Trial Outcomes & Findings for Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis (NCT NCT03589885)

Results Overview

Percentage of participants who achieve ≥ 75% reduction in PASI compared to baseline. A PASI (Psoriasis Area and Severity Index) score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

122 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-10-11

Participant Flow

A total of 144 subjects were screened at 22 study centers in 6 countries, and 122 subjects were randomized.

Participant milestones

Participant milestones
Measure	Secukinumab 300 mg (2 mL AI) Secukinumab 300 mg provided in 2 mL auto-injector form	Secukinumab 300 mg (2x 1 mL PFS) Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL	Placebo Placebo to Secukinumab	Placebo-Secukinumab 300 mg (2 mL AI) Placebo patients up to Week 12 who thereafter received secukinumab in 2 mL AI up to the end of treatment	Placebo-Secukinumab 300 mg (2 x 1 mL PFS) Placebo patients up to Week 12 who thereafter received secukinumab in 2 x 1 mL PFS up to the end of treatment
Treatment Period 1-Randomized Set STARTED	41	41	40	0	0
Treatment Period 1-Randomized Set COMPLETED	41	39	37	0	0
Treatment Period 1-Randomized Set NOT COMPLETED	0	2	3	0	0
Treatment Period 2-Randomized Set STARTED	41	39	4	16	17
Treatment Period 2-Randomized Set COMPLETED	40	34	3	16	16
Treatment Period 2-Randomized Set NOT COMPLETED	1	5	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Secukinumab 300 mg (2 mL AI) Secukinumab 300 mg provided in 2 mL auto-injector form	Secukinumab 300 mg (2x 1 mL PFS) Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL	Placebo Placebo to Secukinumab	Placebo-Secukinumab 300 mg (2 x 1 mL PFS) Placebo patients up to Week 12 who thereafter received secukinumab in 2 x 1 mL PFS up to the end of treatment
Treatment Period 1-Randomized Set Adverse Event	0	1	0	0
Treatment Period 1-Randomized Set Lack of Efficacy	0	0	2	0
Treatment Period 1-Randomized Set Lost to Follow-up	0	1	0	0
Treatment Period 1-Randomized Set Withdrawal by Subject	0	0	1	0
Treatment Period 2-Randomized Set Adverse Event	0	1	0	0
Treatment Period 2-Randomized Set Pregnancy	1	0	0	0
Treatment Period 2-Randomized Set Lost to Follow-up	0	3	1	1
Treatment Period 2-Randomized Set Withdrawal by Subject	0	1	0	0

Baseline Characteristics

Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Secukinumab 2 mL Auto-injector n=41 Participants Secukinumab 300 mg provided in 2 mL auto-injector form	Secukinumab 1 mL Prefilled Syringe n=41 Participants Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL	Placebo n=40 Participants Placebo to Secukinumab	Total n=122 Participants Total of all reporting groups
Age, Customized < 65	39 Participants n=5 Participants	37 Participants n=7 Participants	36 Participants n=5 Participants	112 Participants n=4 Participants
Age, Customized ≥ 65	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	37 Participants n=4 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	29 Participants n=7 Participants	28 Participants n=5 Participants	85 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	39 Participants n=7 Participants	37 Participants n=5 Participants	115 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set: Set used for efficacy analysis (122 participants)

Percentage of participants who achieve ≥ 75% reduction in PASI compared to baseline. A PASI (Psoriasis Area and Severity Index) score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).

Outcome measures

Outcome measures
Measure	Secukinumab 2 mL Auto-injector n=41 Participants Secukinumab 300 mg provided in 2 mL auto-injector form	Secukinumab 1 mL Prefilled Syringe n=41 Participants Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL	Placebo n=40 Participants Placebo to secukinumab	Placebo-Secukinumab 300 mg (2 mL Auto-injector) Placebo patients up to Week 12 who thereafter received secukinumab in 2 mL aI up to the end of treatment	Placebo-Secukinumab 300 mg (2x 1 mL Prefilled Syringe) Placebo patients up to Week 12 who thereafter received secukinumab in 2x 1mL PFS up to the end of treatment
PASI 75 Response After 12 Weeks of Treatment	39 Participants	34 Participants	4 Participants	—	—

PRIMARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set: Set used for efficacy analysis (122 participants)

Percentage of participants who achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline. This scale ranges from 0 (clear, no signs of psoriasis) to 4 (severe).

Outcome measures

Outcome measures
Measure	Secukinumab 2 mL Auto-injector n=41 Participants Secukinumab 300 mg provided in 2 mL auto-injector form	Secukinumab 1 mL Prefilled Syringe n=41 Participants Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL	Placebo n=40 Participants Placebo to secukinumab	Placebo-Secukinumab 300 mg (2 mL Auto-injector) Placebo patients up to Week 12 who thereafter received secukinumab in 2 mL aI up to the end of treatment	Placebo-Secukinumab 300 mg (2x 1 mL Prefilled Syringe) Placebo patients up to Week 12 who thereafter received secukinumab in 2x 1mL PFS up to the end of treatment
IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment	31 Participants	28 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set: Set used for efficacy analysis (122 participants)

Percentage of participants who achieve ≥ 90% reduction in PASI compared to baseline

Outcome measures

Outcome measures
Measure	Secukinumab 2 mL Auto-injector n=41 Participants Secukinumab 300 mg provided in 2 mL auto-injector form	Secukinumab 1 mL Prefilled Syringe n=41 Participants Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL	Placebo n=40 Participants Placebo to secukinumab	Placebo-Secukinumab 300 mg (2 mL Auto-injector) Placebo patients up to Week 12 who thereafter received secukinumab in 2 mL aI up to the end of treatment	Placebo-Secukinumab 300 mg (2x 1 mL Prefilled Syringe) Placebo patients up to Week 12 who thereafter received secukinumab in 2x 1mL PFS up to the end of treatment
PASI 90 Response	31 Participants	26 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: 52 weeks

Population: Full Analysis Set: Set used for efficacy analysis

Percentage of participants who achieve ≥ 50%, 75%, 90% and 100% reduction in PASI and achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline at each visit up to 52 weeks

Outcome measures

Outcome measures
Measure	Secukinumab 2 mL Auto-injector n=41 Participants Secukinumab 300 mg provided in 2 mL auto-injector form	Secukinumab 1 mL Prefilled Syringe n=41 Participants Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL	Placebo n=40 Participants Placebo to secukinumab	Placebo-Secukinumab 300 mg (2 mL Auto-injector) n=16 Participants Placebo patients up to Week 12 who thereafter received secukinumab in 2 mL aI up to the end of treatment	Placebo-Secukinumab 300 mg (2x 1 mL Prefilled Syringe) n=17 Participants Placebo patients up to Week 12 who thereafter received secukinumab in 2x 1mL PFS up to the end of treatment
PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response PASI 50	41 Participants	40 Participants	4 Participants	15 Participants	15 Participants
PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response PASI 75	38 Participants	37 Participants	1 Participants	13 Participants	14 Participants
PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response PASI 90	30 Participants	28 Participants	0 Participants	12 Participants	14 Participants
PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response PASI 100	23 Participants	18 Participants	0 Participants	11 Participants	11 Participants
PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response IGA 0/1	30 Participants	33 Participants	0 Participants	12 Participants	13 Participants

SECONDARY outcome

Timeframe: From randomization until Week 28

Population: Safety Set was used for this analyses. For each visit only subjects with a value at both PRE-module at baseline and the respective POST-baseline visit are included.

Subject usability (ability to follow instructions for use and potential use-related hazards) and satisfaction with the new secukinumab 2 mL AI utilizing a self-administered Self-Injection Assessment Questionnaire (SIAQ) and investigator/site staff observation of secukinumab 300 mg 2 mL AI administration. The Satisfaction with Self-Injection (SA) domain score ranges from 0 (worst experience) to 10 (best experience).

Outcome measures

Outcome measures
Measure	Secukinumab 2 mL Auto-injector n=122 Participants Secukinumab 300 mg provided in 2 mL auto-injector form	Secukinumab 1 mL Prefilled Syringe n=122 Participants Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL	Placebo n=122 Participants Placebo to secukinumab	Placebo-Secukinumab 300 mg (2 mL Auto-injector) Placebo patients up to Week 12 who thereafter received secukinumab in 2 mL aI up to the end of treatment	Placebo-Secukinumab 300 mg (2x 1 mL Prefilled Syringe) Placebo patients up to Week 12 who thereafter received secukinumab in 2x 1mL PFS up to the end of treatment
Successful Self-injection Baseline	5.75 Scores on a scale Standard Deviation 2.442	—	—	—	—
Successful Self-injection Baseline (1) =POST-module at baseline visit	5.75 Scores on a scale Standard Deviation 2.452	7.52 Scores on a scale Standard Deviation 2.046	1.77 Scores on a scale Standard Deviation 2.789	—	—
Successful Self-injection Week 1	5.72 Scores on a scale Standard Deviation 2.463	8.11 Scores on a scale Standard Deviation 1.759	2.39 Scores on a scale Standard Deviation 3.169	—	—
Successful Self-injection Week 4	5.70 Scores on a scale Standard Deviation 2.495	8.27 Scores on a scale Standard Deviation 1.731	2.57 Scores on a scale Standard Deviation 3.080	—	—
Successful Self-injection Week 8	5.68 Scores on a scale Standard Deviation 2.490	8.62 Scores on a scale Standard Deviation 1.545	2.94 Scores on a scale Standard Deviation 2.869	—	—
Successful Self-injection Week 12	5.70 Scores on a scale Standard Deviation 2.523	8.56 Scores on a scale Standard Deviation 1.623	2.86 Scores on a scale Standard Deviation 2.985	—	—
Successful Self-injection Week 28	5.62 Scores on a scale Standard Deviation 2.485	8.69 Scores on a scale Standard Deviation 1.681	3.07 Scores on a scale Standard Deviation 3.238	—	—

SECONDARY outcome

Timeframe: Change from Baseline up to 52 weeks

Population: Full Analysis Set-For each post-baseline visit only subjects with a value at both baseline and the respective post-baseline visit are included.

DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.

Outcome measures

Outcome measures
Measure	Secukinumab 2 mL Auto-injector n=41 Participants Secukinumab 300 mg provided in 2 mL auto-injector form	Secukinumab 1 mL Prefilled Syringe n=41 Participants Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL	Placebo n=40 Participants Placebo to secukinumab	Placebo-Secukinumab 300 mg (2 mL Auto-injector) Placebo patients up to Week 12 who thereafter received secukinumab in 2 mL aI up to the end of treatment	Placebo-Secukinumab 300 mg (2x 1 mL Prefilled Syringe) Placebo patients up to Week 12 who thereafter received secukinumab in 2x 1mL PFS up to the end of treatment
Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score) Week 12	-13.21 Scores on a Scale Standard Deviation 7.701	-11.95 Scores on a Scale Standard Deviation 7.861	-1.97 Scores on a Scale Standard Deviation 6.966	—	—
Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score) Week 28	-13.59 Scores on a Scale Standard Deviation 7.639	-12.23 Scores on a Scale Standard Deviation 8.438	-13.00 Scores on a Scale Standard Deviation 12.490	—	—
Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score) Week 52	-12.44 Scores on a Scale Standard Deviation 8.219	-12.23 Scores on a Scale Standard Deviation 8.408	-14.33 Scores on a Scale Standard Deviation 11.240	—	—

Adverse Events

Secukinumab 300 mg (2 mL Auto-Injector)

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Secukinumab 300 mg (2 x 1 mL PFS)

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Any Secukinumab 300 mg (2 mL AI)

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Any Secukinumab 300 mg (2 x 1 mL PFS)

Serious events: 4 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Any Secukinumab 300 mg

Serious events: 5 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Secukinumab 300 mg (2 mL Auto-Injector) n=41 participants at risk Secukinumab 300 mg provided in 2 mL auto-injector form	Secukinumab 300 mg (2 x 1 mL PFS) n=41 participants at risk Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL	Any Secukinumab 300 mg (2 mL AI) n=57 participants at risk Any Secukinumab 300 mg (2 mL AI)	Any Secukinumab 300 mg (2 x 1 mL PFS) n=58 participants at risk Any Secukinumab 300 mg (2 x 1 mL PFS)	Placebo n=40 participants at risk Placebo to Secukinumab sub-cutaneous form	Any Secukinumab 300 mg n=115 participants at risk Any Secukinumab 300 mg
Infections and infestations Appendicitis	0.00% 0/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	2.4% 1/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/57 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	1.7% 1/58 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/40 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.87% 1/115 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.
Infections and infestations COVID-19	0.00% 0/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	2.4% 1/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/57 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	1.7% 1/58 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/40 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.87% 1/115 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.
Infections and infestations Device related infection	2.4% 1/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	1.8% 1/57 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/58 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/40 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.87% 1/115 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.
Injury, poisoning and procedural complications Concussion	0.00% 0/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	2.4% 1/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/57 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	1.7% 1/58 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/40 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.87% 1/115 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.
Injury, poisoning and procedural complications Head injury	0.00% 0/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	2.4% 1/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/57 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	1.7% 1/58 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/40 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.87% 1/115 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	2.4% 1/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/57 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	1.7% 1/58 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/40 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.87% 1/115 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.
Nervous system disorders Syncope	0.00% 0/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	2.4% 1/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/57 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	1.7% 1/58 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/40 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.87% 1/115 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/57 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	1.7% 1/58 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/40 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.87% 1/115 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.

Other adverse events

Other adverse events
Measure	Secukinumab 300 mg (2 mL Auto-Injector) n=41 participants at risk Secukinumab 300 mg provided in 2 mL auto-injector form	Secukinumab 300 mg (2 x 1 mL PFS) n=41 participants at risk Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL	Any Secukinumab 300 mg (2 mL AI) n=57 participants at risk Any Secukinumab 300 mg (2 mL AI)	Any Secukinumab 300 mg (2 x 1 mL PFS) n=58 participants at risk Any Secukinumab 300 mg (2 x 1 mL PFS)	Placebo n=40 participants at risk Placebo to Secukinumab sub-cutaneous form	Any Secukinumab 300 mg n=115 participants at risk Any Secukinumab 300 mg
Gastrointestinal disorders Nausea	0.00% 0/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	7.3% 3/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/57 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	5.2% 3/58 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/40 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	2.6% 3/115 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.
General disorders Influenza like illness	7.3% 3/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	7.3% 3/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	7.0% 4/57 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	5.2% 3/58 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	2.5% 1/40 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	6.1% 7/115 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.
Infections and infestations Nasopharyngitis	14.6% 6/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	14.6% 6/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	14.0% 8/57 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	13.8% 8/58 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/40 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	13.9% 16/115 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.
Infections and infestations Upper respiratory tract infection	7.3% 3/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	9.8% 4/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	7.0% 4/57 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	10.3% 6/58 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	2.5% 1/40 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	8.7% 10/115 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.
Nervous system disorders Headache	4.9% 2/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	9.8% 4/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	5.3% 3/57 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	6.9% 4/58 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	2.5% 1/40 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	6.1% 7/115 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.
Skin and subcutaneous tissue disorders Pruritus	7.3% 3/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	4.9% 2/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	5.3% 3/57 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	5.2% 3/58 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	5.0% 2/40 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	5.2% 6/115 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.
Vascular disorders Hypertension	9.8% 4/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	4.9% 2/41 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	8.8% 5/57 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	3.4% 2/58 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	0.00% 0/40 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.	6.1% 7/115 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment. Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

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 (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER