Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma

Completed · Phase 2 · Has a placebo group

Conditions studied: Eosinophilic Asthma, Asthma

In brief

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.

Key facts

Study ID: NCT04046939
Run by: Knopp Biosciences
People needed: 534
Starts: 2019-08-15
Expected to finish: 2021-03-02
Last updated by the study team: 2023-04-13

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Research Site — Los Angeles, California, United States
Research Site — Mission Viejo, California, United States
Research Site — Westminster, California, United States
Research Site — Denver, Colorado, United States
Research Site — Daytona Beach, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Tampa, Florida, United States
Research Site — Tampa, Florida, United States
Research Site — Lawrenceville, Georgia, United States
Research Site — Winder, Georgia, United States
Research Site — Boise, Idaho, United States
Research Site — Farmington Hills, Michigan, United States
Research site — Plymouth, Minnesota, United States
Research Site — St Louis, Missouri, United States
Research Site — St Louis, Missouri, United States
Research Site — Las Vegas, Nevada, United States
Research Site — New Brunswick, New Jersey, United States
Research Site — Corning, New York, United States
Research Site — New Hyde Park, New York, United States
Research Site — Raleigh, North Carolina, United States
Research Site — Winston-Salem, North Carolina, United States
Research Site — Cincinnati, Ohio, United States
Research Site — Cincinnati, Ohio, United States
Research Site — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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