Study of Safety, Tolerability, and Efficacy of Secukinuma... | NCT01807520

ID	Type	Description	Link
2012-005413-40	EudraCT Number

Label	Type	Description	Intervention Names
Secukinumab (AIN457) 150 mg	Experimental	Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, patients received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment are administered by sub-cutaneous injections.	Biological: Secukinumab
Secukinumab (AIN457) 300 mg	Experimental	Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, patients received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment are administered by sub-cutaneous injections.	Biological: Secukinumab
Placebo	Placebo Comparator	Patients assigned to placebo were dosed weekly for five weeks, then at Week 8 and Week 12. At Week 16, placebo patients were randomized in a 1:1 ratio, to receive secukinumab either 150 mg or 300 mg and were dosed weekly for five weeks starting at Week 16, then once every four weeks up to and including Week 132. All doses of study treatment are administered by sub-cutaneous injections.	Biological: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Secukinumab	Biological	Study treatment was provided in pre-filled 1 mL syringes.	Secukinumab (AIN457) 150 mg Secukinumab (AIN457) 300 mg

Measure	Description	Time Frame
Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment	The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement. The adjusted mean is presented.	Baseline, 16 weeks

Measure	Description	Time Frame
Percent Change From Baseline in NAPSI Score	The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with chronic moderate to severe plaque type psoriasis for at least 6 months prior to randomization, including significant nail involvement, defined as Nail Psoriasis Severity Index (NAPSI) score ≥16 AND number of fingernails involved ≥4 AND Psoriasis Area and Severity Index (PASI) score ≥12 AND Body Surface Area (BSA) score ≥10%
Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical treatment (including super potent topical corticosteroids) and/or phototherapy and/or previous systemic therapy

Exclusion Criteria:

Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis)
Drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers, calcium channel inhibitors or lithium)
Ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails which may potentially confound the evaluation of study treatment effects
Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods do apply
Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting IL-17 or the IL-17 receptor
Exposure to any investigational drugs within 4 weeks prior to study treatment initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer
History of hypersensitivity to constituents of the study treatment
Other protocol-defined inclusion/exclusion criteria do apply

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Birmingham	Alabama	35233	United States
Novartis Investigative Site

ID	Title	Description
FG000	AIN457 150 mg	Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
FG001

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

Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment

The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement. The adjusted mean is presented.

Only participants from the full analysis set (FAS) who had values at both baseline and week 16, were analyzed. The FAS consisted of all randomized participants to whom treatment was assigned. The analysis was based on Last Observation Carried Forward (LOCF).

Posted

Mean

Standard Error

percent change

Baseline, 16 weeks

ID	Title	Description
OG000	AIN457 150 mg	Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
OG001	AIN457 300 mg	Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
OG002	Placebo	Participants who received placebo during treatment period 1

Units	Counts
Participants	OG00063 OG00164 OG00256

Title

Denominators

Categories

Title	Measurements
	OG000-38.4± 4.54 OG001-46.1± 3.43 OG002-11.7± 4.28

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Mixed model reapeated measures		<0.0001		Mean Difference (Net)	-26.7	Standard Error of the Mean	6.26	2-Sided	95	-39.1	-14.3					Superiority or Other
OG001 OG002		Mixed model repeated measures

Secondary

Percent Change From Baseline in NAPSI Score

Only participants from the full analysis set (FAS) who had values at both baseline and the post-baseline time point, were analyzed. The FAS consisted of all randomized participants to whom treatment was assigned. The analysis was based on Last Observation Carried Forward (LOCF).

Posted

Mean

Standard Deviation

percent change

baseline, 16 weeks, 132 weeks

ID	Title	Description
OG000	AIN457 150 mg	Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
OG001	AIN457 300 mg	Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.

Secondary

Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI75) and Investigator Global Assessment (IGA Mod 2011) Response 0 or 1 Over Time up to Week 16 of the Treatment Compared to Placebo and Over Time up to Week 132

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). The IGA scale referred exclusively to the participant's disease at the time of the assessment. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe. To be considered IGA responder at any point in time, the patient must have an IGA score of 0 or 1 and have achieved a reduction of at least two points on the IGA scale from baseline.

Participants from the FAS, who had evaluable data at a given time point, were analyzed for that time point. The FAS consisted of all randomized participants to whom treatment was assigned. Multiple imputation was applied where the number of evaluable participants was based on a rounded mean number of responders for 500 imputations.

Posted

Number

Percentage of participants

16 weeks, 132 weeks

ID	Title	Description
OG000	AIN457 150 mg	Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.

Secondary

Number of Participants Who Develop Immunogenicity Against Secukinumab

The number of participants who tested positive for anti-secukinumab antibodies. It refers to the number of participants who had no positive values at baseline but developed them only after start of secukinumab treatment. None of the participants had a loss of efficacy and the test was only transiently positive.

Participants from the safety set was analyzed. The safety set included all participants who took at least one dose of study treatment.

Posted

Number

Participants

Week 132

ID	Title	Description
OG000	AIN457 150 mg	Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
OG001	AIN457 300 mg	Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
OG002	Placebo - AIN457 150 mg

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG0031 affected190 at risk
Myocardial infarction	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Cataract subcapsular	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Pyrexia	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Eczema impetiginous	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Eczema infected	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Sciatica	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Erythrodermic psoriasis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0010 affected94 at risk EG0021 affected65 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Palpitations	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0013 affected94 at risk EG0020 affected65 at risk EG0034 affected190 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Dry eye	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Eye irritation	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Eye pruritus	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Visual impairment	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0012 affected94 at risk EG0022 affected65 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0005 affected96 at risk EG0015 affected94 at risk EG0025 affected65 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected96 at risk EG0015 affected94 at risk EG0020 affected65 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Loose tooth	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected96 at risk EG0013 affected94 at risk EG0021 affected65 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Fatigue	General disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected96 at risk EG0015 affected94 at risk EG0020 affected65 at risk EG003
Influenza like illness	General disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Injection site erythema	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0010 affected94 at risk EG0022 affected65 at risk EG003
Pyrexia	General disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected96 at risk EG0011 affected94 at risk EG0021 affected65 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Bronchitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0004 affected96 at risk EG0017 affected94 at risk EG0020 affected65 at risk EG003
Cellulitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0013 affected94 at risk EG0020 affected65 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected96 at risk EG0014 affected94 at risk EG0020 affected65 at risk EG003
Ear infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Erysipelas	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0021 affected65 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0021 affected65 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0006 affected96 at risk EG0016 affected94 at risk EG0020 affected65 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected96 at risk EG0013 affected94 at risk EG0020 affected65 at risk EG003
Hordeolum	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Influenza	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0016 affected94 at risk EG0022 affected65 at risk EG003
Localised infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0013 affected94 at risk EG0020 affected65 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0013 affected94 at risk EG0020 affected65 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00025 affected96 at risk EG00127 affected94 at risk EG0028 affected65 at risk EG003
Onychomycosis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0013 affected94 at risk EG0020 affected65 at risk EG003
Oral herpes	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0012 affected94 at risk EG0024 affected65 at risk EG003
Otitis externa	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0013 affected94 at risk EG0020 affected65 at risk EG003
Pneumonia	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Pulpitis dental	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0004 affected96 at risk EG0014 affected94 at risk EG0021 affected65 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Rhinitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0017 affected94 at risk EG0020 affected65 at risk EG003
Sinusitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected96 at risk EG0016 affected94 at risk EG0020 affected65 at risk EG003
Skin infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0013 affected94 at risk EG0020 affected65 at risk EG003
Tinea pedis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0005 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Tonsillitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0004 affected96 at risk EG0014 affected94 at risk EG0020 affected65 at risk EG003
Tooth abscess	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0013 affected94 at risk EG0020 affected65 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00015 affected96 at risk EG0018 affected94 at risk EG0022 affected65 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected96 at risk EG0015 affected94 at risk EG0020 affected65 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0010 affected94 at risk EG0021 affected65 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0010 affected94 at risk EG0022 affected65 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Weight increased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0010 affected94 at risk EG0021 affected65 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected96 at risk EG0018 affected94 at risk EG0022 affected65 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0009 affected96 at risk EG0017 affected94 at risk EG0021 affected65 at risk EG003
Dactylitis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0005 affected96 at risk EG0011 affected94 at risk EG0022 affected65 at risk EG003
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0021 affected65 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0012 affected94 at risk EG0021 affected65 at risk EG003
Dizziness	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Headache	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0009 affected96 at risk EG00110 affected94 at risk EG0024 affected65 at risk EG003
Poor quality sleep	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Sciatica	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0006 affected96 at risk EG0010 affected94 at risk EG0021 affected65 at risk EG003
Depression	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected96 at risk EG0014 affected94 at risk EG0022 affected65 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0013 affected94 at risk EG0020 affected65 at risk EG003
Stress	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0013 affected94 at risk EG0020 affected65 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0007 affected96 at risk EG0017 affected94 at risk EG0022 affected65 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0013 affected94 at risk EG0021 affected65 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0012 affected94 at risk EG0020 affected65 at risk EG003
Alopecia areata	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0020 affected65 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected96 at risk EG0014 affected94 at risk EG0020 affected65 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0014 affected94 at risk EG0020 affected65 at risk EG003
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected96 at risk EG0013 affected94 at risk EG0020 affected65 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0005 affected96 at risk EG0013 affected94 at risk EG0021 affected65 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0010 affected94 at risk EG0021 affected65 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG00016 affected96 at risk EG0016 affected94 at risk EG0027 affected65 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0010 affected94 at risk EG0020 affected65 at risk EG003
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected96 at risk EG0011 affected94 at risk EG0022 affected65 at risk EG003
Hypertension	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0005 affected96 at risk EG0014 affected94 at risk EG0020 affected65 at risk EG003

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Title	Description
BG000	AIN457 150 mg	Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
BG001	AIN457 300 mg	Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
BG002	Placebo	Participants who received placebo during treatment period 1
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Any AIN457 150 mg	Participants who received AIN457 150 mg during treatment period 1 and/or treatment period 2	10	96	76	96
EG001	Any AIN457 300 mg	Participants who received AIN457 300 mg during treatment period 1 and/or treatment period 2	9	94	79	94
EG002	Placebo	Participants who received placebo during treatment period 1	1	65	37	65
EG003	Any AIN457 Dose	Participants who received AIN457 150 mg or AIN457 300 mg	19	190	155	190