Trial Outcomes & Findings for 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 (NCT NCT02762994)
NCT ID: NCT02762994
Last Updated: 2021-03-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-03-23
Participant Flow
Participant milestones
| Measure |
BCD-085, 40 mg
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
30
|
28
|
|
Overall Study
COMPLETED
|
30
|
30
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
BCD-085, 40 mg
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Placebo
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
2
|
Baseline Characteristics
Provided information only of the women enrolled in the study (35 subjects).
Baseline characteristics by cohort
| Measure |
BCD-085, 40 mg
n=30 Participants
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
n=30 Participants
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
n=28 Participants
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
n=26 Participants
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Placebo
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41.50 years
n=30 Participants
|
35.00 years
n=30 Participants
|
45.00 years
n=28 Participants
|
41.50 years
n=26 Participants
|
40.50 years
n=114 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=30 Participants
|
11 Participants
n=30 Participants
|
6 Participants
n=28 Participants
|
11 Participants
n=26 Participants
|
35 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=30 Participants
|
19 Participants
n=30 Participants
|
22 Participants
n=28 Participants
|
15 Participants
n=26 Participants
|
79 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
28 Participants
n=28 Participants
|
26 Participants
n=26 Participants
|
114 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=114 Participants
|
|
Body weight
|
82.00 kg
n=30 Participants
|
80.50 kg
n=30 Participants
|
87.25 kg
n=28 Participants
|
77.55 kg
n=26 Participants
|
82.00 kg
n=114 Participants
|
|
Height
|
178.50 cm
n=30 Participants
|
173.00 cm
n=30 Participants
|
177.00 cm
n=28 Participants
|
175.00 cm
n=26 Participants
|
176.00 cm
n=114 Participants
|
|
BMI
|
25.81 kg/m^2
n=30 Participants
|
26.85 kg/m^2
n=30 Participants
|
29.72 kg/m^2
n=28 Participants
|
24.95 kg/m^2
n=26 Participants
|
26.23 kg/m^2
n=114 Participants
|
|
Number of Women With Child Bearing Potential
|
5 participants
n=7 Participants • Provided information only of the women enrolled in the study (35 subjects).
|
8 participants
n=11 Participants • Provided information only of the women enrolled in the study (35 subjects).
|
4 participants
n=6 Participants • Provided information only of the women enrolled in the study (35 subjects).
|
8 participants
n=11 Participants • Provided information only of the women enrolled in the study (35 subjects).
|
25 participants
n=35 Participants • Provided information only of the women enrolled in the study (35 subjects).
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
BCD-085, 40 mg
n=30 Participants
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
n=30 Participants
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
n=28 Participants
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
n=26 Participants
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Placebo
|
|---|---|---|---|---|
|
Number of Patients With PASI 75 Response After 12 Weeks of Therapy
|
24 Participants
|
25 Participants
|
26 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 4, Week 8Population: 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.
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.
Outcome measures
| Measure |
BCD-085, 40 mg
n=30 Participants
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
n=30 Participants
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
n=28 Participants
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
n=26 Participants
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Placebo
|
|---|---|---|---|---|
|
Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy
Week 4
|
9 Participants
|
10 Participants
|
9 Participants
|
2 Participants
|
|
Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy
Week 8
|
22 Participants
|
19 Participants
|
20 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12Population: 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.
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.
Outcome measures
| Measure |
BCD-085, 40 mg
n=30 Participants
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
n=30 Participants
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
n=28 Participants
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
n=26 Participants
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Placebo
|
|---|---|---|---|---|
|
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
|
22 Participants
|
16 Participants
|
4 Participants
|
|
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
|
27 Participants
|
27 Participants
|
6 Participants
|
|
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
|
30 Participants
|
28 Participants
|
12 Participants
|
|
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
|
2 Participants
|
6 Participants
|
0 Participants
|
|
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
|
12 Participants
|
15 Participants
|
2 Participants
|
|
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
|
18 Participants
|
22 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12Population: 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.
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)
Outcome measures
| Measure |
BCD-085, 40 mg
n=30 Participants
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
n=30 Participants
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
n=28 Participants
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
n=26 Participants
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
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
|
61.309 percent change
Standard Deviation 23.423
|
58.855 percent change
Standard Deviation 27.382
|
59.524 percent change
Standard Deviation 26.251
|
26.277 percent change
Standard Deviation 25.933
|
|
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
|
78.883 percent change
Standard Deviation 20.350
|
85.012 percent change
Standard Deviation 16.389
|
36.512 percent change
Standard Deviation 29.541
|
|
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 15.670
|
88.682 percent change
Standard Deviation 13.607
|
92.771 percent change
Standard Deviation 11.426
|
45.495 percent change
Standard Deviation 36.892
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12Population: The efficacy population comprised of 114 patients.
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.
Outcome measures
| Measure |
BCD-085, 40 mg
n=30 Participants
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
n=30 Participants
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
n=28 Participants
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
n=26 Participants
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
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
|
43.046 percentage of BSA
Standard Deviation 31.699
|
45.610 percentage of BSA
Standard Deviation 30.987
|
39.948 percentage of BSA
Standard Deviation 35.084
|
13.692 percentage of BSA
Standard Deviation 22.333
|
|
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
|
67.233 percentage of BSA
Standard Deviation 30.765
|
68.516 percentage of BSA
Standard Deviation 33.657
|
24.075 percentage of BSA
Standard Deviation 32.046
|
|
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
|
82.811 percentage of BSA
Standard Deviation 19.751
|
82.074 percentage of BSA
Standard Deviation 29.460
|
36.912 percentage of BSA
Standard Deviation 39.447
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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)
Outcome measures
| Measure |
BCD-085, 40 mg
n=17 Participants
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
n=18 Participants
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
n=19 Participants
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
n=12 Participants
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Placebo
|
|---|---|---|---|---|
|
Relative Change in NAPSI Score After 12 Weeks of Therapy With BCD-085
|
25.204 percent change
Standard Deviation 45.347
|
47.095 percent change
Standard Deviation 29.800
|
66.370 percent change
Standard Deviation 29.455
|
7.828 percent change
Standard Deviation 36.243
|
SECONDARY outcome
Timeframe: Week 1, Week 4, Week 8, Week 12Population: 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.
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
Outcome measures
| Measure |
BCD-085, 40 mg
n=30 Participants
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
n=30 Participants
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
n=28 Participants
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
n=26 Participants
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
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
|
-19.600 units on a scale
Standard Deviation 23.562
|
-25.367 units on a scale
Standard Deviation 29.678
|
-26.071 units on a scale
Standard Deviation 29.034
|
-14.269 units on a scale
Standard Deviation 34.582
|
|
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
|
-33.700 units on a scale
Standard Deviation 31.682
|
-43.214 units on a scale
Standard Deviation 30.927
|
-13.269 units on a scale
Standard Deviation 32.863
|
|
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
|
-35.633 units on a scale
Standard Deviation 34.927
|
-47.304 units on a scale
Standard Deviation 33.431
|
-15.538 units on a scale
Standard Deviation 34.195
|
|
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
|
-40.700 units on a scale
Standard Deviation 30.563
|
-48.214 units on a scale
Standard Deviation 30.839
|
-18.269 units on a scale
Standard Deviation 34.898
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12Population: 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.
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).
Outcome measures
| Measure |
BCD-085, 40 mg
n=30 Participants
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
n=30 Participants
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
n=28 Participants
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
n=26 Participants
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Placebo
|
|---|---|---|---|---|
|
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
|
27 Participants
|
25 Participants
|
8 Participants
|
|
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
|
11 Participants
|
8 Participants
|
2 Participants
|
|
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
|
19 Participants
|
21 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12Population: 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.
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.
Outcome measures
| Measure |
BCD-085, 40 mg
n=30 Participants
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
n=30 Participants
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
n=28 Participants
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
n=26 Participants
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
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
|
3.740 units on a scale
Standard Deviation 8.929
|
1.957 units on a scale
Standard Deviation 8.691
|
6.943 units on a scale
Standard Deviation 9.347
|
2.923 units on a scale
Standard Deviation 8.185
|
|
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
|
3.647 units on a scale
Standard Deviation 8.886
|
7.457 units on a scale
Standard Deviation 9.115
|
0.992 units on a scale
Standard Deviation 10.703
|
|
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
|
1.820 units on a scale
Standard Deviation 10.255
|
7.804 units on a scale
Standard Deviation 8.574
|
3.465 units on a scale
Standard Deviation 9.437
|
|
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 7.020
|
7.387 units on a scale
Standard Deviation 9.915
|
4.196 units on a scale
Standard Deviation 11.329
|
3.327 units on a scale
Standard Deviation 12.181
|
|
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
|
8.443 units on a scale
Standard Deviation 10.287
|
6.364 units on a scale
Standard Deviation 9.946
|
2.792 units on a scale
Standard Deviation 9.677
|
|
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
|
8.693 units on a scale
Standard Deviation 10.551
|
5.686 units on a scale
Standard Deviation 9.925
|
3.004 units on a scale
Standard Deviation 11.361
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12Population: 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.
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).
Outcome measures
| Measure |
BCD-085, 40 mg
n=30 Participants
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
n=30 Participants
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
n=28 Participants
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
n=26 Participants
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
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
|
-9.833 units on a scale
Standard Deviation 7.292
|
-9.000 units on a scale
Standard Deviation 6.988
|
-8.143 units on a scale
Standard Deviation 5.662
|
-4.308 units on a scale
Standard Deviation 7.121
|
|
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
|
-11.133 units on a scale
Standard Deviation 7.380
|
-10.679 units on a scale
Standard Deviation 5.157
|
-4.846 units on a scale
Standard Deviation 7.619
|
|
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
|
-12.333 units on a scale
Standard Deviation 7.369
|
-10.107 units on a scale
Standard Deviation 7.809
|
-5.654 units on a scale
Standard Deviation 7.402
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: 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).
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.
Outcome measures
| Measure |
BCD-085, 40 mg
n=31 Participants
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
n=30 Participants
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
n=28 Participants
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
n=28 Participants
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Placebo
|
|---|---|---|---|---|
|
Frequency of AE/SAE
Therapy-related AEs/SAEs
|
6 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Frequency of AE/SAE
AEs, grade 3
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Frequency of AE/SAE
Therapy-related AEs, grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of AE/SAE
Any AEs/SAEs
|
14 Participants
|
11 Participants
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: 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).
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.
Outcome measures
| Measure |
BCD-085, 40 mg
n=31 Participants
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
n=30 Participants
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
n=28 Participants
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
n=28 Participants
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Placebo
|
|---|---|---|---|---|
|
Frequency of Local Reactions
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: 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).
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.
Outcome measures
| Measure |
BCD-085, 40 mg
n=31 Participants
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
n=30 Participants
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
n=28 Participants
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
n=28 Participants
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Placebo
|
|---|---|---|---|---|
|
Frequency of AE/SAE Grade 4 CTCAE 4.03
Any AEs, grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of AE/SAE Grade 4 CTCAE 4.03
Any SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: 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).
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.
Outcome measures
| Measure |
BCD-085, 40 mg
n=31 Participants
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
n=30 Participants
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
n=28 Participants
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
n=28 Participants
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Placebo
|
|---|---|---|---|---|
|
Frequency of Withdrawal Due to AE/SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
BCD-085, 40 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
BCD-085, 80 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
BCD-085, 120 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BCD-085, 40 mg
n=31 participants at risk
Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 80 mg
n=30 participants at risk
Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
BCD-085, 120 mg
n=28 participants at risk
Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
BCD-085
|
Placebo
n=28 participants at risk
Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
Placebo
|
|---|---|---|---|---|
|
Infections and infestations
ARVI
|
9.7%
3/31 • Number of events 3 • 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.
|
3.3%
1/30 • Number of events 1 • 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.
|
3.6%
1/28 • Number of events 1 • 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.
|
3.6%
1/28 • Number of events 1 • 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.
|
|
Infections and infestations
Conjuctivitis
|
3.2%
1/31 • Number of events 1 • 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.
|
0.00%
0/30 • 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.
|
0.00%
0/28 • 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.
|
0.00%
0/28 • 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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.9%
4/31 • Number of events 4 • 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.
|
6.7%
2/30 • Number of events 2 • 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.
|
3.6%
1/28 • Number of events 1 • 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.
|
3.6%
1/28 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/31 • 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.
|
0.00%
0/30 • 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.
|
0.00%
0/28 • 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.
|
3.6%
1/28 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/31 • 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.
|
0.00%
0/30 • 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.
|
0.00%
0/28 • 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.
|
7.1%
2/28 • Number of events 2 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/31 • 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.
|
0.00%
0/30 • 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.
|
0.00%
0/28 • 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.
|
3.6%
1/28 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
ESR increased
|
0.00%
0/31 • 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.
|
0.00%
0/30 • 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.
|
0.00%
0/28 • 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.
|
7.1%
2/28 • Number of events 2 • 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.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.2%
1/31 • Number of events 1 • 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.
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/28 • 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.
|
0.00%
0/28 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.2%
1/31 • Number of events 1 • 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.
|
0.00%
0/30 • 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.
|
0.00%
0/28 • 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.
|
3.6%
1/28 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
3.2%
1/31 • Number of events 1 • 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.
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/28 • 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.
|
3.6%
1/28 • Number of events 1 • 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.
|
|
Hepatobiliary disorders
Total bilirubin increased
|
3.2%
1/31 • Number of events 1 • 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.
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/28 • 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.
|
7.1%
2/28 • Number of events 2 • 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.
|
|
Hepatobiliary disorders
GGT increased
|
0.00%
0/31 • 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.
|
10.0%
3/30 • Number of events 3 • 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.
|
3.6%
1/28 • Number of events 1 • 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.
|
7.1%
2/28 • Number of events 2 • 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.
|
|
Hepatobiliary disorders
AST increased
|
0.00%
0/31 • 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.
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/28 • 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.
|
10.7%
3/28 • Number of events 3 • 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.
|
|
Hepatobiliary disorders
ALT increased
|
0.00%
0/31 • 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.
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/28 • 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.
|
10.7%
3/28 • Number of events 3 • 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.
|
|
Vascular disorders
Arterial BP increased
|
0.00%
0/31 • 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.
|
6.7%
2/30 • Number of events 2 • 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.
|
10.7%
3/28 • Number of events 3 • 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.
|
0.00%
0/28 • 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.
|
|
Vascular disorders
Systolic BP increased
|
0.00%
0/31 • 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.
|
0.00%
0/30 • 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.
|
3.6%
1/28 • Number of events 1 • 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.
|
0.00%
0/28 • 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.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.2%
1/31 • Number of events 1 • 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.
|
0.00%
0/30 • 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.
|
0.00%
0/28 • 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.
|
0.00%
0/28 • 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.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.2%
1/31 • Number of events 1 • 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.
|
0.00%
0/30 • 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.
|
0.00%
0/28 • 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.
|
0.00%
0/28 • 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.
|
|
Metabolism and nutrition disorders
LDH increased
|
3.2%
1/31 • Number of events 1 • 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.
|
0.00%
0/30 • 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.
|
0.00%
0/28 • 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.
|
3.6%
1/28 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/31 • 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.
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/28 • 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.
|
0.00%
0/28 • 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.
|
|
General disorders
Flu-like symptoms
|
3.2%
1/31 • Number of events 1 • 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.
|
0.00%
0/30 • 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.
|
3.6%
1/28 • Number of events 1 • 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.
|
0.00%
0/28 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place