculated by summing the score of all items (total maximum score is 30; total minimum score is 0). The higher score representing greater health-related quality of life impairment.
The mean score change was estimated as the difference between the DLQI at baseline and at the assessed visit (the baseline score was subtracted from the visit score).
Time Frame
Week 4, Week 8, Week 12
Title
Frequency of AE/SAE
Description
Number of participants with AEs and SAEs was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.
Time Frame
14 weeks
Title
Frequency of Local Reactions
Description
Number of participants with local reactions was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.
Time Frame
14 weeks
Title
Frequency of AE/SAE Grade 4 CTCAE 4.03
Description
Number of participants with AEs/SAEs grade 4 CTCAE 4.03 was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.
Time Frame
14 weeks
Title
Frequency of Withdrawal Due to AE/SAE
Description
Number of participants who withdrew due to AEs/SAEs was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Ivanov, PhD
Organizational Affiliation
JCS BIOCAD
Official's Role
Study Chair
Facility Information:
Facility Name
BIOCAD
City
Saint Petersburg
State/Province
Strelna
ZIP/Postal Code
198515
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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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