Trial Outcomes & Findings for AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis (NCT NCT00941031)
NCT ID: NCT00941031
Last Updated: 2015-08-20
Results Overview
Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
404 participants
Primary outcome timeframe
13 weeks
Results posted on
2015-08-20
Participant Flow
Participant milestones
| Measure |
Induction Single Dose
Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
|
Induction Monthly Dose
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
|
Induction Early Loading
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
|
Placebo Dose
Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
|
Fixed Interval
Fixed-time interval regimen - "FI": secukinumab (AIN457) 150 mg s.c. administered at Week 13 and at Week 25 and placebo at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29
|
Start of Relapse
Treatment at start of relapse regimen - "SR": Placebo administered at Week 13 and possibly at Week 25 if no start of relapse observed, and secukinumab (AIN457) 150 mg s.c. administered at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29
|
Open Label
Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase - "OL": secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.21 to Week 29
|
|---|---|---|---|---|---|---|---|
|
Induction Period
STARTED
|
66
|
138
|
133
|
67
|
0
|
0
|
0
|
|
Induction Period
COMPLETED
|
61
|
134
|
127
|
58
|
0
|
0
|
0
|
|
Induction Period
NOT COMPLETED
|
5
|
4
|
6
|
9
|
0
|
0
|
0
|
|
Maintenance Period
STARTED
|
0
|
0
|
0
|
0
|
65
|
67
|
247
|
|
Maintenance Period
COMPLETED
|
0
|
0
|
0
|
0
|
56
|
61
|
204
|
|
Maintenance Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
9
|
6
|
43
|
Reasons for withdrawal
| Measure |
Induction Single Dose
Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
|
Induction Monthly Dose
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
|
Induction Early Loading
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
|
Placebo Dose
Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
|
Fixed Interval
Fixed-time interval regimen - "FI": secukinumab (AIN457) 150 mg s.c. administered at Week 13 and at Week 25 and placebo at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29
|
Start of Relapse
Treatment at start of relapse regimen - "SR": Placebo administered at Week 13 and possibly at Week 25 if no start of relapse observed, and secukinumab (AIN457) 150 mg s.c. administered at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29
|
Open Label
Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase - "OL": secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.21 to Week 29
|
|---|---|---|---|---|---|---|---|
|
Induction Period
Lack of Efficacy
|
2
|
1
|
0
|
5
|
0
|
0
|
0
|
|
Induction Period
Withdrawal by Subject
|
1
|
2
|
2
|
2
|
0
|
0
|
0
|
|
Induction Period
Adminstative Problems
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Induction Period
Adverse Event
|
1
|
0
|
3
|
2
|
0
|
0
|
0
|
|
Maintenance Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
6
|
2
|
13
|
|
Maintenance Period
Administrative Problems
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Maintenance Period
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Maintenance Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
2
|
8
|
|
Maintenance Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
2
|
7
|
|
Maintenance Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
13
|
Baseline Characteristics
AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis
Baseline characteristics by cohort
| Measure |
Induction Single Dose
n=66 Participants
Baseline through Week 12
|
Induction Monthly Dose
n=138 Participants
|
Induction Early Loading Dose
n=133 Participants
|
Placebo
n=67 Participants
|
Total
n=404 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.7 Years
STANDARD_DEVIATION 11.32 • n=5 Participants
|
44.2 Years
STANDARD_DEVIATION 12.96 • n=7 Participants
|
44.5 Years
STANDARD_DEVIATION 12.45 • n=5 Participants
|
44.2 Years
STANDARD_DEVIATION 12.59 • n=4 Participants
|
44.1 Years
STANDARD_DEVIATION 12.44 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
98 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
306 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
353 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 13 weeksPopulation: (Full analysis set, LOCF) Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment
Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment
Outcome measures
| Measure |
Induction Single Dose
n=66 Participants
Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
|
Induction Monthly Dose
n=138 Participants
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
|
Induction Early Loading Dose
n=132 Participants
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
|
Placebo Dose
n=66 Participants
Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
|
|---|---|---|---|---|
|
The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo.
PASI 50
|
18 Participants achieving goal
|
83 Participants achieving goal
|
101 Participants achieving goal
|
7 Participants achieving goal
|
|
The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo.
PASI 90
|
2 Participants achieving goal
|
24 Participants achieving goal
|
42 Participants achieving goal
|
1 Participants achieving goal
|
|
The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo.
PASI 75
|
7 Participants achieving goal
|
58 Participants achieving goal
|
72 Participants achieving goal
|
1 Participants achieving goal
|
SECONDARY outcome
Timeframe: week 21 to 29Population: (Full analysis set, LOCF)
Outcome measures
| Measure |
Induction Single Dose
n=65 Participants
Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
|
Induction Monthly Dose
n=67 Participants
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
|
Induction Early Loading Dose
n=247 Participants
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
|
Placebo Dose
Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
|
|---|---|---|---|---|
|
The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29
PASI 90
|
38 Participants achieving goal
|
14 Participants achieving goal
|
53 Participants achieving goal
|
—
|
|
The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29
PASI 50
|
64 Participants achieving goal
|
60 Participants achieving goal
|
200 Participants achieving goal
|
—
|
|
The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29
PASI 75
|
55 Participants achieving goal
|
45 Participants achieving goal
|
114 Participants achieving goal
|
—
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Full analysis set
The investigator's global assessment (IGA) was used to evaluate overall psoriatic disease, with scores ranging from 0 (clear) to 5 (very severe disease). Treatment success was defined as patients who achieved IGA 0 or 1 and improvement of at least 2 points on the IGA scale compared to baseline. The IGA rating score for involvement of hands and feet ranged from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Induction Single Dose
n=66 Participants
Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
|
Induction Monthly Dose
n=137 Participants
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
|
Induction Early Loading Dose
n=132 Participants
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
|
Placebo Dose
n=66 Participants
Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
|
|---|---|---|---|---|
|
The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo
0=clear
|
0 Participants achieving goal
|
2 Participants achieving goal
|
17 Participants achieving goal
|
1 Participants achieving goal
|
|
The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo
1= almost clear
|
3 Participants achieving goal
|
29 Participants achieving goal
|
32 Participants achieving goal
|
0 Participants achieving goal
|
|
The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo
3= moderate disease
|
28 Participants achieving goal
|
44 Participants achieving goal
|
33 Participants achieving goal
|
26 Participants achieving goal
|
|
The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo
5= very serious disease
|
3 Participants achieving goal
|
2 Participants achieving goal
|
0 Participants achieving goal
|
7 Participants achieving goal
|
|
The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo
2= mild disease
|
17 Participants achieving goal
|
42 Participants achieving goal
|
38 Participants achieving goal
|
3 Participants achieving goal
|
|
The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo
4=severe disease
|
15 Participants achieving goal
|
18 Participants achieving goal
|
12 Participants achieving goal
|
29 Participants achieving goal
|
Adverse Events
INDUCTION: Single
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
INDUCTION: Monthly
Serious events: 3 serious events
Other events: 53 other events
Deaths: 0 deaths
INDUCTION: Early
Serious events: 6 serious events
Other events: 46 other events
Deaths: 0 deaths
INDUCTION: Placebo
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
MAINTENANCE: Fixed Interval
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
MAINTENANCE: Start of Relapse
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
MAINTENANCE: Open Label
Serious events: 12 serious events
Other events: 83 other events
Deaths: 0 deaths
FOLLOW-UP: Fixed Interval
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
FOLLOW-UP: Start of Relapse
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
FOLLOW-UP: Open Label
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
INDUCTION: Single
n=66 participants at risk
INDUCTION: Early loading induction - 'Early'
|
INDUCTION: Monthly
n=138 participants at risk
INDUCTION: with monthly injections - 'Monthly'
|
INDUCTION: Early
n=133 participants at risk
INDUCTION: with single injection - 'Single'
|
INDUCTION: Placebo
n=67 participants at risk
INDUCTION: Placebo - 'Placebo'
|
MAINTENANCE: Fixed Interval
n=65 participants at risk
MAINTENANCE: Fixed-time interval regimen - 'FI'
|
MAINTENANCE: Start of Relapse
n=67 participants at risk
MAINTENANCE: Treatment at start of relapse regimen - 'SR'
|
MAINTENANCE: Open Label
n=247 participants at risk
MAINTENANCE: Open label Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase - "OL": secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.
|
FOLLOW-UP: Fixed Interval
n=17 participants at risk
FOLLOW-UP: Fixed-time interval regimen - 'FI'
|
FOLLOW-UP: Start of Relapse
n=15 participants at risk
FOLLOW-UP: Treatment at start of relapse regimen - 'SR'
|
FOLLOW-UP: Open Label
n=72 participants at risk
FOLLOW-UP: Open label
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/66
|
0.00%
0/138
|
0.75%
1/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.40%
1/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/66
|
0.00%
0/138
|
0.75%
1/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
1.4%
1/72
|
|
Eye disorders
Cataract
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.40%
1/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/66
|
0.72%
1/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Gastrointestinal disorders
Colonic stenosis
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.40%
1/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
1.5%
1/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
1.5%
1/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Infections and infestations
Acute tonsillitis
|
1.5%
1/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Infections and infestations
Anal abscess
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
1.5%
1/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Infections and infestations
Appendicitis
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.40%
1/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
1.5%
1/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/66
|
0.00%
0/138
|
0.75%
1/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Infections and infestations
Septic shock
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
1.4%
1/72
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.40%
1/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/66
|
0.00%
0/138
|
0.75%
1/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.40%
1/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/66
|
0.72%
1/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
1.5%
1/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
1.5%
1/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
1.5%
1/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.40%
1/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.40%
1/247
|
0.00%
0/17
|
0.00%
0/15
|
1.4%
1/72
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
1.5%
1/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.40%
1/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
1.4%
1/72
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
1.4%
1/72
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.40%
1/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.40%
1/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/66
|
0.00%
0/138
|
0.75%
1/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis
|
0.00%
0/66
|
0.00%
0/138
|
0.75%
1/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.40%
1/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/66
|
0.72%
1/138
|
0.00%
0/133
|
1.5%
1/67
|
0.00%
0/65
|
0.00%
0/67
|
0.40%
1/247
|
0.00%
0/17
|
0.00%
0/15
|
1.4%
1/72
|
|
Vascular disorders
Hypertensive crisis
|
1.5%
1/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
Other adverse events
| Measure |
INDUCTION: Single
n=66 participants at risk
INDUCTION: Early loading induction - 'Early'
|
INDUCTION: Monthly
n=138 participants at risk
INDUCTION: with monthly injections - 'Monthly'
|
INDUCTION: Early
n=133 participants at risk
INDUCTION: with single injection - 'Single'
|
INDUCTION: Placebo
n=67 participants at risk
INDUCTION: Placebo - 'Placebo'
|
MAINTENANCE: Fixed Interval
n=65 participants at risk
MAINTENANCE: Fixed-time interval regimen - 'FI'
|
MAINTENANCE: Start of Relapse
n=67 participants at risk
MAINTENANCE: Treatment at start of relapse regimen - 'SR'
|
MAINTENANCE: Open Label
n=247 participants at risk
MAINTENANCE: Open label Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase - "OL": secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.
|
FOLLOW-UP: Fixed Interval
n=17 participants at risk
FOLLOW-UP: Fixed-time interval regimen - 'FI'
|
FOLLOW-UP: Start of Relapse
n=15 participants at risk
FOLLOW-UP: Treatment at start of relapse regimen - 'SR'
|
FOLLOW-UP: Open Label
n=72 participants at risk
FOLLOW-UP: Open label
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Inflammation
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
6.7%
1/15
|
0.00%
0/72
|
|
Infections and infestations
Nasopharyngitis
|
12.1%
8/66
|
22.5%
31/138
|
22.6%
30/133
|
17.9%
12/67
|
9.2%
6/65
|
7.5%
5/67
|
14.2%
35/247
|
0.00%
0/17
|
0.00%
0/15
|
2.8%
2/72
|
|
Infections and infestations
Upper respiratory tract infection
|
4.5%
3/66
|
4.3%
6/138
|
1.5%
2/133
|
9.0%
6/67
|
3.1%
2/65
|
0.00%
0/67
|
6.9%
17/247
|
0.00%
0/17
|
6.7%
1/15
|
1.4%
1/72
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
2/66
|
5.8%
8/138
|
0.00%
0/133
|
0.00%
0/67
|
1.5%
1/65
|
1.5%
1/67
|
3.6%
9/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
6.7%
1/15
|
0.00%
0/72
|
|
Nervous system disorders
Headache
|
9.1%
6/66
|
5.8%
8/138
|
8.3%
11/133
|
4.5%
3/67
|
4.6%
3/65
|
1.5%
1/67
|
5.3%
13/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/66
|
0.00%
0/138
|
0.00%
0/133
|
0.00%
0/67
|
0.00%
0/65
|
0.00%
0/67
|
0.00%
0/247
|
0.00%
0/17
|
6.7%
1/15
|
0.00%
0/72
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/66
|
0.00%
0/138
|
0.75%
1/133
|
0.00%
0/67
|
0.00%
0/65
|
1.5%
1/67
|
0.00%
0/247
|
5.9%
1/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/66
|
1.4%
2/138
|
3.0%
4/133
|
6.0%
4/67
|
0.00%
0/65
|
0.00%
0/67
|
3.2%
8/247
|
0.00%
0/17
|
0.00%
0/15
|
0.00%
0/72
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
9.1%
6/66
|
5.1%
7/138
|
3.0%
4/133
|
9.0%
6/67
|
6.2%
4/65
|
9.0%
6/67
|
6.5%
16/247
|
11.8%
2/17
|
6.7%
1/15
|
1.4%
1/72
|
|
Vascular disorders
Hypertension
|
4.5%
3/66
|
0.72%
1/138
|
1.5%
2/133
|
1.5%
1/67
|
3.1%
2/65
|
7.5%
5/67
|
2.0%
5/247
|
0.00%
0/17
|
0.00%
0/15
|
1.4%
1/72
|
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 (ie, data from all sites) in the clinical trial
- Publication restrictions are in place
Restriction type: OTHER