Trial Outcomes & Findings for Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis (NCT NCT04732117)
NCT ID: NCT04732117
Last Updated: 2026-04-09
Results Overview
ASAS40 response was defined as relative improvement of at least 40% and absolute improvement of at least 2 units on a 0 to 10 scale in at least 3 of the 4 main domains of the ASAS and no worsening at all in the remaining domain. The 4 main domains of the ASAS are: 1.Patient's Global Assessment of Disease Activity (score ranged from 0 \[not active\] to 10 \[very active\]); 2.Back Pain (score ranged from 0 \[no pain\] to 10 \[severe pain\]); 3.Function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]) (score ranged from 0 \[easy\] to 10 \[impossible\]); 4.Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) (score ranged from 0 \[none\] to 10 \[very severe\]). The percentage of TNF-alpha-inhibitor-naïve participants who achieved ASAS40 response at Week 16 was assessed using a logistic regression model. Discontinued participants and those with missing responses were considered non-responders
COMPLETED
PHASE3
137 participants
Baseline, Week 16
2026-04-09
Participant Flow
A screening period of up to 10 weeks before randomization assessed participant eligibility
Participant milestones
| Measure |
Secukinumab
Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
Placebo
Participants initially received placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
|---|---|---|
|
Double-Blind period (up to Week 16)
STARTED
|
68
|
69
|
|
Double-Blind period (up to Week 16)
COMPLETED
|
67
|
68
|
|
Double-Blind period (up to Week 16)
NOT COMPLETED
|
1
|
1
|
|
Open-label period
STARTED
|
67
|
68
|
|
Open-label period
Escalated to secukinumab 300 mg
|
12
|
17
|
|
Open-label period
COMPLETED
|
64
|
65
|
|
Open-label period
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Secukinumab
Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
Placebo
Participants initially received placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
|---|---|---|
|
Double-Blind period (up to Week 16)
Lost to Follow-up
|
1
|
0
|
|
Double-Blind period (up to Week 16)
Subject Decision
|
0
|
1
|
|
Open-label period
Subject discontinuation
|
3
|
3
|
Baseline Characteristics
Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis
Baseline characteristics by cohort
| Measure |
Secukinumab
n=68 Participants
Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
Placebo
n=69 Participants
Participants initially received placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.4 Years
STANDARD_DEVIATION 7.83 • n=36 Participants
|
29.4 Years
STANDARD_DEVIATION 7.44 • n=78 Participants
|
29.4 Years
STANDARD_DEVIATION 7.61 • n=23 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=36 Participants
|
17 Participants
n=78 Participants
|
40 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=36 Participants
|
52 Participants
n=78 Participants
|
97 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Asian
|
68 Participants
n=36 Participants
|
69 Participants
n=78 Participants
|
137 Participants
n=23 Participants
|
|
TNF-alpha inhibitors exposure
TNF alpha-inhibitor-naive
|
61 Participants
n=36 Participants
|
62 Participants
n=78 Participants
|
123 Participants
n=23 Participants
|
|
TNF-alpha inhibitors exposure
Prior exposure to a TNF-alpha inhibitor
|
7 Participants
n=36 Participants
|
7 Participants
n=78 Participants
|
14 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants to whom study treatment was assigned and who were TNF-alpha-naive at baseline
ASAS40 response was defined as relative improvement of at least 40% and absolute improvement of at least 2 units on a 0 to 10 scale in at least 3 of the 4 main domains of the ASAS and no worsening at all in the remaining domain. The 4 main domains of the ASAS are: 1.Patient's Global Assessment of Disease Activity (score ranged from 0 \[not active\] to 10 \[very active\]); 2.Back Pain (score ranged from 0 \[no pain\] to 10 \[severe pain\]); 3.Function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]) (score ranged from 0 \[easy\] to 10 \[impossible\]); 4.Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) (score ranged from 0 \[none\] to 10 \[very severe\]). The percentage of TNF-alpha-inhibitor-naïve participants who achieved ASAS40 response at Week 16 was assessed using a logistic regression model. Discontinued participants and those with missing responses were considered non-responders
Outcome measures
| Measure |
Secukinumab
n=61 Participants
Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
Placebo
n=62 Participants
Participants initially received placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
|---|---|---|
|
Assessment of SpondyloArthritis International Society 40 (ASAS40) Response Rate in TNF-alpha-inhibitor-naive Participants at Week 16
|
58.72 Percentage of participants
Interval 46.41 to 71.03
|
26.03 Percentage of participants
Interval 15.12 to 36.94
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants to whom study treatment was assigned
ASAS40 response was defined as relative improvement of at least 40% and absolute improvement of at least 2 units on a 0 to 10 scale in at least 3 of the 4 main domains of the ASAS and no worsening at all in the remaining domain. The 4 main domains of the ASAS are: 1.Patient's Global Assessment of Disease Activity (score ranged from 0 \[not active\] to 10 \[very active\]); 2.Back Pain (score ranged from 0 \[no pain\] to 10 \[severe pain\]); 3.Function (BASFI) (score ranged from 0 \[easy\] to 10 \[impossible\]); 4.Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration) (score ranged from 0 \[none\] to 10 \[very severe\]). The percentage of participants who achieved ASAS40 response at Week 16 was assessed using a logistic regression model. Discontinued participants and those with missing responses were considered non-responders
Outcome measures
| Measure |
Secukinumab
n=68 Participants
Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
Placebo
n=69 Participants
Participants initially received placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
|---|---|---|
|
ASAS40 Response Rate in All Participants at Week 16
|
60.10 Percentage of participants
Interval 48.46 to 71.75
|
24.78 Percentage of participants
Interval 14.57 to 34.98
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants to whom study treatment was assigned
The ASAS 5/6 response was defined as an improvement of ≥20% in at least five of all six domains of the ASAS: 1.Patient's Global Assessment of Disease Activity (score ranged from 0 \[not active\] to 10 \[very active\]); 2.Back Pain (score ranged from 0 \[no pain\] to 10 \[severe pain\]); 3.Function (BASFI) (score ranged from 0 \[easy\] to 10 \[impossible\]); 4.Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration) (score ranged from 0 \[none\] to 10 \[very severe\]); 5) spinal mobility represented by the BAS Disease Metrology Index (BASDMI) (scale ranged from 0 \[no limitation of movement\] to 10 \[very severe limitation of movement\]; and 6) C-reactive protein (acute phase reactant). The percentage of participants who achieved ASAS 5/6 response at Week 16 was assessed using a logistic regression model. Missing responses were imputed as non-responders. Discontinued participants were considered non-responders
Outcome measures
| Measure |
Secukinumab
n=68 Participants
Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
Placebo
n=69 Participants
Participants initially received placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
|---|---|---|
|
ASAS 5/6 Response Rate at Week 16.
|
61.97 Percentage of participants
Interval 51.12 to 72.82
|
25.89 Percentage of participants
Interval 16.13 to 35.64
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants to whom study treatment was assigned with measures at both baseline and Week 16
The BASDAI consisted of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which was used to answer 6 questions pertaining to the 5 major symptoms of AS: 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. BASDAI score was calculated as the mean of the 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, where higher score indicated high disease activity. The change from baseline in BASDAI scores at Week 16 was assessed using Mixed-effects model repeated measures (MMRM). A negative change from baseline indicated improvement.
Outcome measures
| Measure |
Secukinumab
n=66 Participants
Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
Placebo
n=65 Participants
Participants initially received placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
|---|---|---|
|
Change From Baseline in Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 16
|
-3.70 Score on a scale
Standard Error 0.240
|
-2.15 Score on a scale
Standard Error 0.237
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants to whom study treatment was assigned
The BASDAI consisted of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which was used to answer 6 questions pertaining to the 5 major symptoms of AS: 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. BASDAI score was calculated as the mean of the 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, where higher score indicated high disease activity. BASDAI 50 was defined as an improvement of at least 50% in the BASDAI total score compared to baseline. The percentage of participants achieving BASDAI 50 at Week 16 was assessed using a logistic regression model. Discontinued participants and with missing responses were considered non-responders
Outcome measures
| Measure |
Secukinumab
n=68 Participants
Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
Placebo
n=69 Participants
Participants initially received placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
|---|---|---|
|
BASDAI 50 Rate at Week 16
|
64.04 Percentage of participants
Interval 52.82 to 75.27
|
25.77 Percentage of participants
Interval 15.68 to 35.85
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants to whom study treatment was assigned with measures at both baseline and Week 16
hsCRP was measured as a marker of inflammation from blood samples. The change from baseline in hsCRP at Week 16 was assessed using MMRM. It was expressed as a ratio of Week 16 to baseline values. Ratios less than 1.0 at Week 16 represented reduced hsCRP.
Outcome measures
| Measure |
Secukinumab
n=64 Participants
Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
Placebo
n=65 Participants
Participants initially received placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
|---|---|---|
|
Change From Baseline of High Sensitivity C-Reactive Protein (hsCRP) at Week 16
|
0.38 Ratio: Week 16 / Baseline
Standard Error 1.137
|
0.74 Ratio: Week 16 / Baseline
Standard Error 1.136
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants to whom study treatment was assigned with measures at both baseline and Week 16
The BASFI is a set of 10 questions designed to determine the degree of functional limitation in subjects with AS. The questions were chosen on the basis of predominant input from subjects with AS. The first eight questions consider activities related to functional anatomy. The final two questions assess the subjects' ability to cope with everyday life. A 0-10 scale (captured as a continuous VAS) is used to answer the questions. The BASFI score is the mean of the ten scales - a value between 0 and 10, with higher scores indicating a higher degree of functional limitation in patients. The change from baseline in BASFI at Week 16 was assessed. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
Secukinumab
n=66 Participants
Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
Placebo
n=65 Participants
Participants initially received placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
|---|---|---|
|
Change From Baseline in Total Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16
|
-2.04 Score on a Scale
Standard Error 0.225
|
-0.93 Score on a Scale
Standard Error 0.222
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants to whom study treatment was assigned with measures at both baseline and Week 16
The MRI assessment of the total edema score of the Sacroiliac Joint (SIJ) measured the degree of edema or fluid accumulation in the joint. The score ranged from 0 to 24, with higher scores indicating more severe inflammation. The change from baseline in inflammation, as measured by the SI joint total edema score at Week 16, was evaluated using an ANCOVA model. Any missing data was imputed using multiple imputation prior to running the ANCOVA analysis.
Outcome measures
| Measure |
Secukinumab
n=65 Participants
Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
Placebo
n=66 Participants
Participants initially received placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
|---|---|---|
|
Change From Baseline in Sacroiliac Joint (SIJ) Edema Score on Magentic Resonance Imaging (MRI) at Week 16
|
-3.09 Score on a Scale
Standard Error 0.34
|
-0.84 Score on a Scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants to whom study treatment was assigned
ASAS20 response was defined as relative improvement of at least 20% and absolute improvement of at least 1 unit on a 0 to 10 scale in at least 3 of the 4 main domains of the ASAS and no worsening of ≥20% and ≥1 unit at all in the remaining domain. The 4 main domains of ASAS are 1.Patient's Global Assessment of Disease Activity (score ranged from 0 \[not active\] to 10 \[very active\]); 2.Back Pain (score ranged from 0 \[no pain\] to 10 \[severe pain\]); 3.Function (BASFI) (score ranged from 0 \[easy\] to 10 \[impossible\]); 4.Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration) (score ranged from 0 \[none\] to 10 \[very severe\]) The percentage of participants who achieved ASAS20 response at Week 16 was assessed using a logistic regression model. Discontinued participants and those with missing responses were considered non-responders
Outcome measures
| Measure |
Secukinumab
n=68 Participants
Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
Placebo
n=69 Participants
Participants initially received placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
|---|---|---|
|
ASAS20 Response Rate at Week 16
|
78.10 Percentage of participants
Interval 68.29 to 87.91
|
47.60 Percentage of participants
Interval 35.82 to 59.39
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants to whom study treatment was assigned with measures at both baseline and Week 16
SF-36 was an instrument used to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consisted of eight subscales (domains) that could be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role- Emotional, and Mental Health. Each domain score ranged from 0 to 100, with higher scores indicating a higher level of functioning. The Physical Component Summary (PCS) was an overall summary score calculated from the 8 domains. It was a norm-based score with a mean of 50 and a standard deviation of 10. Higher scores indicated a higher level of functioning. The change from baseline in PCS at Week 16 was evaluated using MMRM. A positive change from baseline indicated an improvement.
Outcome measures
| Measure |
Secukinumab
n=67 Participants
Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
Placebo
n=67 Participants
Participants initially received placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
|---|---|---|
|
Change From Baseline in Short Form-36 Physical Component Summary (SF-36 PCS) at Week 16
|
9.35 Score on a Scale
Standard Error 0.772
|
4.34 Score on a Scale
Standard Error 0.753
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants to whom study treatment was assigned with measures at both baseline and Week 16
The ASQoL was a self-administered questionnaire designed to assess health-related quality of life (HRQoL) in participants with ankylosing spondylitis. The ASQoL contained 18 items with a dichotomous yes/no response option. A single point was assigned for each "yes" response and no points for each "no" response resulting in overall scores that ranged from 0 (least severity) to 18 (highest severity). As such, a lower score indicated a better quality of life. Items included an assessment of mobility/energy, self-care, and mood/emotion. The change from baseline in ASQoL at Week 16 was assessed using MMRM. A negative change from baseline indicated an improvement.
Outcome measures
| Measure |
Secukinumab
n=67 Participants
Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
Placebo
n=67 Participants
Participants initially received placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16
|
-4.90 Score on a scale
Standard Error 0.455
|
-3.07 Score on a scale
Standard Error 0.447
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants to whom study treatment was assigned
The ASAS partial remission criteria were defined as a value not above 2 units (on a scale of 10) in each of the 4 main ASAS domains: 1. Patient's Global Assessment of Disease Activity (score ranged from 0 \[not active\] to 10 \[very active\]); 2. Back Pain (assessed on a scale of 0 \[no pain\] to 10 \[severe pain\]); 3. Function (BASFI) (score ranged from 0 \[easy\] to 10 \[impossible\]); 4. Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration) (score ranged from 0 \[none\] to 10 \[very severe\]). The percentage of participants who achieved ASAS partial remission response at Week 16 was assessed using a logistic regression model. Missing responses were imputed as non-responders. Discontinued participants were considered non-responders.
Outcome measures
| Measure |
Secukinumab
n=68 Participants
Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
Placebo
n=69 Participants
Participants initially received placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.
|
|---|---|---|
|
ASAS Partial Remission Rate at Week 16
|
30.83 Percentage of participants
Interval 19.92 to 41.73
|
14.52 Percentage of participants
Interval 6.23 to 22.8
|
Adverse Events
Secukinumab 150 mg
Secukinumab 300 mg
Any Secukinumab
Placebo
Serious adverse events
| Measure |
Secukinumab 150 mg
n=135 participants at risk
Participants who received at least one dose of secukinumab 150 mg during the 16-week double-blind treatment period or who received at least one dose of secukinumab 150 mg during the open- label treatment period. AEs were collected from the first dose of secukinumab 150 mg up to end of study or day of start of secukinumab 300 mg if dose escalation
|
Secukinumab 300 mg
n=29 participants at risk
Participants who received at least one dose of secukinumab 300 mg during the open- label treatment period. AEs were collected from the first dose of secukinumab 300 mg up to end of study
|
Any Secukinumab
n=135 participants at risk
Participants who received at least one dose of secukinumab, regardless of dose. AEs were collected from first dose of secukinumab up to end of study
|
Placebo
n=69 participants at risk
Participants who received placebo. AEs were collected from first dose of placebo up to Week 16
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
1.4%
1/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.74%
1/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.74%
1/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Infections and infestations
Paronychia
|
0.00%
0/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
3.4%
1/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.74%
1/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
3.4%
1/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.74%
1/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.74%
1/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.74%
1/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour of the rectum
|
0.74%
1/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.74%
1/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Reproductive system and breast disorders
Plasma cell mastitis
|
0.74%
1/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.74%
1/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
Other adverse events
| Measure |
Secukinumab 150 mg
n=135 participants at risk
Participants who received at least one dose of secukinumab 150 mg during the 16-week double-blind treatment period or who received at least one dose of secukinumab 150 mg during the open- label treatment period. AEs were collected from the first dose of secukinumab 150 mg up to end of study or day of start of secukinumab 300 mg if dose escalation
|
Secukinumab 300 mg
n=29 participants at risk
Participants who received at least one dose of secukinumab 300 mg during the open- label treatment period. AEs were collected from the first dose of secukinumab 300 mg up to end of study
|
Any Secukinumab
n=135 participants at risk
Participants who received at least one dose of secukinumab, regardless of dose. AEs were collected from first dose of secukinumab up to end of study
|
Placebo
n=69 participants at risk
Participants who received placebo. AEs were collected from first dose of placebo up to Week 16
|
|---|---|---|---|---|
|
General disorders and administration site conditions
Pyrexia
|
5.2%
7/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
3.4%
1/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
5.9%
8/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
2.9%
2/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.4%
6/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
6.9%
2/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
5.2%
7/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Blood and lymphatic system disorders
Monocytopenia
|
7.4%
10/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
6.9%
2/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
8.1%
11/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
4.3%
3/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
6/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
3.4%
1/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
5.2%
7/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
5.8%
4/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
4.4%
6/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
3.4%
1/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
5.2%
7/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
2.9%
2/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Infections and infestations
Bronchitis
|
0.74%
1/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
6.9%
2/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
2.2%
3/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
2.9%
2/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Infections and infestations
COVID-19
|
17.0%
23/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
13.8%
4/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
20.0%
27/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
10.1%
7/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Infections and infestations
Pharyngitis
|
2.2%
3/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
10.3%
3/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
3.7%
5/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
1.4%
1/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Infections and infestations
Suspected COVID-19
|
8.1%
11/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
3.4%
1/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
8.9%
12/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
2.9%
2/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Infections and infestations
Tonsillitis
|
1.5%
2/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
6.9%
2/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
2.2%
3/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
2.9%
2/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Infections and infestations
Upper respiratory tract infection
|
31.9%
43/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
24.1%
7/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
36.3%
49/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
31.9%
22/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Infections and infestations
Urinary tract infection
|
6.7%
9/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
3.4%
1/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
7.4%
10/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
5.8%
4/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Investigations
Alanine aminotransferase increased
|
8.1%
11/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
3.4%
1/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
8.9%
12/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
7.2%
5/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Investigations
Lipoprotein (a) increased
|
3.0%
4/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
3.0%
4/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
7.2%
5/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Investigations
Low density lipoprotein increased
|
10.4%
14/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
3.4%
1/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
10.4%
14/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
7.2%
5/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Investigations
Weight increased
|
3.0%
4/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
6.9%
2/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
4.4%
6/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Investigations
White blood cells urine positive
|
4.4%
6/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
3.4%
1/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
5.2%
7/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
1.4%
1/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
8.1%
11/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
8.1%
11/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
4.3%
3/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
17.0%
23/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
17.0%
23/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
14.5%
10/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.7%
9/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
3.4%
1/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
7.4%
10/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
4.3%
3/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
19.3%
26/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
13.8%
4/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
20.7%
28/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
14.5%
10/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
5/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
13.8%
4/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
6.7%
9/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
5.8%
4/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
4/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
3.0%
4/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
14.5%
10/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
10.4%
14/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
3.4%
1/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
11.1%
15/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
0.00%
0/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
|
Renal and urinary disorders
Proteinuria
|
2.2%
3/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
6.9%
2/29 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
3.7%
5/135 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
2.9%
2/69 • From start of treatment to end of study, assessed up to approximately 65 weeks
Any sign or symptom that occurred during the conduct of the trial
|
Additional Information
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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER