Clinical Trial Results:
A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled 28-week Phase 3 Efficacy and Safety Study of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma (SUNRISE)
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Summary
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EudraCT number |
2021-006691-17 |
Trial protocol |
CZ |
Global end of trial date |
24 Mar 2025
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Mar 2026
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First version publication date |
26 Mar 2026
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
D5180C00024
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05398263 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
AstraZeneca AB
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Sponsor organisation address |
151 85, Sodertalje, Sweden,
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Public contact |
Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
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Scientific contact |
Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
24 Mar 2025
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
24 Mar 2025
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To evaluate the effect of tezepelumab compared with placebo in reducing the prescribed oral corticosteroids (OCS) maintenance dose in
participants with asthma requiring chronic treatment with maintenance OCS in addition to high-dose inhaled corticosteroids (ICS) plus long-acting β2 agonists (LABA)
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Protection of trial subjects |
The investigator or his/her representative explained the nature of the study to the participant or his/her legally authorised representative and answered all questions regarding the study. Participants were informed that their participation was voluntary and they were free to refuse to participate and could withdraw their consent at any time and for any reason during the study. Participants or their legally authorised representative were required to sign a statement of informed consent that meets the requirements of 21 CFR 50, local regulations, ICH guidelines, Health Insurance Portability and Accountability Act (HIPAA) requirements, where applicable, and the Institutional Review Board/Independent Ethics Committee (IRB/IEC) or study centre. The medical record had to include a statement that written informed consent was obtained before the participant was enrolled in the study and the date the written consent was obtained. The authorised person obtaining the informed consent had also to sign the informed consent form (ICF). Participants had to be re-consented to the most current version of the ICF(s) during their participation in the study. A copy of the ICF(s) had to be provided to the participant or the participant’s legally authorised representative. Participants who were re-screened were required to sign a new ICF.
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Background therapy |
Participants must have received a physician-prescribed medium- or high-dose ICS (medium dose ICS corresponds to 500 μg and high dose ICS corresponds to > 500 μg fluticasone propionate dry powder formulation or equivalents) as per GINA guideline (GINA 2022) for at least 12 months prior to Visit 1. Participants must have received physician-prescribed LABA and high dose ICS (total daily dose > 500μg fluticasone propionate dry powder formulation or equivalent) for at least 3 months prior to Visit 1. The ICS and LABA can be parts of a combination product or given by separate inhalers. Participants must have received OCS for the treatment of asthma for at least 6 months prior to Visit 1 and on a stable dose of between ≥ 7.5 to ≤ 30 mg (prednisone or prednisolone) daily or daily equivalent for at least one month prior to Visit 1. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 Aug 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Thailand: 11
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Country: Number of subjects enrolled |
United States: 6
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Country: Number of subjects enrolled |
India: 4
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Country: Number of subjects enrolled |
Korea, Republic of: 4
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Country: Number of subjects enrolled |
Canada: 1
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Country: Number of subjects enrolled |
Chile: 31
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Country: Number of subjects enrolled |
Mexico: 18
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Country: Number of subjects enrolled |
Brazil: 8
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Country: Number of subjects enrolled |
Peru: 11
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Country: Number of subjects enrolled |
Poland: 11
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Country: Number of subjects enrolled |
Czechia: 9
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Country: Number of subjects enrolled |
Türkiye: 8
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Worldwide total number of subjects |
122
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EEA total number of subjects |
20
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
99
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From 65 to 84 years |
23
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted at 63 centres (excluding one site that was excluded from the analyses) in 12 countries. A total of 246 subjects were screened between 9AUG2022 and 29NOV2024, of which 122 were randomized and treated. This study was terminated early by the sponsor because of recruitment challenges. | ||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Subjects were randomized in 2:1 ratio for tezepelumab or placebo. Randomization was stratified by region and eosinophil count at Visit 1 (< 150 cells/μL, 150-< 300 cells/μL, ≥ 300 cells/μL). | ||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | ||||||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Tezepelumab | ||||||||||||||||||||||||||||||
Arm description |
Tezepelumab 210 mg administered every 4 weeks subcutaneously | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Tezepelumab 210 mg administered every 4 weeks subcutaneously
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Investigational medicinal product code |
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Other name |
Tezepelumab
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
210 mg Q4W
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Arm title
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Placebo | ||||||||||||||||||||||||||||||
Arm description |
Placebo administered every 4 weeks subcutaneously | ||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo administered every 4 weeks subcutaneously
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Q4W
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Baseline characteristics reporting groups
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Reporting group title |
Tezepelumab
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Reporting group description |
Tezepelumab 210 mg administered every 4 weeks subcutaneously | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo administered every 4 weeks subcutaneously | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Tezepelumab
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Reporting group description |
Tezepelumab 210 mg administered every 4 weeks subcutaneously | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo administered every 4 weeks subcutaneously | ||
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End point title |
Categorised percent reduction from baseline in the daily maintenance OCS dose at Week 28 whilst maintaining asthma control. | ||||||||||||||||||||||||
End point description |
Categorised percent reduction from baseline at Week 28. Percent change from baseline is defined as {final dose-baseline dose)/baseline dose}*100%, and the categories of percent change from baseline in daily OCS dose are defined as: ≥90% to ≤100% reduction, ≥75% to <90% reduction, ≥50% to <75% reduction, >0% to <50% reduction, and, no change or any increase.
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End point type |
Primary
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End point timeframe |
Baseline to Week 28
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Statistical analysis title |
Proportional odds model | ||||||||||||||||||||||||
Statistical analysis description |
Response variable: categorised % reduction from baseline in final OCS dose. Covariates in the model: treatment, region, baseline daily OCS dose and logarithm of baseline blood eosinophil counts.
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Comparison groups |
Tezepelumab v Placebo
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Number of subjects included in analysis |
122
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Analysis specification |
Pre-specified
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Analysis type |
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P-value |
= 0.003 | ||||||||||||||||||||||||
Method |
Proportional odds model | ||||||||||||||||||||||||
Parameter type |
Cumulative Odds Ratio | ||||||||||||||||||||||||
Point estimate |
2.93
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||
sides |
2-sided
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lower limit |
1.43 | ||||||||||||||||||||||||
upper limit |
6.03 | ||||||||||||||||||||||||
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End point title |
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) at Week 28 | ||||||||||||
End point description |
Change from baseline in pre-BD FEV1 at Week 28. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 28
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Proportion of subjects with daily OCS dose ≤5 mg at Week 28 | |||||||||
End point description |
Proportion of subjects with daily OCS dose ≤5 mg at Week 28.
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End point type |
Secondary
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End point timeframe |
Week 28
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| No statistical analyses for this end point | ||||||||||
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End point title |
Annualised asthma exacerbation rate (AAER) over 28 weeks | ||||||||||||
End point description |
The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 28 weeks.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 28
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Proportion of subjects with ≥50% reduction from baseline in daily OCS dose at Week 28 | |||||||||
End point description |
Proportion of subjects with ≥50% reduction from baseline in daily OCS dose at Week 28. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}*100%.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 28
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| No statistical analyses for this end point | ||||||||||
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End point title |
Proportion of subjects with 100% reduction from baseline in daily OCS dose at Week 28 | |||||||||
End point description |
Proportion of subjects with 100% reduction from baseline in daily OCS dose at Week 28. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}*100%.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 28
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| No statistical analyses for this end point | ||||||||||
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End point title |
Change from baseline in Asthma Control Questionnaire 6 (ACQ-6) score at Week 28 | ||||||||||||
End point description |
Change from baseline in ACQ-6 as compared to placebo at Week 28. The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 28
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Time to first asthma exacerbation | |||||||||
End point description |
Time to first asthma exacerbation, presented as number of subjects with at least one asthma exacerbation as reported by the investigator in the eCRF
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End point type |
Secondary
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End point timeframe |
Baseline to Week 28
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| No statistical analyses for this end point | ||||||||||
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End point title |
Change from baseline in weekly mean home peak expiratory flow (PEF) (morning and evening) at Week 28 | ||||||||||||||||||
End point description |
Change from baseline in weekly mean morning and evening peak expiratory flow (PEF) as compared to placebo at Week 28. Home PEF testing will be performed by the subject in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Each timepoint is calculated as weekly.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 28
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change from baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s)+12) total score at Week 28 | ||||||||||||
End point description |
Change from baseline in AQLQ(S)+12 as compared to placebo at Week 28. The AQLQ(S)+12 is a questionnaire that measures the health-related quality of life experienced by asthma subjects. The total score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment).
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End point type |
Secondary
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End point timeframe |
Baseline to Week 28
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Score at Week 28 | ||||||||||||
End point description |
Change from baseline in SGRQ as compared to placebo at Week 28. The questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual’s respiratory condition. The total score indicates the impact of disease on overall health status. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 28
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from baseline in fractional exhaled nitric oxide (FeNO) at Week 28 | ||||||||||||
End point description |
Change from baseline in fractional exhaled nitric oxide (FeNO) at Week 28.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 28
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| No statistical analyses for this end point | |||||||||||||
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End point title |
PK: Serum trough concentrations at Week 0, 12 and 28 | |||||||||||||||||||||
End point description |
Pharmacokinetics samples are collected at baseline and at Week 12 prior to study intervention administration, and at Week 28 (End of Treatment visit).
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End point type |
Secondary
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End point timeframe |
Baseline, Week 12 and Week 28
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| Notes [1] - The placebo arm is not applicable since it is not the experimental product. |
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change from baseline in peripheral blood eosinophils at Week 28 | ||||||||||||
End point description |
Change from baseline in blood eosinophil counts at Week 28.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 28
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from baseline in total serum immunoglobulin E (IgE) at Week 28 | ||||||||||||
End point description |
Change from baseline in total serum IgE at Week 28.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 28
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Immunogenicity: Incidence of anti-drug antibodies (ADA) at Week 0, 12, 28, and 40 | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Immunogenicity samples are collected at baseline and at Week 12 prior to study intervention administration, at Week 28 (End of Treatment visit) and at Week 40 (Follow-up visit). Persistently positive is defined as positive at >=2 post baseline assessments (with >=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment boosted ADA defined as baseline positive ADA that was boosted to a 4 fold or higher level following treatment. Treatment emergent ADA defined as sum of treatment induced ADA and treatment boosted ADA.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 40
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From first dose of study drug until end of study or withdrawal date.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
27.1
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Reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Placebo administered every 4 weeks subcutaneously | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Tezepelumab
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Reporting group description |
Tezepelumab 210 mg administered every 4 weeks subcutaneously | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 3% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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22 Aug 2022 |
The main reasons for this amendment include:
a) Adding assessment of the pre-specified events by the Independent Adjudication Committee to the study design,
b) Removing the requirement of pre-BD FEV1 spirometry for participants who achieve a
permanent stop of OCS dose reduction, except for the mandatory spirometry at visits 6, 7, 8,
10, 13 regardless of OCS dose reduction status and revising statistical analyses for secondary
endpoints,
c) Revising restrictions for COVID-19 vaccination,
d) Adding important potential risks and adverse event of special interest (serious cardiac
events),
e) Revising the estimand for the intercurrent events related to the initiation of other biologic
for treatment of asthma.
Other reasons include updating wording of the asthma exacerbation definition, as well as,
adding clinical chemistry test of blood lipid panel at Visit 1 and 12-lead ECG assessment at
Visit 13 and IPD. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
