Trial Outcomes & Findings for Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma (NCT NCT04410523)
NCT ID: NCT04410523
Last Updated: 2024-06-20
Results Overview
FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. Pre-dose FEV1 is defined as average of the two FEV1 measurements taken at approximately 45 minutes and 15 minutes prior to dosing. The baseline pre-dose FEV1 value is defined as the average of the values taken approximately 2 hours 45 minutes and 2 hours 15 minutes prior to the first dose of double-blind treatment at Day 1. The least-squares means for change from baseline in pre-dose FEV1 averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM). A positive average change from baseline in pre-dose FEV1 is considered a favorable outcome.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
335 participants
Primary outcome timeframe
Baseline, Weeks 8-12
Results posted on
2024-06-20
Participant Flow
Participants took part in 116 investigative sites in 15 countries.
The screening period of approximately 2 weeks began after the participants had provided written informed consent. There was a single blinded placebo run-in period of 4 weeks (extended to 8 weeks for subjects experiencing an asthma exacerbation or respiratory tract infection during the run-in period) before starting the double blinded treatment period.
Participant milestones
| Measure |
CSJ117 0.5mg
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
CSJ117 8 mg inhaled once daily
|
Placebo
Placebo inhaled once daily
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
37
|
37
|
76
|
74
|
75
|
|
Overall Study
COMPLETED
|
32
|
32
|
35
|
69
|
71
|
65
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
2
|
7
|
3
|
10
|
Reasons for withdrawal
| Measure |
CSJ117 0.5mg
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
CSJ117 8 mg inhaled once daily
|
Placebo
Placebo inhaled once daily
|
|---|---|---|---|---|---|---|
|
Overall Study
Study terminated by sponsor
|
1
|
3
|
2
|
6
|
3
|
4
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol deviation
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Subject decision
|
2
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
Baseline characteristics by cohort
| Measure |
CSJ117 0.5mg
n=36 Participants
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
n=37 Participants
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
n=37 Participants
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
n=76 Participants
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
n=74 Participants
CSJ117 8 mg inhaled once daily
|
Placebo
n=75 Participants
Placebo inhaled once daily
|
Total
n=335 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 12.89 • n=5 Participants
|
51.2 years
STANDARD_DEVIATION 12.09 • n=7 Participants
|
51.4 years
STANDARD_DEVIATION 13.31 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 12.80 • n=4 Participants
|
52.7 years
STANDARD_DEVIATION 12.22 • n=21 Participants
|
51.5 years
STANDARD_DEVIATION 13.46 • n=8 Participants
|
51.3 years
STANDARD_DEVIATION 12.76 • n=8 Participants
|
|
Age, Customized
18 - <40 years
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
68 Participants
n=8 Participants
|
|
Age, Customized
40 - <65 years
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
213 Participants
n=8 Participants
|
|
Age, Customized
≥65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
54 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
209 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
126 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
73 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
53 Participants
n=8 Participants
|
243 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 8-12Population: Full Analysis Set (FAS). The FAS included all participants to whom double-blind treatment had been assigned and who received at least one dose of double-blind treatment.
FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. Pre-dose FEV1 is defined as average of the two FEV1 measurements taken at approximately 45 minutes and 15 minutes prior to dosing. The baseline pre-dose FEV1 value is defined as the average of the values taken approximately 2 hours 45 minutes and 2 hours 15 minutes prior to the first dose of double-blind treatment at Day 1. The least-squares means for change from baseline in pre-dose FEV1 averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM). A positive average change from baseline in pre-dose FEV1 is considered a favorable outcome.
Outcome measures
| Measure |
CSJ117 0.5mg
n=36 Participants
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
n=37 Participants
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
n=37 Participants
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
n=76 Participants
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
n=74 Participants
CSJ117 8 mg inhaled once daily
|
Placebo
n=75 Participants
Placebo inhaled once daily
|
|---|---|---|---|---|---|---|
|
Average Change From Baseline in Pre-dose FEV1 at Week 8 and Week 12
|
0.173 liters (L)
Standard Error 0.0445
|
0.109 liters (L)
Standard Error 0.0446
|
0.116 liters (L)
Standard Error 0.0419
|
0.060 liters (L)
Standard Error 0.0299
|
0.043 liters (L)
Standard Error 0.0305
|
0.051 liters (L)
Standard Error 0.0309
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8-12Population: Full Analysis Set
Fractional exhaled Nitric Oxide (FeNO) pre-dose measurements were done at the investigational sites prior to spirometry assessments. FeNO is defined as the mean of two serial measurements. The measurement of exhaled nitric oxide is widely accepted as a non-invasive marker of airway inflammation (inflammation leads to elevation of FeNO). The baseline FeNO pre-dose measurements were taken at the end of the run-in period. The least-squares means for change from baseline in FeNO averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM). A negative average change from baseline in FeNO is considered a favorable outcome.
Outcome measures
| Measure |
CSJ117 0.5mg
n=36 Participants
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
n=37 Participants
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
n=37 Participants
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
n=76 Participants
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
n=74 Participants
CSJ117 8 mg inhaled once daily
|
Placebo
n=75 Participants
Placebo inhaled once daily
|
|---|---|---|---|---|---|---|
|
Average Change From Baseline in FeNO at Week 8 and Week 12
|
-2.869 parts per billion (ppb)
Standard Error 1.9670
|
-5.299 parts per billion (ppb)
Standard Error 1.9872
|
-4.190 parts per billion (ppb)
Standard Error 1.8760
|
-1.587 parts per billion (ppb)
Standard Error 1.3312
|
-0.208 parts per billion (ppb)
Standard Error 1.3248
|
-1.301 parts per billion (ppb)
Standard Error 1.3142
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants in the Full Analysis Set with a valid measurement for the outcome measure
PEF (Peak Expiratory Flow) is a person's maximum speed of expiration. All participants were instructed to record PEF twice daily before taking any medication using an electronic peak expiratory flow device (eDiary/ePEF), once in the morning and once approximately 12 hours later in the evening at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the eDiary/ePEF. Mean morning and evening PEF values were calculated by weekly intervals. The baseline values of PEF were the mean values in the run-in period. A positive change from baseline in PEF is considered a favorable outcome.
Outcome measures
| Measure |
CSJ117 0.5mg
n=31 Participants
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
n=33 Participants
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
n=32 Participants
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
n=65 Participants
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
n=66 Participants
CSJ117 8 mg inhaled once daily
|
Placebo
n=61 Participants
Placebo inhaled once daily
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Morning PEF at Week 12
|
-0.9785 liters/minute
Standard Deviation 22.73169
|
-1.7035 liters/minute
Standard Deviation 28.83957
|
18.9496 liters/minute
Standard Deviation 50.09045
|
-0.0319 liters/minute
Standard Deviation 33.56218
|
3.5702 liters/minute
Standard Deviation 37.05293
|
-2.2060 liters/minute
Standard Deviation 24.56187
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants in the Full Analysis Set with a valid measurement for the outcome measure
PEF (Peak Expiratory Flow) is a person's maximum speed of expiration. All participants were instructed to record PEF twice daily before taking any medication using an electronic peak expiratory flow device (eDiary/ePEF), once in the morning and once approximately 12 hours later in the evening at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the eDiary/ePEF. Mean morning and evening PEF values were calculated by weekly intervals. The baseline values of PEF were the mean values in the run-in period. A positive change from baseline in PEF is considered a favorable outcome.
Outcome measures
| Measure |
CSJ117 0.5mg
n=29 Participants
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
n=30 Participants
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
n=31 Participants
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
n=59 Participants
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
n=62 Participants
CSJ117 8 mg inhaled once daily
|
Placebo
n=58 Participants
Placebo inhaled once daily
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Evening PEF at Week 12
|
-5.3894 liters/minute
Standard Deviation 29.13968
|
-7.8709 liters/minute
Standard Deviation 29.06055
|
14.0265 liters/minute
Standard Deviation 44.90062
|
0.3893 liters/minute
Standard Deviation 30.47064
|
2.6905 liters/minute
Standard Deviation 32.27860
|
-3.2785 liters/minute
Standard Deviation 22.93816
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8-12Population: Full Analysis Set
The Asthma Control Questionnaire-5 (ACQ-5) is a five-item, self-completed questionnaire, which is used as a measure of asthma symptom control. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the overall ACQ-5 score is the mean of all 5 questions, therefore between 0 (totally controlled) and 6 (severely uncontrolled). The baseline values of ACQ-5 were collected at the end of the run-in period. The least-squares means for change from baseline in ACQ-5 score averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM). A negative change from baseline in ACQ-5 is considered a favorable outcome.
Outcome measures
| Measure |
CSJ117 0.5mg
n=36 Participants
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
n=37 Participants
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
n=37 Participants
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
n=76 Participants
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
n=74 Participants
CSJ117 8 mg inhaled once daily
|
Placebo
n=75 Participants
Placebo inhaled once daily
|
|---|---|---|---|---|---|---|
|
Average Change From Baseline in ACQ-5 Score at Week 8 and Week 12
|
-0.764 score on a scale
Standard Error 0.1230
|
-1.142 score on a scale
Standard Error 0.1225
|
-1.011 score on a scale
Standard Error 0.1171
|
-0.739 score on a scale
Standard Error 0.0824
|
-0.837 score on a scale
Standard Error 0.0829
|
-0.722 score on a scale
Standard Error 0.0846
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8-12Population: Full Analysis Set
The Asthma Quality of Life Questionnaire+12 (AQLQ+12) is a disease specific questionnaire, which is used as a measure of health-related quality of life. The AQLQ+12 comprises a total of 32 individual questions that span a total of 4 domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The overall AQLQ+12 score is the mean of all 32 individual responses, therefore between 7 and 1 with higher scores indicating less impairment in health-related quality of life. The baseline values of AQLQ+12 were collected at the end of the run-in period. The least-squares means for change from baseline in AQLQ+12 score averaged between Week 8 and Week 12 visits were obtained from a linear mixed effects model for repeated measures (MMRM). A positive change from baseline is considered a favorable outcome.
Outcome measures
| Measure |
CSJ117 0.5mg
n=36 Participants
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
n=37 Participants
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
n=37 Participants
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
n=76 Participants
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
n=74 Participants
CSJ117 8 mg inhaled once daily
|
Placebo
n=75 Participants
Placebo inhaled once daily
|
|---|---|---|---|---|---|---|
|
Average Change From Baseline in AQLQ+12 Score at Week 8 and Week 12
|
0.467 score on a scale
Standard Error 0.1223
|
0.781 score on a scale
Standard Error 0.1220
|
0.642 score on a scale
Standard Error 0.1177
|
0.597 score on a scale
Standard Error 0.0828
|
0.636 score on a scale
Standard Error 0.0826
|
0.564 score on a scale
Standard Error 0.0842
|
SECONDARY outcome
Timeframe: Baseline, Week 8 and Week 12Population: Participants in the Full Analysis Set with a valid measurement for the outcome measure at each timepoint
Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) are patient reported outcome measures of asthma symptom severity. Patients recorded asthma symptoms twice daily in the eDiary. Severity of daytime asthma symptoms were assessed before going to bed and severity of nighttime symptoms upon waking. Both diaries comprised of 6 items assessing breathing symptoms (difficulty breathing, wheezing, and shortness of breath), chest symptoms (chest tightness and chest pain), and cough symptoms (cough). All items were assessed using an 11-point numeric rating scale ranging from 0 ('None') to 10 ('As bad as you can imagine'). The overall score is the mean of all 6 individual responses, therefore between 0 and 10 with higher scores indicating more severe symptoms. Mean daily scores of both diaries were calculated by weekly intervals. The baseline values were defined as the average score during the run-in period. A negative change from baseline is a favorable outcome.
Outcome measures
| Measure |
CSJ117 0.5mg
n=33 Participants
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
n=33 Participants
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
n=37 Participants
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
n=73 Participants
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
n=72 Participants
CSJ117 8 mg inhaled once daily
|
Placebo
n=67 Participants
Placebo inhaled once daily
|
|---|---|---|---|---|---|---|
|
Change From Baseline in ADSD Score at Week 8 and Week 12
Week 8
|
-0.24 score on a scale
Standard Deviation 0.678
|
-0.42 score on a scale
Standard Deviation 0.622
|
-0.35 score on a scale
Standard Deviation 0.773
|
-0.32 score on a scale
Standard Deviation 0.555
|
-0.33 score on a scale
Standard Deviation 0.787
|
-0.25 score on a scale
Standard Deviation 0.580
|
|
Change From Baseline in ADSD Score at Week 8 and Week 12
Week 12
|
-0.29 score on a scale
Standard Deviation 0.752
|
-0.59 score on a scale
Standard Deviation 0.938
|
-0.38 score on a scale
Standard Deviation 0.687
|
-0.33 score on a scale
Standard Deviation 0.581
|
-0.35 score on a scale
Standard Deviation 0.820
|
-0.37 score on a scale
Standard Deviation 0.754
|
SECONDARY outcome
Timeframe: Baseline, Week 8 and Week 12Population: Participants in the Full Analysis Set with a valid measurement for the outcome measure at each timepoint
Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) are patient reported outcome measures of asthma symptom severity. Patients recorded asthma symptoms twice daily in the eDiary. Severity of daytime asthma symptoms were assessed before going to bed and severity of nighttime symptoms upon waking. Both diaries comprised of 6 items assessing breathing symptoms (difficulty breathing, wheezing, and shortness of breath), chest symptoms (chest tightness and chest pain), and cough symptoms (cough). All items were assessed using an 11-point numeric rating scale ranging from 0 ('None') to 10 ('As bad as you can imagine'). The overall score is the mean of all 6 individual responses, therefore between 0 and 10 with higher scores indicating more severe symptoms. Mean daily scores of both diaries were calculated by weekly intervals. The baseline values were defined as the average score during the run-in period. A negative change from baseline is a favorable outcome.
