Trial Outcomes & Findings for Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients (NCT NCT03055494)
NCT ID: NCT03055494
Last Updated: 2023-03-10
Results Overview
Response in skin histology/K16 expression to treatment (answered no)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
102 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-03-10
Participant Flow
A total of 133 patients were screened for the study, with 82 (61.7%) of these completing the screening phase.
This is The Randomized Set; i.e., all randomized participants
Participant milestones
| Measure |
Secukinumab 300 mg
Participants received secukinumab 300 mg s.c. at randomization
|
Placebo/Secukinumab 300 mg
Participants received placebo at randomization and were started on secukinumab 300 mg at Week 12
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
28
|
|
Overall Study
COMPLETED
|
44
|
27
|
|
Overall Study
NOT COMPLETED
|
10
|
1
|
Reasons for withdrawal
| Measure |
Secukinumab 300 mg
Participants received secukinumab 300 mg s.c. at randomization
|
Placebo/Secukinumab 300 mg
Participants received placebo at randomization and were started on secukinumab 300 mg at Week 12
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Non-compliance with study treatment
|
1
|
0
|
Baseline Characteristics
Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients
Baseline characteristics by cohort
| Measure |
Secukinumab 300 mg
n=54 Participants
Participants received secukinumab 300 mg s.c. at randomization
|
Placebo
n=28 Participants
Participants received placebo at randomization
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 15.20 • n=5 Participants
|
50.4 years
STANDARD_DEVIATION 13.10 • n=7 Participants
|
44.5 years
STANDARD_DEVIATION 15.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
44 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set (FAS) comprised all patients to assigned study medication. Patients inappropriately randomized (eg, IRT was called in error for randomization of a screen failed patient) were excluded from FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment which they were assigned at randomization.
Response in skin histology/K16 expression to treatment (answered no)
Outcome measures
| Measure |
Secukinumab 300 mg
n=54 Participants
Participants received secukinumab 300 mg s.c. at randomization
|
Placebo
n=28 Participants
Participants received placebo at randomization
|
|---|---|---|
|
Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 12
|
43 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set (FAS) comprised all patients to assigned study medication. Patients inappropriately randomized (eg, IRT was called in error for randomization of a screen failed patient) were excluded from FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment which they were assigned at randomization.
Psoriasis Area and Severity Index 90
Outcome measures
| Measure |
Secukinumab 300 mg
n=54 Participants
Participants received secukinumab 300 mg s.c. at randomization
|
Placebo
n=28 Participants
Participants received placebo at randomization
|
|---|---|---|
|
Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 12
|
29 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS) comprised all patients to assigned study medication. Patients inappropriately randomized (eg, IRT was called in error for randomization of a screen failed patient) were excluded from FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment which they were assigned at randomization.
Response in skin histology/K16 expression to treatment (answered no)
Outcome measures
| Measure |
Secukinumab 300 mg
n=54 Participants
Participants received secukinumab 300 mg s.c. at randomization
|
Placebo
n=28 Participants
Participants received placebo at randomization
|
|---|---|---|
|
Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 52
|
33 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: FAS
Psoriasis Area and Severity Index 90
Outcome measures
| Measure |
Secukinumab 300 mg
n=54 Participants
Participants received secukinumab 300 mg s.c. at randomization
|
Placebo
n=28 Participants
Participants received placebo at randomization
|
|---|---|---|
|
Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 52
|
31 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: baseline, Week 12Population: Safety Set The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received.
Vital signs: summary statistics for change from baseline to Week 12
Outcome measures
| Measure |
Secukinumab 300 mg
n=54 Participants
Participants received secukinumab 300 mg s.c. at randomization
|
Placebo
n=28 Participants
Participants received placebo at randomization
|
|---|---|---|
|
Change in Systolic Blood Pressure From Baseline to Week 12
|
-2.6 mmHg
Standard Deviation 11.05
|
-1.5 mmHg
Standard Deviation 11.43
|
SECONDARY outcome
Timeframe: baseline, Week 12Population: Safety Set The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received.
Vital signs: summary statistics for change from baseline to Week 12
Outcome measures
| Measure |
Secukinumab 300 mg
n=54 Participants
Participants received secukinumab 300 mg s.c. at randomization
|
Placebo
n=28 Participants
Participants received placebo at randomization
|
|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline to Week 12
|
-0.5 mmHg
Standard Deviation 7.92
|
-0.2 mmHg
Standard Deviation 6.18
|
SECONDARY outcome
Timeframe: baseline, Week 12Population: Safety Set The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received.
Vital signs: summary statistics for change from baseline to Week 12
Outcome measures
| Measure |
Secukinumab 300 mg
n=54 Participants
Participants received secukinumab 300 mg s.c. at randomization
|
Placebo
n=28 Participants
Participants received placebo at randomization
|
|---|---|---|
|
Change in Body Weight From Baseline to Week 12
|
0.340 kg
Standard Deviation 2.5475
|
0.096 kg
Standard Deviation 3.8729
|
SECONDARY outcome
Timeframe: baseline, Week 12Population: Safety Set The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received.
Vital signs: summary statistics for change from baseline to Week 12
Outcome measures
| Measure |
Secukinumab 300 mg
n=54 Participants
Participants received secukinumab 300 mg s.c. at randomization
|
Placebo
n=28 Participants
Participants received placebo at randomization
|
|---|---|---|
|
Change in Glucose Level From Baseline to Week 12
|
0.027 mmol/L
Standard Deviation 0.7505
|
0.332 mmol/L
Standard Deviation 1.2933
|
SECONDARY outcome
Timeframe: baseline, Week 12Population: Safety Set The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received.
Vital signs: summary statistics for change from baseline to Week 12
Outcome measures
| Measure |
Secukinumab 300 mg
n=54 Participants
Participants received secukinumab 300 mg s.c. at randomization
|
Placebo
n=28 Participants
Participants received placebo at randomization
|
|---|---|---|
|
Change in Insulin Level From Baseline to Week 12
|
15.037 pmol/L
Standard Deviation 146.6361
|
141.035 pmol/L
Standard Deviation 446.2800
|
SECONDARY outcome
Timeframe: baseline, Week 12Population: Safety Set The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received.
Vital signs: summary statistics for change from baseline to Week 12
Outcome measures
| Measure |
Secukinumab 300 mg
n=54 Participants
Participants received secukinumab 300 mg s.c. at randomization
|
Placebo
n=28 Participants
Participants received placebo at randomization
|
|---|---|---|
|
Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 12
|
-5.010 mg/L
Standard Deviation 24.1279
|
-1.273 mg/L
Standard Deviation 7.6405
|
SECONDARY outcome
Timeframe: baseline, Week 12Population: Safety Set The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received.
Vital signs: summary statistics for change from baseline to Week 12 Healthy Range: 1.0 (0.5-1.4) Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.
Outcome measures
| Measure |
Secukinumab 300 mg
n=54 Participants
Participants received secukinumab 300 mg s.c. at randomization
|
Placebo
n=28 Participants
Participants received placebo at randomization
|
|---|---|---|
|
Change in Homeostatic Model Assessment of Insulin Resistance (UNIT) (HOMA-IR) From Baseline to Week 12
|
0.620 SI units
Standard Deviation 6.0125
|
7.646 SI units
Standard Deviation 26.5633
|
SECONDARY outcome
Timeframe: baseline, week 12Population: Safety Set The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received.
Vital signs: summary statistics for change from baseline to week 12 For people without diabetes, the normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% mean you have a higher chance of getting diabetes. Levels of 6.5% or higher mean you have diabetes.
Outcome measures
| Measure |
Secukinumab 300 mg
n=54 Participants
Participants received secukinumab 300 mg s.c. at randomization
|
Placebo
n=28 Participants
Participants received placebo at randomization
|
|---|---|---|
|
Change in Hemoglobin A1c (HbA1c) Test for Diabetes Score From Baseline to Week 12
|
0.018 scores
Standard Deviation 0.1889
|
0.014 scores
Standard Deviation 0.2138
|
Adverse Events
Secukinumab 300 mg
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo/Secukinumab 300 mg
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Secukinumab 300 mg
n=54 participants at risk
Secukinumab 300 mg
|
Placebo/Secukinumab 300 mg
n=28 participants at risk
Participants received placebo at randomization and were started on secukinumab 300 mg at Week 12
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Psychiatric disorders
Suicidal ideation
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
Other adverse events
| Measure |
Secukinumab 300 mg
n=54 participants at risk
Secukinumab 300 mg
|
Placebo/Secukinumab 300 mg
n=28 participants at risk
Participants received placebo at randomization and were started on secukinumab 300 mg at Week 12
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Cardiac disorders
Palpitations
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Ear and labyrinth disorders
Ear discomfort
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Ear and labyrinth disorders
Ear pain
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Eye disorders
Eye irritation
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Eye disorders
Lacrimation increased
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Aphthous ulcer
|
3.7%
2/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
2/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Glossodynia
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Toothache
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
General disorders
Cyst
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
General disorders
Fatigue
|
3.7%
2/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
General disorders
Influenza like illness
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
General disorders
Pain
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
General disorders
Peripheral swelling
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
General disorders
Pyrexia
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Bronchitis
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
7.1%
2/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Cellulitis
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Conjunctivitis
|
3.7%
2/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Cystitis
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Eye infection bacterial
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Folliculitis
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Gastroenteritis viral
|
3.7%
2/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Hordeolum
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Impetigo
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Incision site cellulitis
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Influenza
|
3.7%
2/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
10.7%
3/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Nasopharyngitis
|
18.5%
10/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Otitis externa candida
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Otitis media
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Pharyngitis streptococcal
|
3.7%
2/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Pneumonia
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Postoperative wound infection
|
3.7%
2/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Sinusitis
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Tinea pedis
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Tonsillitis
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Tooth abscess
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
13.0%
7/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Urinary tract infection
|
3.7%
2/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
7.1%
2/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Fall
|
3.7%
2/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Muscle strain
|
3.7%
2/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
7.1%
2/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Investigations
Blood pressure increased
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
7.1%
2/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
4/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Nervous system disorders
Headache
|
5.6%
3/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
7.1%
2/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Nervous system disorders
Migraine
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Psychiatric disorders
Anxiety
|
3.7%
2/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Psychiatric disorders
Depression
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
7.1%
2/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Psychiatric disorders
Insomnia
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Psychiatric disorders
Irritability
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Reproductive system and breast disorders
Testicular oedema
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
4/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
7.1%
2/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.7%
2/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.7%
2/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
0.00%
0/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
1.9%
1/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
3.6%
1/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
|
Vascular disorders
Hypertension
|
0.00%
0/54 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
10.7%
3/28 • Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
|
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 publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER