Status:
COMPLETED
Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma
Lead Sponsor:
Knopp Biosciences
Conditions:
Eosinophilic Asthma
Asthma
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
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 perip...
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2021
Estimated Enrollment :
534 Patients enrolled
Trial Details
Trial ID
NCT04046939
Start Date
August 15 2019
End Date
March 2 2021
Last Update
April 13 2023
Active Locations (36)
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1
Research Site
Los Angeles, California, United States, 90048
2
Research Site
Mission Viejo, California, United States, 92691
3
Research Site
Westminster, California, United States, 92683
4
Research Site
Denver, Colorado, United States, 80230