Trial Outcomes & Findings for Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis (NCT NCT04209205)

NCT ID: NCT04209205

Last Updated: 2025-05-16

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 381 participants
• Primary outcome timeframe: Baseline up to Week 16
• Results posted on: 2025-05-16

Participant Flow

479 participants were screened and and 381 were randomized.

Participant milestones

Measure	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).	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).
Overall Study STARTED	191	190
Overall Study COMPLETED	173	167
Overall Study NOT COMPLETED	18	23

Reasons for withdrawal

Measure	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).	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).
Overall Study Adverse Event	2	3
Overall Study Lost to Follow-up	3	1
Overall Study Physician Decision	1	1
Overall Study Subject decision	10	10
Overall Study Progressive disease	1	0
Overall Study Protocol deviation	0	1
Overall Study New therapy for study indication	1	0
Overall Study Adverse event - placebo not switched	0	1
Overall Study Subject decision - placebo not switched	0	5
Overall Study Death - placebo not switched	0	1

Baseline Characteristics

Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis

Baseline characteristics by cohort

Measure	AIN457 6 mg/kg - 3 mg/kg i.v. n=191 Participants 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).	Placebo to AIN457 3 mg/kg i.v. n=190 Participants 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).	Total n=381 Participants Total of all reporting groups
Age, Customized <65 years	170 Participants n=5 Participants	165 Participants n=7 Participants	335 Participants n=5 Participants
Age, Customized 65-74 years	17 Participants n=5 Participants	24 Participants n=7 Participants	41 Participants n=5 Participants
Age, Customized >= 75 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	104 Participants n=5 Participants	105 Participants n=7 Participants	209 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	85 Participants n=7 Participants	172 Participants n=5 Participants
Race/Ethnicity, Customized White	148 Participants n=5 Participants	153 Participants n=7 Participants	301 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 16

Population: Full analysis set from which subset of ACR50 responders was analyzed

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)

Outcome measures

Measure	AIN457 6 mg/kg - 3 mg/kg i.v. n=191 Participants 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).	Placebo to AIN457 3 mg/kg i.v. n=190 Participants 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).
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)	31.35 Percentage of participants Interval 24.8 to 37.9	6.33 Percentage of participants Interval 2.87 to 9.79

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Full analysis set from which subset of ACR20 responders was analyzed

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.

Outcome measures

Measure	AIN457 6 mg/kg - 3 mg/kg i.v. n=191 Participants 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).	Placebo to AIN457 3 mg/kg i.v. n=190 Participants 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).
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)	59.60 Percentage of participants Interval 52.67 to 66.52	29.01 Percentage of participants Interval 22.57 to 35.44

SECONDARY outcome

Timeframe: Baseline up to Week 16

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

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

Outcome measures

Measure	AIN457 6 mg/kg - 3 mg/kg i.v. n=191 Participants 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).	Placebo to AIN457 3 mg/kg i.v. n=190 Participants 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).
Percentage of Participants With Minimal Disease Activity (MDA 5/7) Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set)	22.45 Percentage of participants Interval 16.57 to 28.33	5.28 Percentage of participants Interval 2.1 to 8.46

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Full analysis set from which subset of PASi90 responders was analyzed

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.

Outcome measures

Measure	AIN457 6 mg/kg - 3 mg/kg i.v. n=49 Participants 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).	Placebo to AIN457 3 mg/kg i.v. n=7 Participants 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).
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)	47.85 Percentage of participants Interval 38.15 to 57.54	6.46 Percentage of participants Interval 1.83 to 11.09

SECONDARY outcome

Timeframe: Baseline up to Week 16

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

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.

Outcome measures

Measure	AIN457 6 mg/kg - 3 mg/kg i.v. n=175 Participants 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).	Placebo to AIN457 3 mg/kg i.v. n=170 Participants 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).
Psoriatic Arthritis Disease Activity Score (PASDAS) Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set)	-2.24 scores on a scale Standard Error 0.103	-1.11 scores on a scale Standard Error 0.103

SECONDARY outcome

Timeframe: Baseline up to Week 16

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

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.

Outcome measures

Measure	AIN457 6 mg/kg - 3 mg/kg i.v. n=181 Participants 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).	Placebo to AIN457 3 mg/kg i.v. n=183 Participants 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).
Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set)	-0.39 scores on a scale Standard Error 0.035	0.15 scores on a scale Standard Error 0.035

SECONDARY outcome

Timeframe: Baseline up to Week 16

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

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.

Outcome measures

Measure	AIN457 6 mg/kg - 3 mg/kg i.v. n=181 Participants 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).	Placebo to AIN457 3 mg/kg i.v. n=182 Participants 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).
Short Form 36-Physical Component Summary (SF36-PCS) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set)	6.47 scores on a scale Standard Error 0.558	2.34 scores on a scale Standard Error 0.550

SECONDARY outcome

Timeframe: Baseline up to Week 16

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

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

Outcome measures

Measure	AIN457 6 mg/kg - 3 mg/kg i.v. n=181 Participants 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).	Placebo to AIN457 3 mg/kg i.v. n=183 Participants 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).
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)	6.15 scores on a scale Standard Error 0.759	3.30 scores on a scale Standard Error 0.750

SECONDARY outcome

Timeframe: Baseline up to Week 16

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

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.

Outcome measures

Measure	AIN457 6 mg/kg - 3 mg/kg i.v. n=124 Participants 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).	Placebo to AIN457 3 mg/kg i.v. n=118 Participants 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).
Modified Nail Psoriasis Severity Index (mNAPSI) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set)	-9.25 scores on a scale Standard Error 1.069	-3.14 scores on a scale Standard Error 1.084

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Dactylitis subset - participants with dactylitis at baseline

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.

Outcome measures

Measure	AIN457 6 mg/kg - 3 mg/kg i.v. n=81 Participants 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).	Placebo to AIN457 3 mg/kg i.v. n=71 Participants 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).
Percentage of Participants With Complete Resolution of Dactylitis at Week 16 Using Non-responder Imputation (Dactylitis Subset)	59.53 Percentage of participants Interval 48.96 to 70.11	32.05 Percentage of participants Interval 21.33 to 42.76

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Enthesitis subset - participants with enthesitis at baseline

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.

Outcome measures

Measure	AIN457 6 mg/kg - 3 mg/kg i.v. n=126 Participants 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).	Placebo to AIN457 3 mg/kg i.v. n=110 Participants 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).
Percentage of Participants With Complete Resolution of Enthesitis at Week 16 Using Non-responder Imputation (Enthesitis Subset (LEI))	55.52 Percentage of participants Interval 46.92 to 64.12	39.16 Percentage of participants Interval 30.14 to 48.19

Adverse Events

AIN457 6 mg/kg - 3 mg/kg i.v

Serious events: 22 serious events

Other events: 136 other events

Deaths: 0 deaths

Placebo up to Week 16

Serious events: 4 serious events

Other events: 35 other events

Deaths: 1 deaths

Serious adverse events

Measure	AIN457 6 mg/kg - 3 mg/kg i.v n=374 participants at risk 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.	Placebo up to Week 16 n=190 participants at risk Matching placebo from baseline to Week 16
Blood and lymphatic system disorders Anaemia	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Cardiac disorders Angina unstable	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Cardiac disorders Myocardial infarction	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Cardiac disorders Ventricular tachycardia	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Ear and labyrinth disorders Vertigo	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Immune system disorders Hypersensitivity	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Infections and infestations COVID-19	1.6% 6/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Infections and infestations COVID-19 pneumonia	0.53% 2/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	1.1% 2/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Infections and infestations Escherichia urinary tract infection	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Infections and infestations Gastroenteritis	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Infections and infestations Perirectal abscess	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Infections and infestations Peritonsillar abscess	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Infections and infestations Pneumonia	0.53% 2/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Infections and infestations Pyelonephritis	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Infections and infestations Urinary tract infection	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Infections and infestations Viral pharyngitis	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Injury, poisoning and procedural complications Procedural complication	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Injury, poisoning and procedural complications Urinary retention postoperative	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Nervous system disorders Cerebrovascular accident	0.00% 0/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.53% 1/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Nervous system disorders Headache	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Nervous system disorders Transient ischaemic attack	0.00% 0/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.53% 1/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Skin and subcutaneous tissue disorders Skin lesion	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Vascular disorders Hypertension	0.27% 1/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.

Other adverse events

Measure	AIN457 6 mg/kg - 3 mg/kg i.v n=374 participants at risk 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.	Placebo up to Week 16 n=190 participants at risk Matching placebo from baseline to Week 16
Gastrointestinal disorders Diarrhoea	2.4% 9/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	1.1% 2/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Gastrointestinal disorders Nausea	2.9% 11/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	1.1% 2/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Infections and infestations Bronchitis	2.1% 8/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.00% 0/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Infections and infestations COVID-19	9.9% 37/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	3.7% 7/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Infections and infestations Nasopharyngitis	3.5% 13/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	1.6% 3/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Infections and infestations Pharyngitis	2.4% 9/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.53% 1/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Infections and infestations Upper respiratory tract infection	2.7% 10/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	3.2% 6/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Infections and infestations Urinary tract infection	4.5% 17/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.53% 1/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Investigations Alanine aminotransferase increased	3.2% 12/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	2.1% 4/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Investigations Aspartate aminotransferase increased	2.9% 11/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	1.1% 2/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Investigations Gamma-glutamyltransferase increased	2.1% 8/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.53% 1/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Investigations SARS-CoV-2 test positive	3.2% 12/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	1.1% 2/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Investigations Weight increased	2.7% 10/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.53% 1/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Musculoskeletal and connective tissue disorders Arthralgia	3.7% 14/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	1.6% 3/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Nervous system disorders Headache	3.2% 12/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	2.6% 5/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
Vascular disorders Hypertension	3.2% 12/374 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.	0.53% 1/190 • Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group. Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: Novartis.email@Novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER