Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (NCT NCT03406078)
NCT ID: NCT03406078
Last Updated: 2021-12-09
Results Overview
Categorized percent reduction from baseline at Week 48. 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.
COMPLETED
PHASE3
150 participants
Baseline to Week 48
2021-12-09
Participant Flow
The study was conducted at 60 centres in 7 countries. A total of 243 subjects were screened between 5MAR2018 and 27SEP2019, of which 150 were randomized and treated. 93 subjects were screen failures mainly due to exclusion criteria met and/or inclusion criteria not met. Assignment was done by Interactive Voice/Web Response System(IVRS/IWRS).
The screening period included a Run-in (2 weeks) and an OCS optimization phase (up to 8 weeks). At the end of period, subjects were randomized in 1:1 ratio for tezepelumab or placebo. Randomization was stratified by region (Central/Eastern Europe, Western Europe and North America, Rest of the World).
Participant milestones
| Measure |
Tezepelumab
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
76
|
|
Overall Study
COMPLETED
|
68
|
73
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Tezepelumab
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma
Baseline characteristics by cohort
| Measure |
Tezepelumab
n=74 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=76 Participants
Placebo administered every 4 weeks subcutaneously
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
53.4 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
62 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 48Categorized percent reduction from baseline at Week 48. 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.
Outcome measures
| Measure |
Tezepelumab
n=74 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=76 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Categorized Percent Reduction From Baseline in the Daily OCS Dose While Not Losing Asthma Control
>=90% to <=100% reduction
|
40 Participants
|
35 Participants
|
|
Categorized Percent Reduction From Baseline in the Daily OCS Dose While Not Losing Asthma Control
>=75% to <90% reduction
|
5 Participants
|
4 Participants
|
|
Categorized Percent Reduction From Baseline in the Daily OCS Dose While Not Losing Asthma Control
>=50% to <75% reduction
|
10 Participants
|
14 Participants
|
|
Categorized Percent Reduction From Baseline in the Daily OCS Dose While Not Losing Asthma Control
>0% to <50% reduction
|
5 Participants
|
9 Participants
|
|
Categorized Percent Reduction From Baseline in the Daily OCS Dose While Not Losing Asthma Control
no change or any increase
|
14 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 48 weeks.
Outcome measures
| Measure |
Tezepelumab
n=74 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=76 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Annualised Asthma Exacerbation Rate (AAER)
|
1.38 Events per year
Interval 0.98 to 1.95
|
2.00 Events per year
Interval 1.46 to 2.74
|
SECONDARY outcome
Timeframe: Baseline to Week 48Proportion (expressed as a percentage) of subjects with 100% reduction from baseline in daily OCS dose at Week 48. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}\*100.
Outcome measures
| Measure |
Tezepelumab
n=74 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=76 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Proportion of Subjects With 100% Reduction From Baseline in Daily OCS Dose at Week 48
|
54.1 Percentage of participants
|
46.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Proportion (expressed as a percentage) of subjects with daily OCS dose ≤5 mg at Week 48.
Outcome measures
| Measure |
Tezepelumab
n=74 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=76 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Proportion of Subjects With Daily OCS Dose ≤5 mg at Week 48
|
71.6 Percentage of participants
|
72.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48Proportion (expressed as a percentage) of subjects with ≥50% reduction from baseline in daily OCS dose at Week 48. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}\*100.
Outcome measures
| Measure |
Tezepelumab
n=74 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=76 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Proportion of Subjects With ≥50% Reduction From Baseline in Daily OCS Dose at Week 48
|
74.3 Percentage of participants
|
69.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Number of participants analysed presents the number of subjects with an observation at Week 48. All subjects from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses.
Change from baseline in pre-BD FEV1 at Week 48. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
Outcome measures
| Measure |
Tezepelumab
n=65 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=64 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1)
|
0.21 Litre
Standard Error 0.046
|
-0.04 Litre
Standard Error 0.046
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Number of participants analysed presents the number of subjects with an observation at Week 48. All subjects from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses.
Change from baseline in Asthma Symptom Diary score at Week 48. The Asthma Symptom Diary comprises of 10 items (5 items in the morning; 5 items in the evening). Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the daily diary. A daily ASD score is the mean of the 10 items. Responses for all 10 items are required to calculate the daily ASD score; otherwise, it is treated as missing. For the 7-day average asthma symptom score, scoring is done with no imputation using the mean of at least 4 of the 7 daily ASD scores as a mean weekly item score. The 7-day average ASD score ranges from 0 to 4, where 0 indicates no asthma symptoms.
Outcome measures
| Measure |
Tezepelumab
n=58 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=68 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Change From Baseline in Weekly Mean Daily Asthma Symptom Score Via the Daily Asthma Symptom Diary
|
-0.36 Score on a scale
Standard Error 0.071
|
-0.26 Score on a scale
Standard Error 0.068
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Number of participants analysed presents the number of subjects with an observation at Week 48. All subjects from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses.
Change from baseline in weekly mean rescue medication use at Week 48. Daily rescue medication use is defined as: Number of night inhaler puffs + 2 x \[number of night nebulizer times\] + number of daytime inhaler puffs + 2 x \[number of day nebulizer times\]. Each timepoint is calculated as weekly means based on daily diary data.
Outcome measures
| Measure |
Tezepelumab
n=60 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=70 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Change From Baseline in Weekly Mean Rescue Medication Use
|
-0.85 Weekly mean rescue medication use
Standard Error 0.280
|
-0.37 Weekly mean rescue medication use
Standard Error 0.268
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Number of participants analysed presents the number of subjects with an observation at Week 48. All subjects from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses.
Change from baseline in weekly mean morning and evening peak expiratory flow (PEF) at Week 48. 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 means using at least 4 of the 7 days of PEF data.
Outcome measures
| Measure |
Tezepelumab
n=74 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=76 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Change From Baseline in Weekly Mean Home Peak Expiratory Flow (PEF) (Morning and Evening)
morning PEF
|
13.29 L/min
Standard Error 5.653
|
-9.71 L/min
Standard Error 5.435
|
|
Change From Baseline in Weekly Mean Home Peak Expiratory Flow (PEF) (Morning and Evening)
evening PEF
|
10.05 L/min
Standard Error 5.980
|
-11.37 L/min
Standard Error 5.749
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Number of participants analysed presents the number of subjects with an observation at Week 48. All subjects from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses.
Change from baseline in weekly mean number (expressed as a percentage) of night time awakenings at Week 48. Night-time awakenings percentage defined as number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data and multiplied by 100%. At least 4 out of 7 days of data is required to calculate a weekly mean.
Outcome measures
| Measure |
Tezepelumab
n=59 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=70 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Change From Baseline in Weekly Mean Number of Night-time Awakening Due to Asthma
|
-15.71 Percentage of nights with awakenings
Standard Error 3.482
|
-12.79 Percentage of nights with awakenings
Standard Error 3.317
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Number of participants analysed presents the number of subjects with an observation at Week 48. All subjects from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses.
Change from baseline in ACQ-6 at Week 48. 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.
Outcome measures
| Measure |
Tezepelumab
n=66 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=68 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score
|
-0.87 Score on a scale
Standard Error 0.125
|
-0.51 Score on a scale
Standard Error 0.123
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Number of participants analysed presents the number of subjects with an observation at Week 48. All subjects from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses.
Change from baseline in AQLQ(S)+12 as compared to placebo at Week 48. 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).
Outcome measures
| Measure |
Tezepelumab
n=66 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=67 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(s)+12) Total Score
|
0.94 Score on a scale
Standard Error 0.124
|
0.58 Score on a scale
Standard Error 0.123
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Number of participants analysed presents the number of subjects with an observation at Week 48. All subjects from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses.
Change from baseline in EQ-5D-5L at Week 48. The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no/slight/moderate/severe/extreme problems) that reflect increasing levels of difficulty. The EQ-5D-5L scores are converted into a single index-based value (Health State Valuation), using the UK population-based weights. The Helth State Valuation is scored between 0 to 1, where higher score indicates a better health state.
Outcome measures
| Measure |
Tezepelumab
n=62 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=58 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Change From Baseline in European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) Score
|
0.07 Score on a scale
Standard Error 0.026
|
0.00 Score on a scale
Standard Error 0.027
|
SECONDARY outcome
Timeframe: Baseline to Week 48Number of participants with asthma specific resource utilizations (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) over 48 weeks.
Outcome measures
| Measure |
Tezepelumab
n=74 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=76 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Number of Participants With Asthma Specific Resource Utilizations
Hospitalisation
|
5 Participants
|
10 Participants
|
|
Number of Participants With Asthma Specific Resource Utilizations
Emergency room visit
|
4 Participants
|
7 Participants
|
|
Number of Participants With Asthma Specific Resource Utilizations
Unscheduled visit to specialist
|
29 Participants
|
41 Participants
|
|
Number of Participants With Asthma Specific Resource Utilizations
Home visit
|
1 Participants
|
2 Participants
|
|
Number of Participants With Asthma Specific Resource Utilizations
Telephone call
|
26 Participants
|
43 Participants
|
|
Number of Participants With Asthma Specific Resource Utilizations
Ambulance transport
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: The work productivity loss is only applicable to subjects who were employed, which is a subset of the study population. The class productivity loss is only applicable to subjects attending school, which is a subset of the study population. No subject in Placebo arm has selected the option 'in school' on the WPAI+CIQ questionnaire at Week 48.
Change from baseline in WPAI+CIQ score at Week 48. The WPAI+CIQ consists of 10 questions about how asthma and asthma related issues impact a subject's ability to work, attend classes, and perform regular daily activities. Work (Class) productivity loss is derived by sum of percentage of missed work (class hours) due to asthma and product of percentage of actual working hours (class) times degree of asthma affecting work (class) productivity while working. Percentage of missed work (class hours) due to asthma is calculated by number of hours missed work (class) due to asthma divided by total number of hours missed work (class) plus number of hours actually worked (in class). Activity impairment is the degree health affected regular activities (other than work or class) rated from 0 to 10, with 0 meaning no effect, divided by 10, and then expressed as a percentage.
Outcome measures
| Measure |
Tezepelumab
n=74 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=76 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questionnaire (WPAI+CIQ) Score
Work productivity loss
|
-6.27 Percentage
Standard Deviation 25.30
|
-9.66 Percentage
Standard Deviation 36.63
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questionnaire (WPAI+CIQ) Score
Class productivity loss
|
-10.00 Percentage
Standard Deviation 0
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questionnaire (WPAI+CIQ) Score
Activity impairment
|
-13.2 Percentage
Standard Deviation 29.3
|
-7.8 Percentage
Standard Deviation 26.4
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Number of participants analysed presents the number of subjects with an observation at Week 48. All subjects from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses.
Change from baseline in fractional exhaled nitric oxide (FeNO) at week 48.
Outcome measures
| Measure |
Tezepelumab
n=58 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=57 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Change From Baseline in FENO
|
-11.71 ppb
Standard Error 2.757
|
-1.40 ppb
Standard Error 2.774
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Number of participants analysed presents the number of subjects with an observation at Week 48. All subjects from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses.
Change from baseline in blood eosinophil counts at week 48.
Outcome measures
| Measure |
Tezepelumab
n=63 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=67 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Change From Baseline in Peripheral Blood Eosinophils
|
-83.79 cells/μL
Standard Error 17.078
|
33.38 cells/μL
Standard Error 16.605
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Number of participants analysed presents the number of subjects with an observation at Week 48. All subjects from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses.
Change from baseline in total serum IgE at week 48.
Outcome measures
| Measure |
Tezepelumab
n=65 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=67 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Change From Baseline From Total Serum IgE
|
-80.66 IU/mL
Standard Error 36.253
|
37.77 IU/mL
Standard Error 35.621
|
SECONDARY outcome
Timeframe: Pre-dose samples at Baseline, Week 4, Week 12, Week 24, Week 40, Week 48, Week 60Population: The placebo arm is not applicable since it is not the experimental product.
Serum trough concentrations at each scheduled visit.
Outcome measures
| Measure |
Tezepelumab
n=74 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
PK: Serum Trough Concentrations
Baseline
|
0 μg/mL
Geometric Coefficient of Variation 0
|
—
|
|
PK: Serum Trough Concentrations
Week 4
|
10.3298 μg/mL
Geometric Coefficient of Variation 42.31
|
—
|
|
PK: Serum Trough Concentrations
Week 12
|
17.9626 μg/mL
Geometric Coefficient of Variation 57.85
|
—
|
|
PK: Serum Trough Concentrations
Week 24
|
18.9210 μg/mL
Geometric Coefficient of Variation 55.83
|
—
|
|
PK: Serum Trough Concentrations
Week 40
|
16.7095 μg/mL
Geometric Coefficient of Variation 181.44
|
—
|
|
PK: Serum Trough Concentrations
Week 48
|
13.9224 μg/mL
Geometric Coefficient of Variation 352.35
|
—
|
|
PK: Serum Trough Concentrations
Week 60
|
3.5591 μg/mL
Geometric Coefficient of Variation 177.36
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 60Anti-drug antibodies (ADA) responses at baseline and post baseline. 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.
Outcome measures
| Measure |
Tezepelumab
n=74 Participants
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=76 Participants
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Immunogenicity: Incidence of Anti-drug Antibodies (ADA)
ADA positive at baseline and/or post-baseline (ADA prevalence)
|
3 Participants
|
2 Participants
|
|
Immunogenicity: Incidence of Anti-drug Antibodies (ADA)
Any baseline ADA positive
|
2 Participants
|
2 Participants
|
|
Immunogenicity: Incidence of Anti-drug Antibodies (ADA)
Only baseline ADA positive
|
1 Participants
|
1 Participants
|
|
Immunogenicity: Incidence of Anti-drug Antibodies (ADA)
Any post-baseline ADA positive
|
2 Participants
|
1 Participants
|
|
Immunogenicity: Incidence of Anti-drug Antibodies (ADA)
Both baseline and at least one post-baseline ADA positive
|
1 Participants
|
1 Participants
|
|
Immunogenicity: Incidence of Anti-drug Antibodies (ADA)
Treatment-induced ADA positive
|
1 Participants
|
0 Participants
|
|
Immunogenicity: Incidence of Anti-drug Antibodies (ADA)
Treatment-boosted ADA positive
|
0 Participants
|
0 Participants
|
|
Immunogenicity: Incidence of Anti-drug Antibodies (ADA)
TE-ADA positive (ADA incidence)
|
1 Participants
|
0 Participants
|
|
Immunogenicity: Incidence of Anti-drug Antibodies (ADA)
ADA persistently positive
|
1 Participants
|
1 Participants
|
|
Immunogenicity: Incidence of Anti-drug Antibodies (ADA)
ADA transiently positive
|
1 Participants
|
0 Participants
|
Adverse Events
Tezepelumab
Placebo
Serious adverse events
| Measure |
Tezepelumab
n=74 participants at risk
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=76 participants at risk
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
1.4%
1/74 • Number of events 1 • Baseline to Week 60
|
0.00%
0/76 • Baseline to Week 60
|
|
Cardiac disorders
Cardiac failure
|
1.4%
1/74 • Number of events 1 • Baseline to Week 60
|
0.00%
0/76 • Baseline to Week 60
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.4%
1/74 • Number of events 2 • Baseline to Week 60
|
0.00%
0/76 • Baseline to Week 60
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.4%
1/74 • Number of events 1 • Baseline to Week 60
|
0.00%
0/76 • Baseline to Week 60
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/74 • Baseline to Week 60
|
1.3%
1/76 • Number of events 1 • Baseline to Week 60
|
|
Infections and infestations
H1n1 influenza
|
0.00%
0/74 • Baseline to Week 60
|
1.3%
1/76 • Number of events 1 • Baseline to Week 60
|
|
Infections and infestations
Intervertebral discitis
|
1.4%
1/74 • Number of events 1 • Baseline to Week 60
|
0.00%
0/76 • Baseline to Week 60
|
|
Infections and infestations
Pneumonia
|
1.4%
1/74 • Number of events 1 • Baseline to Week 60
|
2.6%
2/76 • Number of events 2 • Baseline to Week 60
|
|
Infections and infestations
Septic shock
|
1.4%
1/74 • Number of events 1 • Baseline to Week 60
|
0.00%
0/76 • Baseline to Week 60
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
1.4%
1/74 • Number of events 1 • Baseline to Week 60
|
0.00%
0/76 • Baseline to Week 60
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/74 • Baseline to Week 60
|
1.3%
1/76 • Number of events 1 • Baseline to Week 60
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/74 • Baseline to Week 60
|
1.3%
1/76 • Number of events 1 • Baseline to Week 60
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/74 • Number of events 1 • Baseline to Week 60
|
0.00%
0/76 • Baseline to Week 60
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/74 • Baseline to Week 60
|
1.3%
1/76 • Number of events 1 • Baseline to Week 60
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/74 • Baseline to Week 60
|
1.3%
1/76 • Number of events 1 • Baseline to Week 60
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
1.4%
1/74 • Number of events 1 • Baseline to Week 60
|
0.00%
0/76 • Baseline to Week 60
|
|
Nervous system disorders
Headache
|
0.00%
0/74 • Baseline to Week 60
|
1.3%
1/76 • Number of events 1 • Baseline to Week 60
|
|
Nervous system disorders
Migraine
|
0.00%
0/74 • Baseline to Week 60
|
1.3%
1/76 • Number of events 1 • Baseline to Week 60
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/74 • Number of events 1 • Baseline to Week 60
|
0.00%
0/76 • Baseline to Week 60
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.4%
1/74 • Number of events 1 • Baseline to Week 60
|
0.00%
0/76 • Baseline to Week 60
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.4%
4/74 • Number of events 6 • Baseline to Week 60
|
10.5%
8/76 • Number of events 11 • Baseline to Week 60
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/74 • Baseline to Week 60
|
1.3%
1/76 • Number of events 1 • Baseline to Week 60
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/74 • Baseline to Week 60
|
1.3%
1/76 • Number of events 1 • Baseline to Week 60
|
Other adverse events
| Measure |
Tezepelumab
n=74 participants at risk
Tezepelumab 210 mg administered every 4 weeks subcutaneously
|
Placebo
n=76 participants at risk
Placebo administered every 4 weeks subcutaneously
|
|---|---|---|
|
Eye disorders
Cataract
|
1.4%
1/74 • Number of events 1 • Baseline to Week 60
|
3.9%
3/76 • Number of events 3 • Baseline to Week 60
|
|
General disorders
Influenza like illness
|
0.00%
0/74 • Baseline to Week 60
|
6.6%
5/76 • Number of events 5 • Baseline to Week 60
|
|
Infections and infestations
Bronchitis
|
5.4%
4/74 • Number of events 4 • Baseline to Week 60
|
3.9%
3/76 • Number of events 3 • Baseline to Week 60
|
|
Infections and infestations
Bronchitis bacterial
|
8.1%
6/74 • Number of events 14 • Baseline to Week 60
|
9.2%
7/76 • Number of events 10 • Baseline to Week 60
|
|
Infections and infestations
Nasopharyngitis
|
16.2%
12/74 • Number of events 14 • Baseline to Week 60
|
25.0%
19/76 • Number of events 29 • Baseline to Week 60
|
|
Infections and infestations
Oral candidiasis
|
5.4%
4/74 • Number of events 4 • Baseline to Week 60
|
5.3%
4/76 • Number of events 5 • Baseline to Week 60
|
|
Infections and infestations
Sinusitis
|
1.4%
1/74 • Number of events 1 • Baseline to Week 60
|
6.6%
5/76 • Number of events 6 • Baseline to Week 60
|
|
Infections and infestations
Upper respiratory tract infection
|
12.2%
9/74 • Number of events 9 • Baseline to Week 60
|
10.5%
8/76 • Number of events 8 • Baseline to Week 60
|
|
Injury, poisoning and procedural complications
Fall
|
4.1%
3/74 • Number of events 3 • Baseline to Week 60
|
1.3%
1/76 • Number of events 1 • Baseline to Week 60
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
4/74 • Number of events 5 • Baseline to Week 60
|
1.3%
1/76 • Number of events 2 • Baseline to Week 60
|
|
Nervous system disorders
Headache
|
4.1%
3/74 • Number of events 3 • Baseline to Week 60
|
10.5%
8/76 • Number of events 9 • Baseline to Week 60
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
8.1%
6/74 • Number of events 7 • Baseline to Week 60
|
10.5%
8/76 • Number of events 15 • Baseline to Week 60
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/74 • Baseline to Week 60
|
5.3%
4/76 • Number of events 6 • Baseline to Week 60
|
|
Vascular disorders
Hypertension
|
2.7%
2/74 • Number of events 2 • Baseline to Week 60
|
7.9%
6/76 • Number of events 6 • Baseline to Week 60
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place