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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCD-085, 40 mg | Experimental | Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. |
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| BCD-085, 80 mg | Experimental | Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. |
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| BCD-085, 120 mg | Experimental | Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. |
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| Placebo | Placebo Comparator | Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCD-085 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roman Ivanov, PhD | JCS BIOCAD | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BIOCAD | Saint Petersburg | Strelna | 198515 | Russia |
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| ID | Title | Description |
|---|---|---|
| FG000 | BCD-085, 40 mg | Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. BCD-085 |
| FG001 | BCD-085, 80 mg | Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. BCD-085 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 3, 2017 | Jul 16, 2020 |
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| Placebo | Other |
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| Week 4, Week 8 |
| 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. | Week 4, Week 8, Week 12 |
| 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) | Week 4, Week 8, Week 12 |
| 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. | Week 4, Week 8, Week 12 |
| 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) | Week 12 |
| 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 | Week 1, Week 4, Week 8, Week 12 |
| 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). | Week 4, Week 8, Week 12 |
| 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. | Week 4, Week 8, Week 12 |
| 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). | Week 4, Week 8, Week 12 |
| 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. | 14 weeks |
| 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. | 14 weeks |
| 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. | 14 weeks |
| 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. | 14 weeks |
| FG002 | BCD-085, 120 mg | Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. BCD-085 |
| FG003 | Placebo | Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Placebo |
| COMPLETED |
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| NOT COMPLETED |
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Provided information only of the patients included in the efficacy assessment (114 subjects).
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| ID | Title | Description |
|---|---|---|
| BG000 | BCD-085, 40 mg | Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. BCD-085 |
| BG001 | BCD-085, 80 mg | Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. BCD-085 |
| BG002 | BCD-085, 120 mg | Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. BCD-085 |
| BG003 | Placebo | Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Placebo |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body weight | Median | Inter-Quartile Range | kg |
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| Height | Median | Inter-Quartile Range | cm |
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| BMI | Median | Inter-Quartile Range | kg/m^2 |
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| Number of Women With Child Bearing Potential | Provided information only of the women enrolled in the study (35 subjects). | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 12 weeks |
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| 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. | 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. | Posted | Count of Participants | Participants | Week 4, Week 8 |
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| 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. | 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. | Posted | Count of Participants | Participants | Week 4, Week 8, Week 12 |
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| 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) | 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. | Posted | Mean | Standard Deviation | percent change | Week 4, Week 8, Week 12 |
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| 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. | The efficacy population comprised of 114 patients. | Posted | Mean | Standard Deviation | percentage of BSA | Week 4, Week 8, Week 12 |
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| 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) | 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. | Posted | Mean | Standard Deviation | percent change | Week 12 |
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| 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | Week 1, Week 4, Week 8, Week 12 |
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| 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). | 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. | Posted | Count of Participants | Participants | Week 4, Week 8, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Week 4, Week 8, Week 12 |
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| 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Week 4, Week 8, Week 12 |
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| 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. | 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). | Posted | Count of Participants | Participants | 14 weeks |
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| 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. | 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). | Posted | Count of Participants | Participants | 14 weeks |
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| 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. | 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). | Posted | Count of Participants | Participants | 14 weeks |
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| 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. | 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). | Posted | Count of Participants | Participants | 14 weeks |
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4 month
The safety analysis included the data from all patients received at least one dose of BCD-085/placebo. 3 patients were removed from the safety analysis because they recalled their informed consent before the first dose.
Aggravation, worsening, and symptoms of the plaque psoriasis were not reportable as AEs. If hospitalization was due to aggravation or worsening of psoriasis it was not reportable as an SAE.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BCD-085, 40 mg | Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. BCD-085 | 0 | 31 | 0 | 31 | 14 | 31 |
| EG001 | BCD-085, 80 mg | Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. BCD-085 | 0 | 30 | 0 | 30 | 11 | 30 |
| EG002 | BCD-085, 120 mg | Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. BCD-085 | 0 | 28 | 0 | 28 | 7 | 28 |
| EG003 | Placebo | Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Placebo | 0 | 28 | 0 | 28 | 11 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ARVI | Infections and infestations | Non-systematic Assessment |
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| Conjuctivitis | Infections and infestations | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrombocytosis | Blood and lymphatic system disorders | Systematic Assessment |
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| ESR increased | Blood and lymphatic system disorders | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Lymphocytosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Total bilirubin increased | Hepatobiliary disorders | Systematic Assessment |
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| GGT increased | Hepatobiliary disorders | Systematic Assessment |
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| AST increased | Hepatobiliary disorders | Systematic Assessment |
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| ALT increased | Hepatobiliary disorders | Systematic Assessment |
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| Arterial BP increased | Vascular disorders | Systematic Assessment |
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| Systolic BP increased | Vascular disorders | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| LDH increased | Metabolism and nutrition disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Flu-like symptoms | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nikiforova Aleksandra | BIOCAD | +7(812) 380 49 33 | 6254 | nikiforovaan@biocad.ru |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 12, 2016 | Jul 17, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo |
Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Placebo |
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| OG003 | Placebo | Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Placebo |
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| OG003 | Placebo | Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Placebo |
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| OG003 | Placebo | Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Placebo |
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Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Placebo
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Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Placebo
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| Placebo |
Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Placebo |
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| OG002 | BCD-085, 120 mg | Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. BCD-085 |
| OG003 | Placebo | Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Placebo |
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