Trial Outcomes & Findings for Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma (NCT NCT02528214)
NCT ID: NCT02528214
Last Updated: 2019-10-01
Results Overview
Percentage reduction of OCS dose was calculated as (optimized OCS dose \[mg/day\] at baseline - final OCS dose at Week 24)/optimized OCS dose at baseline x 100. Result is presented as Least Squares Mean (Standard Error) percentage reduction from baseline derived from ANCOVA model with missing data multiply imputed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
210 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2019-10-01
Participant Flow
The study was conducted at 68 centers in 17 countries. A total of 390 participants were screened between October 2015 \& April 2017, of which,210 were randomized \& treated. 180 participants were screen failures mainly due to exclusion criteria met \& inclusion criteria not met. Assignment was done by Interactive Voice/Web Response System(IVRS/IWRS).
Screening period included an OCS optimization phase (up to 10 weeks) where participants using OCS other than prednisone/prednisolone switched to these OCS. At the end of period, participants were randomized in 1:1 ratio (dupilumab:placebo).Randomization was stratified by optimized OCS dose (=\<10 \& \>10 mg/day) at randomization visit \& by country.
Participant milestones
| Measure |
Placebo q2w
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection every 2 weeks (q2w) for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
103
|
|
Overall Study
Treated
|
107
|
103
|
|
Overall Study
COMPLETED
|
107
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Placebo q2w
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection every 2 weeks (q2w) for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Other than specified above
|
0
|
1
|
Baseline Characteristics
Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma
Baseline characteristics by cohort
| Measure |
Placebo q2w
n=107 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
n=103 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
51.9 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
51.3 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Age, Customized
<18 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
Between 18 and 64 years
|
88 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
100 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/of African descent
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Oriental
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Baseline Blood Eosinophil Count
<0.15 Giga/L
|
38 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Baseline Blood Eosinophil Count
>=0.15 - <0.3 Giga/L
|
28 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Baseline Blood Eosinophil Count
>=0.3 Giga/L
|
41 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Baseline Optimized Daily OCS Dose
|
11.75 mg/day
STANDARD_DEVIATION 6.31 • n=5 Participants
|
10.75 mg/day
STANDARD_DEVIATION 5.9 • n=7 Participants
|
11.26 mg/day
STANDARD_DEVIATION 6.12 • n=5 Participants
|
|
Daily OCS Dose at Visit 1 (i.e. preoptimization)
|
11.83 mg/day
STANDARD_DEVIATION 6.02 • n=5 Participants
|
11.79 mg/day
STANDARD_DEVIATION 6.4 • n=7 Participants
|
11.81 mg/day
STANDARD_DEVIATION 6.20 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on intent-to-treat (ITT) population which included randomized population analysed according to the treatment group allocated by randomization regardless of whether the treatment kit was used or not.
Percentage reduction of OCS dose was calculated as (optimized OCS dose \[mg/day\] at baseline - final OCS dose at Week 24)/optimized OCS dose at baseline x 100. Result is presented as Least Squares Mean (Standard Error) percentage reduction from baseline derived from ANCOVA model with missing data multiply imputed.
Outcome measures
| Measure |
Placebo q2w
n=107 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
n=103 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
|---|---|---|
|
Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control
|
41.85 Percentage reduction from baseline
Standard Error 4.57
|
70.09 Percentage reduction from baseline
Standard Error 4.90
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Analysis population included ITT patients with available data.
The Primary Outcome Measure (Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control) is summarized above, as LS Mean (SE). Table below provides a supplementary presentation of the Primary Outcome Measure data; result is presented as median (inter-quartile range). Percentage reduction of OCS dose was calculated as (optimized OCS dose \[mg/day\] at baseline - final OCS dose at Week 24)/optimized OCS dose at baseline x 100.
Outcome measures
| Measure |
Placebo q2w
n=106 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
n=101 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
|---|---|---|
|
Supplementary Presentation of Primary Outcome Measure Data: Median Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
|
50.0 percentage reduction from baseline
Interval 0.0 to 100.0
|
100.0 percentage reduction from baseline
Interval 62.5 to 100.0
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was performed on ITT population.
Participants were classified according to the binary status of whether or not the 50% OCS dose reduction criterion was achieved at week 24.
Outcome measures
| Measure |
Placebo q2w
n=107 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
n=103 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
|---|---|---|
|
Percentage of Participants Achieving >= 50% Reduction in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
|
53.3 percentage of participants
|
79.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was performed on ITT population.
Participants were classified according to the binary status of whether or not the reduction of OCS dose to \<5 mg/day was achieved at Week 24.
Outcome measures
| Measure |
Placebo q2w
n=107 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
n=103 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
|---|---|---|
|
Percentage of Participants Achieving a Reduction in Oral Corticosteroids Dose to <5 mg/Day at Week 24 While Maintaining Asthma Control
|
37.4 percentage of participants
|
71.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was performed on ITT population.
For all participants except those with baseline OCS dose at 35 mg/day, the maximum possible reduction corresponds to reduction to 0 mg/day (no longer requiring OCS). For participants starting with 35 mg/day at baseline, the maximum possible reduction is 32.5 mg/day (i.e. minimum dose per protocol is 2.5 mg).
Outcome measures
| Measure |
Placebo q2w
n=107 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
n=103 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
|---|---|---|
|
Percentage of Participants Achieving Maximum Possible Reduction in Oral Corticosteroids Dose Per Protocol at Week 24 While Maintaining Asthma Control
|
29.9 percentage of participants
|
52.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was performed on ITT population with baseline OCS dose less than or equal to 30 mg/day.
Participants were classified according to the binary status of whether or not the participant still required OCS at Week 24 while maintaining asthma control.
Outcome measures
| Measure |
Placebo q2w
n=106 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
n=103 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
|---|---|---|
|
Percentage of Participants Who No Longer Required Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
|
29.2 percentage of participants
|
52.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Analysis was performed on ITT population but not included in the hierarchical testing procedure. Here, "number analyzed"= participants with available data for specified categories.
Absolute reduction was calculated by subtracting Week 24 value from baseline value.
Outcome measures
| Measure |
Placebo q2w
n=107 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
n=103 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
|---|---|---|
|
Absolute Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
Absolute reduction at Week 24
|
5.45 mg/day
Standard Deviation 6.80
|
7.66 mg/day
Standard Deviation 6.10
|
|
Absolute Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
Baseline
|
11.75 mg/day
Standard Deviation 6.31
|
10.75 mg/day
Standard Deviation 5.90
|
|
Absolute Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
Week 24
|
6.32 mg/day
Standard Deviation 6.75
|
3.13 mg/day
Standard Deviation 5.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 24Population: Analysis was performed ITT population.
A severe asthma exacerbation event was defined as a deterioration of asthma during the 24-week treatment period requiring: use of systemic corticosteroids for \>=3 days (at least double the dose currently used); and/or hospitalization related to asthma symptoms or emergency room visit because of asthma requiring intervention with a systemic corticosteroid treatment. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Outcome measures
| Measure |
Placebo q2w
n=107 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
n=103 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
|---|---|---|
|
Annualized Rate of Severe Exacerbation Events During The 24-Week Treatment Period
|
1.597 Exacerbation per participant-year
Interval 1.248 to 2.043
|
0.649 Exacerbation per participant-year
Interval 0.442 to 0.955
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12 and Week 24Population: Analysis was performed on ITT population. Here, "number analyzed"= participants with available data for specified categories.
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Outcome measures
| Measure |
Placebo q2w
n=107 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
n=103 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
|---|---|---|
|
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 12 and 24
Week 12
|
1.68 liter
Standard Deviation 0.61
|
1.82 liter
Standard Deviation 0.63
|
|
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 12 and 24
Baseline
|
1.63 liter
Standard Deviation 0.61
|
1.53 liter
Standard Deviation 0.53
|
|
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 12 and 24
Change at Week 12
|
0.06 liter
Standard Deviation 0.50
|
0.29 liter
Standard Deviation 0.43
|
|
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 12 and 24
Week 24
|
1.63 liter
Standard Deviation 0.65
|
1.84 liter
Standard Deviation 0.60
|
|
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 12 and 24
Change at Week 24
|
0.00 liter
Standard Deviation 0.51
|
0.29 liter
Standard Deviation 0.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and at Weeks 2, 4, 8, 12, 16, 20, and 24Population: Analysis was performed on ITT population. Here, number analyzed = participants with available data for specified categories.
The ACQ-5 has 5 questions, reflecting top-scoring 5 asthma symptoms: woken at night by symptoms, wake in mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during previous week and to respond to each of 5 symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
Outcome measures
| Measure |
Placebo q2w
n=107 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
n=103 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
|---|---|---|
|
Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Score at Weeks 2, 4, 8, 12, 16, 20, and 24
Change at Week 2
|
-0.18 score on a scale
Standard Deviation 0.67
|
-0.49 score on a scale
Standard Deviation 0.86
|
|
Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Score at Weeks 2, 4, 8, 12, 16, 20, and 24
Change at Week 4
|
-0.36 score on a scale
Standard Deviation 0.81
|
-0.61 score on a scale
Standard Deviation 1.01
|
|
Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Score at Weeks 2, 4, 8, 12, 16, 20, and 24
Change at Week 8
|
-0.39 score on a scale
Standard Deviation 1.13
|
-0.68 score on a scale
Standard Deviation 1.06
|
|
Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Score at Weeks 2, 4, 8, 12, 16, 20, and 24
Change at Week 12
|
-0.54 score on a scale
Standard Deviation 1.17
|
-0.92 score on a scale
Standard Deviation 1.09
|
|
Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Score at Weeks 2, 4, 8, 12, 16, 20, and 24
Change at Week 16
|
-0.57 score on a scale
Standard Deviation 1.05
|
-0.87 score on a scale
Standard Deviation 1.18
|
|
Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Score at Weeks 2, 4, 8, 12, 16, 20, and 24
Change at Week 20
|
-0.53 score on a scale
Standard Deviation 1.09
|
-0.83 score on a scale
Standard Deviation 1.19
|
|
Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Score at Weeks 2, 4, 8, 12, 16, 20, and 24
Change at Week 24
|
-0.57 score on a scale
Standard Deviation 1.19
|
-0.94 score on a scale
Standard Deviation 1.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12 and Week 24Population: Analysis was performed on ITT population. Here, number analyzed = participants with available data for specified categories.
AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that were most important to participants with asthma. AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item was scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire were averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
Outcome measures
| Measure |
Placebo q2w
n=107 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
n=103 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
|---|---|---|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12 and Week 24
Change at Week 12
|
0.56 score on a scale
Standard Deviation 1.08
|
0.78 score on a scale
Standard Deviation 1.09
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12 and Week 24
Change at Week 24
|
0.56 score on a scale
Standard Deviation 0.97
|
0.94 score on a scale
Standard Deviation 1.17
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12 and Week 24Population: Analysis was performed on ITT population. Here, number analyzed = participants with available data for specified categories
EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable).
Outcome measures
| Measure |
Placebo q2w
n=107 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
n=103 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
|---|---|---|
|
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Week 12 and Week 24
Single Index: Change at Week 12
|
0.04 score on a scale
Standard Deviation 0.20
|
0.03 score on a scale
Standard Deviation 0.17
|
|
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Week 12 and Week 24
Single Index: Change at Week 24
|
0.05 score on a scale
Standard Deviation 0.18
|
0.05 score on a scale
Standard Deviation 0.18
|
|
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Week 12 and Week 24
VAS Score: Change at Week 12
|
5.99 score on a scale
Standard Deviation 16.85
|
9.34 score on a scale
Standard Deviation 18.20
|
|
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Week 12 and Week 24
VAS Score: Change at Week 24
|
4.16 score on a scale
Standard Deviation 16.74
|
11.06 score on a scale
Standard Deviation 17.60
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12 and Week 24Population: Analysis was performed on ITT population. Here, number analyzed = participants with available data for specified categories.
The HADS is a general scale to detect states of anxiety and depression already used and validated in asthma, which includes HADS-A and HADS-D subscales. The instrument is comprised of 14 items: 7 related to anxiety (HADS-A) and 7 to depression (HADS-D). Each item on the questionnaire is scored from 0-3. And, the total score is the sum of the scores of the 14 items ranging from 0 (no symptoms) to 42 (severe symptoms), with higher scores indicating higher anxiety/depression complains.
Outcome measures
| Measure |
Placebo q2w
n=107 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
n=103 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
|---|---|---|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 12 and Week 24
Change at Week 12
|
-0.75 score on a scale
Standard Deviation 5.50
|
-2.13 score on a scale
Standard Deviation 5.32
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 12 and Week 24
Change at Week 24
|
-0.99 score on a scale
Standard Deviation 5.36
|
-2.53 score on a scale
Standard Deviation 5.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12 and Week 24Population: Analysis was performed on ITT population with bilateral nasal polyposis/chronic rhinosinusitis. Here, number analyzed = participants with available data for specified categories.
The SNOT-22 is a validated measure of health related quality of life in sino nasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life.
Outcome measures
| Measure |
Placebo q2w
n=41 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
Dupilumab 300 mg q2w
n=31 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
|
|---|---|---|
|
Change From Baseline in Sino Nasal Outcome Test-22 (SNOT-22) Global Score at Week 12 and Week 24
Change at Week 12
|
-3.79 score on a scale
Standard Deviation 21.34
|
-12.45 score on a scale
Standard Deviation 17.10
|
|
Change From Baseline in Sino Nasal Outcome Test-22 (SNOT-22) Global Score at Week 12 and Week 24
Change at Week 24
|
-2.46 score on a scale
Standard Deviation 19.11
|
-14.56 score on a scale
Standard Deviation 15.89
|
Adverse Events
Placebo q2w
Serious events: 6 serious events
Other events: 30 other events
Deaths: 0 deaths
Dupilumab 300mg q2w
Serious events: 9 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo q2w
n=107 participants at risk
Participants who received Placebo (for Dupilumab) in combination with OCS and stable ICS (mean exposure of 24 weeks).
|
Dupilumab 300mg q2w
n=103 participants at risk
Participants who received Dupilumab 300 mg q2w in combination with OCS and stable ICS (mean exposure of 24 weeks).
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
0.97%
1/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
0.97%
1/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.93%
1/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
0.00%
0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
1.9%
2/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.93%
1/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
0.00%
0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.8%
3/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
2.9%
3/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.93%
1/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
0.00%
0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
0.97%
1/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
0.97%
1/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
0.97%
1/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
0.97%
1/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
0.97%
1/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
|
Injury, poisoning and procedural complications
Foreign body aspiration
|
0.00%
0/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
0.97%
1/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
Other adverse events
| Measure |
Placebo q2w
n=107 participants at risk
Participants who received Placebo (for Dupilumab) in combination with OCS and stable ICS (mean exposure of 24 weeks).
|
Dupilumab 300mg q2w
n=103 participants at risk
Participants who received Dupilumab 300 mg q2w in combination with OCS and stable ICS (mean exposure of 24 weeks).
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
5.6%
6/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
6.8%
7/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
|
Infections and infestations
Influenza
|
5.6%
6/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
2.9%
3/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
|
Infections and infestations
Sinusitis
|
3.7%
4/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
6.8%
7/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
17.8%
19/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
8.7%
9/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/107 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
6.8%
7/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs were treatment emergent AEs developed/worsened occurred during 'treatment-emergent period' (from first dose of study drug injection until 98 days after last dose of drug) or entry in the LTS12551 study (NCT02134028). Analysis was performed on safety population which included all participants who actually received at least 1 dose or part of a dose of the IMP and analyzed according to the treatment that participants actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER