Trial Outcomes & Findings for Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis (NCT NCT01412944)
NCT ID: NCT01412944
Last Updated: 2015-03-18
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
PHASE3
Target enrollment
43 participants
Primary outcome timeframe
Week 8
Results posted on
2015-03-18
Participant Flow
This study consisted of 3 study periods: I.V. (I.V. infusion and subcutaneous (s.c.) regimens given in a double-blind fashion), Maintenance and follow-up. Participants, who were identified as partial responders at week 12 of study CAIN457A2304 (NCT01406938), were eligible to roll into CAIN457A2307.
Participants of the CAIN457A2304 150 mg or AIN457 300 mg treatment groups, who were partial responders at week 12 of CAIN457A2304, were randomized in a 1:1 ratio to the AIN457 300 mg s.c. or AIN457 10 mg/kg I.V. treatment groups of CAIN457A2307.
Participant milestones
| Measure |
AIN457 Subcutaneous (s.c.)
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.
|
AIN457 300 mg - AIN457 300 mg s.c.
|
AIN457 150 mg - AIN457 10 mg/kg I.V.
|
AIN457 300 mg - AIN457 10 mg/kg I.V.
|
|---|---|---|---|---|---|---|
|
IV: Per Previous CAIN457A2304 Treatment
STARTED
|
0
|
0
|
15
|
6
|
14
|
8
|
|
IV: Per Previous CAIN457A2304 Treatment
COMPLETED
|
0
|
0
|
14
|
6
|
14
|
6
|
|
IV: Per Previous CAIN457A2304 Treatment
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
2
|
|
IV: Per CAIN457A2307
STARTED
|
21
|
22
|
0
|
0
|
0
|
0
|
|
IV: Per CAIN457A2307
COMPLETED
|
20
|
20
|
0
|
0
|
0
|
0
|
|
IV: Per CAIN457A2307
NOT COMPLETED
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Entire: IV + Maintenance
STARTED
|
21
|
22
|
0
|
0
|
0
|
0
|
|
Entire: IV + Maintenance
COMPLETED
|
19
|
17
|
0
|
0
|
0
|
0
|
|
Entire: IV + Maintenance
NOT COMPLETED
|
2
|
5
|
0
|
0
|
0
|
0
|
|
Follow-up
STARTED
|
0
|
0
|
2
|
1
|
2
|
0
|
|
Follow-up
COMPLETED
|
0
|
0
|
2
|
1
|
2
|
0
|
|
Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
AIN457 Subcutaneous (s.c.)
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.
|
AIN457 300 mg - AIN457 300 mg s.c.
|
AIN457 150 mg - AIN457 10 mg/kg I.V.
|
AIN457 300 mg - AIN457 10 mg/kg I.V.
|
|---|---|---|---|---|---|---|
|
IV: Per Previous CAIN457A2304 Treatment
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
|
IV: Per Previous CAIN457A2304 Treatment
Protocol deviation
|
0
|
0
|
0
|
0
|
0
|
1
|
|
IV: Per Previous CAIN457A2304 Treatment
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
IV: Per CAIN457A2307
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
IV: Per CAIN457A2307
Protocol deviation
|
0
|
1
|
0
|
0
|
0
|
0
|
|
IV: Per CAIN457A2307
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Entire: IV + Maintenance
Withdrawal by Subject
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Entire: IV + Maintenance
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Entire: IV + Maintenance
Protocol deviation
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Entire: IV + Maintenance
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Entire: IV + Maintenance
Lack of Efficacy
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis
Baseline characteristics by cohort
| Measure |
AIN457 Subcutaneous (s.c.)
n=21 Participants
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
AIN457 I.V.
n=22 Participants
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.6 Years
STANDARD_DEVIATION 14.53 • n=5 Participants
|
45.7 Years
STANDARD_DEVIATION 12.14 • n=7 Participants
|
46.6 Years
STANDARD_DEVIATION 13.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had week 8 values, were included in the 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 Subcutaneous (s.c.)
n=21 Participants
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
AIN457 I.V.
n=21 Participants
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
|---|---|---|
|
Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI
|
66.7 Percentage of participants
|
90.5 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 8Population: The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had week 8 values, were included in the analysis.
The IGA mod 2011 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, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
Outcome measures
| Measure |
AIN457 Subcutaneous (s.c.)
n=21 Participants
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
AIN457 I.V.
n=21 Participants
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
|---|---|---|
|
Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response
|
66.7 Percentage of participants
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40Population: The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.
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). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 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 and 4 = severe.
Outcome measures
| Measure |
AIN457 Subcutaneous (s.c.)
n=21 Participants
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
AIN457 I.V.
n=21 Participants
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
|---|---|---|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 20 PASI 90
|
14.3 Percentage of participants
|
57.1 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 20 PASI 100
|
4.8 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 24 IGA 0/1
|
23.8 Percentage of participants
|
47.6 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 24 PASI 75
|
52.4 Percentage of participants
|
76.2 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 24 PASI 50
|
81.0 Percentage of participants
|
85.7 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 24 PASI 90
|
19.0 Percentage of participants
|
57.1 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 24 PASI 100
|
9.5 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 28 IGA 0/1
|
23.8 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 28 PASI 75
|
61.9 Percentage of participants
|
61.9 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 28 PASI 50
|
76.2 Percentage of participants
|
85.7 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 28 PASI 90
|
23.8 Percentage of participants
|
38.1 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 28 PASI 100
|
0.0 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 32 IGA 0/1
|
14.3 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 32 PASI 75
|
57.1 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 32 PASI 50
|
76.2 Percentage of participants
|
81.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 32 PASI 90
|
19.0 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 32 PASI 100
|
0.0 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 36 IGA 0/1
|
19.0 Percentage of participants
|
52.4 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 36 PASI 75
|
57.1 Percentage of participants
|
61.9 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 36 PASI 50
|
81.0 Percentage of participants
|
76.2 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 36PASI 90
|
23.8 Percentage of participants
|
47.6 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 36 PASI 100
|
0.0 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 40 IGA 0/1
|
28.6 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 40 PASI 75
|
47.6 Percentage of participants
|
61.9 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 40 PASI 50
|
85.7 Percentage of participants
|
71.4 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 40 PASI 90
|
23.8 Percentage of participants
|
47.6 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 40 PASI 100
|
0.0 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 2 IGA 0/1
|
9.5 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 2 PASI 75
|
19.0 Percentage of participants
|
47.6 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 2 PASI 50
|
85.7 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 2 PASI 90
|
0.0 Percentage of participants
|
19.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 2 PASI 100
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 4 IGA 0/1
|
9.5 Percentage of participants
|
47.6 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 4 PASI 75
|
33.3 Percentage of participants
|
76.2 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 4 PASI 50
|
85.7 Percentage of participants
|
95.2 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 4 PASI 90
|
4.8 Percentage of participants
|
28.6 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 4 PASI 100
|
0.0 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 8 IGA 0/1
|
33.3 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 8 PASI 75
|
66.7 Percentage of participants
|
90.5 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 8 PASI 50
|
90.5 Percentage of participants
|
95.2 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 8 PASI 90
|
9.5 Percentage of participants
|
61.9 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 8 PASI 100
|
0.0 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 12 IGA 0/1
|
38.1 Percentage of participants
|
71.4 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 12 PASI 75
|
61.9 Percentage of participants
|
85.7 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 12 PASI 50
|
85.7 Percentage of participants
|
95.2 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 12 PASI 90
|
19.0 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 12 PASI 100
|
0.0 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 16 IGA 0/1
|
28.6 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 16 PASI 75
|
66.7 Percentage of participants
|
81.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 16 PASI 50
|
85.7 Percentage of participants
|
85.7 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 16 PASI 90
|
14.3 Percentage of participants
|
57.1 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 16 PASI 100
|
0.0 Percentage of participants
|
19.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 20 IGA 0/1
|
23.8 Percentage of participants
|
61.9 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 20 PASI 75
|
66.7 Percentage of participants
|
81.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 20 PASI 50
|
81.0 Percentage of participants
|
85.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40Population: The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.
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). A negative mean percentage change indicates improvement.
Outcome measures
| Measure |
AIN457 Subcutaneous (s.c.)
n=21 Participants
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
AIN457 I.V.
n=21 Participants
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
|---|---|---|
|
Mean Percent Change From Baseline in PASI Scores
Week 2
|
-65.427 Percent change
Standard Deviation 14.1732
|
-74.824 Percent change
Standard Deviation 10.6180
|
|
Mean Percent Change From Baseline in PASI Scores
Week 4
|
-69.804 Percent change
Standard Deviation 14.4443
|
-83.063 Percent change
Standard Deviation 10.7849
|
|
Mean Percent Change From Baseline in PASI Scores
Week 8
|
-75.422 Percent change
Standard Deviation 15.0913
|
-90.980 Percent change
Standard Deviation 9.6116
|
|
Mean Percent Change From Baseline in PASI Scores
Week 12
|
-76.026 Percent change
Standard Deviation 17.0949
|
-89.754 Percent change
Standard Deviation 11.1194
|
|
Mean Percent Change From Baseline in PASI Scores
Week 16
|
-75.079 Percent change
Standard Deviation 18.6092
|
-89.645 Percent change
Standard Deviation 13.4471
|
|
Mean Percent Change From Baseline in PASI Scores
Week 20
|
-74.494 Percent change
Standard Deviation 20.5253
|
-86.816 Percent change
Standard Deviation 19.4202
|
|
Mean Percent Change From Baseline in PASI Scores
Week 24
|
-72.703 Percent change
Standard Deviation 22.4086
|
-85.803 Percent change
Standard Deviation 19.8869
|
|
Mean Percent Change From Baseline in PASI Scores
Week 28
|
-72.281 Percent change
Standard Deviation 23.4549
|
-80.487 Percent change
Standard Deviation 25.7435
|
|
Mean Percent Change From Baseline in PASI Scores
Week 32
|
-71.770 Percent change
Standard Deviation 22.7398
|
-79.557 Percent change
Standard Deviation 27.2634
|
|
Mean Percent Change From Baseline in PASI Scores
Week 36
|
-72.151 Percent change
Standard Deviation 21.4637
|
-79.329 Percent change
Standard Deviation 27.2362
|
|
Mean Percent Change From Baseline in PASI Scores
Week 40
|
-73.663 Percent change
Standard Deviation 18.2709
|
-77.416 Percent change
Standard Deviation 28.5592
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40Population: The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.
The IGA mod 2011 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, and 4 = severe.
Outcome measures
| Measure |
AIN457 Subcutaneous (s.c.)
n=21 Participants
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
AIN457 I.V.
n=21 Participants
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
|---|---|---|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 40 - almost clear
|
28.6 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 2 - clear
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 2 - almost clear
|
9.5 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 2 - mild
|
57.1 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 2 - moderate
|
33.3 Percentage of participants
|
23.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 2 - severe
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 4 - clear
|
0.0 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 4 - almost clear
|
9.5 Percentage of participants
|
38.1 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 4 - mild
|
61.9 Percentage of participants
|
47.6 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 4 - moderate
|
28.6 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 4 - severe
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 8 - clear
|
0.0 Percentage of participants
|
19.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 8 - almost clear
|
33.3 Percentage of participants
|
47.6 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 8 - mild
|
38.1 Percentage of participants
|
23.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 8 - moderate
|
28.6 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 8 - severe
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 12 - clear
|
0.0 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 12 - almost clear
|
38.1 Percentage of participants
|
57.1 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 12 - mild
|
33.3 Percentage of participants
|
19.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 12 - moderate
|
28.6 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 12 - severe
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 16 - clear
|
0.0 Percentage of participants
|
19.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 16 - almost clear
|
28.6 Percentage of participants
|
52.4 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 16 - mild
|
42.9 Percentage of participants
|
19.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 16 - moderate
|
28.6 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 16 - severe
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 20 - clear
|
4.8 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 20 - almost clear
|
19.0 Percentage of participants
|
52.4 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 20 - mild
|
47.6 Percentage of participants
|
23.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 20 - moderate
|
28.6 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 20 - severe
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 24 - clear
|
9.5 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 24 - almost clear
|
14.3 Percentage of participants
|
38.1 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 24 - mild
|
33.3 Percentage of participants
|
28.6 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 24 - moderate
|
42.9 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 24 - severe
|
0.0 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 28 - clear
|
9.5 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 28 - almost clear
|
14.3 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 28 - mild
|
47.6 Percentage of participants
|
28.6 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 28 - moderate
|
28.6 Percentage of participants
|
23.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 28 - severe
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 32 - clear
|
4.8 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 32 - almost clear
|
9.5 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 32 - mild
|
47.6 Percentage of participants
|
23.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 32 - moderate
|
38.1 Percentage of participants
|
23.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 32 - severe
|
0.0 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 36 - clear
|
0.0 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 36 - almost clear
|
19.0 Percentage of participants
|
52.4 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 36 - mild
|
42.9 Percentage of participants
|
19.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 36 - moderate
|
38.1 Percentage of participants
|
19.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 36 - severe
|
0.0 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 40 - clear
|
0.0 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 40 - mild
|
33.3 Percentage of participants
|
23.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 40 - moderate
|
38.1 Percentage of participants
|
23.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category
week 40 - severe
|
0.0 Percentage of participants
|
4.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40Population: The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A DLQI of 0 or 1 indicates no impairment or little impairment, respectively. A negative mean percentage change from baseline indicates improvement.
Outcome measures
| Measure |
AIN457 Subcutaneous (s.c.)
n=21 Participants
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
AIN457 I.V.
n=21 Participants
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
|---|---|---|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
Baseline
|
0.0 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
Week 8 (n=20,20)
|
25.0 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
Week 16 (n=20,20)
|
40.0 Percentage of participants
|
70.0 Percentage of participants
|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
Week 24 (n=20,20)
|
40.0 Percentage of participants
|
55.0 Percentage of participants
|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
Week 32 (n=20,20)
|
40.0 Percentage of participants
|
55.0 Percentage of participants
|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
Week 40 (n=20,20)
|
40.0 Percentage of participants
|
55.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 8, 16, 24, 32 and 40Population: The FAS population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Outcome measures
| Measure |
AIN457 Subcutaneous (s.c.)
n=20 Participants
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
AIN457 I.V.
n=20 Participants
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
|---|---|---|
|
Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores
week 8
|
-67.1 Percent change
Standard Deviation 28.35
|
-82.4 Percent change
Standard Deviation 31.13
|
|
Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores
week 16
|
-68.7 Percent change
Standard Deviation 32.34
|
-74.8 Percent change
Standard Deviation 42.19
|
|
Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores
week 24
|
-66.9 Percent change
Standard Deviation 29.27
|
-63.2 Percent change
Standard Deviation 42.65
|
|
Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores
week 32
|
-65.4 Percent change
Standard Deviation 34.64
|
-58.1 Percent change
Standard Deviation 53.40
|
|
Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores
week 40
|
-74.2 Percent change
Standard Deviation 24.25
|
-53.8 Percent change
Standard Deviation 56.21
|
SECONDARY outcome
Timeframe: Baseline, weeks 8, 16, 24, 32 and 40Population: The FAS population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.
Outcome measures
| Measure |
AIN457 Subcutaneous (s.c.)
n=20 Participants
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
AIN457 I.V.
n=20 Participants
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
|---|---|---|
|
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)
week 8
|
71.0 Percent change
Standard Deviation 157.11
|
73.1 Percent change
Standard Deviation 99.42
|
|
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)
week 16
|
76.9 Percent change
Standard Deviation 153.63
|
57.5 Percent change
Standard Deviation 98.10
|
|
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)
week 24
|
74.6 Percent change
Standard Deviation 171.69
|
45.3 Percent change
Standard Deviation 82.05
|
|
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)
week 32
|
80.2 Percent change
Standard Deviation 177.33
|
40.9 Percent change
Standard Deviation 80.96
|
|
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)
week 40
|
87.2 Percent change
Standard Deviation 173.59
|
41.3 Percent change
Standard Deviation 86.92
|
SECONDARY outcome
Timeframe: Baseline, weeks 12, 24 and 40Population: Participants from full analysis set (FAS), who had values at baseline and post-baseline, were included in the analysis. The FAS included all participants to whom treatment was assigned.
The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.
Outcome measures
| Measure |
AIN457 Subcutaneous (s.c.)
n=20 Participants
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
AIN457 I.V.
n=20 Participants
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
|
|---|---|---|
|
Number of Participants Who Developed Anti-secukinumab Antibodies
|
0 Number of participants
|
0 Number of participants
|
SECONDARY outcome
Timeframe: End of studyThis outcome measure was not analyzed due to the small sample size of the study (43 participants).
Outcome measures
Outcome data not reported
Adverse Events
I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
I.V. Period: AIN457 300 mg - AIN457 300 mg s.c.
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
I.V. Period: AIN457 150 mg - AIN457 10 mg/kg i.v.
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
I.V. Period: AIN457 300 mg - AIN457 10 mg/kg i.v.
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Entire Period: AIN457 150 mg - AIN457 300 mg s.c.
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Entire Period: AIN457 300 mg - AIN457 300 mg s.c.
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Entire Period: AIN457 150 mg - AIN457 10 mg/kg i.v.
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Entire Period: AIN457 300 mg - AIN457 10 mg/kg i.v.
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Follow up: AIN457 300 mg - AIN457 300 mg s.c.
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Follow-up: AIN457 300 mg - 10 mg/kg i.v.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Follow-up: AIN457 150 mg - 300 mg s.c.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Follow-up: AIN457 150 mg - 10 mg/kg i.v.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.
n=15 participants at risk
|
I.V. Period: AIN457 300 mg - AIN457 300 mg s.c.
n=6 participants at risk
|
I.V. Period: AIN457 150 mg - AIN457 10 mg/kg i.v.
n=14 participants at risk
|
I.V. Period: AIN457 300 mg - AIN457 10 mg/kg i.v.
n=8 participants at risk
|
Entire Period: AIN457 150 mg - AIN457 300 mg s.c.
n=15 participants at risk
|
Entire Period: AIN457 300 mg - AIN457 300 mg s.c.
n=6 participants at risk
|
Entire Period: AIN457 150 mg - AIN457 10 mg/kg i.v.
n=14 participants at risk
|
Entire Period: AIN457 300 mg - AIN457 10 mg/kg i.v.
n=8 participants at risk
|
Follow up: AIN457 300 mg - AIN457 300 mg s.c.
n=1 participants at risk
|
Follow-up: AIN457 300 mg - 10 mg/kg i.v.
|
Follow-up: AIN457 150 mg - 300 mg s.c.
n=2 participants at risk
|
Follow-up: AIN457 150 mg - 10 mg/kg i.v.
n=2 participants at risk
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
Other adverse events
| Measure |
I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.
n=15 participants at risk
|
I.V. Period: AIN457 300 mg - AIN457 300 mg s.c.
n=6 participants at risk
|
I.V. Period: AIN457 150 mg - AIN457 10 mg/kg i.v.
n=14 participants at risk
|
I.V. Period: AIN457 300 mg - AIN457 10 mg/kg i.v.
n=8 participants at risk
|
Entire Period: AIN457 150 mg - AIN457 300 mg s.c.
n=15 participants at risk
|
Entire Period: AIN457 300 mg - AIN457 300 mg s.c.
n=6 participants at risk
|
Entire Period: AIN457 150 mg - AIN457 10 mg/kg i.v.
n=14 participants at risk
|
Entire Period: AIN457 300 mg - AIN457 10 mg/kg i.v.
n=8 participants at risk
|
Follow up: AIN457 300 mg - AIN457 300 mg s.c.
n=1 participants at risk
|
Follow-up: AIN457 300 mg - 10 mg/kg i.v.
|
Follow-up: AIN457 150 mg - 300 mg s.c.
n=2 participants at risk
|
Follow-up: AIN457 150 mg - 10 mg/kg i.v.
n=2 participants at risk
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Eye disorders
CONJUNCTIVITIS ALLERGIC
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Eye disorders
EYELIDS PRURITUS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
12.5%
1/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
GINGIVITIS ULCERATIVE
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
ILEAL ULCER
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
CHEST PAIN
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
FATIGUE
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
INJECTION SITE PAIN
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Immune system disorders
ALLERGY TO PLANTS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Immune system disorders
SEASONAL ALLERGY
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
BRONCHITIS
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
BRONCHITIS BACTERIAL
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
12.5%
1/8
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
12.5%
1/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
FOLLICULITIS
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
14.3%
2/14
|
12.5%
1/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
HELICOBACTER INFECTION
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
NASOPHARYNGITIS
|
13.3%
2/15
|
16.7%
1/6
|
7.1%
1/14
|
12.5%
1/8
|
20.0%
3/15
|
16.7%
1/6
|
21.4%
3/14
|
25.0%
2/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
ONYCHOMYCOSIS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
ORAL CANDIDIASIS
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/15
|
16.7%
1/6
|
7.1%
1/14
|
0.00%
0/8
|
6.7%
1/15
|
16.7%
1/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
PILONIDAL CYST
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
RHINITIS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
12.5%
1/8
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
12.5%
1/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
TINEA PEDIS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
TONSILLITIS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
12.5%
1/8
|
6.7%
1/15
|
0.00%
0/6
|
7.1%
1/14
|
12.5%
1/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION BACTERIAL
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
12.5%
1/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
12.5%
1/8
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
12.5%
1/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
12.5%
1/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PYOGENIC GRANULOMA
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
14.3%
2/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
12.5%
1/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
TENSION HEADACHE
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Renal and urinary disorders
ENURESIS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
12.5%
1/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
12.5%
1/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL OEDEMA
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
DERMATITIS BULLOUS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
INTERTRIGO
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
12.5%
1/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
12.5%
1/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
100.0%
1/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEIC DERMATITIS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
12.5%
1/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
SKIN FISSURES
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
12.5%
1/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Vascular disorders
FLUSHING
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Vascular disorders
HYPERTENSION
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Vascular disorders
HYPOTENSION
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
6.7%
1/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
|
Vascular disorders
THROMBOPHLEBITIS
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/15
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/1
|
—
0/0
|
0.00%
0/2
|
0.00%
0/2
|
Additional Information
Study Director
Novartis
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