Study to Demonstrate the Efficacy, Safety and Tolerabilit... | NCT04209205

NCT04209205

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AIN457 6 mg/kg - 3 mg/kg i.v.	Experimental	AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).	Drug: AIN457 6 mg/kg i.v. Drug: AIN457 3 mg/kg
Placebo	Placebo Comparator	Matching placebo from baseline to Week 16 and switch to AIN457 3mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AIN457 6 mg/kg i.v.	Drug	AIN457 6 mg/kg delivered by i.v. infusion	AIN457 6 mg/kg - 3 mg/kg i.v.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With American College of Rheumatology 50 (ACR50) Response Comparison Between Treatment Groups Using Non-responder Imputation at Week 16 (Full Analysis Set)	Percentage of participants with active psoriatic arthritis (PsA) who achieved an American College of Rheumatology 50 (ACR50) response The ACR50 is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP)	Baseline up to Week 16

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With American College of Rheumatology 20 (ACR20) Response Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set)	Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.

Eligibility Module

Eligibility Criteria

Patients eligible for inclusion in this study had to fulfill all of the following criteria:

Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
Rheumatoid factor and anti-CCP antibodies negative at screening
Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or documented history of plaque psoriasis
Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs
Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 16
Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52.

Patients fulfilling any of the following criteria are not eligible for inclusion in this study:

Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor
Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization. The following wash-out periods need to be observed:
Oral or topical retinoids- 4 weeks
Photochemotherapy (e.g. PUVA)- 4 weeks
Phototherapy (UVA or UVB)- 2 weeks
Topical skin treatments (except in face, eyes, scalp and genital area during screening, only corticosteroids with mild to moderate potency)- 2 weeks
Any intramuscular or intravenous corticosteroid treatment within 4 weeks before randomization.
Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before randomization.
Subjects who have previously been treated with more than 3 different TNF inhibitors (investigational or approved).
Subjects who have ever received biologic immunomodulating agents, investigational or approved except for those targeting TNFα.
Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Birmingham	Alabama	35205	United States
Novartis Investigative Site

Label	URL
A Plain Language Trial Summary is available on www.novctrd.com	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	AIN457 6 mg/kg - 3 mg/kg i.v.	AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).
FG001	Placebo to AIN457 3 mg/kg i.v.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 24, 2019	May 8, 2023

Masking Info

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 of Participants With American College of Rheumatology 50 (ACR50) Response Comparison Between Treatment Groups Using Non-responder Imputation at Week 16 (Full Analysis Set)

Percentage of participants with active psoriatic arthritis (PsA) who achieved an American College of Rheumatology 50 (ACR50) response

The ACR50 is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP)

Full analysis set from which subset of ACR50 responders was analyzed

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline up to Week 16

ID	Title	Description
OG000	AIN457 6 mg/kg - 3 mg/kg i.v.	AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).
OG001	Placebo to AIN457 3 mg/kg i.v.	Matching placebo from baseline to Week 16 and switch to AIN457 3 mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).

Units	Counts
Participants	OG000191 OG001190

Title

Denominators

Categories

Title	Measurements
	OG00031.35(24.80 to 37.90) OG0016.33(2.87 to 9.79)

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 OG001		Regression, Logistic		<.0001		Marginal difference	25.02			2-Sided	95	17.61	32.43					Superiority

Secondary

Percentage of Participants With American College of Rheumatology 20 (ACR20) Response Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set)

Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.

Full analysis set from which subset of ACR20 responders was analyzed

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline up to Week 16

ID	Title	Description
OG000	AIN457 6 mg/kg - 3 mg/kg i.v.	AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).
OG001	Placebo to AIN457 3 mg/kg i.v.	Matching placebo from baseline to Week 16 and switch to AIN457 3 mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).

Secondary

Percentage of Participants With Minimal Disease Activity (MDA 5/7) Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set)

MDA is assessed as 5 of the 7 following: ≤ 1 tender and swollen joint; entheseal count, PASI ≤ 1 or BSA ≤3%, PsA ≤ 15 and disease activity ≤ 20 (VAS) and HAQ-DI© ≤ 0.5

Full analysis set from which subset of MDA 5/7 responders was analyzed

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline up to Week 16

ID	Title	Description
OG000	AIN457 6 mg/kg - 3 mg/kg i.v.	AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).
OG001	Placebo to AIN457 3 mg/kg i.v.	Matching placebo from baseline to Week 16 and switch to AIN457 3 mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).

Units	Counts
Participants

Secondary

Percentage of Participants With Psoriasis Area and Severity Index 90 (PASi90) Score for Patients With a >= 3% Body Surface Area Psoriasis at Baseline Using On-responder Imputation at Week 16 (Full Analysis Set)

Change from baseline of a 90% reduction in the PASI score for patients with a >= 3% body surface area psoriasis at baseline. Four body surface areas are evaluated (head, trunk and upper and lower limbs) for plaque, erythema, scaling and thickness. The degree of severity of each sign in each of the 4 body areas was assigned a score of 0 to 4. Scores ranged from 0 to 72 and higher scores represent worsening severity.

Full analysis set from which subset of PASi90 responders was analyzed

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline up to Week 16

ID	Title	Description
OG000	AIN457 6 mg/kg - 3 mg/kg i.v.	AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).
OG001	Placebo to AIN457 3 mg/kg i.v.	Matching placebo from baseline to Week 16 and switch to AIN457 3 mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).

Units

Secondary

Psoriatic Arthritis Disease Activity Score (PASDAS) Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set)

PASDAS is a composite measure developed to assess disease activity in Psoriatic arthritis. It is calculated by utilizing seven measures: Patient reported measures (excluding mental component) (SF-36-PCS), skin, peripheral joint counts (tender and swollen joint counts), dactylitis (LDI), enthesitis (LEI), acute phase response (CRP), and patient and physician global VAS scores. The typical score range is between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement.

Full analysis set with participants with valid measures at baseline and Week 16

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline up to Week 16

ID	Title	Description
OG000	AIN457 6 mg/kg - 3 mg/kg i.v.	AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).
OG001	Placebo to AIN457 3 mg/kg i.v.	Matching placebo from baseline to Week 16 and switch to AIN457 3 mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).

Secondary

Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set)

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.

Full analysis set with participants with valid measures at baseline and Week 16

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline up to Week 16

ID	Title	Description
OG000	AIN457 6 mg/kg - 3 mg/kg i.v.	AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).
OG001	Placebo to AIN457 3 mg/kg i.v.	Matching placebo from baseline to Week 16 and switch to AIN457 3 mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).

Secondary

Short Form 36-Physical Component Summary (SF36-PCS) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set)

The SF-36 is used to measure health-related quality of life with acute and chronic conditions. It consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Range of scoring is 0 -100, with higher scores indicating better health status.

Full analysis set with participants with valid measures at baseline and Week 16

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline up to Week 16

ID	Title	Description
OG000	AIN457 6 mg/kg - 3 mg/kg i.v.	AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).
OG001	Placebo to AIN457 3 mg/kg i.v.	Matching placebo from baseline to Week 16 and switch to AIN457 3 mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).

Units	Counts
Participants

Secondary

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set)

The FACIT-Fatigue is a 13 item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Response scale ranges from 0-4 and the total score range is 0 - 52. Higher scores indicate better quality of life

Full analysis set with participants with valid measures at baseline and Week 16

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline up to Week 16

ID	Title	Description
OG000	AIN457 6 mg/kg - 3 mg/kg i.v.	AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).
OG001	Placebo to AIN457 3 mg/kg i.v.	Matching placebo from baseline to Week 16 and switch to AIN457 3 mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).

Units	Counts
Participants

Secondary

Modified Nail Psoriasis Severity Index (mNAPSI) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set)

The mNAPSI is an instrument to assess psoriatic nail involvement. Three groups of features (onycholysis and oil-drop dyshromia, pitting and crumbling) were graded on a scale from 0 to 3 for a total subscale of 0 to 9. The next 4 abnormalities (leukonychia, splinter hemorrhages, hyperkeratosis and red spots in the lunula) were graded as absent (0) or present (1) for a total subscale of 0 to 4. The total score was from 0-13 where higher scores represent worse nail disease.

Full analysis set with participants with valid measures at baseline and Week 16

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline up to Week 16

ID	Title	Description
OG000	AIN457 6 mg/kg - 3 mg/kg i.v.	AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).
OG001	Placebo to AIN457 3 mg/kg i.v.	Matching placebo from baseline to Week 16 and switch to AIN457 3 mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).

Units

Secondary

Percentage of Participants With Complete Resolution of Dactylitis at Week 16 Using Non-responder Imputation (Dactylitis Subset)

Dactylitis is characterized by swelling of the entire finger or toe. The Leeds Dactylitis Index (LDI) measures the ratio of the circumference of the affected (swollen) digit. The ratio of circumference is multiplied by a tenderness score, using a modification of LDI that is a binary score (1 for tender, 0 for non-tender). The LDI requires a finger circumference gauge or a dactylometer to measure digital circumference. Scores range from 0 - 20 and lower score indicates better outcome.

Dactylitis subset - participants with dactylitis at baseline

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline up to Week 16

ID	Title	Description
OG000	AIN457 6 mg/kg - 3 mg/kg i.v.	AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).
OG001	Placebo to AIN457 3 mg/kg i.v.	Matching placebo from baseline to Week 16 and switch to AIN457 3 mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).

Units	Counts

Secondary

Percentage of Participants With Complete Resolution of Enthesitis at Week 16 Using Non-responder Imputation (Enthesitis Subset (LEI))

Enthesitis is inflammation of the enthesis which is where a a tendon or ligament attaches to the bone. The Leeds enthesitis index (LEI) is a validated index that uses 6 sites for evaluation of enthesitis: lateral epicondyle humerus L + R, proximal achilles L + R and medial condyle femur L+R. If enthesitis is present at any of the 6 sites, the subject is counted as a subject with enthesitis.

Enthesitis subset - participants with enthesitis at baseline

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline up to Week 16

ID	Title	Description
OG000	AIN457 6 mg/kg - 3 mg/kg i.v.	AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).
OG001	Placebo to AIN457 3 mg/kg i.v.	Matching placebo from baseline to Week 16 and switch to AIN457 3 mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Angina unstable	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Myocardial infarction	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Hypersensitivity	Immune system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
COVID-19	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0006 affected374 at risk EG0010 affected190 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0002 affected374 at risk EG0012 affected190 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Gastroenteritis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Perirectal abscess	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Peritonsillar abscess	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Pneumonia	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0002 affected374 at risk EG0010 affected190 at risk
Pyelonephritis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Urinary tract infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Viral pharyngitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected374 at risk EG0011 affected190 at risk
Headache	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected374 at risk EG0011 affected190 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk
Hypertension	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected374 at risk EG0010 affected190 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0009 affected374 at risk EG0012 affected190 at risk
Nausea	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG00011 affected374 at risk EG0012 affected190 at risk
Bronchitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0008 affected374 at risk EG0010 affected190 at risk
COVID-19	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG00037 affected374 at risk EG0017 affected190 at risk
Nasopharyngitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG00013 affected374 at risk EG0013 affected190 at risk
Pharyngitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0009 affected374 at risk EG0011 affected190 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG00010 affected374 at risk EG0016 affected190 at risk
Urinary tract infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG00017 affected374 at risk EG0011 affected190 at risk
Alanine aminotransferase increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG00012 affected374 at risk EG0014 affected190 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG00011 affected374 at risk EG0012 affected190 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0008 affected374 at risk EG0011 affected190 at risk
SARS-CoV-2 test positive	Investigations	MedDRA (25.0)	Systematic Assessment	EG00012 affected374 at risk EG0012 affected190 at risk
Weight increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG00010 affected374 at risk EG0011 affected190 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG00014 affected374 at risk EG0013 affected190 at risk
Headache	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG00012 affected374 at risk EG0015 affected190 at risk
Hypertension	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG00012 affected374 at risk EG0011 affected190 at risk

ID	Term
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D001168	Arthritis
D007592	Joint Diseases
D011565	Psoriasis
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Title	Description
BG000	AIN457 6 mg/kg - 3 mg/kg i.v.	AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).
BG001	Placebo to AIN457 3 mg/kg i.v.	Matching placebo from baseline to Week 16 and switch to AIN457 3 mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AIN457 6 mg/kg - 3 mg/kg i.v	AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52). Includes participants switched from placebo at Week 16.	0	374	22	374	136	374
EG001	Placebo up to Week 16	Matching placebo from baseline to Week 16	1	190	4	190	35	190