Trial Outcomes & Findings for 16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis (NCT NCT02159053)

Last Updated: 2019-04-10

Results Overview

ASAS 20 response is a validated composite assessment, defined as an improvement of at least 20 percent (%) and 1 unit on a scale of 10 in three main domains and no worsening of at least 20% and 1 unit on a scale of 10 in the fourth domain within a defined time frame. Four main ASAS domains include: 1. Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe 2. Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale 4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

350 participants

Primary outcome timeframe

16 Weeks

Results posted on

2019-04-10

Participant Flow

The study was conducted at 85 centers in 19 countries.

A total of 424 participants were screened, out of which 350 participants completed the screening phase and were randomized to three treatment groups in 1:1:1 ratio.

Participant milestones

Participant milestones
Measure	Secukinumab 150 mg With Loading Dose Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.	Secukinumab 150 mg Without Loading Dose Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.	Placebo Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.
Overall Study STARTED	116	117	117
Overall Study Paticipants Week 16 Onwards	116	117	113
Overall Study COMPLETED	96	96	97
Overall Study NOT COMPLETED	20	21	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Secukinumab 150 mg With Loading Dose Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.	Secukinumab 150 mg Without Loading Dose Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.	Placebo Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.
Overall Study Death	2	0	1
Overall Study Physician Decision	0	1	1
Overall Study Lack of Efficacy	3	4	7
Overall Study Adverse Event	7	6	5
Overall Study Participants/guardian decision	8	10	6

Baseline Characteristics

16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Secukinumab 150 mg With Loading Dose n=116 Participants Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.	Secukinumab 150 mg Without Loading Dose n=117 Participants Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.	Placebo n=117 Participants Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.	Total n=350 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	110 Participants n=5 Participants	114 Participants n=7 Participants	110 Participants n=5 Participants	334 Participants n=4 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	16 Participants n=4 Participants
Age, Continuous	44.5 years STANDARD_DEVIATION 11.62 • n=5 Participants	41.2 years STANDARD_DEVIATION 11.07 • n=7 Participants	43.4 years STANDARD_DEVIATION 12.46 • n=5 Participants	43.0 years STANDARD_DEVIATION 11.78 • n=4 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	34 Participants n=7 Participants	41 Participants n=5 Participants	110 Participants n=4 Participants
Sex: Female, Male Male	81 Participants n=5 Participants	83 Participants n=7 Participants	76 Participants n=5 Participants	240 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 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	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	113 Participants n=5 Participants	117 Participants n=7 Participants	114 Participants n=5 Participants	344 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
Patient's global assessment of disease activity	73.5 units on a scale STANDARD_DEVIATION 15.02 • n=5 Participants	73.2 units on a scale STANDARD_DEVIATION 15.99 • n=7 Participants	73.7 units on a scale STANDARD_DEVIATION 15.05 • n=5 Participants	73.5 units on a scale STANDARD_DEVIATION 15.32 • n=4 Participants
Total back pain (0-100 mm)	74.9 units on a scale STANDARD_DEVIATION 13.07 • n=5 Participants	74.2 units on a scale STANDARD_DEVIATION 14.18 • n=7 Participants	75 units on a scale STANDARD_DEVIATION 13.8 • n=5 Participants	74.7 units on a scale STANDARD_DEVIATION 13.66 • n=4 Participants
BASDAI	7 units on a scale STANDARD_DEVIATION 1.225 • n=5 Participants	6.95 units on a scale STANDARD_DEVIATION 1.306 • n=7 Participants	7.06 units on a scale STANDARD_DEVIATION 1.271 • n=5 Participants	7.01 units on a scale STANDARD_DEVIATION 1.265 • n=4 Participants
hs C-reactive protein	11.78 Milligrams per Litre (mg/L) STANDARD_DEVIATION 18.203 • n=5 Participants	13.84 Milligrams per Litre (mg/L) STANDARD_DEVIATION 19.795 • n=7 Participants	11.67 Milligrams per Litre (mg/L) STANDARD_DEVIATION 16.699 • n=5 Participants	12.43 Milligrams per Litre (mg/L) STANDARD_DEVIATION 18.251 • n=4 Participants

PRIMARY outcome

Timeframe: 16 Weeks

Population: The analysis was performed in Full analysis set (FAS) population, defined as all participants who were randomized and received study treatment. Here, "Number of participants analysed" signifies participants evaluable for ASAS20 at Week 16.

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg With Loading Dose n=114 Participants Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.	Secukinumab 150 mg Without Loading Dose n=110 Participants Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.	Placebo n=112 Participants Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.	All Secukinumab 150 mg Treated Participants All participants who were s.c. administered with secukinumab during the study.
Percentage of Participants Responded for Assessment of Spondyloarthritis International Society 20 Criteria (ASAS20) at 16 Weeks	60.5 percentage of participants Interval 50.9 to 69.4	65.5 percentage of participants Interval 55.7 to 74.1	49.1 percentage of participants Interval 49.1 to 58.7	—

SECONDARY outcome

Timeframe: 16 Weeks

Population: The analysis was performed in FAS population. Here, "Number of participants analysed" signifies participants evaluable for ASAS 40 response at Week 16.

ASAS 20 response is a validated composite assessment, defined as an improvement of at least 40% and 2 unit on a scale of 10 in three main domains and no worsening at all in the remaining domain within a defined time frame. Four main ASAS domains include: 1. Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe 2. Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale 4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem).

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg With Loading Dose n=114 Participants Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.	Secukinumab 150 mg Without Loading Dose n=110 Participants Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.	Placebo n=112 Participants Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.	All Secukinumab 150 mg Treated Participants All participants who were s.c. administered with secukinumab during the study.
Percentage of Participants Responded for ASAS 40 Response at 16 Weeks	39.5 percentage of participants Interval 30.6 to 49.1	38.2 percentage of participants Interval 29.2 to 48.0	29.5 percentage of participants Interval 21.4 to 38.9	—

SECONDARY outcome

Timeframe: Baseline, 16 Weeks

Population: The analysis was performed in FAS population. Here, "Number of participants analysed" signifies participants evaluable for hsCRP at Week 16.

Blood levels of C-reactive protein (CRP) is an acute phase reactant, which are indicative of inflammation and of its severity, and can be used to monitor treatment response. A hsCRP test is implemented to assess the efficacy of secukinumab (with or without load) versus placebo in reducing ankylosing spondylitis elicited systemic inflammation over the time.

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg With Loading Dose n=113 Participants Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.	Secukinumab 150 mg Without Loading Dose n=109 Participants Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.	Placebo n=112 Participants Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.	All Secukinumab 150 mg Treated Participants All participants who were s.c. administered with secukinumab during the study.
Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at 16 Weeks	-4.23 Ratio Standard Deviation 15.007	-6.57 Ratio Standard Deviation 12.778	0.62 Ratio Standard Deviation 11.699	—

SECONDARY outcome

Timeframe: 16 Weeks

Population: The analysis was performed in FAS population. Here, "Number of participants analysed" signifies participants evaluable for ASAS 5/6 response at Week 16.

ASAS 5/6 response is a validated composite assessment, defined as an improvement of at least 20% in score in at least 5 of 6 clinical domains relevant to ankylosing spondylitis and no worsening in the remaining domain. ASAS domains includes: 1. Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe 2. Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain 3. Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale 4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem) 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment 6. C-reactive protein (CRP, acute phase reactant).

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg With Loading Dose n=114 Participants Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.	Secukinumab 150 mg Without Loading Dose n=110 Participants Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.	Placebo n=112 Participants Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.	All Secukinumab 150 mg Treated Participants All participants who were s.c. administered with secukinumab during the study.
Percentage of Participants Responded for ASAS 5/6 Response at 16 Weeks	37.7 percentage of participants Interval 29.0 to 47.3	45.5 percentage of participants Interval 36.0 to 55.2	30.4 percentage of participants Interval 22.2 to 39.9	—

SECONDARY outcome

Timeframe: Baseline, 16 Weeks

Population: The analysis was performed in FAS population. Here, "Number of participants analysed" signifies participants evaluable for BASDAI at Week 16.

BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating "worst problem" on continuous VAS), to answer 6 questions (clinical domains) pertaining to 5 major symptoms of ankylosing spondylitis. Computed composite scores of 4 or greater indicate suboptimal disease control. BASDAI questions includes: 1. Fatigue 2. Spinal pain 3. Joint pain / swelling 4. Areas of localized tenderness (called enthesitis, or inflammation of tendons and ligaments) 5. Morning stiffness duration 6. Morning stiffness severity. Each symptom has equal weighting, the mean of two scores related to morning stiffness was taken (questions 5 and 6). The resulting 0 to 10 score was added to the scores from questions 1-4. The resulting 0 to 50 score was divided by 5 to give a final 0-10 BASDAI score. BASDAI was a quick and simple index taking between 30 seconds and 2 minutes for completion.

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg With Loading Dose n=114 Participants Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.	Secukinumab 150 mg Without Loading Dose n=110 Participants Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.	Placebo n=112 Participants Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.	All Secukinumab 150 mg Treated Participants All participants who were s.c. administered with secukinumab during the study.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 Weeks	-2.405 units on a scale Standard Deviation 2.1206	-2.533 units on a scale Standard Deviation 2.1463	-1.917 units on a scale Standard Deviation 2.2221	—

SECONDARY outcome

Timeframe: Baseline, 16 Weeks

Population: The analysis was performed in FAS population.Here, "Number of participants analysed" signifies participants evaluable for PCS of the SF-36 at Week 16.

SF-36 is a 36 item questionnaire which measures Quality of Life across eight subscales that were scored individually: physical functioning, role- physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores = more disability, higher scores = less disability. The overall summary scores, SF-36 physical Component Summary (PCS) was used to assess improvement from baseline in the Health-Related Quality Of Life of subjects. The change in SF-36 scores were evaluated using MMRM.

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg With Loading Dose n=114 Participants Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.	Secukinumab 150 mg Without Loading Dose n=112 Participants Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.	Placebo n=113 Participants Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.	All Secukinumab 150 mg Treated Participants All participants who were s.c. administered with secukinumab during the study.
Change From Baseline in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36)	6.754 scores on a scale Standard Deviation 6.9624	7.242 scores on a scale Standard Deviation 8.3627	4.700 scores on a scale Standard Deviation 7.5912	—

SECONDARY outcome

Timeframe: Baseline, 16 Weeks

Population: The analysis was performed in FAS population. Here, "Number of participants analysed" signifies participants evaluable for ASQoL at Week 16.

ASQoL is a self-administered 18 item questionnaire that assesses disease-specific quality of life (QoL), consisting of statements that are relevant to the physical and mental conditions for a subject with ankylosing spondylitis: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score ranges from 0 (good QoL) to 18 (poor QoL). The change in ASQoL scores was evaluated using a mixed effect repeated measures model (MMRM).

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg With Loading Dose n=114 Participants Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.	Secukinumab 150 mg Without Loading Dose n=112 Participants Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.	Placebo n=113 Participants Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.	All Secukinumab 150 mg Treated Participants All participants who were s.c. administered with secukinumab during the study.
Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 Weeks	-4.2 units on a scale Standard Deviation 4.63	-4.7 units on a scale Standard Deviation 5.05	-3.0 units on a scale Standard Deviation 4.74	—

SECONDARY outcome

Timeframe: 104 Weeks

Population: The analysis was performed on the safety population, defined as all participants who took at least one dose of study treatment during the treatment period.

AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg With Loading Dose n=116 Participants Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.	Secukinumab 150 mg Without Loading Dose n=117 Participants Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.	Placebo n=117 Participants Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.	All Secukinumab 150 mg Treated Participants n=346 Participants All participants who were s.c. administered with secukinumab during the study.
Number of Participants With Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs) and Related Discontinuations at 104 Weeks AEs	100 participants	98 participants	65 participants	289 participants
Number of Participants With Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs) and Related Discontinuations at 104 Weeks SAEs	16 participants	11 participants	4 participants	39 participants
Number of Participants With Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs) and Related Discontinuations at 104 Weeks Death	2 participants	0 participants	0 participants	4 participants
Number of Participants With Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs) and Related Discontinuations at 104 Weeks Discontinued study treatment due to any AEs	9 participants	5 participants	1 participants	20 participants

SECONDARY outcome

Timeframe: Week 4

Population: The analysis was performed in FAS population. Here, "Number of participants analysed" signifies participants evaluable for ASAS 20 at Week 16.

ASAS 20 response is a validated composite assessment, defined as an improvement of at least 20% and 1 unit on a scale of 10 in three main domains and no worsening of at least 20% and 1 unit on a scale of 10 in the fourth domain within a defined time frame. Four main ASAS domains include: 1. Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe 2. Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale 4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem).

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg With Loading Dose n=116 Participants Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.	Secukinumab 150 mg Without Loading Dose n=114 Participants Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.	Placebo n=115 Participants Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.	All Secukinumab 150 mg Treated Participants All participants who were s.c. administered with secukinumab during the study.
Percentage of Participants Responded for ASAS 20 at Week 4	49.1 percentage of participants Interval 39.8 to 58.5	55.3 percentage of participants Interval 45.7 to 64.6	40.0 percentage of participants Interval 31.1 to 49.6	—

SECONDARY outcome

Timeframe: Week 4

Population: The analysis was performed in FAS population. Here, "Number of participants analysed" signifies participants evaluable for ASAS 40 response at Week 16.

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg With Loading Dose n=116 Participants Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.	Secukinumab 150 mg Without Loading Dose n=114 Participants Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.	Placebo n=115 Participants Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.	All Secukinumab 150 mg Treated Participants All participants who were s.c. administered with secukinumab during the study.
Percentage of Participants Responded for ASAS 40 Response at Week 4	29.3 percentage of participants Interval 21.4 to 38.6	27.2 percentage of participants Interval 19.5 to 36.5	18.3 percentage of participants Interval 11.9 to 26.8	—

Adverse Events

Secukinumab 150 mg Without Loading Dose

Serious events: 18 serious events

Other events: 90 other events

Deaths: 2 deaths

Secukinumab 150 mg With Loading

Serious events: 11 serious events

Other events: 89 other events

Deaths: 0 deaths

All Secukinumab 150 mg Treated Participants

Serious events: 43 serious events

Other events: 254 other events

Deaths: 4 deaths

Placebo

Serious events: 4 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 8627788300

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