Trial Outcomes & Findings for Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy (NCT NCT05569174)

NCT ID: NCT05569174

Last Updated: 2026-01-23

Results Overview

The WORC Index consisted of 21 items divided into 5 Domains: Physical Symptoms (6 items), Sport/Recreation (4 items), Work Function (4 items), Lifestyle Function (4 items) and Emotional Function (3 items). Each of the 21 items in the WORC was rated using a visual analogue scale (VAS) ranging from 0 (no impact on quality of life) to 100 (worst possible impact). Thus, the total score ranged from 0 to 2100 points. The score was reported as a percentage of normal by subtracting the total score from 2100, dividing by 2100, and multiplying by 100. Total final WORC percentage scores ranged from 0%, the lowest functional status level, to 100%, the highest functional status level. Change from baseline in the WORC percentage total score was assessed at Week 24. A positive change from baseline indicated an improvement.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 62 participants
• Primary outcome timeframe: Baseline, Week 24
• Results posted on: 2026-01-23

Participant Flow

Patients were randomized in 19 study sites across Germany

A total of 100 participants were screened and 62 participants were randomized in nearly equal numbers to the 2 treatment groups (secukinumab: N=30; placebo: N=32) and received study treatment

Participant milestones

Measure	Secukinumab Participants received 300 mg of secukinumab s.c. for 12 weeks	Placebo Participants received placebo s.c. for 12 weeks
Overall Study STARTED	30	32
Overall Study COMPLETED	30	27
Overall Study NOT COMPLETED	0	5

Reasons for withdrawal

Measure	Secukinumab Participants received 300 mg of secukinumab s.c. for 12 weeks	Placebo Participants received placebo s.c. for 12 weeks
Overall Study Adverse Event	0	1
Overall Study Lack of compliance	0	1
Overall Study Withdrawal of consent	0	1
Overall Study Participant wish	0	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy

Baseline characteristics by cohort

Measure	Secukinumab n=30 Participants Participants received 300 mg of secukinumab s.c. for 12 weeks	Placebo n=32 Participants Participants received placebo s.c. for 12 weeks	Total n=62 Participants Total of all reporting groups
Age, Continuous	52.3 years STANDARD_DEVIATION 7.5 • n=270 Participants	52.1 years STANDARD_DEVIATION 9.0 • n=4 Participants	52.2 years STANDARD_DEVIATION 8.2 • n=9 Participants
Sex: Female, Male Female	20 Participants n=270 Participants	15 Participants n=4 Participants	35 Participants n=9 Participants
Sex: Female, Male Male	10 Participants n=270 Participants	17 Participants n=4 Participants	27 Participants n=9 Participants
Race/Ethnicity, Customized Caucasian	29 Participants n=270 Participants	31 Participants n=4 Participants	60 Participants n=9 Participants
Race/Ethnicity, Customized Black	1 Participants n=270 Participants	0 Participants n=4 Participants	1 Participants n=9 Participants
Race/Ethnicity, Customized Asian	0 Participants n=270 Participants	1 Participants n=4 Participants	1 Participants n=9 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: FAS: all patients to whom study/reference treatment was assigned by randomization. Only participants with both a baseline and a Week 24 assessment were included in the analysis.

The WORC Index consisted of 21 items divided into 5 Domains: Physical Symptoms (6 items), Sport/Recreation (4 items), Work Function (4 items), Lifestyle Function (4 items) and Emotional Function (3 items). Each of the 21 items in the WORC was rated using a visual analogue scale (VAS) ranging from 0 (no impact on quality of life) to 100 (worst possible impact). Thus, the total score ranged from 0 to 2100 points. The score was reported as a percentage of normal by subtracting the total score from 2100, dividing by 2100, and multiplying by 100. Total final WORC percentage scores ranged from 0%, the lowest functional status level, to 100%, the highest functional status level.

Change from baseline in the WORC percentage total score was assessed at Week 24. A positive change from baseline indicated an improvement.

Outcome measures

Measure	Secukinumab n=28 Participants Participants received 300 mg of secukinumab s.c. for 12 weeks	Placebo n=28 Participants Participants received placebo s.c. for 12 weeks
Change From Baseline in the Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Percentage Score at Week 24	55.7 Score on a Scale Standard Deviation 28.1	46.8 Score on a Scale Standard Deviation 26.9

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: FAS: all patients to whom study/reference treatment was assigned by randomization. Only participants with both a baseline and a Week 24 assessment were included in the analysis.

The WORC Index consisted of 21 items divided into 5 Domains: Physical Symptoms (6 items), Sport/Recreation (4 items), Work Function (4 items), Lifestyle Function (4 items) and Emotional Function (3 items). Each of the 21 items in the WORC was rated using a VAS ranging from 0 (no impact on quality of life) to 100 (worst possible impact).

Each subdomain score was calculated as a percentage of normal function, ranging from 0% (worst condition) to 100% (best condition).

Change from baseline in the WORC Index percentage sub-domain score was assessed at Week 24. A positive change from baseline indicated an improvement

Outcome measures

Measure	Secukinumab n=28 Participants Participants received 300 mg of secukinumab s.c. for 12 weeks	Placebo n=28 Participants Participants received placebo s.c. for 12 weeks
Change From Baseline in the WORC Percentage Sub-scores at Week 24 Physical symptom score	48.8 Score on a Scale Standard Deviation 31.2	40.0 Score on a Scale Standard Deviation 25.0
Change From Baseline in the WORC Percentage Sub-scores at Week 24 Sports and recreation	51.8 Score on a Scale Standard Deviation 30.9	44.0 Score on a Scale Standard Deviation 30.6
Change From Baseline in the WORC Percentage Sub-scores at Week 24 Work	59.7 Score on a Scale Standard Deviation 32.0	49.9 Score on a Scale Standard Deviation 30.5
Change From Baseline in the WORC Percentage Sub-scores at Week 24 Lifestyle	59.5 Score on a Scale Standard Deviation 27.3	52.9 Score on a Scale Standard Deviation 26.4
Change From Baseline in the WORC Percentage Sub-scores at Week 24 Emotional function	64.2 Score on a Scale Standard Deviation 23.6	54.3 Score on a Scale Standard Deviation 31.5

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: FAS: all patients to whom study/reference treatment was assigned by randomization. Only participants with both a baseline and a Week 24 assessment were included in the analysis.

The participant's global assessment of disease activity was performed using 100 mm VAS ranging from 0="no activity" to 100= "most active", after the question " Please indicate with a vertical mark ( | ) through the horizontal line the global activity of your disease in the last 24 hours".

Change from baseline in the participant's global assessment of disease activity score was assessed at Week 24. A negative change from baseline indicated improvement

Outcome measures

Measure	Secukinumab n=26 Participants Participants received 300 mg of secukinumab s.c. for 12 weeks	Placebo n=25 Participants Participants received placebo s.c. for 12 weeks
Change From Baseline in Participant's Global Assessment of Disease Activity Score at Week 24	-46.4 Score on a scale Standard Deviation 36.6	-18.5 Score on a scale Standard Deviation 37.2

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: FAS: all patients to whom study/reference treatment was assigned by randomization. Only participants with both a baseline and a Week 24 assessment were included in the analysis.

The SF-36 Health Survey was a validated questionnaire assessing health-related quality of life. Participants completed the survey throughout the study, reflecting their health status over the previous 4 weeks. It consisted of eight subscales that were scored individually; and two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Component summary scores (PCS and MCS) were derived from weighted combinations of the eight subscales. Each domain and component summary score ranged from 0 to 100, with higher scores indicating better quality of life.

Change from baseline to Week 24 in all subscale and summary scores was assessed, where a positive change indicated improvement.

Outcome measures

Measure	Secukinumab n=26 Participants Participants received 300 mg of secukinumab s.c. for 12 weeks	Placebo n=25 Participants Participants received placebo s.c. for 12 weeks
Change From Baseline in Short Form 36 (SF-36v2) Score at Week 24 Physical component summary	9.4 Score on a Scale Standard Deviation 9.1	9.7 Score on a Scale Standard Deviation 7.9
Change From Baseline in Short Form 36 (SF-36v2) Score at Week 24 Mental component summary	8.0 Score on a Scale Standard Deviation 10.7	6.3 Score on a Scale Standard Deviation 11.9
Change From Baseline in Short Form 36 (SF-36v2) Score at Week 24 General health	3.0 Score on a Scale Standard Deviation 8.5	3.9 Score on a Scale Standard Deviation 10.6
Change From Baseline in Short Form 36 (SF-36v2) Score at Week 24 Vitality	8.3 Score on a Scale Standard Deviation 9.9	7.7 Score on a Scale Standard Deviation 11.0
Change From Baseline in Short Form 36 (SF-36v2) Score at Week 24 Social functioning	8.3 Score on a Scale Standard Deviation 10.1	8.2 Score on a Scale Standard Deviation 10.9
Change From Baseline in Short Form 36 (SF-36v2) Score at Week 24 Role emotional	11.5 Score on a Scale Standard Deviation 13.1	5.8 Score on a Scale Standard Deviation 14.5
Change From Baseline in Short Form 36 (SF-36v2) Score at Week 24 Mental health	7.6 Score on a Scale Standard Deviation 10.0	9.1 Score on a Scale Standard Deviation 10.9
Change From Baseline in Short Form 36 (SF-36v2) Score at Week 24 Physical function	8.8 Score on a Scale Standard Deviation 9.5	8.6 Score on a Scale Standard Deviation 6.4
Change From Baseline in Short Form 36 (SF-36v2) Score at Week 24 Role-physical	9.9 Score on a Scale Standard Deviation 10.3	9.3 Score on a Scale Standard Deviation 10.9
Change From Baseline in Short Form 36 (SF-36v2) Score at Week 24 Bodily pain	16.2 Score on a Scale Standard Deviation 10.2	15.1 Score on a Scale Standard Deviation 9.2

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: FAS: all patients to whom study/reference treatment was assigned by randomization. Only participants with both a baseline and a Week 24 assessment were included in the analysis.

The QuickDASH was an abbreviated form of the DASH. The QuickDASH Index was self-administered and used 11 items to measure physical function and symptoms in participants with any or multiple musculoskeletal disorders of the upper limb. It had a recall period of 1 week. Each item of the QuickDASH had five response options. The raw score was calculated as the sum of responses, converted to an average, and rescaled to a total score ranging from 0 (no disability) to 100 (most severe disability) Change from baseline to Week 24 was assessed. A negative change from baseline indicated improvement.

Outcome measures

Measure	Secukinumab n=26 Participants Participants received 300 mg of secukinumab s.c. for 12 weeks	Placebo n=25 Participants Participants received placebo s.c. for 12 weeks
Change From Baseline in Quick Disability of the Arm, Shoulder and Hand (DASH) Questionnaire Score at Week 24	-34.1 Score on a Scale Standard Deviation 23.7	-33.5 Score on a Scale Standard Deviation 24.6

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: FAS: all patients to whom study/reference treatment was assigned by randomization. Only participants with both a baseline and a Week 24 assessment were included in the analysis.

The score for pain was assessed by using an 11-point NRS ranging from 0 "no pain at all" to 10 "worst possible pain", after the question "On a numeric scale of 0-10 where would you rate your pain at this time".

Change from baseline to Wek 24 was assessed. A negative change from baseline indicated improvement

Outcome measures

Measure	Secukinumab n=26 Participants Participants received 300 mg of secukinumab s.c. for 12 weeks	Placebo n=25 Participants Participants received placebo s.c. for 12 weeks
Change From Baseline in the Numeric Rating Scale (NRS) Pain Score at Week 24	-4.5 Score on a Scale Standard Deviation 2.8	-4.6 Score on a Scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: FAS: all patients to whom study/reference treatment was assigned by randomization. Only participants with both a baseline and a Week 24 assessment were included in the analysis.

The EQ-5D-5L was a standardized instrument used to evaluate patients' overall health-related quality of life (QoL). It consisted of two components: the descriptive system and the EQ visual analogue scale (EQ VAS).

The descriptive system assessed five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension was rated on five levels, from 1 (no problems) to 5 (extreme problems). These ratings were combined to generate a composite health index, which could be converted into a single summary health utility score using published value sets. Total scores ranged from 0 to 1, with lower scores indicating greater health impairment.

Changes in total scores from baseline to Week 24 were analyzed, with positive changes indicating improvement in health-related quality of life.

Outcome measures

Measure	Secukinumab n=26 Participants Participants received 300 mg of secukinumab s.c. for 12 weeks	Placebo n=25 Participants Participants received placebo s.c. for 12 weeks
Change From Baseline in EuroQol 5 Dimensions- 5 Levels (EQ-5D-5L) at Week 24- Total Score	0.265 Score on a Scale Standard Deviation 0.226	0.342 Score on a Scale Standard Deviation 0.228

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: FAS: all patients to whom study/reference treatment was assigned by randomization. Only participants with both a baseline and a Week 24 assessment were included in the analysis.

The EQ-5D-5L was a standardized instrument used to evaluate patients' overall health-related quality of life (QoL). It consisted of two components: the descriptive system and the EQ visual analogue scale (EQ VAS).

The EQ VAS captured the respondent's self-rated health on a vertical scale ranging from 0 (worst imaginable health) to 100 (best imaginable health).

Changes in EQ VAS scores from baseline to Week 24 were analyzed, with positive changes indicating improvement in health-related quality of life.

Outcome measures

Measure	Secukinumab n=26 Participants Participants received 300 mg of secukinumab s.c. for 12 weeks	Placebo n=25 Participants Participants received placebo s.c. for 12 weeks
Change From Baseline in EuroQol 5 Dimensions- 5 Levels (EQ-5D-5L) at Week 24- EQ VAS	18.3 Score on a Scale Standard Deviation 36.5	23.8 Score on a Scale Standard Deviation 27.3

Adverse Events

Secukinumab

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Secukinumab n=30 participants at risk AEs from start of treatment to 84 days after the last dose of study treatment, assessed up to approximately 24 weeks	Placebo n=32 participants at risk AEs from start of treatment to 84 days after the last dose of study treatment, assessed up to approximately 24 weeks
Infections and infestations Oropharyngeal candidiasis	3.3% 1/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Vaginal cuff dehiscence	0.00% 0/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Investigations Lipase increased	0.00% 0/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neuroendocrine tumour	0.00% 0/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Nervous system disorders Occipital lobe stroke	0.00% 0/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Psychiatric disorders Depression	3.3% 1/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Vascular disorders Paradoxical embolism	0.00% 0/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.

Other adverse events

Measure	Secukinumab n=30 participants at risk AEs from start of treatment to 84 days after the last dose of study treatment, assessed up to approximately 24 weeks	Placebo n=32 participants at risk AEs from start of treatment to 84 days after the last dose of study treatment, assessed up to approximately 24 weeks
Infections and infestations Oral herpes	6.7% 2/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Respiratory tract infection	6.7% 2/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Sinusitis	0.00% 0/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Ligament sprain	6.7% 2/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hypercholesterolaemia	6.7% 2/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 3/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	34.4% 11/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	13.3% 4/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	9.4% 3/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Neck pain	3.3% 1/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Nervous system disorders Headache	26.7% 8/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	18.8% 6/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Psychiatric disorders Depression	6.7% 2/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Vascular disorders Hypertension	10.0% 3/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	3.3% 1/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
General disorders and administration site conditions Fatigue	0.00% 0/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Bronchitis	0.00% 0/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	9.4% 3/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations COVID-19	13.3% 4/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	9.4% 3/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Gastrointestinal infection	6.7% 2/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Nasopharyngitis	16.7% 5/30 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	21.9% 7/32 • From start of treatment to end of study, assessed up to approximately 24 weeks The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: +1 862 778 8300

Email: novartis.email@Novartis.com

Results disclosure agreements

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

Restriction type: OTHER