Phase 2
N=534
Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma
Eosinophilic Asthma · Asthma
Bottom Line
View on ClinicalTrials.gov: NCT04046939 ↗Enrolled (actual)
534
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Change in Blood Absolute Eosinophil Count From Baseline to Week 12 — 0.8980; 0.4031; 0.3056; 0.2051 ratio to baseline — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dexpramipexole (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Knopp Biosciences
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Blood Absolute Eosinophil Count From Baseline to Week 12 |
0.8980; 0.4031; 0.3056; 0.2051 | <.0001 sig |
| SECONDARY Change in Pre-bronchodilator FEV1 (Liters) From Baseline to Week 12 |
0.0700; 0.208; 0.0557; 0.247; 0.151 | 0.4154 |
| SECONDARY Change in Asthma Control Questionnaire (ACQ-6) Score From Baseline to Week 12 |
-0.391; -0.419; -0.437; -0.655 | 0.3059 |
| SECONDARY Change in Post-bronchodilator FEV1 From Baseline to Week 12 |
-0.00546; 0.0932; -0.000717; 0.176 | 0.0716 |
| SECONDARY Change in Quality of Life, as Measured by the Asthma Quality of Life Questionnaire (AQLQ) From Baseline to Week 12 |
0.376; 0.531; 0.312; 0.584 | 0.4512 |
| SECONDARY Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12 |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12 |
1; 2; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12 |
0; 0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04046939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.