Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma (NCT NCT02918019)
NCT ID: NCT02918019
Last Updated: 2022-12-28
Results Overview
Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that result in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days. Adjusted rates for the overall mITT population (all participants that received at least one dose of study drug) were estimated using Poisson regression and adjusted for blood eosinophil level at the first visit, the number of asthma exacerbations requiring systemic corticosteroids in the 12 months prior to study entry, the total daily ICS dose at the first visit, and geographic region, with patient time at risk used as an offset term.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
517 participants
Primary outcome timeframe
Baseline to Week 54
Results posted on
2022-12-28
Participant Flow
Adult participants with severe, uncontrolled asthma receiving medium- or high-dose inhaled corticosteroid (ICS) therapy and at least one additional controller medication.
Fifteen participants were randomized in error and only 502 of 517 participants received at least one dose of study drug. The 15 participants were not included in further analysis.
Participant milestones
| Measure |
Placebo
Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 70mg
Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 210mg
Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 490mg
Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
127
|
127
|
126
|
122
|
|
Overall Study
COMPLETED
|
121
|
117
|
117
|
113
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
9
|
9
|
Reasons for withdrawal
| Measure |
Placebo
Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 70mg
Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 210mg
Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 490mg
Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
1
|
|
Overall Study
Principal investigator request
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
3
|
2
|
0
|
|
Overall Study
Protocol deviation
|
1
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
6
|
4
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
Baseline Characteristics
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
Baseline characteristics by cohort
| Measure |
Placebo
n=127 Participants
Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 70mg
n=127 Participants
Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 210mg
n=126 Participants
Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 490mg
n=122 Participants
Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Total
n=502 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 12.2 • n=93 Participants
|
52.4 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
52.5 years
STANDARD_DEVIATION 12.0 • n=27 Participants
|
51.4 years
STANDARD_DEVIATION 12.0 • n=483 Participants
|
51.9 years
STANDARD_DEVIATION 12.0 • n=36 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=93 Participants
|
81 Participants
n=4 Participants
|
90 Participants
n=27 Participants
|
79 Participants
n=483 Participants
|
332 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
170 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
66 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
109 Participants
n=93 Participants
|
108 Participants
n=4 Participants
|
110 Participants
n=27 Participants
|
108 Participants
n=483 Participants
|
435 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
29 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
107 Participants
n=93 Participants
|
105 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
102 Participants
n=483 Participants
|
422 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 54Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that result in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days. Adjusted rates for the overall mITT population (all participants that received at least one dose of study drug) were estimated using Poisson regression and adjusted for blood eosinophil level at the first visit, the number of asthma exacerbations requiring systemic corticosteroids in the 12 months prior to study entry, the total daily ICS dose at the first visit, and geographic region, with patient time at risk used as an offset term.
Outcome measures
| Measure |
Placebo
n=120 Participants
Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 70mg
n=127 Participants
Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 210mg
n=126 Participants
Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 490mg
n=122 Participants
Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
|---|---|---|---|---|
|
Reduction in Rate of Asthma Exacerbations
|
0.74 Number of asthma exacerbations per year
|
0.47 Number of asthma exacerbations per year
|
0.58 Number of asthma exacerbations per year
|
0.42 Number of asthma exacerbations per year
|
SECONDARY outcome
Timeframe: Baseline to Week 54FEV1 measures how much air a person can exhale during the first second of a forced breath. Adjusted means are reported.
Outcome measures
| Measure |
Placebo
n=120 Participants
Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 70mg
n=117 Participants
Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 210mg
n=115 Participants
Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 490mg
n=113 Participants
Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
|---|---|---|---|---|
|
Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
|
107 Milliliters (mL)
95% Confidence Interval 47 • Interval 47.0 to 167.0
|
130 Milliliters (mL)
95% Confidence Interval 70 • Interval 70.0 to 191.0
|
154 Milliliters (mL)
95% Confidence Interval 93 • Interval 93.0 to 215.0
|
172 Milliliters (mL)
95% Confidence Interval 110 • Interval 110.0 to 234.0
|
SECONDARY outcome
Timeframe: 52 WeeksAsthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that result in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days.
Outcome measures
| Measure |
Placebo
n=127 Participants
Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 70mg
n=127 Participants
Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 210mg
n=126 Participants
Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 490mg
n=122 Participants
Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
|---|---|---|---|---|
|
Time to First Asthma Exacerbation
|
NA Weeks
Interval 46.6 to
Value not estimable due to insufficient no. of participants with event
|
NA Weeks
Value not estimable due to insufficient no. of participants with event
|
NA Weeks
Value not estimable due to insufficient no. of participants with event
|
NA Weeks
Value not estimable due to insufficient no. of participants with event
|
SECONDARY outcome
Timeframe: Week 54The AQLQ measures the functional problems (physical, emotional, social, and occupational) most troublesome to adults (17-70 years) with asthma. There are 32 questions in 4 domains - symptoms, activity limitation, emotional function, and environmental stimuli - scored on a 7 point scale, with 7= no impairment and 1= severely impaired. For this study, improvement achievement was defined as an increase of at least 0.5 points from baseline to week 54. Adjusted rates are reported.
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 70mg
n=116 Participants
Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 210mg
n=115 Participants
Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 490mg
n=112 Participants
Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
|---|---|---|---|---|
|
Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score
Week 54 - Responder
|
55.3 Percentage
|
64.8 Percentage
|
61.3 Percentage
|
68.9 Percentage
|
|
Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score
Week 54 - Non-responder
|
44.7 Percentage
|
35.2 Percentage
|
38.7 Percentage
|
31.1 Percentage
|
SECONDARY outcome
Timeframe: Baseline to Week 54Adjusted mean values are all equal to zero.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 70mg
n=106 Participants
Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 210mg
n=102 Participants
Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 490mg
n=99 Participants
Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
|---|---|---|---|---|
|
Absolute Change in Patient-Reported Use of Short-Acting Rescue Therapy
|
0 Usage
Interval 0.0 to 0.0
|
0 Usage
Interval 0.0 to 0.0
|
0 Usage
Interval 0.0 to 0.0
|
0 Usage
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline through Week 54The adjusted mean proportion of weeks without a nighttime awakening from baseline through week 54 are reported. The proportion of weeks is expressed as a percentage.
Outcome measures
| Measure |
Placebo
n=127 Participants
Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 70mg
n=126 Participants
Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 210mg
n=126 Participants
Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 490mg
n=122 Participants
Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
|---|---|---|---|---|
|
Proportion of Weeks Without Patient-Reported Asthma-Related Nighttime Awakenings
|
0.4 Percentage of weeks
Interval -0.7 to 1.5
|
0.4 Percentage of weeks
Interval -0.7 to 1.5
|
0.3 Percentage of weeks
Interval -0.7 to 1.3
|
0.3 Percentage of weeks
Interval -0.7 to 1.3
|
SECONDARY outcome
Timeframe: Baseline to Week 54The ADSD is a 6-item daily measure of asthma symptom severity that assesses three core categories of asthma symptoms: breathing symptoms, chest symptoms, and cough. Symptoms are rated at their worst using an 11-point numeric rating scale ranging from 0 (no symptoms) to 10 (the worst symptoms imaginable). Adjusted means are reported.
Outcome measures
| Measure |
Placebo
n=126 Participants
Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 70mg
n=124 Participants
Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 210mg
n=125 Participants
Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 490mg
n=122 Participants
Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
|---|---|---|---|---|
|
Absolute Change in Patient-Reported Daytime Asthma Symptom Severity as Measured by the Asthma Daily Symptom Diary (ADSD)
|
-1 Scores on a scale
Interval -2.0 to -1.0
|
-2 Scores on a scale
Interval -2.0 to -1.0
|
-1 Scores on a scale
Interval -2.0 to -1.0
|
-1 Scores on a scale
Interval -2.0 to -1.0
|
SECONDARY outcome
Timeframe: Baseline to Week 54An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Placebo
n=127 Participants
Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 70mg
n=127 Participants
Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 210mg
n=126 Participants
Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 490mg
n=122 Participants
Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events
|
77.2 Percentage
|
70.9 Percentage
|
72.2 Percentage
|
72.1 Percentage
|
SECONDARY outcome
Timeframe: BaselineThe prevalence of ADAs at baseline was defined as the proportion of the evaluable participant population in a study that is ADA positive at baseline.
Outcome measures
| Measure |
Placebo
n=124 Participants
Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 70mg
n=126 Participants
Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 210mg
n=126 Participants
Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 490mg
n=121 Participants
Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
|---|---|---|---|---|
|
Percentage of Participants With Anti-Drug Antibodies (ADAs)
|
5.6 Percentage
|
0.8 Percentage
|
1.6 Percentage
|
1.7 Percentage
|
SECONDARY outcome
Timeframe: Weeks 26 and 54Population: The analysis population consisted of all PK-evaluable participants with at least one serum PK collected for the given treatment.
Outcome measures
| Measure |
Placebo
n=125 Participants
Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 70mg
n=126 Participants
Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 210mg
n=117 Participants
Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 490mg
Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
|---|---|---|---|---|
|
Serum Concentration of Astegolimab (MSTT1041A)
Week 26 pre-dose
|
4.75 ug/mL
Geometric Coefficient of Variation 123.3
|
16.9 ug/mL
Geometric Coefficient of Variation 167.3
|
40.5 ug/mL
Geometric Coefficient of Variation 161.2
|
—
|
|
Serum Concentration of Astegolimab (MSTT1041A)
Week 54
|
4.47 ug/mL
Geometric Coefficient of Variation 144.1
|
17.4 ug/mL
Geometric Coefficient of Variation 155.4
|
38.7 ug/mL
Geometric Coefficient of Variation 226.4
|
—
|
SECONDARY outcome
Timeframe: From baseline to the first appearance of ADAs at any point post-baseline (up to Week 54)The incidence of ADAs at post-baseline timepoints was defined as the proportion of the study population found to have developed treatment-emergent ADAs.
Outcome measures
| Measure |
Placebo
n=126 Participants
Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 70mg
n=125 Participants
Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 210mg
n=123 Participants
Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 490mg
n=120 Participants
Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
|---|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent ADAs
|
7.1 Percentage
|
9.6 Percentage
|
8.9 Percentage
|
3.3 Percentage
|
Adverse Events
Placebo
Serious events: 8 serious events
Other events: 76 other events
Deaths: 0 deaths
Astegolimab (MSTT1041A) 70mg
Serious events: 14 serious events
Other events: 65 other events
Deaths: 0 deaths
Astegolimab (MSTT1041A) 210mg
Serious events: 9 serious events
Other events: 75 other events
Deaths: 1 deaths
Astegolimab (MSTT1041A) 490mg
Serious events: 6 serious events
Other events: 68 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=127 participants at risk
Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 70mg
n=127 participants at risk
Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 210mg
n=126 participants at risk
Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 490mg
n=122 participants at risk
Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
|---|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/126 • Number of events 1 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
1.6%
2/126 • Number of events 2 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Cardiac disorders
Atrial tachycardia
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Eye disorders
Cataract
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.82%
1/122 • Number of events 1 • Baseline to Week 54
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
General disorders
Chest pain
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
General disorders
Death
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/126 • Number of events 1 • Baseline to Week 54
|
0.82%
1/122 • Number of events 1 • Baseline to Week 54
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/126 • Number of events 1 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Immune system disorders
Anaphylactic reaction
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Infections and infestations
Cellulitis
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.82%
1/122 • Number of events 1 • Baseline to Week 54
|
|
Infections and infestations
Chronic sinusitis
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Infections and infestations
Pneumonia
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.82%
1/122 • Number of events 1 • Baseline to Week 54
|
|
Infections and infestations
Pyelonephritis
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/126 • Number of events 1 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/127 • Baseline to Week 54
|
1.6%
2/127 • Number of events 2 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Nervous system disorders
Headache
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/126 • Number of events 1 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Nervous system disorders
Migraine
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Nervous system disorders
Syncope
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.6%
2/127 • Number of events 2 • Baseline to Week 54
|
1.6%
2/127 • Number of events 2 • Baseline to Week 54
|
3.2%
4/126 • Number of events 4 • Baseline to Week 54
|
0.82%
1/122 • Number of events 1 • Baseline to Week 54
|
|
Respiratory, thoracic and mediastinal disorders
Chronic rhinosinusitis with nasal polyps
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/127 • Baseline to Week 54
|
1.6%
2/127 • Number of events 2 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.82%
1/122 • Number of events 1 • Baseline to Week 54
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Vascular disorders
Hypertension
|
0.79%
1/127 • Number of events 1 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
0.79%
1/126 • Number of events 1 • Baseline to Week 54
|
0.00%
0/122 • Baseline to Week 54
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/127 • Baseline to Week 54
|
0.00%
0/126 • Baseline to Week 54
|
0.82%
1/122 • Number of events 1 • Baseline to Week 54
|
Other adverse events
| Measure |
Placebo
n=127 participants at risk
Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 70mg
n=127 participants at risk
Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 210mg
n=126 participants at risk
Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
Astegolimab (MSTT1041A) 490mg
n=122 participants at risk
Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
|
|---|---|---|---|---|
|
General disorders
Injection site reaction
|
0.79%
1/127 • Number of events 3 • Baseline to Week 54
|
7.9%
10/127 • Number of events 38 • Baseline to Week 54
|
6.3%
8/126 • Number of events 23 • Baseline to Week 54
|
4.9%
6/122 • Number of events 107 • Baseline to Week 54
|
|
Infections and infestations
Influenza
|
3.9%
5/127 • Number of events 5 • Baseline to Week 54
|
1.6%
2/127 • Number of events 2 • Baseline to Week 54
|
1.6%
2/126 • Number of events 2 • Baseline to Week 54
|
5.7%
7/122 • Number of events 7 • Baseline to Week 54
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
13/127 • Number of events 18 • Baseline to Week 54
|
9.4%
12/127 • Number of events 21 • Baseline to Week 54
|
16.7%
21/126 • Number of events 30 • Baseline to Week 54
|
13.1%
16/122 • Number of events 23 • Baseline to Week 54
|
|
Infections and infestations
Rhinitis
|
5.5%
7/127 • Number of events 8 • Baseline to Week 54
|
5.5%
7/127 • Number of events 11 • Baseline to Week 54
|
2.4%
3/126 • Number of events 3 • Baseline to Week 54
|
1.6%
2/122 • Number of events 3 • Baseline to Week 54
|
|
Infections and infestations
Sinusitis
|
2.4%
3/127 • Number of events 3 • Baseline to Week 54
|
5.5%
7/127 • Number of events 9 • Baseline to Week 54
|
2.4%
3/126 • Number of events 3 • Baseline to Week 54
|
4.1%
5/122 • Number of events 7 • Baseline to Week 54
|
|
Infections and infestations
Upper respiratory tract infection
|
9.4%
12/127 • Number of events 19 • Baseline to Week 54
|
7.1%
9/127 • Number of events 10 • Baseline to Week 54
|
6.3%
8/126 • Number of events 9 • Baseline to Week 54
|
4.9%
6/122 • Number of events 6 • Baseline to Week 54
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
2/127 • Number of events 3 • Baseline to Week 54
|
5.5%
7/127 • Number of events 7 • Baseline to Week 54
|
3.2%
4/126 • Number of events 5 • Baseline to Week 54
|
3.3%
4/122 • Number of events 4 • Baseline to Week 54
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.5%
7/127 • Number of events 8 • Baseline to Week 54
|
3.9%
5/127 • Number of events 5 • Baseline to Week 54
|
4.0%
5/126 • Number of events 5 • Baseline to Week 54
|
3.3%
4/122 • Number of events 4 • Baseline to Week 54
|
|
Nervous system disorders
Headache
|
4.7%
6/127 • Number of events 6 • Baseline to Week 54
|
6.3%
8/127 • Number of events 10 • Baseline to Week 54
|
4.8%
6/126 • Number of events 7 • Baseline to Week 54
|
11.5%
14/122 • Number of events 20 • Baseline to Week 54
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
45.7%
58/127 • Number of events 108 • Baseline to Week 54
|
33.1%
42/127 • Number of events 68 • Baseline to Week 54
|
42.1%
53/126 • Number of events 83 • Baseline to Week 54
|
32.0%
39/122 • Number of events 61 • Baseline to Week 54
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER