Trial Outcomes & Findings for A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis (NCT NCT01071252)
NCT ID: NCT01071252
Last Updated: 2015-02-16
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
125 participants
Primary outcome timeframe
week 13
Results posted on
2015-02-16
Participant Flow
Participant milestones
| Measure |
AIN457 1x25mg
AIN457 25mg Subcutaneously as a single dose
|
AIN457 3x25mg
AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x75mg
AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x150mg
AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
Placebo
Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
26
|
21
|
27
|
22
|
|
Overall Study
COMPLETED
|
14
|
16
|
17
|
20
|
11
|
|
Overall Study
NOT COMPLETED
|
15
|
10
|
4
|
7
|
11
|
Reasons for withdrawal
| Measure |
AIN457 1x25mg
AIN457 25mg Subcutaneously as a single dose
|
AIN457 3x25mg
AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x75mg
AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x150mg
AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
Placebo
Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
|---|---|---|---|---|---|
|
Overall Study
unsatisfactory therapeutic effect
|
4
|
6
|
2
|
0
|
6
|
|
Overall Study
Withdrawal by Subject
|
8
|
2
|
1
|
2
|
3
|
|
Overall Study
administrative problems
|
1
|
1
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
Baseline characteristics by cohort
| Measure |
AIN457 1x25mg
n=29 Participants
AIN457 25mg Subcutaneously as a single dose
|
AIN457 3x25mg
n=26 Participants
AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x75mg
n=21 Participants
AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x150mg
n=27 Participants
AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
Placebo
n=22 Participants
Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 12.65 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 13.43 • n=7 Participants
|
45.8 years
STANDARD_DEVIATION 12.36 • n=5 Participants
|
45.4 years
STANDARD_DEVIATION 11.64 • n=4 Participants
|
45.9 years
STANDARD_DEVIATION 10.88 • n=21 Participants
|
45.9 years
STANDARD_DEVIATION 12.07 • n=8 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
91 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: week 13Population: The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.
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 1x25mg
n=29 Participants
AIN457 25mg Subcutaneously as a single dose
|
AIN457 3x25mg
n=26 Participants
AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x75mg
n=21 Participants
AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x150mg
n=27 Participants
AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
Placebo
n=22 Participants
Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
|---|---|---|---|---|---|
|
Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13
|
3.4 percentage of participants
|
19.2 percentage of participants
|
57.1 percentage of participants
|
81.5 percentage of participants
|
9.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37Population: The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.
IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline.
Outcome measures
| Measure |
AIN457 1x25mg
n=29 Participants
AIN457 25mg Subcutaneously as a single dose
|
AIN457 3x25mg
n=26 Participants
AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x75mg
n=21 Participants
AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x150mg
n=27 Participants
AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
Placebo
n=22 Participants
Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
|---|---|---|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Response
Week 2
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Response
Week 3
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Response
Week 5
|
0 percentage of participants
|
3.8 percentage of participants
|
4.8 percentage of participants
|
7.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Response
Week 9
|
0 percentage of participants
|
7.7 percentage of participants
|
28.6 percentage of participants
|
37 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Response
Week 13
|
0 percentage of participants
|
11.5 percentage of participants
|
33.3 percentage of participants
|
48.1 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Response
Week 17
|
3.4 percentage of participants
|
19.2 percentage of participants
|
28.6 percentage of participants
|
51.9 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Response
Week 21
|
0 percentage of participants
|
19.2 percentage of participants
|
38.1 percentage of participants
|
40.7 percentage of participants
|
13.6 percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Response
Week 25
|
0 percentage of participants
|
15.4 percentage of participants
|
33.3 percentage of participants
|
37 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Response
Week 29
|
0 percentage of participants
|
11.5 percentage of participants
|
19.0 percentage of participants
|
40.7 percentage of participants
|
13.6 percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Response
Week 33
|
0 percentage of participants
|
15.4 percentage of participants
|
19.0 percentage of participants
|
29.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Response
Week 37
|
0 percentage of participants
|
15.4 percentage of participants
|
9.5 percentage of participants
|
25.9 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37Population: The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.
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 1x25mg
n=29 Participants
AIN457 25mg Subcutaneously as a single dose
|
AIN457 3x25mg
n=26 Participants
AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x75mg
n=21 Participants
AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x150mg
n=27 Participants
AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
Placebo
n=22 Participants
Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 17 PASI 90
|
0 Percentage of Participants
|
15.4 Percentage of Participants
|
9.5 Percentage of Participants
|
44.4 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 21 PASI 90
|
0 Percentage of Participants
|
15.4 Percentage of Participants
|
9.5 Percentage of Participants
|
37.0 Percentage of Participants
|
4.5 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 25 PASI 50
|
13.8 Percentage of Participants
|
50.0 Percentage of Participants
|
57.1 Percentage of Participants
|
85.2 Percentage of Participants
|
31.8 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 25 PASI 75
|
0 Percentage of Participants
|
19.2 Percentage of Participants
|
33.3 Percentage of Participants
|
70.4 Percentage of Participants
|
9.1 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 25 PASI 90
|
0 Percentage of Participants
|
11.5 Percentage of Participants
|
19.0 Percentage of Participants
|
29.6 Percentage of Participants
|
4.5 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 2 PASI 50
|
3.4 Percentage of Participants
|
7.7 Percentage of Participants
|
4.8 Percentage of Participants
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 2 PASI 75
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 9 PASI 50
|
10.3 Percentage of Participants
|
38.5 Percentage of Participants
|
52.4 Percentage of Participants
|
85.2 Percentage of Participants
|
13.6 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 9 PASI 75
|
3.4 Percentage of Participants
|
11.5 Percentage of Participants
|
33.3 Percentage of Participants
|
66.7 Percentage of Participants
|
9.1 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 9 PASI 90
|
0 Percentage of Participants
|
3.8 Percentage of Participants
|
9.5 Percentage of Participants
|
14.8 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 13 PASI 50
|
17.2 Percentage of Participants
|
57.7 Percentage of Participants
|
81.0 Percentage of Participants
|
85.2 Percentage of Participants
|
18.2 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 13 PASI 75
|
3.4 Percentage of Participants
|
19.2 Percentage of Participants
|
57.1 Percentage of Participants
|
81.5 Percentage of Participants
|
9.1 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 13 PASI 90
|
0 Percentage of Participants
|
7.7 Percentage of Participants
|
19.0 Percentage of Participants
|
51.9 Percentage of Participants
|
4.5 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 17 PASI 50
|
20.7 Percentage of Participants
|
53.8 Percentage of Participants
|
76.2 Percentage of Participants
|
85.2 Percentage of Participants
|
27.3 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 17 PASI 75
|
6.9 Percentage of Participants
|
26.9 Percentage of Participants
|
42.9 Percentage of Participants
|
81.5 Percentage of Participants
|
13.6 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 21 PASI 50
|
13.8 Percentage of Participants
|
50.0 Percentage of Participants
|
57.1 Percentage of Participants
|
85.2 Percentage of Participants
|
31.8 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 21 PASI 75
|
0 Percentage of Participants
|
23.1 Percentage of Participants
|
38.1 Percentage of Participants
|
77.8 Percentage of Participants
|
13.6 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 2 PASI 90
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 3 PASI 50
|
3.4 Percentage of Participants
|
7.7 Percentage of Participants
|
23.8 Percentage of Participants
|
18.5 Percentage of Participants
|
4.5 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 5 PASI 50
|
10.3 Percentage of Participants
|
15.4 Percentage of Participants
|
28.6 Percentage of Participants
|
48.1 Percentage of Participants
|
4.5 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 3 PASI 75
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 3 PASI 90
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 5 PASI 75
|
0 Percentage of Participants
|
7.7 Percentage of Participants
|
4.8 Percentage of Participants
|
14.8 Percentage of Participants
|
4.5 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 5 PASI 90
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
3.7 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 29 PASI 50
|
17.2 Percentage of Participants
|
46.2 Percentage of Participants
|
52.4 Percentage of Participants
|
85.2 Percentage of Participants
|
27.3 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 29 PASI 75
|
0 Percentage of Participants
|
15.4 Percentage of Participants
|
23.8 Percentage of Participants
|
59.3 Percentage of Participants
|
13.6 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 29 PASI 90
|
0 Percentage of Participants
|
7.7 Percentage of Participants
|
14.3 Percentage of Participants
|
22.2 Percentage of Participants
|
9.1 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 33 PASI 50
|
10.3 Percentage of Participants
|
34.6 Percentage of Participants
|
47.6 Percentage of Participants
|
77.8 Percentage of Participants
|
22.7 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 33 PASI 75
|
3.4 Percentage of Participants
|
19.2 Percentage of Participants
|
23.8 Percentage of Participants
|
55.6 Percentage of Participants
|
4.5 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 33 PASI 90
|
0 Percentage of Participants
|
0 Percentage of Participants
|
9.5 Percentage of Participants
|
18.5 Percentage of Participants
|
4.5 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 37 PASI 50
|
17.2 Percentage of Participants
|
30.8 Percentage of Participants
|
47.6 Percentage of Participants
|
63.0 Percentage of Participants
|
22.7 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 37 PASI 75
|
3.4 Percentage of Participants
|
19.2 Percentage of Participants
|
19.0 Percentage of Participants
|
25.9 Percentage of Participants
|
4.5 Percentage of Participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Week 37 PASI 90
|
0 Percentage of Participants
|
3.8 Percentage of Participants
|
9.5 Percentage of Participants
|
11.1 Percentage of Participants
|
4.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: 37 weeksPopulation: The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.
Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups.
Outcome measures
| Measure |
AIN457 1x25mg
n=1 Participants
AIN457 25mg Subcutaneously as a single dose
|
AIN457 3x25mg
n=5 Participants
AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x75mg
n=12 Participants
AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x150mg
n=22 Participants
AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
Placebo
Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
|---|---|---|---|---|---|
|
To Assess the Time to Relapse
|
NA days
Not Estimable because no relapses occured
|
NA days
Not Estimable because no relapses occured
|
NA days
Interval 198.0 to
Not Estimable because very low relapses occured
|
203 days
Interval 203.0 to
Not Estimable because very low relapses occured
|
—
|
Adverse Events
AIN457 1x25mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
AIN457 3x25mg
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
AIN457 3x75mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
AIN457 3x150mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AIN457 1x25mg
n=29 participants at risk
AIN457 25mg Subcutaneously as a single dose
|
AIN457 3x25mg
n=26 participants at risk
AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x75mg
n=21 participants at risk
AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x150mg
n=27 participants at risk
AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
Placebo
n=22 participants at risk
Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/29
|
0.00%
0/26
|
0.00%
0/21
|
0.00%
0/27
|
4.5%
1/22
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/29
|
3.8%
1/26
|
0.00%
0/21
|
0.00%
0/27
|
0.00%
0/22
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/29
|
3.8%
1/26
|
0.00%
0/21
|
0.00%
0/27
|
0.00%
0/22
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/29
|
0.00%
0/26
|
0.00%
0/21
|
0.00%
0/27
|
4.5%
1/22
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.00%
0/29
|
0.00%
0/26
|
4.8%
1/21
|
0.00%
0/27
|
0.00%
0/22
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/29
|
3.8%
1/26
|
0.00%
0/21
|
0.00%
0/27
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/29
|
3.8%
1/26
|
0.00%
0/21
|
0.00%
0/27
|
0.00%
0/22
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/29
|
3.8%
1/26
|
0.00%
0/21
|
0.00%
0/27
|
0.00%
0/22
|
Other adverse events
| Measure |
AIN457 1x25mg
n=29 participants at risk
AIN457 25mg Subcutaneously as a single dose
|
AIN457 3x25mg
n=26 participants at risk
AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x75mg
n=21 participants at risk
AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
AIN457 3x150mg
n=27 participants at risk
AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
Placebo
n=22 participants at risk
Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
|
|---|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/29
|
0.00%
0/26
|
0.00%
0/21
|
11.1%
3/27
|
4.5%
1/22
|
|
General disorders
Oedema peripheral
|
0.00%
0/29
|
0.00%
0/26
|
0.00%
0/21
|
7.4%
2/27
|
4.5%
1/22
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
1/29
|
15.4%
4/26
|
19.0%
4/21
|
14.8%
4/27
|
9.1%
2/22
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/29
|
3.8%
1/26
|
0.00%
0/21
|
7.4%
2/27
|
0.00%
0/22
|
|
Infections and infestations
Respiratory tract infection viral
|
3.4%
1/29
|
3.8%
1/26
|
4.8%
1/21
|
0.00%
0/27
|
9.1%
2/22
|
|
Infections and infestations
Upper respiratory tract infection
|
10.3%
3/29
|
7.7%
2/26
|
4.8%
1/21
|
7.4%
2/27
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Muscle strain
|
3.4%
1/29
|
0.00%
0/26
|
0.00%
0/21
|
7.4%
2/27
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/29
|
3.8%
1/26
|
9.5%
2/21
|
3.7%
1/27
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.9%
2/29
|
0.00%
0/26
|
0.00%
0/21
|
0.00%
0/27
|
4.5%
1/22
|
|
Nervous system disorders
Headache
|
3.4%
1/29
|
7.7%
2/26
|
4.8%
1/21
|
3.7%
1/27
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
1/29
|
0.00%
0/26
|
0.00%
0/21
|
3.7%
1/27
|
13.6%
3/22
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
27.6%
8/29
|
15.4%
4/26
|
19.0%
4/21
|
11.1%
3/27
|
9.1%
2/22
|
|
Vascular disorders
Hypertension
|
3.4%
1/29
|
3.8%
1/26
|
0.00%
0/21
|
7.4%
2/27
|
0.00%
0/22
|
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