Trial Outcomes & Findings for Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma (NCT NCT04046939)
NCT ID: NCT04046939
Last Updated: 2023-04-13
Results Overview
The primary endpoint of this study was the change in AEC from Baseline to Week 12 on a ratio scale. The analysis used a mixed effects model repeated-measures (MMRM) with terms for log10 transformed baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and log10 transformed baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the log10 transformed post-baseline value minus the log10 transformed baseline value. The estimates of Geometric LS Means and their ratios were obtained by back transforming the corresponding estimates of LS means and their differences to the original scale.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
534 participants
Primary outcome timeframe
Baseline, 12 Weeks
Results posted on
2023-04-13
Participant Flow
Of the 534 participants enrolled, 144 subjects received placebo treatment during the Run-in Period. Of those, 103 completed the Run-in Period, were eligible for randomization, and entered the Primary Assessment Period.
Participant milestones
| Measure |
Placebo BID
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo: placebo twice daily oral dosing for up to 12 weeks
|
37.5 mg BID Dexpramipexole
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
75 mg BID Dexpramipexole
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
150 mg BID Dexpramipexole
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
|---|---|---|---|---|
|
Screening Period
STARTED
|
534
|
0
|
0
|
0
|
|
Screening Period
Received Placebo During Run-In Period
|
144
|
0
|
0
|
0
|
|
Screening Period
COMPLETED
|
103
|
0
|
0
|
0
|
|
Screening Period
NOT COMPLETED
|
431
|
0
|
0
|
0
|
|
Primary Assessment Period
STARTED
|
27
|
22
|
26
|
28
|
|
Primary Assessment Period
COMPLETED
|
25
|
22
|
24
|
28
|
|
Primary Assessment Period
NOT COMPLETED
|
2
|
0
|
2
|
0
|
|
Eosinophil Recovery Period
STARTED
|
25
|
22
|
24
|
28
|
|
Eosinophil Recovery Period
COMPLETED
|
24
|
22
|
24
|
27
|
|
Eosinophil Recovery Period
NOT COMPLETED
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo BID
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo: placebo twice daily oral dosing for up to 12 weeks
|
37.5 mg BID Dexpramipexole
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
75 mg BID Dexpramipexole
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
150 mg BID Dexpramipexole
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
|---|---|---|---|---|
|
Primary Assessment Period
Adverse Event
|
1
|
0
|
0
|
0
|
|
Primary Assessment Period
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
|
Primary Assessment Period
Physician Decision
|
0
|
0
|
1
|
0
|
|
Eosinophil Recovery Period
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma
Baseline characteristics by cohort
| Measure |
Placebo BID
n=27 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo: placebo twice daily oral dosing for up to 12 weeks
|
37.5 mg BID Dexpramipexole
n=22 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
75 mg BID Dexpramipexole
n=26 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
150 mg BID Dexpramipexole
n=28 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 12.89 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 13.41 • n=7 Participants
|
44.5 years
STANDARD_DEVIATION 15.46 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 12.53 • n=4 Participants
|
45.3 years
STANDARD_DEVIATION 13.42 • n=21 Participants
|
|
Age, Customized
<50 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Age, Customized
50 to 65 years
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Age, Customized
>65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Body mass index
|
34.31 kg/m^2
STANDARD_DEVIATION 12.749 • n=5 Participants
|
31.73 kg/m^2
STANDARD_DEVIATION 7.379 • n=7 Participants
|
33.44 kg/m^2
STANDARD_DEVIATION 10.690 • n=5 Participants
|
32.13 kg/m^2
STANDARD_DEVIATION 7.040 • n=4 Participants
|
32.95 kg/m^2
STANDARD_DEVIATION 9.738 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 WeeksPopulation: The efficacy population will be a modified intent-to-treat sample and consist of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who have at least one post-randomization AEC evaluation.
The primary endpoint of this study was the change in AEC from Baseline to Week 12 on a ratio scale. The analysis used a mixed effects model repeated-measures (MMRM) with terms for log10 transformed baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and log10 transformed baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the log10 transformed post-baseline value minus the log10 transformed baseline value. The estimates of Geometric LS Means and their ratios were obtained by back transforming the corresponding estimates of LS means and their differences to the original scale.
Outcome measures
| Measure |
Placebo BID
n=25 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo: placebo twice daily oral dosing for up to 12 weeks
|
37.5 mg BID Dexpramipexole
n=22 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
75 mg BID Dexpramipexole
n=24 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
150 mg BID Dexpramipexole
n=28 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
Combined 150 mg BID and 75 mg BID Arms
Following a 2-4 week placebo run-in, randomized subjects in this combined treatment group received 1 tablet of either 150 mg dexpramipexole twice daily for 12 weeks or 75 mg dexpramipexole trice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
|---|---|---|---|---|---|
|
Change in Blood Absolute Eosinophil Count From Baseline to Week 12
|
0.8980 ratio to baseline
Standard Error 1.26
|
0.4031 ratio to baseline
Standard Error 1.28
|
0.3056 ratio to baseline
Standard Error 1.27
|
0.2051 ratio to baseline
Standard Error 1.25
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: The efficacy population will be a modified intent-to-treat sample and consist of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who have at least one post-randomization FEV1 evaluation. Spirometry restrictions were put in place during the COVID-19 pandemic. Subjects who did not complete the Week 8 and Week 12 post dose assessments due to these restrictions were excluded from this analysis.
FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Outcome measures
| Measure |
Placebo BID
n=17 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo: placebo twice daily oral dosing for up to 12 weeks
|
37.5 mg BID Dexpramipexole
n=18 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
75 mg BID Dexpramipexole
n=21 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
150 mg BID Dexpramipexole
n=24 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
Combined 150 mg BID and 75 mg BID Arms
n=45 Participants
Following a 2-4 week placebo run-in, randomized subjects in this combined treatment group received 1 tablet of either 150 mg dexpramipexole twice daily for 12 weeks or 75 mg dexpramipexole trice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
|---|---|---|---|---|---|
|
Change in Pre-bronchodilator FEV1 (Liters) From Baseline to Week 12
|
0.0700 liters
Standard Error 0.08329
|
0.208 liters
Standard Error 0.08387
|
0.0557 liters
Standard Error 0.07848
|
0.247 liters
Standard Error 0.07769
|
0.151 liters
Standard Error 0.05746
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: The efficacy population was a modified intent-to-treat sample and consist of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who have at least one post-randomization evaluation.
ACQ-6 is simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. The 6-point self-administered scale has items measuring asthma symptoms and rescue inhaler use. The ACQ score is the mean of the questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). The original protocol planned to analyze the ACQ-7 score. As a result of FEV1 testing restrictions imposed on the study during the COVID-19 pandemic, the analysis was prospectively modified to the ACQ-6 score prior to database lock. The ACQ-6 is a validated questionnaire and is identical to the ACQ-7, with the exception of FEV1 data that is also utilized in the ACQ-7 questionnaire total score calculation.
Outcome measures
| Measure |
Placebo BID
n=25 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo: placebo twice daily oral dosing for up to 12 weeks
|
37.5 mg BID Dexpramipexole
n=22 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
75 mg BID Dexpramipexole
n=24 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
150 mg BID Dexpramipexole
n=28 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
Combined 150 mg BID and 75 mg BID Arms
Following a 2-4 week placebo run-in, randomized subjects in this combined treatment group received 1 tablet of either 150 mg dexpramipexole twice daily for 12 weeks or 75 mg dexpramipexole trice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
|---|---|---|---|---|---|
|
Change in Asthma Control Questionnaire (ACQ-6) Score From Baseline to Week 12
|
-0.391 scores on a scale
Standard Error 0.1866
|
-0.419 scores on a scale
Standard Error 0.1974
|
-0.437 scores on a scale
Standard Error 0.1924
|
-0.655 scores on a scale
Standard Error 0.1803
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: The efficacy population was a modified intent-to-treat sample and consist of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who have at least one post-randomization evaluation.
Post-bronchodilator FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation, after treatment with inhaled albuterol.
Outcome measures
| Measure |
Placebo BID
n=20 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo: placebo twice daily oral dosing for up to 12 weeks
|
37.5 mg BID Dexpramipexole
n=18 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
75 mg BID Dexpramipexole
n=22 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
150 mg BID Dexpramipexole
n=23 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
Combined 150 mg BID and 75 mg BID Arms
Following a 2-4 week placebo run-in, randomized subjects in this combined treatment group received 1 tablet of either 150 mg dexpramipexole twice daily for 12 weeks or 75 mg dexpramipexole trice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
|---|---|---|---|---|---|
|
Change in Post-bronchodilator FEV1 From Baseline to Week 12
|
-0.00546 liters
Standard Error 0.07208
|
0.0932 liters
Standard Error 0.07455
|
-0.000717 liters
Standard Error 0.06977
|
0.176 liters
Standard Error 0.07182
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: The efficacy population was a modified intent-to-treat sample and consist of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who have at least one post-randomization evaluation.
The AQLQ is a 32-item asthma specific questionnaire designed to measure functional impairments that are most important to patients with asthma. The 32 questions in the AQLQ are divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.
Outcome measures
| Measure |
Placebo BID
n=26 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo: placebo twice daily oral dosing for up to 12 weeks
|
37.5 mg BID Dexpramipexole
n=22 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
75 mg BID Dexpramipexole
n=25 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
150 mg BID Dexpramipexole
n=28 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
Combined 150 mg BID and 75 mg BID Arms
Following a 2-4 week placebo run-in, randomized subjects in this combined treatment group received 1 tablet of either 150 mg dexpramipexole twice daily for 12 weeks or 75 mg dexpramipexole trice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
|---|---|---|---|---|---|
|
Change in Quality of Life, as Measured by the Asthma Quality of Life Questionnaire (AQLQ) From Baseline to Week 12
|
0.376 scores on a scale
Standard Error 0.1999
|
0.531 scores on a scale
Standard Error 0.2112
|
0.312 scores on a scale
Standard Error 0.2055
|
0.584 scores on a scale
Standard Error 0.1979
|
—
|
SECONDARY outcome
Timeframe: Immediately post-baseline up to Week 12Population: The safety population includes all subjects who were randomized and received at least one dose of study drug during the primary treatment period.
Number of Participants with Potentially Clinically Significant Hematology Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.
Outcome measures
| Measure |
Placebo BID
n=27 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo: placebo twice daily oral dosing for up to 12 weeks
|
37.5 mg BID Dexpramipexole
n=22 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
75 mg BID Dexpramipexole
n=26 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
150 mg BID Dexpramipexole
n=28 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
Combined 150 mg BID and 75 mg BID Arms
Following a 2-4 week placebo run-in, randomized subjects in this combined treatment group received 1 tablet of either 150 mg dexpramipexole twice daily for 12 weeks or 75 mg dexpramipexole trice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Hematocrit ≥54% - Females
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Eosinophils >1.6 x 10^9/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Basophils >1.6 x 10^9/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Erythrocytes ≤3.5 x 10^12/L
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Erythrocytes ≥6.4 x 10^12/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Hematocrit ≤32% - Females
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Hematocrit ≤37% - Males
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Hematocrit ≥60% - Males
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Hemoglobin ≤9.5 g/dL - Females
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Hemoglobin ≥17.5 g/dL - Females
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Hemoglobin ≤11.5 g/dL - Males
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Hemoglobin ≥19.0 g/dL - Males
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Leukocytes <3.0 x 10^9/L
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Leukocytes ≥16 x 10^9/L
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Lymphocytes >12 x 10^9/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Monocytes >2.5 x 10^9/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Neutrophils <1.5 x 10^9/L
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Neutrophils ≥13.5 x 10^9/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Platelets ≤75 x 10^9/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Lymphocytes <0.8 x 10^9/L
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Platelets ≥700 x 10^9/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Immediately post-baseline up to Week 12Population: The safety population includes all subjects who were randomized and received at least one dose of study drug during the primary treatment period.
Number of Participants with Potentially Clinically Significant Blood Chemistry Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.
Outcome measures
| Measure |
Placebo BID
n=27 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo: placebo twice daily oral dosing for up to 12 weeks
|
37.5 mg BID Dexpramipexole
n=22 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
75 mg BID Dexpramipexole
n=26 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
150 mg BID Dexpramipexole
n=28 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
Combined 150 mg BID and 75 mg BID Arms
Following a 2-4 week placebo run-in, randomized subjects in this combined treatment group received 1 tablet of either 150 mg dexpramipexole twice daily for 12 weeks or 75 mg dexpramipexole trice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Albumin ≤ 2.5 g/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Alkaline Phosphatase ≥ 1.5 x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
AST ≥ 3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Bicarbonate ≤ 16 mEq/L
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Bicarbonate ≥ 35 mEq/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Bilirubin ≥ 1.5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Chloride ≤ 90 mEq/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Chloride ≥ 118 mEq/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Creatinine ≥ 2 mg/dL - Females
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Glucose ≥ 175 mg/dL
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Magnesium ≥ 2.9 mg/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Potassium ≤ 3 mEq/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Potassium ≥ 6 mEq/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Protein [Serum] ≤ 4.5 g/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Sodium ≤ 126 mEq/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Sodium ≥ 156 mEq/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Urate ≥ 8.5 mg/dL - Females
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Urate ≥ 10.5 mg/dL - Males
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Urea Nitrogen ≥ 30 mg/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
ALT ≥ 3 x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Bilirubin > 2 X ULN and (ALT or AST ≥ 3 X ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Calcium ≤ 8 mg/dL
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Calcium ≥ 12 mg/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Creatinine ≥ 2 mg/dL - Males
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Glucose ≤ 39.6 mg/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Magnesium ≤ 1.2 mg/dL
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Phosphate ≤ 1.86 mg/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Phosphate ≥ 5.27 mg/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Protein [Serum] ≥ 10 g/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Immediately post-baseline up to Week 12Population: The safety population includes all subjects who were randomized and received at least one dose of study drug during the primary treatment period.
Number of Participants with Potentially Clinically Significant Urinalysis Results (glycosuria, ketonuria, or proteinuria) by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline urinalysis value in each treatment group. Patients are only counted once per criterion per laboratory test. The number of participants with potential clinical important urinalysis findings at any post-baseline visit were reported.
Outcome measures
| Measure |
Placebo BID
n=27 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo: placebo twice daily oral dosing for up to 12 weeks
|
37.5 mg BID Dexpramipexole
n=22 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
75 mg BID Dexpramipexole
n=26 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
150 mg BID Dexpramipexole
n=28 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
Combined 150 mg BID and 75 mg BID Arms
Following a 2-4 week placebo run-in, randomized subjects in this combined treatment group received 1 tablet of either 150 mg dexpramipexole twice daily for 12 weeks or 75 mg dexpramipexole trice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12
glycosuria (glucose in urine ++++)
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12
ketonuria (ketones in urine ≥ ++++)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12
proteinuria (protein in urine ≥ ++)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Immediately post-baseline up to Week 12Population: The safety population includes all subjects who were randomized and received at least one dose of study drug during the primary treatment period.
Number of Participants with Potentially Clinically Significant Vital Signs Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.
Outcome measures
| Measure |
Placebo BID
n=27 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo: placebo twice daily oral dosing for up to 12 weeks
|
37.5 mg BID Dexpramipexole
n=22 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
75 mg BID Dexpramipexole
n=26 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
150 mg BID Dexpramipexole
n=28 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
Combined 150 mg BID and 75 mg BID Arms
Following a 2-4 week placebo run-in, randomized subjects in this combined treatment group received 1 tablet of either 150 mg dexpramipexole twice daily for 12 weeks or 75 mg dexpramipexole trice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Systolic blood pressure: >180 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Systolic blood pressure: Decrease >30 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Diastolic blood pressure: >105 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Diastolic blood pressure: <50 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Pulse: <50 bpm
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Systolic blood pressure: Increase >40 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Systolic blood pressure: <90 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Diastolic blood pressure: Increase >30 mmHg
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Diastolic blood pressure: Decrease >20 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Pulse: >120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Pulse: Increase >30 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Pulse: Decrease >20 bpm
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Temperature: >38.5°C and an increase ≥1°C
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Body weight: Increase ≥7% from Baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Body weight: Decrease ≥7% from Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Immediately post-baseline up to Week 12Population: The safety population includes all subjects who were randomized and received at least one dose of study drug during the primary treatment period.
Number of Participants with Potentially Clinically Significant ECG Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.
Outcome measures
| Measure |
Placebo BID
n=27 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo: placebo twice daily oral dosing for up to 12 weeks
|
37.5 mg BID Dexpramipexole
n=22 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
75 mg BID Dexpramipexole
n=26 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
150 mg BID Dexpramipexole
n=28 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
Combined 150 mg BID and 75 mg BID Arms
Following a 2-4 week placebo run-in, randomized subjects in this combined treatment group received 1 tablet of either 150 mg dexpramipexole twice daily for 12 weeks or 75 mg dexpramipexole trice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
Change from Baseline in PR >25% and PR value >220 ms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
Change from Baseline in QRS >25% and QRS value >110 ms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
Heart Rate >120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
Heart Rate Increase from Baseline >30 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
QT Interval: >450 ms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
QT Interval: >480 ms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
QT Interval: >500 ms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
QT Interval: Increase from Baseline >30 ms
|
7 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
QT Interval: Increase from Baseline >60 ms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
QTcF Interval: >450 ms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
QTcF Interval: >480 ms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
QTcF Interval: >500 ms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
QTcF Interval: Increase from Baseline >30 ms
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
QTcF Interval: Increase from Baseline >60 ms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: The efficacy population was a modified intent-to-treat sample and consists of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who had both Baseline (non-zero) and Week 12 values.
The EPX:protein ratio was used to normalize the EPX for the quantity of sample, yielding the values in ng EPX per mg protein. The ratio of nasal Eosinophil Peroxidase to Protein is a biomarker for airway eosinophils. A lower ratio to Baseline represents a lowering in airway eosinophilia, which is a marker of successful drug therapy.
Outcome measures
| Measure |
Placebo BID
n=15 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo: placebo twice daily oral dosing for up to 12 weeks
|
37.5 mg BID Dexpramipexole
n=16 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
75 mg BID Dexpramipexole
n=19 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
150 mg BID Dexpramipexole
n=19 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
Combined 150 mg BID and 75 mg BID Arms
Following a 2-4 week placebo run-in, randomized subjects in this combined treatment group received 1 tablet of either 150 mg dexpramipexole twice daily for 12 weeks or 75 mg dexpramipexole trice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
|---|---|---|---|---|---|
|
Change in Nasal Eosinophil Peroxidase (Presented as Ratio to Protein) From Baseline to Week 12
|
0.833 ratio to baseline
Interval 0.258 to 2.99
|
0.645 ratio to baseline
Interval 0.275 to 1.18
|
0.174 ratio to baseline
Interval 0.0 to 0.708
|
0.110 ratio to baseline
Interval 0.0 to 0.943
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: The efficacy population was a modified intent-to-treat sample and consists of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who have at least one post-randomization evaluation.
The analysis used a mixed effects model repeated-measures MMRM with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value. Basophils were enumerated as part of the WBC automated differential performed by the Central Laboratory.
Outcome measures
| Measure |
Placebo BID
n=25 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo: placebo twice daily oral dosing for up to 12 weeks
|
37.5 mg BID Dexpramipexole
n=22 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
75 mg BID Dexpramipexole
n=24 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
150 mg BID Dexpramipexole
n=28 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
Combined 150 mg BID and 75 mg BID Arms
Following a 2-4 week placebo run-in, randomized subjects in this combined treatment group received 1 tablet of either 150 mg dexpramipexole twice daily for 12 weeks or 75 mg dexpramipexole trice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
|---|---|---|---|---|---|
|
Change in Blood Absolute Blood Basophil Count From Baseline to Week 12
|
-0.00439 cells (10*9/L)
Standard Error 0.006323
|
-0.00655 cells (10*9/L)
Standard Error 0.006674
|
-0.0250 cells (10*9/L)
Standard Error 0.006487
|
-0.0277 cells (10*9/L)
Standard Error 0.006082
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: The efficacy population was a modified intent-to-treat sample and consists of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who have at least one post-randomization evaluation.
FeNO is non-invasive biomarker of airway inflammation in asthma participants.
Outcome measures
| Measure |
Placebo BID
n=17 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo: placebo twice daily oral dosing for up to 12 weeks
|
37.5 mg BID Dexpramipexole
n=17 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
75 mg BID Dexpramipexole
n=20 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
150 mg BID Dexpramipexole
n=23 Participants
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
Combined 150 mg BID and 75 mg BID Arms
Following a 2-4 week placebo run-in, randomized subjects in this combined treatment group received 1 tablet of either 150 mg dexpramipexole twice daily for 12 weeks or 75 mg dexpramipexole trice daily for 12 weeks.
Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks
|
|---|---|---|---|---|---|
|
Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 12
|
3.38 parts per billion
Standard Error 4.6447
|
-6.79 parts per billion
Standard Error 4.7849
|
-3.14 parts per billion
Standard Error 4.3651
|
-4.86 parts per billion
Standard Error 4.2175
|
—
|
Adverse Events
Screening Period
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Primary Assessment Period: Placebo BID
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Primary Assessment Period: 37.5 mg BID
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Primary Assessment Period: 75 mg BID
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Primary Assessment Period: 150 mg BID
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Eosinophil Recovery Period: Assigned to Placebo BID During Primary Assessment Period
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Eosinophil Recovery Period: Assigned to 37.5 mg BID During Primary Assessment Period
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Eosinophil Recovery Period: Assigned to 75 mg BID During Primary Assessment Period
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Eosinophil Recovery Period: Assigned to 150 mg BID During Primary Assessment Period
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Screening Period
n=103 participants at risk
All subjects who signed informed consent and entered the Primary Assessment Period
|
Primary Assessment Period: Placebo BID
n=27 participants at risk
Following the 2-4 week placebo Run-in Period, randomized subjects continued to receive 1 tablet placebo twice daily for 12 weeks during the Primary Assessment Period.
Placebo: 1 placebo tablet twice daily
|
Primary Assessment Period: 37.5 mg BID
n=22 participants at risk
Following the 2-4 week placebo Run-in Period, randomized subjects received 1 tablet dexpramipexole 37.5 mg twice daily for 12 weeks during the Primary Assessment Period.
Dexpramipexole: 1 dexpramipexole tablet twice daily
|
Primary Assessment Period: 75 mg BID
n=26 participants at risk
Following the 2-4 week placebo Run-in Period, randomized subjects received 1 tablet dexpramipexole 75 mg twice daily for 12 weeks during the Primary Assessment Period.
Dexpramipexole: 1 dexpramipexole tablet twice daily
|
Primary Assessment Period: 150 mg BID
n=28 participants at risk
Following the 2-4 week placebo Run-in Period, randomized subjects received 1 tablet dexpramipexole 150 mg twice daily for 12 weeks during the Primary Assessment Period.
Dexpramipexole: 1 dexpramipexole tablet twice daily
|
Eosinophil Recovery Period: Assigned to Placebo BID During Primary Assessment Period
n=25 participants at risk
Following the Primary Assessment Period, subjects were followed within their randomized treatment group
|
Eosinophil Recovery Period: Assigned to 37.5 mg BID During Primary Assessment Period
n=22 participants at risk
Following the Primary Assessment Period, subjects were followed within their randomized treatment group
|
Eosinophil Recovery Period: Assigned to 75 mg BID During Primary Assessment Period
n=24 participants at risk
Following the Primary Assessment Period, subjects were followed within their randomized treatment group
|
Eosinophil Recovery Period: Assigned to 150 mg BID During Primary Assessment Period
n=28 participants at risk
Following the Primary Assessment Period, subjects were followed within their randomized treatment group
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Monocytopenia
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Congenital, familial and genetic disorders
Sinus Bradycardia
|
0.97%
1/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.97%
1/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.5%
1/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
General disorders
Chest discomfort
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
General disorders
Fatigue
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
General disorders
Peripheral swelling
|
0.97%
1/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.5%
1/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.5%
1/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Infections and infestations
Ear infection fungal
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Infections and infestations
Influenza
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
7.1%
2/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.7%
1/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
13.6%
3/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.0%
1/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.2%
1/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Infections and infestations
Otitis externa
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.7%
1/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.7%
1/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
7.7%
2/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.2%
1/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Infections and infestations
Urethritis
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.7%
1/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Injury, poisoning and procedural complications
Fall
|
0.97%
1/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Injury, poisoning and procedural complications
Foreign body in ear
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.2%
1/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.5%
1/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Investigations
Coronavirus test positive
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
7.1%
2/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.7%
1/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.0%
1/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
7.1%
2/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.7%
1/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.5%
1/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.7%
1/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
7.7%
2/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.2%
1/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Nervous system disorders
Headache
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.7%
1/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Nervous system disorders
Migraine
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Psychiatric disorders
Depression
|
0.97%
1/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Psychiatric disorders
Insomnia
|
0.97%
1/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
7.4%
2/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
9.1%
2/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
7.1%
2/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.0%
1/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.5%
1/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
7.1%
2/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.97%
1/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.2%
1/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.7%
1/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.2%
1/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.7%
1/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.5%
1/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.5%
1/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.8%
1/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Vascular disorders
Hypertension
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.6%
1/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
7.7%
2/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.5%
1/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.5%
1/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.5%
1/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.97%
1/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.5%
1/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.5%
1/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.5%
1/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
|
Nervous system disorders
Tension headache
|
0.00%
0/103 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
3.7%
1/27 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/26 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/25 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
4.5%
1/22 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/24 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
0.00%
0/28 • Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization)
|
Additional Information
Vice President, Clinical and Translational Medicine
Knopp Biosciences
Phone: 4124881776
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Knopp's agreements with its investigators may vary. However, Knopp does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial, and are subject to a minimum 60 day review period by Knopp.
- Publication restrictions are in place
Restriction type: OTHER