Trial Outcomes & Findings for Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis (NCT NCT01807520)

Last Updated: 2018-03-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

198 participants

Primary outcome timeframe

Baseline, 16 weeks

Results posted on

2018-03-13

Participant Flow

The study was made up of 4 periods: screening, treatment period 1, treatment period 2 and post-treatment follow-up.

In treatment period 1, participants were randomized in a 1:1:1 ratio to secukinumab 150mg, secukinumab 300mg or placebo. In treatment period 2, placebo participants were re-randomized in a 1:1 ratio to secukinumab 150mg or secukinumab 300mg. The follow-up period occurred 8 weeks post treatment period 2 (12 weeks post the last dose of secukinumab).

Participant milestones

Participant milestones
Measure	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.	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.	Placebo Participants who received placebo during treatment period 1	Placebo - AIN457 150 mg Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 150 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.	Placebo - AIN457 300 mg Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.	Any AIN457 150 mg Participants who received AIN457 150 mg during treatment period 1 and/or treatment period 2	Any AIN457 300 mg Participants who received AIN457 300 mg during treatment period 1 and/or treatment period 2
Treatment Period 1 (0-16 Weeks) STARTED	67	66	65	0	0	0	0
Treatment Period 1 (0-16 Weeks) Full Analysis Set	67	66	65	0	0	0	0
Treatment Period 1 (0-16 Weeks) Safety Set	67	65	65	0	0	0	0
Treatment Period 1 (0-16 Weeks) COMPLETED	63	65	58	0	0	0	0
Treatment Period 1 (0-16 Weeks) NOT COMPLETED	4	1	7	0	0	0	0
Treatment Period 2 (16-132 Weeks) STARTED	63	65	0	29	29	0	0
Treatment Period 2 (16-132 Weeks) Safety Set	63	65	0	29	29	0	0
Treatment Period 2 (16-132 Weeks) Full Analysis Set	67	66	0	29	29	0	0
Treatment Period 2 (16-132 Weeks) COMPLETED	38	47	0	22	24	0	0
Treatment Period 2 (16-132 Weeks) NOT COMPLETED	25	18	0	7	5	0	0
Follow-up Period (132-140 Weeks) STARTED	0	0	2	0	0	81	76
Follow-up Period (132-140 Weeks) COMPLETED	0	0	2	0	0	77	75
Follow-up Period (132-140 Weeks) NOT COMPLETED	0	0	0	0	0	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	Placebo Participants who received placebo during treatment period 1	Placebo - AIN457 150 mg Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 150 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.	Placebo - AIN457 300 mg Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.	Any AIN457 150 mg Participants who received AIN457 150 mg during treatment period 1 and/or treatment period 2	Any AIN457 300 mg Participants who received AIN457 300 mg during treatment period 1 and/or treatment period 2
Treatment Period 1 (0-16 Weeks) Withdrawal by Subject	0	1	3	0	0	0	0
Treatment Period 1 (0-16 Weeks) Protocol deviation	1	0	1	0	0	0	0
Treatment Period 1 (0-16 Weeks) Physician Decision	0	0	1	0	0	0	0
Treatment Period 1 (0-16 Weeks) Lost to Follow-up	1	0	0	0	0	0	0
Treatment Period 1 (0-16 Weeks) Lack of Efficacy	0	0	2	0	0	0	0
Treatment Period 1 (0-16 Weeks) Adverse Event	2	0	0	0	0	0	0
Treatment Period 2 (16-132 Weeks) Study terminated	7	4	0	0	2	0	0
Treatment Period 2 (16-132 Weeks) Protocol deviation	0	0	0	1	0	0	0
Treatment Period 2 (16-132 Weeks) Pregnancy	1	0	0	0	0	0	0
Treatment Period 2 (16-132 Weeks) Non-compliant with study treatment	0	2	0	0	0	0	0
Treatment Period 2 (16-132 Weeks) Lost to Follow-up	4	0	0	1	0	0	0
Treatment Period 2 (16-132 Weeks) Lack of Efficacy	5	3	0	0	1	0	0
Treatment Period 2 (16-132 Weeks) Adverse Event	3	3	0	3	0	0	0
Treatment Period 2 (16-132 Weeks) Withdrawal by Subject	5	6	0	2	2	0	0
Follow-up Period (132-140 Weeks) Lack of Efficacy	0	0	0	0	0	1	0
Follow-up Period (132-140 Weeks) Study terminated	0	0	0	0	0	1	0
Follow-up Period (132-140 Weeks) Lost to Follow-up	0	0	0	0	0	2	1

Baseline Characteristics

Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AIN457 150 mg n=67 Participants 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.	AIN457 300 mg n=66 Participants 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.	Placebo n=65 Participants Participants who received placebo during treatment period 1	Total n=198 Participants Total of all reporting groups
Age, Continuous	43.5 Years STANDARD_DEVIATION 10.94 • n=5 Participants	45.1 Years STANDARD_DEVIATION 12.9 • n=7 Participants	43.6 Years STANDARD_DEVIATION 11.2 • n=5 Participants	44.1 Years STANDARD_DEVIATION 11.68 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants	38 Participants n=4 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	53 Participants n=7 Participants	52 Participants n=5 Participants	160 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 16 weeks

Population: 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).

Outcome measures

Outcome measures
Measure	AIN457 150 mg n=63 Participants 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.	AIN457 300 mg n=64 Participants 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.	Placebo n=56 Participants Participants who received placebo during treatment period 1	Placebo - AIN457 300 mg Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment	-38.4 percent change Standard Error 4.54	-46.1 percent change Standard Error 3.43	-11.7 percent change Standard Error 4.28	—

SECONDARY outcome

Timeframe: baseline, 16 weeks, 132 weeks

Population: 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).

Outcome measures

Outcome measures
Measure	AIN457 150 mg n=67 Participants 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.	AIN457 300 mg n=65 Participants 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.	Placebo n=29 Participants Participants who received placebo during treatment period 1	Placebo - AIN457 300 mg n=29 Participants Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
Percent Change From Baseline in NAPSI Score Week 16	-37.9 percent change Standard Deviation 37.32	-45.3 percent change Standard Deviation 27.22	-15.4 percent change Standard Deviation 32.79	-7.8 percent change Standard Deviation 31.77
Percent Change From Baseline in NAPSI Score Week 132	-52.9 percent change Standard Deviation 42.90	-70.5 percent change Standard Deviation 29.2	-62.9 percent change Standard Deviation 29.05	-72.7 percent change Standard Deviation 22.84

SECONDARY outcome

Timeframe: 16 weeks, 132 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	AIN457 150 mg n=67 Participants 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.	AIN457 300 mg n=65 Participants 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.	Placebo Participants who received placebo during treatment period 1	Placebo - AIN457 300 mg Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
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 Week 16, PASI 75	76.6 Percentage of participants	87.1 Percentage of participants	—	—
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 Week 16, IGA 0/1	67.8 Percentage of participants	74.0 Percentage of participants	—	—
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 Week 132, PASI 75	61.6 Percentage of participants	82.7 Percentage of participants	—	—
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 Week 132, IGA 0/1	52.2 Percentage of participants	61.2 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 132

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

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.

Outcome measures

Outcome measures
Measure	AIN457 150 mg n=67 Participants 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.	AIN457 300 mg n=65 Participants 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.	Placebo n=29 Participants Participants who received placebo during treatment period 1	Placebo - AIN457 300 mg n=29 Participants Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
Number of Participants Who Develop Immunogenicity Against Secukinumab	2 Participants	5 Participants	4 Participants	3 Participants

Adverse Events

Any AIN457 150 mg

Serious events: 10 serious events

Other events: 76 other events

Deaths: 0 deaths

Any AIN457 300 mg

Serious events: 9 serious events

Other events: 79 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Any AIN457 Dose

Serious events: 19 serious events

Other events: 155 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Any AIN457 150 mg n=96 participants at risk Participants who received AIN457 150 mg during treatment period 1 and/or treatment period 2	Any AIN457 300 mg n=94 participants at risk Participants who received AIN457 300 mg during treatment period 1 and/or treatment period 2	Placebo n=65 participants at risk Participants who received placebo during treatment period 1	Any AIN457 Dose n=190 participants at risk Participants who received AIN457 150 mg or AIN457 300 mg
Psychiatric disorders Suicidal ideation	0.00% 0/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Blood and lymphatic system disorders Neutropenia	1.0% 1/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Cardiac disorders Myocardial infarction	0.00% 0/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Eye disorders Cataract subcapsular	0.00% 0/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Gastrointestinal disorders Inguinal hernia	0.00% 0/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
General disorders Pyrexia	0.00% 0/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Hepatobiliary disorders Hepatotoxicity	0.00% 0/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Infections and infestations Eczema impetiginous	1.0% 1/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Infections and infestations Eczema infected	1.0% 1/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Infections and infestations Pyelonephritis	1.0% 1/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Injury, poisoning and procedural complications Foot fracture	0.00% 0/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Injury, poisoning and procedural complications Laceration	1.0% 1/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Injury, poisoning and procedural complications Radius fracture	1.0% 1/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	1.0% 1/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.0% 1/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Nervous system disorders Sciatica	0.00% 0/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Psychiatric disorders Psychotic disorder	1.0% 1/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	1.0% 1/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140
Skin and subcutaneous tissue disorders Erythrodermic psoriasis	0.00% 0/96 • up to week 140	0.00% 0/94 • up to week 140	1.5% 1/65 • up to week 140	0.00% 0/190 • up to week 140
Skin and subcutaneous tissue disorders Psoriasis	1.0% 1/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	0.53% 1/190 • up to week 140

Other adverse events

Other adverse events
Measure	Any AIN457 150 mg n=96 participants at risk Participants who received AIN457 150 mg during treatment period 1 and/or treatment period 2	Any AIN457 300 mg n=94 participants at risk Participants who received AIN457 300 mg during treatment period 1 and/or treatment period 2	Placebo n=65 participants at risk Participants who received placebo during treatment period 1	Any AIN457 Dose n=190 participants at risk Participants who received AIN457 150 mg or AIN457 300 mg
Cardiac disorders Palpitations	1.0% 1/96 • up to week 140	3.2% 3/94 • up to week 140	0.00% 0/65 • up to week 140	2.1% 4/190 • up to week 140
Ear and labyrinth disorders Vertigo	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Endocrine disorders Hypothyroidism	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Eye disorders Dry eye	2.1% 2/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Eye disorders Eye irritation	2.1% 2/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Eye disorders Eye pruritus	0.00% 0/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Eye disorders Visual impairment	0.00% 0/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Gastrointestinal disorders Abdominal pain	0.00% 0/96 • up to week 140	2.1% 2/94 • up to week 140	3.1% 2/65 • up to week 140	1.1% 2/190 • up to week 140
Gastrointestinal disorders Abdominal pain upper	0.00% 0/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Gastrointestinal disorders Diarrhoea	5.2% 5/96 • up to week 140	5.3% 5/94 • up to week 140	7.7% 5/65 • up to week 140	5.3% 10/190 • up to week 140
Gastrointestinal disorders Dyspepsia	3.1% 3/96 • up to week 140	5.3% 5/94 • up to week 140	0.00% 0/65 • up to week 140	4.2% 8/190 • up to week 140
Gastrointestinal disorders Haemorrhoids	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Gastrointestinal disorders Loose tooth	2.1% 2/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Gastrointestinal disorders Nausea	4.2% 4/96 • up to week 140	3.2% 3/94 • up to week 140	1.5% 1/65 • up to week 140	3.7% 7/190 • up to week 140
Gastrointestinal disorders Toothache	3.1% 3/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	2.1% 4/190 • up to week 140
Gastrointestinal disorders Vomiting	3.1% 3/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	2.1% 4/190 • up to week 140
General disorders Fatigue	4.2% 4/96 • up to week 140	5.3% 5/94 • up to week 140	0.00% 0/65 • up to week 140	4.7% 9/190 • up to week 140
General disorders Influenza like illness	3.1% 3/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	2.1% 4/190 • up to week 140
General disorders Injection site erythema	0.00% 0/96 • up to week 140	0.00% 0/94 • up to week 140	3.1% 2/65 • up to week 140	0.00% 0/190 • up to week 140
General disorders Pyrexia	3.1% 3/96 • up to week 140	1.1% 1/94 • up to week 140	1.5% 1/65 • up to week 140	2.1% 4/190 • up to week 140
Hepatobiliary disorders Hepatic steatosis	2.1% 2/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	2.1% 4/190 • up to week 140
Immune system disorders Seasonal allergy	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Infections and infestations Bronchitis	4.2% 4/96 • up to week 140	7.4% 7/94 • up to week 140	0.00% 0/65 • up to week 140	5.8% 11/190 • up to week 140
Infections and infestations Cellulitis	1.0% 1/96 • up to week 140	3.2% 3/94 • up to week 140	0.00% 0/65 • up to week 140	2.1% 4/190 • up to week 140
Infections and infestations Conjunctivitis	3.1% 3/96 • up to week 140	4.3% 4/94 • up to week 140	0.00% 0/65 • up to week 140	3.7% 7/190 • up to week 140
Infections and infestations Ear infection	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Infections and infestations Erysipelas	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	1.5% 1/65 • up to week 140	1.6% 3/190 • up to week 140
Infections and infestations Fungal skin infection	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	1.5% 1/65 • up to week 140	1.6% 3/190 • up to week 140
Infections and infestations Gastroenteritis	6.2% 6/96 • up to week 140	6.4% 6/94 • up to week 140	0.00% 0/65 • up to week 140	6.3% 12/190 • up to week 140
Infections and infestations Herpes zoster	3.1% 3/96 • up to week 140	3.2% 3/94 • up to week 140	0.00% 0/65 • up to week 140	3.2% 6/190 • up to week 140
Infections and infestations Hordeolum	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Infections and infestations Influenza	0.00% 0/96 • up to week 140	6.4% 6/94 • up to week 140	3.1% 2/65 • up to week 140	3.2% 6/190 • up to week 140
Infections and infestations Localised infection	0.00% 0/96 • up to week 140	3.2% 3/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Infections and infestations Lower respiratory tract infection	2.1% 2/96 • up to week 140	3.2% 3/94 • up to week 140	0.00% 0/65 • up to week 140	2.6% 5/190 • up to week 140
Infections and infestations Nasopharyngitis	26.0% 25/96 • up to week 140	28.7% 27/94 • up to week 140	12.3% 8/65 • up to week 140	27.4% 52/190 • up to week 140
Infections and infestations Onychomycosis	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Infections and infestations Oral candidiasis	1.0% 1/96 • up to week 140	3.2% 3/94 • up to week 140	0.00% 0/65 • up to week 140	2.1% 4/190 • up to week 140
Infections and infestations Oral herpes	2.1% 2/96 • up to week 140	2.1% 2/94 • up to week 140	6.2% 4/65 • up to week 140	2.1% 4/190 • up to week 140
Infections and infestations Otitis externa	1.0% 1/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Infections and infestations Pharyngitis	2.1% 2/96 • up to week 140	3.2% 3/94 • up to week 140	0.00% 0/65 • up to week 140	2.6% 5/190 • up to week 140
Infections and infestations Pneumonia	0.00% 0/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Infections and infestations Pulpitis dental	4.2% 4/96 • up to week 140	4.3% 4/94 • up to week 140	1.5% 1/65 • up to week 140	4.2% 8/190 • up to week 140
Infections and infestations Respiratory tract infection	2.1% 2/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	2.1% 4/190 • up to week 140
Infections and infestations Rhinitis	2.1% 2/96 • up to week 140	7.4% 7/94 • up to week 140	0.00% 0/65 • up to week 140	4.7% 9/190 • up to week 140
Infections and infestations Sinusitis	3.1% 3/96 • up to week 140	6.4% 6/94 • up to week 140	0.00% 0/65 • up to week 140	4.7% 9/190 • up to week 140
Infections and infestations Skin infection	1.0% 1/96 • up to week 140	3.2% 3/94 • up to week 140	0.00% 0/65 • up to week 140	2.1% 4/190 • up to week 140
Infections and infestations Tinea pedis	5.2% 5/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	3.2% 6/190 • up to week 140
Infections and infestations Tonsillitis	4.2% 4/96 • up to week 140	4.3% 4/94 • up to week 140	0.00% 0/65 • up to week 140	4.2% 8/190 • up to week 140
Infections and infestations Tooth abscess	0.00% 0/96 • up to week 140	3.2% 3/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Infections and infestations Upper respiratory tract infection	15.6% 15/96 • up to week 140	8.5% 8/94 • up to week 140	3.1% 2/65 • up to week 140	12.1% 23/190 • up to week 140
Infections and infestations Urinary tract infection	3.1% 3/96 • up to week 140	5.3% 5/94 • up to week 140	0.00% 0/65 • up to week 140	4.2% 8/190 • up to week 140
Infections and infestations Viral upper respiratory tract infection	3.1% 3/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	2.6% 5/190 • up to week 140
Infections and infestations Vulvovaginal candidiasis	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Injury, poisoning and procedural complications Arthropod sting	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Injury, poisoning and procedural complications Avulsion fracture	0.00% 0/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Injury, poisoning and procedural complications Contusion	2.1% 2/96 • up to week 140	0.00% 0/94 • up to week 140	1.5% 1/65 • up to week 140	1.1% 2/190 • up to week 140
Injury, poisoning and procedural complications Fall	2.1% 2/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Injury, poisoning and procedural complications Ligament sprain	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Injury, poisoning and procedural complications Limb injury	2.1% 2/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	2.1% 4/190 • up to week 140
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/96 • up to week 140	0.00% 0/94 • up to week 140	3.1% 2/65 • up to week 140	0.00% 0/190 • up to week 140
Injury, poisoning and procedural complications Tendon rupture	2.1% 2/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Investigations Aspartate aminotransferase increased	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Investigations Weight increased	0.00% 0/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Metabolism and nutrition disorders Gout	2.1% 2/96 • up to week 140	0.00% 0/94 • up to week 140	1.5% 1/65 • up to week 140	1.1% 2/190 • up to week 140
Musculoskeletal and connective tissue disorders Arthralgia	4.2% 4/96 • up to week 140	8.5% 8/94 • up to week 140	3.1% 2/65 • up to week 140	6.3% 12/190 • up to week 140
Musculoskeletal and connective tissue disorders Back pain	9.4% 9/96 • up to week 140	7.4% 7/94 • up to week 140	1.5% 1/65 • up to week 140	8.4% 16/190 • up to week 140
Musculoskeletal and connective tissue disorders Dactylitis	0.00% 0/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Musculoskeletal and connective tissue disorders Joint swelling	2.1% 2/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Musculoskeletal and connective tissue disorders Muscle spasms	2.1% 2/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.0% 1/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Musculoskeletal and connective tissue disorders Pain in extremity	5.2% 5/96 • up to week 140	1.1% 1/94 • up to week 140	3.1% 2/65 • up to week 140	3.2% 6/190 • up to week 140
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	1.5% 1/65 • up to week 140	1.6% 3/190 • up to week 140
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	1.0% 1/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	1.0% 1/96 • up to week 140	2.1% 2/94 • up to week 140	1.5% 1/65 • up to week 140	1.6% 3/190 • up to week 140
Nervous system disorders Dizziness	3.1% 3/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	2.1% 4/190 • up to week 140
Nervous system disorders Headache	9.4% 9/96 • up to week 140	10.6% 10/94 • up to week 140	6.2% 4/65 • up to week 140	10.0% 19/190 • up to week 140
Nervous system disorders Poor quality sleep	2.1% 2/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Nervous system disorders Sciatica	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Psychiatric disorders Anxiety	6.2% 6/96 • up to week 140	0.00% 0/94 • up to week 140	1.5% 1/65 • up to week 140	3.2% 6/190 • up to week 140
Psychiatric disorders Depression	3.1% 3/96 • up to week 140	4.3% 4/94 • up to week 140	3.1% 2/65 • up to week 140	3.7% 7/190 • up to week 140
Psychiatric disorders Insomnia	2.1% 2/96 • up to week 140	3.2% 3/94 • up to week 140	0.00% 0/65 • up to week 140	2.6% 5/190 • up to week 140
Psychiatric disorders Stress	3.1% 3/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Renal and urinary disorders Haematuria	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Respiratory, thoracic and mediastinal disorders Asthma	1.0% 1/96 • up to week 140	3.2% 3/94 • up to week 140	0.00% 0/65 • up to week 140	2.1% 4/190 • up to week 140
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.0% 1/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Respiratory, thoracic and mediastinal disorders Cough	7.3% 7/96 • up to week 140	7.4% 7/94 • up to week 140	3.1% 2/65 • up to week 140	7.4% 14/190 • up to week 140
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.0% 1/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.1% 2/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	2.1% 4/190 • up to week 140
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.2% 4/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	2.1% 4/190 • up to week 140
Respiratory, thoracic and mediastinal disorders Productive cough	2.1% 2/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	2.1% 2/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	2.1% 4/190 • up to week 140
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/96 • up to week 140	3.2% 3/94 • up to week 140	1.5% 1/65 • up to week 140	1.6% 3/190 • up to week 140
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Skin and subcutaneous tissue disorders Acne	1.0% 1/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Skin and subcutaneous tissue disorders Actinic keratosis	1.0% 1/96 • up to week 140	2.1% 2/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Skin and subcutaneous tissue disorders Alopecia areata	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Skin and subcutaneous tissue disorders Dermatitis	3.1% 3/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	1.6% 3/190 • up to week 140
Skin and subcutaneous tissue disorders Dry skin	3.1% 3/96 • up to week 140	4.3% 4/94 • up to week 140	0.00% 0/65 • up to week 140	3.7% 7/190 • up to week 140
Skin and subcutaneous tissue disorders Eczema	1.0% 1/96 • up to week 140	4.3% 4/94 • up to week 140	0.00% 0/65 • up to week 140	2.6% 5/190 • up to week 140
Skin and subcutaneous tissue disorders Intertrigo	1.0% 1/96 • up to week 140	3.2% 3/94 • up to week 140	0.00% 0/65 • up to week 140	2.1% 4/190 • up to week 140
Skin and subcutaneous tissue disorders Pruritus	5.2% 5/96 • up to week 140	3.2% 3/94 • up to week 140	1.5% 1/65 • up to week 140	4.2% 8/190 • up to week 140
Skin and subcutaneous tissue disorders Pruritus generalised	2.1% 2/96 • up to week 140	0.00% 0/94 • up to week 140	1.5% 1/65 • up to week 140	1.1% 2/190 • up to week 140
Skin and subcutaneous tissue disorders Psoriasis	16.7% 16/96 • up to week 140	6.4% 6/94 • up to week 140	10.8% 7/65 • up to week 140	11.6% 22/190 • up to week 140
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	2.1% 2/96 • up to week 140	0.00% 0/94 • up to week 140	0.00% 0/65 • up to week 140	1.1% 2/190 • up to week 140
Skin and subcutaneous tissue disorders Skin fissures	2.1% 2/96 • up to week 140	1.1% 1/94 • up to week 140	3.1% 2/65 • up to week 140	1.6% 3/190 • up to week 140
Vascular disorders Hypertension	5.2% 5/96 • up to week 140	4.3% 4/94 • up to week 140	0.00% 0/65 • up to week 140	4.7% 9/190 • up to week 140

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

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

Restriction type: OTHER