AIN457 Regimen Finding Study in Patients With Moderate to... | NCT00941031 | Trialant
NCT00941031
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Aug 20, 2015Estimated
Enrollment
404Actual
Phase
Phase 2
Conditions
Chronic Plaque-type Psoriasis
Interventions
AIN457
AIN457A
AIN457A
Placebo
Countries
United States
France
Germany
Iceland
Israel
Japan
Norway
Protocol Section
Identification Module
NCT ID
NCT00941031
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CAIN457A2211
Secondary IDs
ID
Type
Description
Link
2008-007525-39
EudraCT Number
Brief Title
AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis
Official Title
A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Mar 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 2009
Primary Completion Date
Dec 2010Actual
Completion Date
Dec 2010Actual
First Submitted Date
Jul 16, 2009
First Submission Date that Met QC Criteria
Jul 16, 2009
First Posted Date
Jul 17, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 30, 2015
Results First Submitted that Met QC Criteria
Mar 23, 2015
Results First Posted Date
Mar 27, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
May 31, 2012
Certification/Extension First Submitted that Passed QC Review
May 31, 2012
Certification/Extension First Posted Date
Jun 6, 2012Estimated
Last Update Submitted Date
Jul 30, 2015
Last Update Posted Date
Aug 20, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Plaque-type Psoriasis
Keywords
Moderate to severe chronic plaque-type psoriasis
AIN457
dermatology
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
404Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Induction Single Dose
Experimental
Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
Drug: AIN457
Induction Monthly Dose
Experimental
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
Drug: AIN457A
Induction Early Loading Dose
Experimental
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
Drug: AIN457A
Placebo Dose
Placebo Comparator
Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AIN457
Drug
Induction Single Dose
Secukinumab
AIN457A
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment
13 weeks
Secondary Outcomes
Measure
Description
Time Frame
The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29
week 21 to 29
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
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Men or women at least 18 years of age at time of consent
Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
At time of randomization, moderate to severe psoriasis as defined by:
PASI score of 12 or greater and
IGA score of 3 or greater and
Body Surface Area (BSA) affected by plaque-type psoriasis of 10 % or greater
At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by:
topical treatment and/or
phototherapy and/or
previous systemic therapy
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded from entry into the study:
Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization
Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) and randomization
Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy) at randomization. Washout periods detailed in the study protocol have to be adhered to
Ongoing use of other prohibited treatments at randomization. Washout periods detailed in the study protocol have to be adhered to. All prior concomitant medications must be on a stable dose for at least four weeks before study drug administration
Known immunosuppression (e.g., AIDS) at screening and / or randomization
History or evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis)
At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratoses, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
History of congestive heart failure (NYHA functional classification ≥III) at screening and / or randomization
History of severe hypersensitivity to any human or humanized biological agents (antibody or soluble receptor) at screening and / or randomization
Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
Paul C, Reich K, Gottlieb AB, Mrowietz U, Philipp S, Nakayama J, Harfst E, Guettner A, Papavassilis C; CAIN457A2211 study group. Secukinumab improves hand, foot and nail lesions in moderate-to-severe plaque psoriasis: subanalysis of a randomized, double-blind, placebo-controlled, regimen-finding phase 2 trial. J Eur Acad Dermatol Venereol. 2014 Dec;28(12):1670-5. doi: 10.1111/jdv.12359. Epub 2014 Jan 7.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Induction Single Dose
Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
FG001
Induction Monthly Dose
Periods
Title
Milestones
Reasons Not Completed
Induction Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Finland
Netherlands
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9
Induction Monthly Dose
Secukinumab
AIN457A
Drug
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5
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).
13 weeks
Little Rock
Arkansas
72205
United States
Novartis Investigative Site
Pasadena
California
91105
United States
Novartis Investigative Site
San Diego
California
92123
United States
Novartis Investigative Site
Newnan
Georgia
30263
United States
Novartis Investigative Site
Snellville
Georgia
30078
United States
Novartis Investigative Site
Champaign
Illinois
61820
United States
Novartis Investigative Site
Springfield
Illinois
62703
United States
Novartis Investigative Site
Evansville
Indiana
47713
United States
Novartis Investigative Site
Topeka
Kansas
66606
United States
Novartis Investigative Site
Louisville
Kentucky
40217
United States
Novartis Investigative Site
Boston
Massachusetts
02111
United States
Novartis Investigative Site
Clinton Twp.
Michigan
48038
United States
Novartis Investigative Site
Detroit
Michigan
48202
United States
Novartis Investigative Site
Minneapolis
Minnesota
55455
United States
Novartis Investigative Site
St Louis
Missouri
63117
United States
Novartis Investigative Site
Omaha
Nebraska
68131
United States
Novartis Investigative Site
Omaha
Nebraska
68144
United States
Novartis Investigative Site
Henderson
Nevada
89052
United States
Novartis Investigative Site
New York
New York
10029
United States
Novartis Investigative Site
Rochester
New York
14623
United States
Novartis Investigative Site
High Point
North Carolina
27262
United States
Novartis Investigative Site
Lake Oswego
Oregon
97035
United States
Novartis Investigative Site
Portland
Oregon
97210
United States
Novartis Investigative Site
Philadelphia
Pennsylvania
19104
United States
Novartis Investigative Site
Austin
Texas
78759
United States
Novartis Investigative Site
Dallas
Texas
75204
United States
Novartis Investigative Site
Charlottesville
Virginia
22911
United States
Novartis Investigative Site
Lynchburg
Virginia
24501
United States
Novartis Investigative Site
Toulouse
France
31059
France
Novartis Investigative Site
Nice
06202
France
Novartis Investigative Site
Berlin
10117
Germany
Novartis Investigative Site
Bonn
53105
Germany
Novartis Investigative Site
Dresden
01307
Germany
Novartis Investigative Site
Erlangen
91054
Germany
Novartis Investigative Site
Frankfurt
60590
Germany
Novartis Investigative Site
Göttingen
37075
Germany
Novartis Investigative Site
Hamburg
20354
Germany
Novartis Investigative Site
Hanover
30625
Germany
Novartis Investigative Site
Kiel
24105
Germany
Novartis Investigative Site
Leipzig
04103
Germany
Novartis Investigative Site
Lübeck
23538
Germany
Novartis Investigative Site
Mainz
55131
Germany
Novartis Investigative Site
Münster
48149
Germany
Novartis Investigative Site
Tübingen
72076
Germany
Novartis Investigative Site
Kopavogur
201
Iceland
Novartis Investigative Site
Afula
18101
Israel
Novartis Investigative Site
Petah Tikva
49100
Israel
Novartis Investigative Site
Ramat Gan
52621
Israel
Novartis Investigative Site
Nagoya
Aichi-ken
467-8602
Japan
Novartis Investigative Site
Fukuoka
Fukuoka
814-0180
Japan
Novartis Investigative Site
Kitakyushu
Fukuoka
807-8556
Japan
Novartis Investigative Site
Kurume
Fukuoka
830-0011
Japan
Novartis Investigative Site
Maebashi
Gunma
371-8511
Japan
Novartis Investigative Site
Chitose
Hokkaido
066-0021
Japan
Novartis Investigative Site
Bunkyo-ku
Tokyo
113-8655
Japan
Novartis Investigative Site
Itabashi-ku
Tokyo
173-8610
Japan
Novartis Investigative Site
Minato-ku
Tokyo
105-8471
Japan
Novartis Investigative Site
Shinagawa-ku
Tokyo
141-8625
Japan
Novartis Investigative Site
Ã…lesund
6017
Norway
Novartis Investigative Site
Bergen
NO-5021
Norway
Novartis Investigative Site
Oslo
0424
Norway
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
FG002
Induction Early Loading
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
FG003
Placebo Dose
Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
FG004
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
FG005
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
FG006
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
FG00066 subjects
FG001138 subjects
FG002133 subjects
FG00367 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG00061 subjects
FG001134 subjects
FG002127 subjects
FG00358 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0005 subjects
FG0014 subjects
FG0026 subjects
FG0039 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0035 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Withdrawal by Subject
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
Adminstative Problems
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Adverse Event
FG0001 subjects
FG0010 subjects
FG0023 subjects
FG0032 subjects
FG004
Maintenance Period
Type
Comment
Milestone Data
STARTED
FG0000 subjectsResponders at week 13 were re randomized to one of the maintenance treatment arms in a ratio of 1:1
FG0010 subjectsResponders at week 13 were re randomized to one of the maintenance treatment arms in a ratio of 1:1
FG0020 subjectsResponders at week 13 were re randomized to one of the maintenance treatment arms in a ratio of 1:1
FG0030 subjectsNon Responders treated with an open label regimen.
FG00465 subjectsResponders at week 13 were re randomized to one of the maintenance treatment arms in a ratio of 1:1
FG00567 subjectsResponders at week 13 were re randomized to one of the maintenance treatment arms in a ratio of 1:1
FG006247 subjectsNon Responders treated with an open label regimen.
COMPLETED
FG0000 subjectsResponders at week 13 were re randomized to one of the maintenance treatment arms in a ratio of 1:1
FG0010 subjectsResponders at week 13 were re randomized to one of the maintenance treatment arms in a ratio of 1:1
FG0020 subjectsResponders at week 13 were re randomized to one of the maintenance treatment arms in a ratio of 1:1
FG003
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Induction Single Dose
Baseline through Week 12
BG001
Induction Monthly Dose
BG002
Induction Early Loading Dose
BG003
Placebo
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00066
BG001138
BG002133
BG00367
BG004404
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00042.7± 11.32
BG00144.2± 12.96
BG00244.5± 12.45
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG00134
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment
(Full analysis set, LOCF) Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment
Posted
Number
Participants achieving goal
13 weeks
ID
Title
Description
OG000
Induction Single Dose
Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
OG001
Induction Monthly Dose
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
OG002
Induction Early Loading Dose
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
OG003
Placebo Dose
Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
Units
Counts
Participants
OG00066
OG001138
OG002132
OG003
Title
Denominators
Categories
PASI 50
Title
Measurements
OG00018
OG00183
OG002101
OG003
Secondary
The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29
(Full analysis set, LOCF)
Posted
Number
Participants achieving goal
week 21 to 29
ID
Title
Description
OG000
Maintenance 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
OG001
Maintenance 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
OG002
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.21 to Week 29
Secondary
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
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).
Full analysis set
Posted
Number
Participants achieving goal
13 weeks
ID
Title
Description
OG000
Induction Single Dose
Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
OG001
Induction Monthly Dose
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
OG002
Induction Early Loading Dose
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
INDUCTION: Single
INDUCTION: Early loading induction - 'Early'
3
66
23
66
EG001
INDUCTION: Monthly
INDUCTION: with monthly injections - 'Monthly'
3
138
53
138
EG002
INDUCTION: Early
INDUCTION: with single injection - 'Single'
6
133
46
133
EG003
INDUCTION: Placebo
INDUCTION: Placebo - 'Placebo'
1
67
29
67
EG004
MAINTENANCE: Fixed Interval
MAINTENANCE: Fixed-time interval regimen - 'FI'
4
65
16
65
EG005
MAINTENANCE: Start of Relapse
MAINTENANCE: Treatment at start of relapse regimen - 'SR'
2
67
16
67
EG006
MAINTENANCE: Open Label
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.
12
247
83
247
EG007
FOLLOW-UP: Fixed Interval
FOLLOW-UP: Fixed-time interval regimen - 'FI'
0
17
3
17
EG008
FOLLOW-UP: Start of Relapse
FOLLOW-UP: Treatment at start of relapse regimen - 'SR'
0
15
4
15
EG009
FOLLOW-UP: Open Label
FOLLOW-UP: Open label
5
72
5
72
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0021 affected133 at risk
EG0030 affected67 at risk
EG0040 affected65 at risk
EG0050 affected67 at risk
EG0060 affected247 at risk
EG0070 affected17 at risk
EG0080 affected15 at risk
EG0090 affected72 at risk
Arrhythmia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0021 affected133 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Cataract
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected138 at risk
EG0020 affected133 at risk
EG003
Colonic stenosis
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Acute tonsillitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0021 affected133 at risk
EG003
Septic shock
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0021 affected133 at risk
EG003
Muscle injury
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected138 at risk
EG0020 affected133 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Colon adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Testis cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0021 affected133 at risk
EG003
Erythrodermic psoriasis
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0021 affected133 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected138 at risk
EG0020 affected133 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Inflammation
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG0030 affected67 at risk
EG0040 affected65 at risk
EG0050 affected67 at risk
EG0060 affected247 at risk
EG0070 affected17 at risk
EG0081 affected15 at risk
EG0090 affected72 at risk
Nasopharyngitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0008 affected66 at risk
EG00131 affected138 at risk
EG00230 affected133 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0003 affected66 at risk
EG0016 affected138 at risk
EG0022 affected133 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0002 affected66 at risk
EG0018 affected138 at risk
EG0020 affected133 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0006 affected66 at risk
EG0018 affected138 at risk
EG00211 affected133 at risk
EG003
Migraine with aura
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0020 affected133 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected138 at risk
EG0021 affected133 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected66 at risk
EG0012 affected138 at risk
EG0024 affected133 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0006 affected66 at risk
EG0017 affected138 at risk
EG0024 affected133 at risk
EG003
Hypertension
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0003 affected66 at risk
EG0011 affected138 at risk
EG0022 affected133 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
862-778-8300
ID
Term
C555450
secukinumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
Non Responders treated with an open label regimen.
FG00456 subjects
FG00561 subjects
FG006204 subjects
9 subjects
FG0056 subjects
FG00643 subjects
0 subjects
FG0046 subjects
FG0052 subjects
FG00613 subjects
Administrative Problems
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0068 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0052 subjects
FG0067 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00613 subjects
44.2
± 12.59
BG00444.1± 12.44
28
BG00323
BG00498
Male
BG00053
BG001104
BG002105
BG00344
BG004306
0
BG0030
BG0040
Asian
BG0007
BG00117
BG00214
BG0038
BG00446
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0031
BG0041
Black or African American
BG0000
BG0011
BG0020
BG0031
BG0042
White
BG00059
BG001120
BG002118
BG00356
BG004353
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0031
BG0042
66
7
PASI 75
Title
Measurements
OG0007
OG00158
OG00272
OG0031
PASI 90
Title
Measurements
OG0002
OG00124
OG00242
OG0031
Units
Counts
Participants
OG00065
OG00167
OG002247
Title
Denominators
Categories
PASI 50
Title
Measurements
OG00064
OG00160
OG002200
PASI 75
Title
Measurements
OG00055
OG00145
OG002114
PASI 90
Title
Measurements
OG00038
OG00114
OG00253
OG003
Placebo Dose
Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12