Trial Outcomes & Findings for Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis (NCT NCT00805480)
NCT ID: NCT00805480
Last Updated: 2015-02-10
Results Overview
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). 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. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2015-02-10
Participant Flow
The planned enrollment was for 100 participants. However, one center was prematurely terminated and the data from this center could not be used for analysis. Therefore, additional participants were randomized to replace the 30 participants from the early terminated center. As a result, a total of 130 participants were enrolled.
Participant milestones
| Measure |
AIN457 3 mg/kg
Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg
Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg x3
Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
|
Placebo
Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
31
|
10
|
|
Overall Study
Pharmacodynamic Analysis Set
|
30
|
25
|
29
|
10
|
|
Overall Study
COMPLETED
|
16
|
22
|
19
|
5
|
|
Overall Study
NOT COMPLETED
|
14
|
7
|
12
|
5
|
Reasons for withdrawal
| Measure |
AIN457 3 mg/kg
Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg
Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg x3
Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
|
Placebo
Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
5
|
11
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis
Baseline characteristics by cohort
| Measure |
AIN457 3 mg/kg
n=30 Participants
Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg
n=29 Participants
Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg x3
n=31 Participants
Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
|
Placebo
n=10 Participants
Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.7 Years
STANDARD_DEVIATION 9.29 • n=93 Participants
|
43.5 Years
STANDARD_DEVIATION 11.75 • n=4 Participants
|
43.4 Years
STANDARD_DEVIATION 10.90 • n=27 Participants
|
40.1 Years
STANDARD_DEVIATION 14.89 • n=483 Participants
|
43.8 Years
STANDARD_DEVIATION 11.09 • n=36 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
20 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
80 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Participants from the PD Analysis Set, who had both baseline and week 12 values, were included in the analysis. As such, the population for each treatment group is different from the PD population in the participant flow. The PD analysis set included participants who had at least one dose of study medication and had no protocol deviations.
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). 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. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Outcome measures
| Measure |
AIN457 3 mg/kg
n=27 Participants
Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg
n=23 Participants
Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg x3
n=27 Participants
Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
|
Placebo
n=5 Participants
Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
|
|---|---|---|---|---|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
|
-12.46 scores on a scale
Standard Deviation 7.668
|
-13.35 scores on a scale
Standard Deviation 6.195
|
-18.02 scores on a scale
Standard Deviation 6.792
|
-4.18 scores on a scale
Standard Deviation 4.698
|
PRIMARY outcome
Timeframe: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56Population: PD analysis set participants (AIN457 groups only), who had not yet relapsed were included in the analysis at each time point. As a result, the number of participants at risk for relapse may decrease as the number of weeks on study increases. The PD set included participants who had at least one dose of study medication and no protocol deviations.
This outcome measure shows the proportion of participants in each of the AIN457 treatment groups who were relapse free throughout the study up to and including week 56.
Outcome measures
| Measure |
AIN457 3 mg/kg
n=30 Participants
Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg
n=25 Participants
Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg x3
n=29 Participants
Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
|
Placebo
Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
|
|---|---|---|---|---|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 20 (n=15,17,26)
|
50.0 Percentage of participants
|
68.0 Percentage of participants
|
89.7 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 36 (n=7,9,17)
|
23.3 Percentage of participants
|
36.0 Percentage of participants
|
58.6 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 56 (n=2,4,5)
|
12.5 Percentage of participants
|
22.2 Percentage of participants
|
27.8 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 1 (n=30,25,29)
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 2 (n=30,25,28)
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
96.6 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 4 (n=30,25,27)
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
93.1 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 6 (n=30,24,27)
|
100.0 Percentage of participants
|
96.0 Percentage of participants
|
93.1 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 8 (n=30,24,27)
|
100.0 Percentage of participants
|
96.0 Percentage of participants
|
93.1 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 10 (n=28,22,27)
|
93.3 Percentage of participants
|
88.0 Percentage of participants
|
93.1 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 12 (n=23,22,27)
|
76.7 Percentage of participants
|
88.0 Percentage of participants
|
93.1 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 14 (n=20,20,27)
|
66.7 Percentage of participants
|
80.0 Percentage of participants
|
93.1 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 16 (n=16,19,26)
|
53.3 Percentage of participants
|
76.0 Percentage of participants
|
89.7 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 24 (n=13,17,25)
|
43.3 Percentage of participants
|
68.0 Percentage of participants
|
86.2 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 28 (n=11,12,24)
|
36.7 Percentage of participants
|
48.0 Percentage of participants
|
82.8 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 32 (n=9,9,19)
|
30.0 Percentage of participants
|
36.0 Percentage of participants
|
65.5 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 40 (n=6,7,14)
|
20.0 Percentage of participants
|
28.0 Percentage of participants
|
48.3 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 44 (n=4,7,10)
|
13.3 Percentage of participants
|
28.0 Percentage of participants
|
34.5 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 48 (n=3,6,8)
|
10.0 Percentage of participants
|
24.0 Percentage of participants
|
27.6 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Week 52 (n=3,5,5)
|
10.0 Percentage of participants
|
20.0 Percentage of participants
|
17.2 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, end of study (EOS) (up to week 56)Population: PD analysis set: The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations which could impact the PD analysis. At weeks 28, 36, 44 and 48, only 28 of the 29 participants in the AIN457 10mg/kg X3 group had values for analysis.
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). 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. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Outcome measures
| Measure |
AIN457 3 mg/kg
n=30 Participants
Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg
n=25 Participants
Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg x3
n=29 Participants
Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
|
Placebo
n=10 Participants
Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
|
|---|---|---|---|---|
|
Percentage of Participants With at Least 50% Improvement From Baseline in PASI
Week 4
|
56.7 Percentage of participants
|
84.0 Percentage of participants
|
89.7 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants With at Least 50% Improvement From Baseline in PASI
Week 20
|
46.7 Percentage of participants
|
68.0 Percentage of participants
|
89.7 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants With at Least 50% Improvement From Baseline in PASI
Week 48 (n=30,25,28,10)
|
6.7 Percentage of participants
|
24.0 Percentage of participants
|
28.6 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants With at Least 50% Improvement From Baseline in PASI
Week 8
|
73.3 Percentage of participants
|
80.0 Percentage of participants
|
93.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 50% Improvement From Baseline in PASI
Week 12
|
66.7 Percentage of participants
|
79.2 Percentage of participants
|
93.1 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants With at Least 50% Improvement From Baseline in PASI
Week 16
|
50.0 Percentage of participants
|
68.0 Percentage of participants
|
89.7 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants With at Least 50% Improvement From Baseline in PASI
Week 24
|
40.0 Percentage of participants
|
68.0 Percentage of participants
|
86.2 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants With at Least 50% Improvement From Baseline in PASI
Week 28 (n=30,25,28,10)
|
33.3 Percentage of participants
|
48.0 Percentage of participants
|
82.1 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants With at Least 50% Improvement From Baseline in PASI
Week 32
|
30.0 Percentage of participants
|
36.0 Percentage of participants
|
65.5 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants With at Least 50% Improvement From Baseline in PASI
Week 36 (n=30,25,28,10)
|
23.3 Percentage of participants
|
36.0 Percentage of participants
|
51.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 50% Improvement From Baseline in PASI
Week 40
|
20.0 Percentage of participants
|
28.0 Percentage of participants
|
48.3 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants With at Least 50% Improvement From Baseline in PASI
Week 44 (n=30,25,28,10)
|
13.3 Percentage of participants
|
28.0 Percentage of participants
|
32.1 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants With at Least 50% Improvement From Baseline in PASI
Week 52
|
6.7 Percentage of participants
|
20.0 Percentage of participants
|
20.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 50% Improvement From Baseline in PASI
End of study (up to week 56)
|
6.7 Percentage of participants
|
16.0 Percentage of participants
|
31.0 Percentage of participants
|
20.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)Population: PD analysis set: The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations which could impact the PD analysis. At weeks 28, 36, 44 and 48, only 28 of the 29 participants in the AIN457 10mg/kg X3 group had values for analysis.
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). 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. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Outcome measures
| Measure |
AIN457 3 mg/kg
n=30 Participants
Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg
n=25 Participants
Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg x3
n=29 Participants
Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
|
Placebo
n=10 Participants
Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
|
|---|---|---|---|---|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 12 - PASI 75
|
40.0 Percentage of participants
|
75.0 Percentage of participants
|
82.6 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 20 - PASI 90
|
0.0 Percentage of participants
|
28.0 Percentage of participants
|
65.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 24 - PASI 75
|
20.0 Percentage of participants
|
40.0 Percentage of participants
|
69.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 28 - PASI 90 (n=30,25,28,10)
|
0.0 Percentage of participants
|
16.0 Percentage of participants
|
42.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 32 - PASI 90
|
0.0 Percentage of participants
|
16.0 Percentage of participants
|
31.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 36 - PASI 90 (n=30,25,28,10)
|
0.0 Percentage of participants
|
8.0 Percentage of participants
|
14.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 48 - PASI 75 (n=30,25,28,10)
|
0.0 Percentage of participants
|
12.0 Percentage of participants
|
10.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
End of study (up to week 56) - PASI 75
|
0.0 Percentage of participants
|
12.0 Percentage of participants
|
13.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 4 - PASI 75
|
30.0 Percentage of participants
|
56.0 Percentage of participants
|
65.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 4 - PASI 90
|
3.3 Percentage of participants
|
28.0 Percentage of participants
|
48.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 8 - PASI 75
|
53.3 Percentage of participants
|
72.0 Percentage of participants
|
89.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 8 - PASI 90
|
6.7 Percentage of participants
|
44.0 Percentage of participants
|
72.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 12 - PASI 90
|
10.0 Percentage of participants
|
54.2 Percentage of participants
|
75.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 16 - PASI 75
|
30.0 Percentage of participants
|
60.0 Percentage of participants
|
82.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 16 - PASI 90
|
3.3 Percentage of participants
|
40.0 Percentage of participants
|
79.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 20 - PASI 75
|
23.3 Percentage of participants
|
52.0 Percentage of participants
|
82.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 24 - PASI 90
|
0.0 Percentage of participants
|
24.0 Percentage of participants
|
62.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 28 - PASI 75 (n=30,25,28,10)
|
16.7 Percentage of participants
|
36.0 Percentage of participants
|
60.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 32 - PASI 75
|
3.3 Percentage of participants
|
24.0 Percentage of participants
|
44.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 36 - PASI 75 (n=30,25,28,10)
|
0.0 Percentage of participants
|
24.0 Percentage of participants
|
28.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 40 - PASI 75
|
0.0 Percentage of participants
|
16.0 Percentage of participants
|
21.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 40 - PASI 90
|
0.0 Percentage of participants
|
12.0 Percentage of participants
|
6.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 44 - PASI 75 (n=30,25,28,10)
|
0.0 Percentage of participants
|
16.0 Percentage of participants
|
10.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 44 - PASI 90 (n=30,25,28,10)
|
0.0 Percentage of participants
|
8.0 Percentage of participants
|
3.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 48 - PASI 90 (n=30,25,28,10)
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
3.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 52 - PASI 75
|
0.0 Percentage of participants
|
12.0 Percentage of participants
|
6.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Week 52 - PASI 90
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
3.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
End of study (up to week 56) - PASI 90
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
10.3 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)Population: PD analysis set participants, who had values at each week category, were included in the analysis. As such, the population at each week varies from the PD population in the participant flow. The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations.
The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.
Outcome measures
| Measure |
AIN457 3 mg/kg
n=30 Participants
Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg
n=25 Participants
Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg x3
n=29 Participants
Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
|
Placebo
n=10 Participants
Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
|
|---|---|---|---|---|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Baseline - Mild disease (n=30,25,29,10)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Baseline - Moderate disease (n=30,25,29,10)
|
60.0 Percentage of participants
|
68.0 Percentage of participants
|
55.2 Percentage of participants
|
70.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Baseline - Severe disease (n=30,25,29,10)
|
36.7 Percentage of participants
|
32.0 Percentage of participants
|
41.4 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Baseline - Very severe (n=30,25,29,10)
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 1 - Clear (n=30,25,29,10)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 1 - Almost clear (n=30,25,29,10)
|
3.3 Percentage of participants
|
12.0 Percentage of participants
|
13.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 1 - Mild disease (n=30,25,29,10)
|
23.3 Percentage of participants
|
32.0 Percentage of participants
|
48.3 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 1 - Moderate disease (n=30,25,29,10)
|
66.7 Percentage of participants
|
56.0 Percentage of participants
|
37.9 Percentage of participants
|
70.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 1 - Severe disease (n=30,25,29,10)
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 1 - Very severe disease (n=30,25,29,10)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 2 - Clear (n=30,25,27,10)
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
6.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 2 - Almost clear (n=30,25,27,10)
|
3.3 Percentage of participants
|
20.0 Percentage of participants
|
24.1 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 6 - Mild disease (n=30,24,27,7)
|
50.0 Percentage of participants
|
32.0 Percentage of participants
|
10.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 6 - Moderate disease (n=30,24,27,7)
|
26.7 Percentage of participants
|
12.0 Percentage of participants
|
3.4 Percentage of participants
|
60.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 2 - Mild disease (n=30,25,27,10)
|
50.0 Percentage of participants
|
64.0 Percentage of participants
|
44.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 2 - Moderate disease (n=30,25,27,10)
|
46.7 Percentage of participants
|
12.0 Percentage of participants
|
17.2 Percentage of participants
|
80.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 2 - Severe disease (n=30,25,27,10)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 2 - Very severe disease (n=30,25,27,10)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 6 - Very severe disease(n=30,24,27,7)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 10 - Clear (n=28,24,25,5)
|
0.0 Percentage of participants
|
28.0 Percentage of participants
|
48.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 10 - Mild disease (n=28,24,25,5)
|
36.7 Percentage of participants
|
20.0 Percentage of participants
|
6.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 10 - Moderate disease (n=28,24,25,5)
|
26.7 Percentage of participants
|
16.0 Percentage of participants
|
0.0 Percentage of participants
|
40.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 12- Moderate disease (n=27,23,27,5)
|
16.7 Percentage of participants
|
20.0 Percentage of participants
|
3.4 Percentage of participants
|
30.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 4 - Clear (n=30,25,27,9)
|
0.0 Percentage of participants
|
16.0 Percentage of participants
|
17.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 14 - Clear (n=22,22,26,4)
|
0.0 Percentage of participants
|
32.0 Percentage of participants
|
58.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 14 - Severe (n=22,22,26,4)
|
10.0 Percentage of participants
|
12.0 Percentage of participants
|
0.0 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 16 - Very severe disease (n=20,21,26,4)
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 20 - Mild disease (n=17,18,26,3)
|
33.3 Percentage of participants
|
8.0 Percentage of participants
|
20.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 20 - Very severe disease (n=17,18,26,3)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 24 - Almost clear (n=15,18,26,3)
|
6.7 Percentage of participants
|
28.0 Percentage of participants
|
31.0 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 24 - Severe disease(n=15,18,26,3)
|
3.3 Percentage of participants
|
4.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 28 - Mild disease (n=14,17,24,2)
|
23.3 Percentage of participants
|
4.0 Percentage of participants
|
37.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 36 - Clear (n=9,9,19,2)
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
6.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 40 - Almost clear (n=8,8,18,2)
|
0.0 Percentage of participants
|
8.0 Percentage of participants
|
10.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 40 - Very severe disease (n=8,8,18,2)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 44 - Mild disease (n=6,8,14,2)
|
6.7 Percentage of participants
|
4.0 Percentage of participants
|
13.8 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 52 - Clear (n=3,7,10,0)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 4 - Almost clear (n=30,25,27,9)
|
16.7 Percentage of participants
|
32.0 Percentage of participants
|
44.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 4 - Mild disease (n=30,25,27,9)
|
46.7 Percentage of participants
|
44.0 Percentage of participants
|
24.1 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 4 - Moderate disease (n=30,25,27,9)
|
36.7 Percentage of participants
|
8.0 Percentage of participants
|
6.9 Percentage of participants
|
40.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 4 - Severe disease(n=30,25,27,9)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 6 - Clear (n=30,24,27,7)
|
0.0 Percentage of participants
|
24.0 Percentage of participants
|
31.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 6 - Almost clear (n=30,24,27,7)
|
23.3 Percentage of participants
|
28.0 Percentage of participants
|
48.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 4 - Very severe disease (n=30,25,27,9)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Baseline - Clear (n=30,25,29,10)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Baseline - Almost clear (n=30,25,29,10)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 6 - Severe disease(n=30,24,27,7)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 8 - Clear (n=30,24,27,7)
|
0.0 Percentage of participants
|
28.0 Percentage of participants
|
41.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 8 - Almost clear (n=30,24,27,7)
|
33.3 Percentage of participants
|
32.0 Percentage of participants
|
34.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 8- Mild disease (n=30,24,27,7)
|
40.0 Percentage of participants
|
20.0 Percentage of participants
|
13.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 8 - Moderate disease(n=30,24,27,7)
|
26.7 Percentage of participants
|
16.0 Percentage of participants
|
3.4 Percentage of participants
|
60.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 8 - Severe disease (n=30,24,27,7)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 8 - Very severe disease (n=30,24,27,7)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 10 - Almost clear (n=28,24,25,5)
|
30.0 Percentage of participants
|
28.0 Percentage of participants
|
31.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 10 - Severe disease (n=28,24,25,5)
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
0.0 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 10 - Very severe disease (n=28,24,25,5)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 12 - Clear (n=27,23,27,5)
|
0.0 Percentage of participants
|
32.0 Percentage of participants
|
48.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 12 - Almost clear (n=27,23,27,5)
|
26.7 Percentage of participants
|
16.0 Percentage of participants
|
27.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 12 - Mild disease (n=27,23,27,5)
|
33.3 Percentage of participants
|
16.0 Percentage of participants
|
13.8 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 12 - Severe disease (n=27,23,27,5)
|
13.3 Percentage of participants
|
8.0 Percentage of participants
|
0.0 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 12 - Very severe disease (n=27,23,27,5)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 14 - Almost clear (n=22,22,26,4)
|
16.7 Percentage of participants
|
12.0 Percentage of participants
|
17.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 14 - Mild disease (n=22,22,26,4)
|
30.0 Percentage of participants
|
24.0 Percentage of participants
|
10.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 14 - Moderate disease (n=22,22,26,4)
|
16.7 Percentage of participants
|
8.0 Percentage of participants
|
3.4 Percentage of participants
|
30.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 14 - Very severe (n=22,22,26,4)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 16 - Clear (n=20,21,26,4)
|
0.0 Percentage of participants
|
24.0 Percentage of participants
|
55.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 16 - Almost clear(n=20,21,26,4)
|
13.3 Percentage of participants
|
24.0 Percentage of participants
|
20.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 16 - Mild disease(n=20,21,26,4)
|
23.3 Percentage of participants
|
16.0 Percentage of participants
|
10.3 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 16 - Moderate disease (n=20,21,26,4)
|
20.0 Percentage of participants
|
12.0 Percentage of participants
|
3.4 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 16 - Severe disease (n=20,21,26,4)
|
6.7 Percentage of participants
|
8.0 Percentage of participants
|
0.0 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 20 - Clear (n=17,18,26,3)
|
0.0 Percentage of participants
|
12.0 Percentage of participants
|
44.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 20 - Almost clear (n=17,18,26,3)
|
6.7 Percentage of participants
|
32.0 Percentage of participants
|
20.7 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 20 - Moderate disease (n=17,18,26,3)
|
10.0 Percentage of participants
|
20.0 Percentage of participants
|
3.4 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 20 - Severe disease (n=17,18,26,3)
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 24 - Clear (n=15,18,26,3)
|
0.0 Percentage of participants
|
8.0 Percentage of participants
|
37.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 24 - Mild disease(n=15,18,26,3)
|
30.0 Percentage of participants
|
12.0 Percentage of participants
|
10.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 24 - Moderate disease(n=15,18,26,3)
|
10.0 Percentage of participants
|
20.0 Percentage of participants
|
10.3 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 24 - Very severe disease(n=15,18,26,3)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 28 - Clear (n=14,17,24,2)
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
13.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 28 - Almost clear (n=14,17,24,2)
|
3.3 Percentage of participants
|
28.0 Percentage of participants
|
24.1 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 28 - Moderate disease (n=14,17,24,2)
|
16.7 Percentage of participants
|
24.0 Percentage of participants
|
6.9 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 28 - Severe disease (n=14,17,24,2)
|
3.3 Percentage of participants
|
8.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 28 - Very severe disease (n=14,17,24,2)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 32 - Clear (n=11,12,23,2)
|
0.0 Percentage of participants
|
8.0 Percentage of participants
|
10.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 32 - Almost clear (n=11,12,23,2)
|
0.0 Percentage of participants
|
12.0 Percentage of participants
|
24.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 32 - Mild disease (n=11,12,23,2)
|
20.0 Percentage of participants
|
16.0 Percentage of participants
|
27.6 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 32 - Moderate disease (n=11,12,23,2)
|
16.7 Percentage of participants
|
8.0 Percentage of participants
|
13.8 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 32 - Severe disease (n=11,12,23,2)
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
3.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 32 - Very severe disease (n=11,12,23,2)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 36 - Almost clear (n=9,9,19,2)
|
0.0 Percentage of participants
|
12.0 Percentage of participants
|
13.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 36 - Mild disease (n=9,9,19,2)
|
16.7 Percentage of participants
|
8.0 Percentage of participants
|
20.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 36 - Moderate disease (n=9,9,19,2)
|
13.3 Percentage of participants
|
12.0 Percentage of participants
|
20.7 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 36 - Severe disease (n=9,9,19,2)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 36 - Very severe disease (n=9,9,19,2)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 40 - Clear (n=8,8,18,2)
|
0.0 Percentage of participants
|
8.0 Percentage of participants
|
3.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 40 - Mild disease (n=8,8,18,2)
|
6.7 Percentage of participants
|
4.0 Percentage of participants
|
31.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 40 - Moderate disease (n=8,8,18,2)
|
20.0 Percentage of participants
|
12.0 Percentage of participants
|
17.2 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 40 - Severe disease (n=8,8,18,2)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 44 - Clear (n=6,8,14,2)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 44 - Almost clear (n=6,8,14,2)
|
0.0 Percentage of participants
|
12.0 Percentage of participants
|
3.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 44 - Moderate disease (n=6,8,14,2)
|
13.3 Percentage of participants
|
16.0 Percentage of participants
|
20.7 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 44 - Severe disease (n=6,8,14,2)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
6.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 44 - Very severe disease (n=6,8,14,2)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 48 - Clear (n=3,7,11,1)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 48 - Almost clear (n=3,7,11,1)
|
0.0 Percentage of participants
|
8.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 48 - Mild disease (n=3,7,11,1)
|
3.3 Percentage of participants
|
8.0 Percentage of participants
|
17.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 48 - Moderate disease (n=3,7,11,1)
|
6.7 Percentage of participants
|
12.0 Percentage of participants
|
17.2 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 48 - Severe disease (n=3,7,11,1)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 48 - Very severe disease (n=3,7,11,1)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 52 - Almost clear (n=3,7,10,0)
|
0.0 Percentage of participants
|
8.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 52 - Mild disease (n=3,7,10,0)
|
6.7 Percentage of participants
|
4.0 Percentage of participants
|
6.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 52 - Moderate disease (n=3,7,10,0)
|
3.3 Percentage of participants
|
16.0 Percentage of participants
|
17.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 52 - Severe disease (n=3,7,10,0)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
6.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Week 52 - Very severe disease (n=3,7,10,0)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
End of study - Clear (n=12,8,13,5)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
6.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
End of study - Almost clear (n=12,8,13,5)
|
3.3 Percentage of participants
|
4.0 Percentage of participants
|
3.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
End of study - Mild disease (n=12,8,13,5)
|
6.7 Percentage of participants
|
8.0 Percentage of participants
|
3.4 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
End of study - Moderate disease (n=12,8,13,5)
|
30.0 Percentage of participants
|
16.0 Percentage of participants
|
27.6 Percentage of participants
|
30.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
End of study - Severe disease (n=12,8,13,5)
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
3.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
End of study - Very severe disease (n=12,8,13,5)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
Adverse Events
AIN457 3 mg/kg
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
AIN457 10 mg/kg
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
AIN457 10 mg/kg x3
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AIN457 3 mg/kg
n=30 participants at risk
Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg
n=29 participants at risk
Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg x3
n=31 participants at risk
Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
|
Placebo
n=10 participants at risk
Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
|
|---|---|---|---|---|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/30
|
3.4%
1/29
|
0.00%
0/31
|
0.00%
0/10
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/30
|
0.00%
0/29
|
3.2%
1/31
|
0.00%
0/10
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/30
|
3.4%
1/29
|
0.00%
0/31
|
0.00%
0/10
|
|
Gastrointestinal disorders
PANCREATITIS
|
3.3%
1/30
|
0.00%
0/29
|
3.2%
1/31
|
0.00%
0/10
|
|
Gastrointestinal disorders
PANCREATITIS RELAPSING
|
0.00%
0/30
|
0.00%
0/29
|
3.2%
1/31
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
3.3%
1/30
|
0.00%
0/29
|
0.00%
0/31
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
3.3%
1/30
|
0.00%
0/29
|
0.00%
0/31
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.00%
0/30
|
3.4%
1/29
|
0.00%
0/31
|
0.00%
0/10
|
Other adverse events
| Measure |
AIN457 3 mg/kg
n=30 participants at risk
Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg
n=29 participants at risk
Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
|
AIN457 10 mg/kg x3
n=31 participants at risk
Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
|
Placebo
n=10 participants at risk
Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
|
|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
3.3%
1/30
|
3.4%
1/29
|
9.7%
3/31
|
10.0%
1/10
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/30
|
0.00%
0/29
|
6.5%
2/31
|
0.00%
0/10
|
|
Gastrointestinal disorders
VOMITING
|
6.7%
2/30
|
0.00%
0/29
|
3.2%
1/31
|
0.00%
0/10
|
|
Infections and infestations
INFLUENZA
|
3.3%
1/30
|
13.8%
4/29
|
3.2%
1/31
|
0.00%
0/10
|
|
Infections and infestations
NASOPHARYNGITIS
|
30.0%
9/30
|
27.6%
8/29
|
12.9%
4/31
|
0.00%
0/10
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/30
|
3.4%
1/29
|
0.00%
0/31
|
10.0%
1/10
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/30
|
3.4%
1/29
|
6.5%
2/31
|
0.00%
0/10
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/30
|
3.4%
1/29
|
6.5%
2/31
|
0.00%
0/10
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.3%
1/30
|
17.2%
5/29
|
9.7%
3/31
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/30
|
0.00%
0/29
|
6.5%
2/31
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
0.00%
0/30
|
3.4%
1/29
|
0.00%
0/31
|
10.0%
1/10
|
|
Investigations
BLOOD AMYLASE INCREASED
|
0.00%
0/30
|
0.00%
0/29
|
0.00%
0/31
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.3%
1/30
|
0.00%
0/29
|
6.5%
2/31
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/30
|
6.9%
2/29
|
3.2%
1/31
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
PSORIATIC ARTHROPATHY
|
0.00%
0/30
|
6.9%
2/29
|
3.2%
1/31
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN LUNG NEOPLASM
|
0.00%
0/30
|
0.00%
0/29
|
0.00%
0/31
|
10.0%
1/10
|
|
Nervous system disorders
HEADACHE
|
3.3%
1/30
|
6.9%
2/29
|
16.1%
5/31
|
0.00%
0/10
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/30
|
10.3%
3/29
|
0.00%
0/31
|
0.00%
0/10
|
|
Vascular disorders
HYPERTENSION
|
13.3%
4/30
|
10.3%
3/29
|
6.5%
2/31
|
0.00%
0/10
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER