Asthma, Eosinophilic Asthma
Conditions
Keywords
Eosinophilic Asthma, Asthma, dexpramipexole
Brief summary
This is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging, multi-center study to evaluate the clinical effects of oral administration of dexpramipexole for 12 weeks on peripheral blood eosinophil count in subjects with eosinophilic asthma.
Detailed description
One hundred subjects will receive study drug or matching placebo over 12 weeks of consecutive dosing. Following a short Run-in Period, eligible subjects will enter the Primary Assessment Period and receive twice-daily dosing of study drug or placebo for 12 weeks. Following 12 weeks of treatment, subjects will enter a 12-week Eosinophil Recovery Period. The primary endpoint for the study is the change in blood absolute eosinophil count from Baseline to Week 12.
Interventions
DRUGDexpramipexole
dexpramipexole twice daily oral dosing for up to 12 weeks
DRUGPlacebo
placebo twice daily oral dosing for up to 12 weeks
Sponsors
Knopp Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Four-arm parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Male or female ≥18 and \<75 years of age at the time of consent * Physician diagnosis of asthma for ≥12 months (relative to Baseline) based on Global Initiative for Asthma (GINA) 2018 Guidelines * Asthma requiring treatment with, at a minimum, low dose inhaled corticosteroids in combination with a long-acting β2 agonist, on a stable dose for at least 1 month before Screening * Bronchodilator reversibility, as evidenced by ≥12% and ≥200 mL improvement in FEV1 15 to 25 minutes following inhalation of albuterol at Screening * Pre-bronchodilator FEV1 ≥40% and \<80% of predicted at Screening and Baseline * AEC ≥0.30 x10\^9/L at the Screening visit * ACQ-7 ≥1.5 at Screening * Negative pregnancy test at Baseline * Adherence ≥85% with twice-daily placebo taken during the Run-in Period
Exclusion criteria
* Treatment for an asthma exacerbation within 8 weeks prior to Baseline visit * Treatment with systemic corticosteroids in the 8 weeks prior to Screening * Treatment with monoclonal antibody therapy, within 5-half-lives prior to Baseline * Treatment with selected drugs known to have a substantial risk of neutropenia * Absolute neutrophil count \<2.0x10\^9/L at Screening, or any documented history of absolute neutrophil count \<2.0x10\^9/L. * Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m\^2 at Screening * Clinically significant abnormal laboratory or ECG values * Other medically significant illness * Use of any smoke or inhaled nicotine delivery device within 1 year prior to Screening * Pregnant women or women breastfeeding * Currently taking pramipexole or other dopamine agonists
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Absolute Eosinophil Count From Baseline to Week 12 | Baseline, 12 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life, as Measured by the Asthma Quality of Life Questionnaire (AQLQ) From Baseline to Week 12 | Baseline, 12 Weeks | 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. |
| Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12 | Immediately post-baseline up to Week 12 | 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. |
| Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Immediately post-baseline up to Week 12 | 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. |
| Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | Immediately post-baseline up to Week 12 | 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. |
| Change in Pre-bronchodilator FEV1 (Liters) From Baseline to Week 12 | Baseline, 12 Weeks | FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation. |
| Change in Asthma Control Questionnaire (ACQ-6) Score From Baseline to Week 12 | Baseline, 12 Weeks | 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. |
| Change in Post-bronchodilator FEV1 From Baseline to Week 12 | Baseline, 12 Weeks | 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. |
| Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Immediately post-baseline up to Week 12 | 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. |
| Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Immediately post-baseline up to Week 12 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 12 | Baseline, Week 12 | FeNO is non-invasive biomarker of airway inflammation in asthma participants. |
| Change in Blood Absolute Blood Basophil Count From Baseline to Week 12 | Baseline, Week 12 | 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. |
| Change in Nasal Eosinophil Peroxidase (Presented as Ratio to Protein) From Baseline to Week 12 | Baseline, Week 12 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 27 |
| 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 | 22 |
| 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 | 26 |
| 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 | 28 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Eosinophil Recovery Period | Withdrawal by Subject | 1 | 0 | 0 | 1 |
| Primary Assessment Period | Adverse Event | 1 | 0 | 0 | 0 |
| Primary Assessment Period | Physician Decision | 0 | 0 | 1 | 0 |
| Primary Assessment Period | Withdrawal by Subject | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo BID | 37.5 mg BID Dexpramipexole | 75 mg BID Dexpramipexole | 150 mg BID Dexpramipexole | Total |
|---|---|---|---|---|---|
| Age, Continuous | 45.8 years STANDARD_DEVIATION 12.89 | 46.6 years STANDARD_DEVIATION 13.41 | 44.5 years STANDARD_DEVIATION 15.46 | 44.6 years STANDARD_DEVIATION 12.53 | 45.3 years STANDARD_DEVIATION 13.42 |
| Age, Customized 50 to 65 years | 10 Participants | 6 Participants | 8 Participants | 9 Participants | 33 Participants |
| Age, Customized <50 years | 15 Participants | 14 Participants | 15 Participants | 18 Participants | 62 Participants |
| Age, Customized >65 years | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 8 Participants |
| Body mass index | 34.31 kg/m^2 STANDARD_DEVIATION 12.749 | 31.73 kg/m^2 STANDARD_DEVIATION 7.379 | 33.44 kg/m^2 STANDARD_DEVIATION 10.69 | 32.13 kg/m^2 STANDARD_DEVIATION 7.04 | 32.95 kg/m^2 STANDARD_DEVIATION 9.738 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 19 Participants | 23 Participants | 25 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 6 Participants | 6 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 21 Participants | 17 Participants | 16 Participants | 22 Participants | 76 Participants |
| Sex: Female, Male Female | 17 Participants | 11 Participants | 14 Participants | 12 Participants | 54 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 12 Participants | 16 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 27 | 0 / 22 | 0 / 26 | 0 / 28 | 0 / 25 | 0 / 22 | 0 / 24 | 0 / 28 |
| other Total, other adverse events | 6 / 103 | 9 / 27 | 7 / 22 | 12 / 26 | 12 / 28 | 2 / 25 | 3 / 22 | 5 / 24 | 10 / 28 |
| serious Total, serious adverse events | 0 / 103 | 0 / 27 | 0 / 22 | 0 / 26 | 0 / 28 | 0 / 25 | 0 / 22 | 0 / 24 | 0 / 28 |
Outcome results
Primary
Change in Blood Absolute Eosinophil Count From Baseline to Week 12
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.
Time frame: Baseline, 12 Weeks
Population: 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.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo BID | Change in Blood Absolute Eosinophil Count From Baseline to Week 12 | 0.8980 ratio to baseline | Standard Error 1.26 |
| 37.5 mg BID Dexpramipexole | Change in Blood Absolute Eosinophil Count From Baseline to Week 12 | 0.4031 ratio to baseline | Standard Error 1.28 |
| 75 mg BID Dexpramipexole | Change in Blood Absolute Eosinophil Count From Baseline to Week 12 | 0.3056 ratio to baseline | Standard Error 1.27 |
| 150 mg BID Dexpramipexole | Change in Blood Absolute Eosinophil Count From Baseline to Week 12 | 0.2051 ratio to baseline | Standard Error 1.25 |
Comparison: The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).p-value: <0.000195% CI: [0.121, 0.431]Mixed Models Analysis
Comparison: The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).p-value: 0.001495% CI: [0.177, 0.653]Mixed Models Analysis
Comparison: The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).p-value: 0.01995% CI: [0.231, 0.874]Mixed Models Analysis
Secondary
Change in Asthma Control Questionnaire (ACQ-6) Score From Baseline to Week 12
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.
Time frame: Baseline, 12 Weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo BID | Change in Asthma Control Questionnaire (ACQ-6) Score From Baseline to Week 12 | -0.391 scores on a scale | Standard Error 0.1866 |
| 37.5 mg BID Dexpramipexole | Change in Asthma Control Questionnaire (ACQ-6) Score From Baseline to Week 12 | -0.419 scores on a scale | Standard Error 0.1974 |
| 75 mg BID Dexpramipexole | Change in Asthma Control Questionnaire (ACQ-6) Score From Baseline to Week 12 | -0.437 scores on a scale | Standard Error 0.1924 |
| 150 mg BID Dexpramipexole | Change in Asthma Control Questionnaire (ACQ-6) Score From Baseline to Week 12 | -0.655 scores on a scale | Standard Error 0.1803 |
Comparison: The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).p-value: 0.305995% CI: [-0.772, 0.245]Mixed Models Analysis
Comparison: The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).p-value: 0.864295% CI: [-0.575, 0.484]Mixed Models Analysis
Comparison: The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).p-value: 0.918295% CI: [-0.56, 0.505]Mixed Models Analysis
Secondary
Change in Post-bronchodilator FEV1 From Baseline to Week 12
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.
Time frame: Baseline, 12 Weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo BID | Change in Post-bronchodilator FEV1 From Baseline to Week 12 | -0.00546 liters | Standard Error 0.07208 |
| 37.5 mg BID Dexpramipexole | Change in Post-bronchodilator FEV1 From Baseline to Week 12 | 0.0932 liters | Standard Error 0.07455 |
| 75 mg BID Dexpramipexole | Change in Post-bronchodilator FEV1 From Baseline to Week 12 | -0.000717 liters | Standard Error 0.06977 |
| 150 mg BID Dexpramipexole | Change in Post-bronchodilator FEV1 From Baseline to Week 12 | 0.176 liters | Standard Error 0.07182 |
Comparison: An ANCOVA analysis was performed comparing the 150 mg BID dexpramipexole group to placebo.p-value: 0.071695% CI: [-0.0163, 0.378]ANCOVA
Comparison: An ANCOVA analysis was performed comparing the 75 mg BID dexpramipexole group to placebo.p-value: 0.961995% CI: [-0.192, 0.202]ANCOVA
Comparison: An ANCOVA analysis was performed comparing the 37.5 mg BID dexpramipexole group to placebo.p-value: 0.336895% CI: [-0.105, 0.302]ANCOVA
Secondary
Change in Pre-bronchodilator FEV1 (Liters) From Baseline to Week 12
FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Time frame: Baseline, 12 Weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo BID | Change in Pre-bronchodilator FEV1 (Liters) From Baseline to Week 12 | 0.0700 liters | Standard Error 0.08329 |
| 37.5 mg BID Dexpramipexole | Change in Pre-bronchodilator FEV1 (Liters) From Baseline to Week 12 | 0.208 liters | Standard Error 0.08387 |
| 75 mg BID Dexpramipexole | Change in Pre-bronchodilator FEV1 (Liters) From Baseline to Week 12 | 0.0557 liters | Standard Error 0.07848 |
| 150 mg BID Dexpramipexole | Change in Pre-bronchodilator FEV1 (Liters) From Baseline to Week 12 | 0.247 liters | Standard Error 0.07769 |
| Combined 150 mg BID and 75 mg BID Arms | Change in Pre-bronchodilator FEV1 (Liters) From Baseline to Week 12 | 0.151 liters | Standard Error 0.05746 |
Comparison: The combined 75 mg and 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).p-value: 0.415495% CI: [-0.116, 0.279]Mixed Models Analysis
Comparison: The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).p-value: 0.117495% CI: [-0.0456, 0.4]Mixed Models Analysis
Comparison: The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).p-value: 0.899895% CI: [-0.24, 0.211]Mixed Models Analysis
Comparison: The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).p-value: 0.242595% CI: [-0.095, 0.37]Mixed Models Analysis
Secondary
Change in Quality of Life, as Measured by the Asthma Quality of Life Questionnaire (AQLQ) From Baseline to Week 12
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.
Time frame: Baseline, 12 Weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo BID | 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 |
| 37.5 mg BID Dexpramipexole | Change in Quality of Life, as Measured by the Asthma Quality of Life Questionnaire (AQLQ) From Baseline to Week 12 | 0.531 scores on a scale | Standard Error 0.2112 |
| 75 mg BID Dexpramipexole | Change in Quality of Life, as Measured by the Asthma Quality of Life Questionnaire (AQLQ) From Baseline to Week 12 | 0.312 scores on a scale | Standard Error 0.2055 |
| 150 mg BID Dexpramipexole | Change in Quality of Life, as Measured by the Asthma Quality of Life Questionnaire (AQLQ) From Baseline to Week 12 | 0.584 scores on a scale | Standard Error 0.1979 |
Comparison: An ANCOVA analysis was performed comparing the 150 mg BID dexpramipexole group to placebo.p-value: 0.451295% CI: [-0.338, 0.755]ANCOVA
Comparison: An ANCOVA analysis was performed comparing the 75 mg BID dexpramipexole group to placebo.p-value: 0.821495% CI: [-0.627, 0.499]ANCOVA
Comparison: An ANCOVA analysis was performed comparing the 37.5 mg BID dexpramipexole group to placebo.p-value: 0.589495% CI: [-0.411, 0.72]ANCOVA
Secondary
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
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.
Time frame: Immediately post-baseline up to Week 12
Population: The safety population includes all subjects who were randomized and received at least one dose of study drug during the primary treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo BID | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | AST ≥ 3 x ULN | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | ALT ≥ 3 x ULN | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Calcium ≤ 8 mg/dL | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Potassium ≥ 6 mEq/L | 0 Participants |
| Placebo BID | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Sodium ≤ 126 mEq/L | 0 Participants |
| Placebo BID | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Calcium ≥ 12 mg/dL | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Bicarbonate ≤ 16 mEq/L | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Chloride ≤ 90 mEq/L | 0 Participants |
| Placebo BID | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Glucose ≥ 175 mg/dL | 2 Participants |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Chloride ≥ 118 mEq/L | 0 Participants |
| Placebo BID | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Bicarbonate ≥ 35 mEq/L | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Potassium ≤ 3 mEq/L | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Sodium ≥ 156 mEq/L | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Calcium ≤ 8 mg/dL | 2 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Glucose ≥ 175 mg/dL | 2 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Potassium ≤ 3 mEq/L | 0 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Magnesium ≤ 1.2 mg/dL | 1 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | AST ≥ 3 x ULN | 0 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Bicarbonate ≤ 16 mEq/L | 0 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | ALT ≥ 3 x ULN | 0 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Sodium ≥ 156 mEq/L | 0 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Bicarbonate ≥ 35 mEq/L | 0 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Sodium ≤ 126 mEq/L | 0 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Potassium ≥ 6 mEq/L | 0 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Calcium ≥ 12 mg/dL | 0 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Chloride ≤ 90 mEq/L | 0 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Chloride ≥ 118 mEq/L | 0 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Alkaline Phosphatase ≥ 1.5 x ULN | 1 Participants |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | ALT ≥ 3 x ULN | 1 Participants |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | AST ≥ 3 x ULN | 0 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Bicarbonate ≤ 16 mEq/L | 1 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Bicarbonate ≥ 35 mEq/L | 0 Participants |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Calcium ≤ 8 mg/dL | 0 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Calcium ≥ 12 mg/dL | 0 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Chloride ≤ 90 mEq/L | 0 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Chloride ≥ 118 mEq/L | 0 Participants |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Glucose ≥ 175 mg/dL | 1 Participants |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Potassium ≤ 3 mEq/L | 0 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Potassium ≥ 6 mEq/L | 0 Participants |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Sodium ≤ 126 mEq/L | 0 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Sodium ≥ 156 mEq/L | 0 Participants |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Potassium ≥ 6 mEq/L | 0 Participants |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Chloride ≥ 118 mEq/L | 0 Participants |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Chloride ≤ 90 mEq/L | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Calcium ≥ 12 mg/dL | 0 Participants |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Calcium ≤ 8 mg/dL | 3 Participants |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Sodium ≤ 126 mEq/L | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Bicarbonate ≥ 35 mEq/L | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Bicarbonate ≤ 16 mEq/L | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | ALT ≥ 3 x ULN | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Sodium ≥ 156 mEq/L | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | AST ≥ 3 x ULN | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Alkaline Phosphatase ≥ 1.5 x ULN | 1 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Potassium ≤ 3 mEq/L | 0 Participants |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Magnesium ≤ 1.2 mg/dL | 1 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Glucose ≥ 175 mg/dL | 1 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 | Urate ≥ 8.5 mg/dL - Females | 1 Participants |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
Secondary
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
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.
Time frame: Immediately post-baseline up to Week 12
Population: The safety population includes all subjects who were randomized and received at least one dose of study drug during the primary treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo BID | 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 |
| Placebo BID | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QTcF Interval: >450 ms | 0 Participants |
| Placebo BID | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QTcF Interval: >500 ms | 0 Participants |
| Placebo BID | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QTcF Interval: >480 ms | 0 Participants |
| Placebo BID | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | Heart Rate >120 bpm | 0 Participants |
| Placebo BID | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QT Interval: >450 ms | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QT Interval: >480 ms | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QT Interval: >500 ms | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QTcF Interval: >500 ms | 0 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QT Interval: >480 ms | 0 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QTcF Interval: >450 ms | 0 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QTcF Interval: Increase from Baseline >30 ms | 0 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QTcF Interval: >480 ms | 0 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QT Interval: Increase from Baseline >30 ms | 3 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QT Interval: >500 ms | 0 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QT Interval: >450 ms | 0 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | Heart Rate >120 bpm | 0 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | Heart Rate >120 bpm | 0 Participants |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QT Interval: >450 ms | 0 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QT Interval: >480 ms | 0 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QT Interval: >500 ms | 0 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QT Interval: Increase from Baseline >30 ms | 2 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QTcF Interval: >450 ms | 0 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QTcF Interval: >480 ms | 0 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QTcF Interval: >500 ms | 0 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QTcF Interval: Increase from Baseline >30 ms | 0 Participants |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QT Interval: Increase from Baseline >30 ms | 0 Participants |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QTcF Interval: Increase from Baseline >30 ms | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QT Interval: >500 ms | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QT Interval: >480 ms | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | Heart Rate >120 bpm | 0 Participants |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QT Interval: >450 ms | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QTcF Interval: >480 ms | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QTcF Interval: >450 ms | 0 Participants |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | Heart Rate Increase from Baseline >30 bpm | 1 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 | QTcF Interval: >500 ms | 0 Participants |
Secondary
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
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.
Time frame: Immediately post-baseline up to Week 12
Population: The safety population includes all subjects who were randomized and received at least one dose of study drug during the primary treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hematocrit ≤32% - Females | 0 Participants |
| Placebo BID | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hematocrit ≥54% - Females | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hematocrit ≤37% - Males | 2 Participants |
| Placebo BID | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hematocrit ≥60% - Males | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hemoglobin ≤11.5 g/dL - Males | 0 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hematocrit ≤32% - Females | 2 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hematocrit ≥54% - Females | 0 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Leukocytes ≥16 x 10^9/L | 1 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hematocrit ≥60% - Males | 0 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hemoglobin ≤9.5 g/dL - Females | 1 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Erythrocytes ≤3.5 x 10^12/L | 1 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hematocrit ≤37% - Males | 0 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hematocrit ≤32% - Females | 0 Participants |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hematocrit ≥54% - Females | 0 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hematocrit ≤37% - Males | 1 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hematocrit ≥60% - Males | 0 Participants |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hemoglobin ≤11.5 g/dL - Males | 0 Participants |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hematocrit ≥60% - Males | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hematocrit ≤37% - Males | 1 Participants |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hematocrit ≥54% - Females | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hematocrit ≤32% - Females | 1 Participants |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Leukocytes ≥16 x 10^9/L | 1 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Leukocytes <3.0 x 10^9/L | 1 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Erythrocytes ≤3.5 x 10^12/L | 2 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Lymphocytes <0.8 x 10^9/L | 1 Participants |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 | Hemoglobin ≤11.5 g/dL - Males | 1 Participants |
| 150 mg BID Dexpramipexole | 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 |
Secondary
Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12
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.
Time frame: Immediately post-baseline up to Week 12
Population: The safety population includes all subjects who were randomized and received at least one dose of study drug during the primary treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo BID | Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12 | glycosuria (glucose in urine ++++) | 1 Participants |
| Placebo BID | Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12 | proteinuria (protein in urine ≥ ++) | 1 Participants |
| Placebo BID | Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12 | ketonuria (ketones in urine ≥ ++++) | 0 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12 | glycosuria (glucose in urine ++++) | 2 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12 | proteinuria (protein in urine ≥ ++) | 0 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12 | ketonuria (ketones in urine ≥ ++++) | 0 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12 | ketonuria (ketones in urine ≥ ++++) | 0 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12 | glycosuria (glucose in urine ++++) | 1 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12 | proteinuria (protein in urine ≥ ++) | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12 | glycosuria (glucose in urine ++++) | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12 | proteinuria (protein in urine ≥ ++) | 0 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12 | ketonuria (ketones in urine ≥ ++++) | 0 Participants |
Secondary
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
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.
Time frame: Immediately post-baseline up to Week 12
Population: The safety population includes all subjects who were randomized and received at least one dose of study drug during the primary treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo BID | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Pulse: Increase >30 bpm | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Pulse: >120 bpm | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Pulse: Decrease >20 bpm | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Pulse: <50 bpm | 0 Participants |
| Placebo BID | 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 |
| Placebo BID | 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 |
| Placebo BID | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Pulse: Decrease >20 bpm | 0 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Pulse: <50 bpm | 1 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Diastolic blood pressure: Increase >30 mmHg | 1 Participants |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | 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 |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Pulse: >120 bpm | 0 Participants |
| 37.5 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Pulse: Increase >30 bpm | 0 Participants |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Pulse: Increase >30 bpm | 0 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Pulse: >120 bpm | 0 Participants |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Pulse: <50 bpm | 0 Participants |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Pulse: Decrease >20 bpm | 1 Participants |
| 75 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Body weight: Increase ≥7% from Baseline | 1 Participants |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 75 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Pulse: Decrease >20 bpm | 1 Participants |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Pulse: Increase >30 bpm | 0 Participants |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Body weight: Decrease ≥7% from Baseline | 1 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Body weight: Increase ≥7% from Baseline | 1 Participants |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Pulse: <50 bpm | 0 Participants |
| 150 mg BID Dexpramipexole | 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 |
| 150 mg BID Dexpramipexole | Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 | Pulse: >120 bpm | 0 Participants |
| 150 mg BID Dexpramipexole | 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 |
Other Pre-specified
Change in Blood Absolute Blood Basophil Count From Baseline to Week 12
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.
Time frame: Baseline, Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo BID | Change in Blood Absolute Blood Basophil Count From Baseline to Week 12 | -0.00439 cells (10*9/L) | Standard Error 0.006323 |
| 37.5 mg BID Dexpramipexole | Change in Blood Absolute Blood Basophil Count From Baseline to Week 12 | -0.00655 cells (10*9/L) | Standard Error 0.006674 |
| 75 mg BID Dexpramipexole | Change in Blood Absolute Blood Basophil Count From Baseline to Week 12 | -0.0250 cells (10*9/L) | Standard Error 0.006487 |
| 150 mg BID Dexpramipexole | Change in Blood Absolute Blood Basophil Count From Baseline to Week 12 | -0.0277 cells (10*9/L) | Standard Error 0.006082 |
Comparison: The 150 mg BID dexpramipexole group was compared to placebo using 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.p-value: 0.008495% CI: [-0.0405, -0.00613]Mixed Models Analysis
Comparison: The 75 mg BID dexpramipexole group was compared to placebo using 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.p-value: 0.023795% CI: [-0.0384, -0.00281]Mixed Models Analysis
Comparison: The 37.5 mg BID dexpramipexole group was compared to placebo using 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.p-value: 0.81495% CI: [-0.0203, 0.016]Mixed Models Analysis
Other Pre-specified
Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 12
FeNO is non-invasive biomarker of airway inflammation in asthma participants.
Time frame: Baseline, Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo BID | Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 12 | 3.38 parts per billion | Standard Error 4.6447 |
| 37.5 mg BID Dexpramipexole | Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 12 | -6.79 parts per billion | Standard Error 4.7849 |
| 75 mg BID Dexpramipexole | Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 12 | -3.14 parts per billion | Standard Error 4.3651 |
| 150 mg BID Dexpramipexole | Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 12 | -4.86 parts per billion | Standard Error 4.2175 |
Comparison: The 150 mg BID dexpramipexole group was compared to placebo using 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.p-value: 0.188695% CI: [-20.6, 4.13]Mixed Models Analysis
Comparison: The 75mg BID dexpramipexole group was compared to placebo using 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.p-value: 0.306195% CI: [-19.1, 6.08]Mixed Models Analysis
Comparison: The 37.5 mg BID dexpramipexole group was compared to placebo using 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.p-value: 0.129495% CI: [-23.4, 3.04]Mixed Models Analysis
Other Pre-specified
Change in Nasal Eosinophil Peroxidase (Presented as Ratio to Protein) From Baseline to Week 12
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.
Time frame: Baseline, Week 12
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo BID | Change in Nasal Eosinophil Peroxidase (Presented as Ratio to Protein) From Baseline to Week 12 | 0.833 ratio to baseline |
| 37.5 mg BID Dexpramipexole | Change in Nasal Eosinophil Peroxidase (Presented as Ratio to Protein) From Baseline to Week 12 | 0.645 ratio to baseline |
| 75 mg BID Dexpramipexole | Change in Nasal Eosinophil Peroxidase (Presented as Ratio to Protein) From Baseline to Week 12 | 0.174 ratio to baseline |
| 150 mg BID Dexpramipexole | Change in Nasal Eosinophil Peroxidase (Presented as Ratio to Protein) From Baseline to Week 12 | 0.110 ratio to baseline |
Comparison: The 150 mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.p-value: 0.0196Wilcoxon (Mann-Whitney)
Comparison: The 75mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.p-value: 0.0207Wilcoxon (Mann-Whitney)
Comparison: The 37.5 mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.p-value: 0.5399Wilcoxon (Mann-Whitney)