Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma

• Status: Completed
• Trial end date: 2021-03-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Knopp Biosciences
• Treatments: Pramipexole

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