Outcome measures
| Measure |
CSJ117 0.5mg
n=34 Participants
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
n=34 Participants
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
n=37 Participants
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
n=74 Participants
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
n=72 Participants
CSJ117 8 mg inhaled once daily
|
Placebo
n=69 Participants
Placebo inhaled once daily
|
|---|---|---|---|---|---|---|
|
Change From Baseline in ANSD Score at Week 8 and Week 12
Week 8
|
-0.15 score on a scale
Standard Deviation 0.637
|
-0.35 score on a scale
Standard Deviation 0.629
|
-0.30 score on a scale
Standard Deviation 0.760
|
-0.27 score on a scale
Standard Deviation 0.547
|
-0.26 score on a scale
Standard Deviation 0.753
|
-0.25 score on a scale
Standard Deviation 0.634
|
|
Change From Baseline in ANSD Score at Week 8 and Week 12
Week 12
|
-0.19 score on a scale
Standard Deviation 0.480
|
-0.46 score on a scale
Standard Deviation 0.868
|
-0.29 score on a scale
Standard Deviation 0.695
|
-0.26 score on a scale
Standard Deviation 0.590
|
-0.23 score on a scale
Standard Deviation 0.769
|
-0.33 score on a scale
Standard Deviation 0.729
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants in the Full Analysis Set with a valid measurement for the outcome measure
Participants were given a short acting β2-agonist (SABA) such as salbutamol (100 µg) or albuterol (90 µg) to use as rescue medication throughout the study. Participants recorded in the eDiary, once in the morning and once in the evening, the use of rescue medication (number of puffs of SABA taken in the previous 12 hours). The total number of puffs of SABA taken per day was calculated and the mean daily use of puffs of SABA was derived by weekly intervals. The baseline value of number of puffs of SABA taken per day is the average of total daily SABA use during the run-in period. A negative change from baseline is considered a favorable outcome.
Outcome measures
| Measure |
CSJ117 0.5mg
n=34 Participants
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
n=33 Participants
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
n=35 Participants
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
n=70 Participants
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
n=70 Participants
CSJ117 8 mg inhaled once daily
|
Placebo
n=68 Participants
Placebo inhaled once daily
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Number of Puffs of SABA Taken Per Day at Week 12
|
-0.2189 puffs of SABA per day
Standard Deviation 0.72340
|
-0.4548 puffs of SABA per day
Standard Deviation 0.88125
|
-0.3420 puffs of SABA per day
Standard Deviation 0.68267
|
-0.4310 puffs of SABA per day
Standard Deviation 0.80279
|
-0.3766 puffs of SABA per day
Standard Deviation 0.98070
|
-0.3543 puffs of SABA per day
Standard Deviation 0.78420
|
SECONDARY outcome
Timeframe: From first dose of double-blind study treatment up to last dose (Week 12)Population: Safety Analysis Set defined as participants who received at least one dose of double-blind treatment.
Number of participants with AEs and SAEs, including asthma exacerbations, changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs during the on-treatment period. The on-treatment period is between the date of first dose of double-blind study treatment and date of the last dose of randomized study treatment. Grades to characterize the severity of the adverse events were based on the Common Terminology Criteria for Adverse Events (CTCAE). For CTCAE, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. The number of participants in each category is reported in the table.
Outcome measures
| Measure |
CSJ117 0.5mg
n=36 Participants
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
n=37 Participants
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
n=37 Participants
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
n=76 Participants
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
n=74 Participants
CSJ117 8 mg inhaled once daily
|
Placebo
n=75 Participants
Placebo inhaled once daily
|
|---|---|---|---|---|---|---|
|
Number of Participants With On-treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
At least one AE
|
12 Participants
|
10 Participants
|
13 Participants
|
22 Participants
|
25 Participants
|
23 Participants
|
|
Number of Participants With On-treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Mild AEs
|
5 Participants
|
8 Participants
|
6 Participants
|
9 Participants
|
13 Participants
|
13 Participants
|
|
Number of Participants With On-treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Moderate AEs
|
6 Participants
|
2 Participants
|
7 Participants
|
12 Participants
|
12 Participants
|
10 Participants
|
|
Number of Participants With On-treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Severe AEs
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With On-treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Study treatment-related AEs
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With On-treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With On-treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
AEs leading to discontinuation
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 and Weeks 2, 4, 8, 12, 14, 16, 20 and 24Population: Participants in the Safety Analysis Set with a valid measurement for the outcome measure. Safety Analysis Set is defined as participants who received at least one dose of double-blind treatment. The number analyzed per row represents participants with data at the corresponding time point.
Immunogenicity (antibody formation against CSJ117) was evaluated in serum by a validated bridging electrochemiluminescence immunoassay (ECLIA).
Outcome measures
| Measure |
CSJ117 0.5mg
n=36 Participants
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
n=36 Participants
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
n=37 Participants
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
n=76 Participants
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
n=74 Participants
CSJ117 8 mg inhaled once daily
|
Placebo
n=75 Participants
Placebo inhaled once daily
|
|---|---|---|---|---|---|---|
|
Number of Participants With Anti-CSJ117 Antibodies
Day 1 · Negative
|
30 Participants
|
33 Participants
|
31 Participants
|
66 Participants
|
63 Participants
|
63 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Day 1 · Positive
|
6 Participants
|
3 Participants
|
6 Participants
|
10 Participants
|
11 Participants
|
12 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Week 2 · Positive
|
8 Participants
|
4 Participants
|
6 Participants
|
10 Participants
|
10 Participants
|
13 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Week 4 · Negative
|
26 Participants
|
29 Participants
|
26 Participants
|
49 Participants
|
47 Participants
|
57 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Week 4 · Positive
|
7 Participants
|
6 Participants
|
11 Participants
|
25 Participants
|
24 Participants
|
14 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Week 8 · Negative
|
17 Participants
|
16 Participants
|
10 Participants
|
22 Participants
|
18 Participants
|
58 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Week 12 · Negative
|
9 Participants
|
11 Participants
|
5 Participants
|
19 Participants
|
11 Participants
|
53 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Week 12 · Positive
|
24 Participants
|
22 Participants
|
30 Participants
|
52 Participants
|
60 Participants
|
13 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Week 14 · Positive
|
19 Participants
|
19 Participants
|
26 Participants
|
46 Participants
|
46 Participants
|
7 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Week 16 · Negative
|
7 Participants
|
8 Participants
|
3 Participants
|
12 Participants
|
7 Participants
|
49 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Week 20 · Positive
|
17 Participants
|
16 Participants
|
23 Participants
|
45 Participants
|
47 Participants
|
8 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Week 24 · Negative
|
11 Participants
|
10 Participants
|
5 Participants
|
13 Participants
|
8 Participants
|
49 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Week 24 · Positive
|
15 Participants
|
15 Participants
|
23 Participants
|
43 Participants
|
45 Participants
|
7 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Week 2 · Negative
|
27 Participants
|
31 Participants
|
31 Participants
|
65 Participants
|
64 Participants
|
56 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Week 8 · Positive
|
17 Participants
|
17 Participants
|
27 Participants
|
50 Participants
|
54 Participants
|
9 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Week 14 · Negative
|
7 Participants
|
6 Participants
|
3 Participants
|
13 Participants
|
6 Participants
|
49 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Week 16 · Positive
|
19 Participants
|
17 Participants
|
26 Participants
|
46 Participants
|
46 Participants
|
7 Participants
|
|
Number of Participants With Anti-CSJ117 Antibodies
Week 20 · Negative
|
9 Participants
|
9 Participants
|
6 Participants
|
13 Participants
|
6 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Day 1 and Week 12: pre-dose, 2 and 4 hours post-dose; Weeks 2, 4 and 8: pre-dose and 4 hours post-dose; Weeks 14, 16, 20 and 24: pre-dosePopulation: Participants in the PK set with a valid measurement for the outcome measure. PK set is defined as participants with at least one evaluable drug concentration data sample. The number analyzed per row represents participants with data at the corresponding time point.
CSJ117 concentration was determined in serum by a validated immunoassay method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero".
Outcome measures
| Measure |
CSJ117 0.5mg
n=36 Participants
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
n=37 Participants
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
n=37 Participants
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
n=75 Participants
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
n=74 Participants
CSJ117 8 mg inhaled once daily
|
Placebo
Placebo inhaled once daily
|
|---|---|---|---|---|---|---|
|
CSJ117 Serum Concentration
Day 1, pre-dose
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
1.34 ng/mL
Standard Deviation 8.02
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
|
CSJ117 Serum Concentration
Day 1, 2 hours post-dose
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
1.86 ng/mL
Standard Deviation 7.36
|
0.00 ng/mL
Standard Deviation 0.00
|
0.157 ng/mL
Standard Deviation 0.947
|
—
|
|
CSJ117 Serum Concentration
Day 1, 4 hours post-dose
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
1.97 ng/mL
Standard Deviation 7.90
|
0.214 ng/mL
Standard Deviation 1.33
|
0.924 ng/mL
Standard Deviation 2.58
|
—
|
|
CSJ117 Serum Concentration
Week 2, pre-dose
|
0.320 ng/mL
Standard Deviation 1.89
|
0.00 ng/mL
Standard Deviation 0.00
|
2.32 ng/mL
Standard Deviation 8.57
|
2.00 ng/mL
Standard Deviation 4.74
|
6.58 ng/mL
Standard Deviation 7.61
|
—
|
|
CSJ117 Serum Concentration
Week 8, pre-dose
|
1.69 ng/mL
Standard Deviation 4.34
|
3.15 ng/mL
Standard Deviation 6.50
|
6.79 ng/mL
Standard Deviation 12.0
|
11.5 ng/mL
Standard Deviation 15.8
|
39.3 ng/mL
Standard Deviation 51.0
|
—
|
|
CSJ117 Serum Concentration
Week 8, 2 hours post-dose
|
1.84 ng/mL
Standard Deviation 4.69
|
3.29 ng/mL
Standard Deviation 6.85
|
6.94 ng/mL
Standard Deviation 12.2
|
11.1 ng/mL
Standard Deviation 14.7
|
39.8 ng/mL
Standard Deviation 49.9
|
—
|
|
CSJ117 Serum Concentration
Week 12, pre-dose
|
1.83 ng/mL
Standard Deviation 4.69
|
2.20 ng/mL
Standard Deviation 4.61
|
10.3 ng/mL
Standard Deviation 16.8
|
14.6 ng/mL
Standard Deviation 20.3
|
49.5 ng/mL
Standard Deviation 62.1
|
—
|
|
CSJ117 Serum Concentration
Week 12, 2 hours post-dose
|
2.02 ng/mL
Standard Deviation 4.68
|
2.49 ng/mL
Standard Deviation 4.81
|
10.2 ng/mL
Standard Deviation 16.4
|
14.3 ng/mL
Standard Deviation 20.3
|
45.7 ng/mL
Standard Deviation 49.7
|
—
|
|
CSJ117 Serum Concentration
Week 12, 4 hours post-dose
|
2.11 ng/mL
Standard Deviation 4.84
|
2.51 ng/mL
Standard Deviation 4.79
|
10.1 ng/mL
Standard Deviation 16.3
|
15.2 ng/mL
Standard Deviation 20.7
|
46.7 ng/mL
Standard Deviation 52.2
|
—
|
|
CSJ117 Serum Concentration
Week 14, pre-dose
|
0.239 ng/mL
Standard Deviation 1.19
|
0.00 ng/mL
Standard Deviation 0.00
|
2.97 ng/mL
Standard Deviation 10.1
|
1.59 ng/mL
Standard Deviation 4.43
|
7.26 ng/mL
Standard Deviation 15.7
|
—
|
|
CSJ117 Serum Concentration
Week 20, pre-dose
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
1.94 ng/mL
Standard Deviation 8.99
|
0.00 ng/mL
Standard Deviation 0.00
|
0.163 ng/mL
Standard Deviation 1.19
|
—
|
|
CSJ117 Serum Concentration
Week 24, pre-dose
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
1.86 ng/mL
Standard Deviation 6.81
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
|
CSJ117 Serum Concentration
Week 2, 2 hours post-dose
|
0.389 ng/mL
Standard Deviation 2.30
|
0.00 ng/mL
Standard Deviation 0.00
|
2.20 ng/mL
Standard Deviation 8.05
|
1.66 ng/mL
Standard Deviation 3.51
|
7.66 ng/mL
Standard Deviation 7.83
|
—
|
|
CSJ117 Serum Concentration
Week 4, pre-dose
|
0.336 ng/mL
Standard Deviation 1.93
|
0.00 ng/mL
Standard Deviation 0.00
|
2.89 ng/mL
Standard Deviation 9.03
|
2.86 ng/mL
Standard Deviation 5.11
|
12.0 ng/mL
Standard Deviation 19.5
|
—
|
|
CSJ117 Serum Concentration
Week 4, 2 hours post-dose
|
0.467 ng/mL
Standard Deviation 2.68
|
0.00 ng/mL
Standard Deviation 0.00
|
3.19 ng/mL
Standard Deviation 9.01
|
3.59 ng/mL
Standard Deviation 5.69
|
13.8 ng/mL
Standard Deviation 22.2
|
—
|
|
CSJ117 Serum Concentration
Week 16, pre-dose
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
2.16 ng/mL
Standard Deviation 10.0
|
0.424 ng/mL
Standard Deviation 1.92
|
2.53 ng/mL
Standard Deviation 8.10
|
—
|
Adverse Events
CSJ117 0.5mg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
CSJ117 1mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
CSJ117 2mg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
CSJ117 4mg
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
CSJ117 8mg
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CSJ117 0.5mg
n=36 participants at risk
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
n=37 participants at risk
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
n=37 participants at risk
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
n=76 participants at risk
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
n=74 participants at risk
CSJ117 1 mg inhaled once daily
|
Placebo
n=75 participants at risk
Placebo inhaled once daily
|
|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
Other adverse events
| Measure |
CSJ117 0.5mg
n=36 participants at risk
CSJ117 0.5 mg inhaled once daily
|
CSJ117 1mg
n=37 participants at risk
CSJ117 1 mg inhaled once daily
|
CSJ117 2mg
n=37 participants at risk
CSJ117 2 mg inhaled once daily
|
CSJ117 4mg
n=76 participants at risk
CSJ117 4 mg inhaled once daily
|
CSJ117 8mg
n=74 participants at risk
CSJ117 1 mg inhaled once daily
|
Placebo
n=75 participants at risk
Placebo inhaled once daily
|
|---|---|---|---|---|---|---|
|
Investigations
Blood glucose increased
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Investigations
Electrocardiogram QT prolonged
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
5.4%
2/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
5.4%
2/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
2/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
2/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
General disorders
Non-cardiac chest pain
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
General disorders
Vaccination site swelling
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Hepatobiliary disorders
Hepatic steatosis
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Acarodermatitis
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Acute sinusitis
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
5.4%
2/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.4%
1/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
COVID-19
|
11.1%
4/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
5.4%
2/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
3.9%
3/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.4%
1/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
9.3%
7/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Candida infection
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Cystitis
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
8.1%
3/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
3.9%
3/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.4%
1/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Laryngitis
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
2/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
5.4%
2/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
5.3%
4/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
2/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
5.3%
4/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.4%
1/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.4%
1/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Otitis media
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Otitis media acute
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Papilloma viral infection
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.6%
2/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
2/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
2/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Sinusitis
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
5.4%
2/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
4.1%
3/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
2/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Tracheitis
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.4%
1/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Urinary tract infection
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Vaginal infection
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.6%
2/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
2/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.6%
2/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.4%
1/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Nervous system disorders
Cervicobrachial syndrome
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Nervous system disorders
Headache
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.4%
1/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
2/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Nervous system disorders
Migraine
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Nervous system disorders
Spinal cord herniation
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Renal and urinary disorders
Pollakiuria
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.6%
2/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
10.8%
4/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
16.2%
6/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
15.8%
12/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
9.5%
7/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
13.3%
10/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic rhinosinusitis with nasal polyps
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
4.1%
3/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
2/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.4%
1/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
1/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Vascular disorders
Hypertension
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
5.4%
2/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.4%
1/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/36 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
2.7%
1/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/37 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
1.3%
1/76 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/74 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
0.00%
0/75 • From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER