Psoriasis
Conditions
Keywords
interleukin 17, monoclonal antibody, psoriasis
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.
Interventions
DRUGBCD-085
OTHERPlacebo
Sponsors
Biocad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With PASI 75 Response After 12 Weeks of Therapy | 12 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Week 4, Week 8, Week 12 | 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 | Week 4, Week 8, Week 12 | 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 | Week 4, Week 8, Week 12 | 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 | Week 12 | 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 | Week 1, Week 4, Week 8, Week 12 | 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 | Week 4, Week 8, Week 12 | 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). |
| Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy | Week 4, Week 8 | 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. |
| Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085 | Week 4, Week 8, Week 12 | 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 | 14 weeks | 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 | 14 weeks | 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 | 14 weeks | 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 | 14 weeks | 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. |
| Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Week 4, Week 8, Week 12 | 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. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BCD-085, 40 mg Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085 | 30 |
| BCD-085, 80 mg Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085 | 30 |
| BCD-085, 120 mg Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085 | 28 |
| Placebo Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Placebo | 26 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | BCD-085, 80 mg | Total | Placebo | BCD-085, 120 mg | BCD-085, 40 mg |
|---|---|---|---|---|---|
| Age, Continuous | 35.00 years | 40.50 years | 41.50 years | 45.00 years | 41.50 years |
| BMI | 26.85 kg/m^2 | 26.23 kg/m^2 | 24.95 kg/m^2 | 29.72 kg/m^2 | 25.81 kg/m^2 |
| Body weight | 80.50 kg | 82.00 kg | 77.55 kg | 87.25 kg | 82.00 kg |
| Height | 173.00 cm | 176.00 cm | 175.00 cm | 177.00 cm | 178.50 cm |
| Number of Women With Child Bearing Potential | 8 participants | 25 participants | 8 participants | 4 participants | 5 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 114 Participants | 26 Participants | 28 Participants | 30 Participants |
| Sex: Female, Male Female | 11 Participants | 35 Participants | 11 Participants | 6 Participants | 7 Participants |
| Sex: Female, Male Male | 19 Participants | 79 Participants | 15 Participants | 22 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 14 / 31 | 11 / 30 | 7 / 28 | 11 / 28 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 | 0 / 28 | 0 / 28 |
Outcome results
Primary
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.
Time frame: 12 weeks
Population: The efficacy analysis was planned to include all patients who received at least one dose of BCD-085/placebo and who attended at least one post-dose visit. The efficacy population comprised of 114 patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BCD-085, 40 mg | Number of Patients With PASI 75 Response After 12 Weeks of Therapy | 24 Participants |
| BCD-085, 80 mg | Number of Patients With PASI 75 Response After 12 Weeks of Therapy | 25 Participants |
| BCD-085, 120 mg | Number of Patients With PASI 75 Response After 12 Weeks of Therapy | 26 Participants |
| Placebo | Number of Patients With PASI 75 Response After 12 Weeks of Therapy | 6 Participants |
Secondary
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.
Time frame: 14 weeks
Population: The safety analysis included all patients who received at least one dose of BCD-085 (31 in Arm 1, 30 in Arm 2, and 28 in each of arms 3 and 4, with the total number n=117).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BCD-085, 40 mg | Frequency of AE/SAE | Any AEs/SAEs | 14 Participants |
| BCD-085, 40 mg | Frequency of AE/SAE | Therapy-related AEs/SAEs | 6 Participants |
| BCD-085, 40 mg | Frequency of AE/SAE | AEs, grade 3 | 1 Participants |
| BCD-085, 40 mg | Frequency of AE/SAE | Therapy-related AEs, grade 3 | 1 Participants |
| BCD-085, 80 mg | Frequency of AE/SAE | Therapy-related AEs/SAEs | 3 Participants |
| BCD-085, 80 mg | Frequency of AE/SAE | AEs, grade 3 | 1 Participants |
| BCD-085, 80 mg | Frequency of AE/SAE | Therapy-related AEs, grade 3 | 1 Participants |
| BCD-085, 80 mg | Frequency of AE/SAE | Any AEs/SAEs | 11 Participants |
| BCD-085, 120 mg | Frequency of AE/SAE | AEs, grade 3 | 1 Participants |
| BCD-085, 120 mg | Frequency of AE/SAE | Therapy-related AEs/SAEs | 2 Participants |
| BCD-085, 120 mg | Frequency of AE/SAE | Therapy-related AEs, grade 3 | 0 Participants |
| BCD-085, 120 mg | Frequency of AE/SAE | Any AEs/SAEs | 7 Participants |
| Placebo | Frequency of AE/SAE | Therapy-related AEs, grade 3 | 0 Participants |
| Placebo | Frequency of AE/SAE | Therapy-related AEs/SAEs | 3 Participants |
| Placebo | Frequency of AE/SAE | Any AEs/SAEs | 11 Participants |
| Placebo | Frequency of AE/SAE | AEs, grade 3 | 2 Participants |
Secondary
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.
Time frame: 14 weeks
Population: The safety analysis included all patients who received at least one dose of BCD-085 (31 in Arm 1, 30 in Arm 2, and 28 in each of arms 3 and 4, with the total number n=117).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BCD-085, 40 mg | Frequency of AE/SAE Grade 4 CTCAE 4.03 | Any AEs, grade 4 | 0 Participants |
| BCD-085, 40 mg | Frequency of AE/SAE Grade 4 CTCAE 4.03 | Any SAEs | 0 Participants |
| BCD-085, 80 mg | Frequency of AE/SAE Grade 4 CTCAE 4.03 | Any SAEs | 0 Participants |
| BCD-085, 80 mg | Frequency of AE/SAE Grade 4 CTCAE 4.03 | Any AEs, grade 4 | 0 Participants |
| BCD-085, 120 mg | Frequency of AE/SAE Grade 4 CTCAE 4.03 | Any AEs, grade 4 | 0 Participants |
| BCD-085, 120 mg | Frequency of AE/SAE Grade 4 CTCAE 4.03 | Any SAEs | 0 Participants |
| Placebo | Frequency of AE/SAE Grade 4 CTCAE 4.03 | Any AEs, grade 4 | 0 Participants |
| Placebo | Frequency of AE/SAE Grade 4 CTCAE 4.03 | Any SAEs | 0 Participants |
Secondary
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.
Time frame: 14 weeks
Population: The safety analysis included all patients who received at least one dose of BCD-085 (31 in Arm 1, 30 in Arm 2, and 28 in each of arms 3 and 4, with the total number n=117).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BCD-085, 40 mg | Frequency of Local Reactions | 1 Participants |
| BCD-085, 80 mg | Frequency of Local Reactions | 0 Participants |
| BCD-085, 120 mg | Frequency of Local Reactions | 0 Participants |
| Placebo | Frequency of Local Reactions | 0 Participants |
Secondary
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.
Time frame: 14 weeks
Population: The safety analysis included all patients who received at least one dose of BCD-085 (31 in Arm 1, 30 in Arm 2, and 28 in each of arms 3 and 4, with the total number n=117).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BCD-085, 40 mg | Frequency of Withdrawal Due to AE/SAE | 0 Participants |
| BCD-085, 80 mg | Frequency of Withdrawal Due to AE/SAE | 0 Participants |
| BCD-085, 120 mg | Frequency of Withdrawal Due to AE/SAE | 0 Participants |
| Placebo | Frequency of Withdrawal Due to AE/SAE | 0 Participants |
Secondary
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).
Time frame: Week 4, Week 8, Week 12
Population: The efficacy analysis was planned to include all patients who received at least one dose of BCD-085/placebo and who attended at least one post-dose visit. The efficacy population comprised of 114 patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BCD-085, 40 mg | Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the DLQI score, Week 4 | -9.833 units on a scale | Standard Deviation 7.292 |
| BCD-085, 40 mg | Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the DLQI score, Week 12 | -13.700 units on a scale | Standard Deviation 7.901 |
| BCD-085, 40 mg | Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the DLQI score, Week 8 | -11.967 units on a scale | Standard Deviation 7.462 |
| BCD-085, 80 mg | Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the DLQI score, Week 4 | -9.000 units on a scale | Standard Deviation 6.988 |
| BCD-085, 80 mg | Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the DLQI score, Week 12 | -12.333 units on a scale | Standard Deviation 7.369 |
| BCD-085, 80 mg | Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the DLQI score, Week 8 | -11.133 units on a scale | Standard Deviation 7.38 |
| BCD-085, 120 mg | Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the DLQI score, Week 8 | -10.679 units on a scale | Standard Deviation 5.157 |
| BCD-085, 120 mg | Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the DLQI score, Week 4 | -8.143 units on a scale | Standard Deviation 5.662 |
| BCD-085, 120 mg | Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the DLQI score, Week 12 | -10.107 units on a scale | Standard Deviation 7.809 |
| Placebo | Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the DLQI score, Week 4 | -4.308 units on a scale | Standard Deviation 7.121 |
| Placebo | Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the DLQI score, Week 12 | -5.654 units on a scale | Standard Deviation 7.402 |
| Placebo | Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the DLQI score, Week 8 | -4.846 units on a scale | Standard Deviation 7.619 |
Secondary
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.
Time frame: Week 4, Week 8, Week 12
Population: The efficacy analysis was planned to include all patients who received at least one dose of BCD-085/placebo and who attended at least one post-dose visit. The efficacy population comprised of 114 patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BCD-085, 40 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the PH score from baseline, Week 4 | 3.740 units on a scale | Standard Deviation 8.929 |
| BCD-085, 40 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the PH score from baseline, Week 8 | 4.763 units on a scale | Standard Deviation 9.311 |
| BCD-085, 40 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the PH score from baseline, Week 12 | 5.117 units on a scale | Standard Deviation 8.731 |
| BCD-085, 40 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the MH score from baseline, Week 4 | 6.633 units on a scale | Standard Deviation 7.02 |
| BCD-085, 40 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the MH score from baseline, Week 8 | 8.773 units on a scale | Standard Deviation 9.176 |
| BCD-085, 40 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the MH score from baseline, Week 12 | 10.437 units on a scale | Standard Deviation 8.939 |
| BCD-085, 80 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the MH score from baseline, Week 12 | 8.693 units on a scale | Standard Deviation 10.551 |
| BCD-085, 80 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the MH score from baseline, Week 4 | 7.387 units on a scale | Standard Deviation 9.915 |
| BCD-085, 80 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the PH score from baseline, Week 4 | 1.957 units on a scale | Standard Deviation 8.691 |
| BCD-085, 80 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the PH score from baseline, Week 12 | 1.820 units on a scale | Standard Deviation 10.255 |
| BCD-085, 80 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the PH score from baseline, Week 8 | 3.647 units on a scale | Standard Deviation 8.886 |
| BCD-085, 80 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the MH score from baseline, Week 8 | 8.443 units on a scale | Standard Deviation 10.287 |
| BCD-085, 120 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the PH score from baseline, Week 8 | 7.457 units on a scale | Standard Deviation 9.115 |
| BCD-085, 120 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the PH score from baseline, Week 12 | 7.804 units on a scale | Standard Deviation 8.574 |
| BCD-085, 120 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the MH score from baseline, Week 4 | 4.196 units on a scale | Standard Deviation 11.329 |
| BCD-085, 120 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the MH score from baseline, Week 12 | 5.686 units on a scale | Standard Deviation 9.925 |
| BCD-085, 120 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the MH score from baseline, Week 8 | 6.364 units on a scale | Standard Deviation 9.946 |
| BCD-085, 120 mg | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the PH score from baseline, Week 4 | 6.943 units on a scale | Standard Deviation 9.347 |
| Placebo | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the MH score from baseline, Week 8 | 2.792 units on a scale | Standard Deviation 9.677 |
| Placebo | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the MH score from baseline, Week 12 | 3.004 units on a scale | Standard Deviation 11.361 |
| Placebo | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the PH score from baseline, Week 8 | 0.992 units on a scale | Standard Deviation 10.703 |
| Placebo | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the MH score from baseline, Week 4 | 3.327 units on a scale | Standard Deviation 12.181 |
| Placebo | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the PH score from baseline, Week 4 | 2.923 units on a scale | Standard Deviation 8.185 |
| Placebo | Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes of the PH score from baseline, Week 12 | 3.465 units on a scale | Standard Deviation 9.437 |
Secondary
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
Time frame: Week 1, Week 4, Week 8, Week 12
Population: The efficacy analysis was planned to include all patients who received at least one dose of BCD-085/placebo and who attended at least one post-dose visit. The efficacy population comprised of 114 patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BCD-085, 40 mg | Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes in the intensity of pruritus, Week 1 | -19.600 units on a scale | Standard Deviation 23.562 |
| BCD-085, 40 mg | Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes in the intensity of pruritus, Week 4 | -34.767 units on a scale | Standard Deviation 24.996 |
| BCD-085, 40 mg | Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes in the intensity of pruritus, Week 8 | -38.533 units on a scale | Standard Deviation 25.871 |
| BCD-085, 40 mg | Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes in the intensity of pruritus, Week 12 | -39.533 units on a scale | Standard Deviation 26.432 |
| BCD-085, 80 mg | Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes in the intensity of pruritus, Week 4 | -33.700 units on a scale | Standard Deviation 31.682 |
| BCD-085, 80 mg | Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes in the intensity of pruritus, Week 8 | -35.633 units on a scale | Standard Deviation 34.927 |
| BCD-085, 80 mg | Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes in the intensity of pruritus, Week 12 | -40.700 units on a scale | Standard Deviation 30.563 |
| BCD-085, 80 mg | Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes in the intensity of pruritus, Week 1 | -25.367 units on a scale | Standard Deviation 29.678 |
| BCD-085, 120 mg | Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes in the intensity of pruritus, Week 8 | -47.304 units on a scale | Standard Deviation 33.431 |
| BCD-085, 120 mg | Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes in the intensity of pruritus, Week 4 | -43.214 units on a scale | Standard Deviation 30.927 |
| BCD-085, 120 mg | Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes in the intensity of pruritus, Week 12 | -48.214 units on a scale | Standard Deviation 30.839 |
| BCD-085, 120 mg | Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes in the intensity of pruritus, Week 1 | -26.071 units on a scale | Standard Deviation 29.034 |
| Placebo | Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes in the intensity of pruritus, Week 12 | -18.269 units on a scale | Standard Deviation 34.898 |
| Placebo | Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes in the intensity of pruritus, Week 4 | -13.269 units on a scale | Standard Deviation 32.863 |
| Placebo | Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes in the intensity of pruritus, Week 1 | -14.269 units on a scale | Standard Deviation 34.582 |
| Placebo | Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 | Changes in the intensity of pruritus, Week 8 | -15.538 units on a scale | Standard Deviation 34.195 |
Secondary
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.
Time frame: Week 4, Week 8, Week 12
Population: The efficacy analysis was planned to include all patients who received at least one dose of BCD-085/placebo and who attended at least one post-dose visit. The efficacy population comprised of 114 patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BCD-085, 40 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 50 achievers, Week 4 | 19 Participants |
| BCD-085, 40 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 50 achievers,Week 8 | 29 Participants |
| BCD-085, 40 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 50 achievers,Week 12 | 29 Participants |
| BCD-085, 40 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 90 achievers, Week 4 | 1 Participants |
| BCD-085, 40 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 90 achievers, Week 8 | 14 Participants |
| BCD-085, 40 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 90 achievers, Week 12 | 20 Participants |
| BCD-085, 80 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 90 achievers, Week 12 | 18 Participants |
| BCD-085, 80 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 90 achievers, Week 4 | 2 Participants |
| BCD-085, 80 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 50 achievers, Week 4 | 22 Participants |
| BCD-085, 80 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 50 achievers,Week 12 | 30 Participants |
| BCD-085, 80 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 50 achievers,Week 8 | 27 Participants |
| BCD-085, 80 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 90 achievers, Week 8 | 12 Participants |
| BCD-085, 120 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 50 achievers,Week 8 | 27 Participants |
| BCD-085, 120 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 50 achievers,Week 12 | 28 Participants |
| BCD-085, 120 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 90 achievers, Week 4 | 6 Participants |
| BCD-085, 120 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 90 achievers, Week 12 | 22 Participants |
| BCD-085, 120 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 90 achievers, Week 8 | 15 Participants |
| BCD-085, 120 mg | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 50 achievers, Week 4 | 16 Participants |
| Placebo | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 90 achievers, Week 8 | 2 Participants |
| Placebo | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 90 achievers, Week 12 | 5 Participants |
| Placebo | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 50 achievers,Week 8 | 6 Participants |
| Placebo | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 90 achievers, Week 4 | 0 Participants |
| Placebo | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 50 achievers, Week 4 | 4 Participants |
| Placebo | Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy | Proportion of PASI 50 achievers,Week 12 | 12 Participants |
Secondary
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.
Time frame: Week 4, Week 8
Population: The efficacy analysis was planned to include all patients who received at least one dose of BCD-085/placebo and who attended at least one post-dose visit. The efficacy population comprised of 114 patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BCD-085, 40 mg | Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy | Week 8 | 22 Participants |
| BCD-085, 40 mg | Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy | Week 4 | 9 Participants |
| BCD-085, 80 mg | Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy | Week 8 | 19 Participants |
| BCD-085, 80 mg | Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy | Week 4 | 10 Participants |
| BCD-085, 120 mg | Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy | Week 4 | 9 Participants |
| BCD-085, 120 mg | Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy | Week 8 | 20 Participants |
| Placebo | Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy | Week 8 | 3 Participants |
| Placebo | Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy | Week 4 | 2 Participants |
Secondary
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).
Time frame: Week 4, Week 8, Week 12
Population: The efficacy analysis was planned to include all patients who received at least one dose of BCD-085/placebo and who attended at least one post-dose visit. The efficacy population comprised of 114 patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BCD-085, 40 mg | Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085 | sPGA score 0 or 1, Week 4 | 10 Participants |
| BCD-085, 40 mg | Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085 | sPGA score 0 or 1, Week 12 | 25 Participants |
| BCD-085, 40 mg | Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085 | sPGA score 0 or 1, Week 8 | 21 Participants |
| BCD-085, 80 mg | Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085 | sPGA score 0 or 1, Week 4 | 11 Participants |
| BCD-085, 80 mg | Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085 | sPGA score 0 or 1, Week 12 | 27 Participants |
| BCD-085, 80 mg | Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085 | sPGA score 0 or 1, Week 8 | 19 Participants |
| BCD-085, 120 mg | Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085 | sPGA score 0 or 1, Week 8 | 21 Participants |
| BCD-085, 120 mg | Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085 | sPGA score 0 or 1, Week 4 | 8 Participants |
| BCD-085, 120 mg | Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085 | sPGA score 0 or 1, Week 12 | 25 Participants |
| Placebo | Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085 | sPGA score 0 or 1, Week 4 | 2 Participants |
| Placebo | Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085 | sPGA score 0 or 1, Week 12 | 8 Participants |
| Placebo | Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085 | sPGA score 0 or 1, Week 8 | 4 Participants |
Secondary
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.
Time frame: Week 4, Week 8, Week 12
Population: The efficacy population comprised of 114 patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BCD-085, 40 mg | Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in BSA at Week 4 | 43.046 percentage of BSA | Standard Deviation 31.699 |
| BCD-085, 40 mg | Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in BSA at Week 12 | 82.888 percentage of BSA | Standard Deviation 24.699 |
| BCD-085, 40 mg | Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in BSA at Week 8 | 70.479 percentage of BSA | Standard Deviation 29.547 |
| BCD-085, 80 mg | Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in BSA at Week 4 | 45.610 percentage of BSA | Standard Deviation 30.987 |
| BCD-085, 80 mg | Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in BSA at Week 12 | 82.811 percentage of BSA | Standard Deviation 19.751 |
| BCD-085, 80 mg | Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in BSA at Week 8 | 67.233 percentage of BSA | Standard Deviation 30.765 |
| BCD-085, 120 mg | Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in BSA at Week 8 | 68.516 percentage of BSA | Standard Deviation 33.657 |
| BCD-085, 120 mg | Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in BSA at Week 4 | 39.948 percentage of BSA | Standard Deviation 35.084 |
| BCD-085, 120 mg | Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in BSA at Week 12 | 82.074 percentage of BSA | Standard Deviation 29.46 |
| Placebo | Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in BSA at Week 4 | 13.692 percentage of BSA | Standard Deviation 22.333 |
| Placebo | Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in BSA at Week 12 | 36.912 percentage of BSA | Standard Deviation 39.447 |
| Placebo | Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in BSA at Week 8 | 24.075 percentage of BSA | Standard Deviation 32.046 |
Secondary
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)
Time frame: Week 12
Population: This analysis did not include patients who had no nail psoriasis at baseline and who had no worsening of nail psoriasis during the study (patients who had NAPSI = 0 at baseline and at Week 12). The final population for NAPSI assessment comprised 66 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BCD-085, 40 mg | Relative Change in NAPSI Score After 12 Weeks of Therapy With BCD-085 | 25.204 percent change | Standard Deviation 45.347 |
| BCD-085, 80 mg | Relative Change in NAPSI Score After 12 Weeks of Therapy With BCD-085 | 47.095 percent change | Standard Deviation 29.8 |
| BCD-085, 120 mg | Relative Change in NAPSI Score After 12 Weeks of Therapy With BCD-085 | 66.370 percent change | Standard Deviation 29.455 |
| Placebo | Relative Change in NAPSI Score After 12 Weeks of Therapy With BCD-085 | 7.828 percent change | Standard Deviation 36.243 |
Secondary
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)
Time frame: Week 4, Week 8, Week 12
Population: The efficacy analysis was planned to include all patients who received at least one dose of BCD-085/placebo and who attended at least one post-dose visit. The efficacy population comprised of 114 patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BCD-085, 40 mg | Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in PASI score at Week 4 | 61.309 percent change | Standard Deviation 23.423 |
| BCD-085, 40 mg | Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in PASI score at Week 12 | 88.698 percent change | Standard Deviation 15.67 |
| BCD-085, 40 mg | Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in PASI score at Week 8 | 82.148 percent change | Standard Deviation 17.751 |
| BCD-085, 80 mg | Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in PASI score at Week 4 | 58.855 percent change | Standard Deviation 27.382 |
| BCD-085, 80 mg | Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in PASI score at Week 12 | 88.682 percent change | Standard Deviation 13.607 |
| BCD-085, 80 mg | Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in PASI score at Week 8 | 78.883 percent change | Standard Deviation 20.35 |
| BCD-085, 120 mg | Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in PASI score at Week 8 | 85.012 percent change | Standard Deviation 16.389 |
| BCD-085, 120 mg | Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in PASI score at Week 4 | 59.524 percent change | Standard Deviation 26.251 |
| BCD-085, 120 mg | Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in PASI score at Week 12 | 92.771 percent change | Standard Deviation 11.426 |
| Placebo | Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in PASI score at Week 4 | 26.277 percent change | Standard Deviation 25.933 |
| Placebo | Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in PASI score at Week 12 | 45.495 percent change | Standard Deviation 36.892 |
| Placebo | Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085 | Mean percentage change from baseline in PASI score at Week 8 | 36.512 percent change | Standard Deviation 29.541 |