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Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma (EXHALE-1)

K

Knopp Biosciences

Status and phase

Completed
Phase 2

Conditions

Asthma
Eosinophilic Asthma

Treatments

Drug: Dexpramipexole
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04046939
KNS-760704-AS201

Details and patient eligibility

About

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.

Full 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.

Enrollment

534 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

534 participants in 4 patient groups, including a placebo group

placebo BID
Placebo Comparator group
Description:
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Treatment:
Drug: Placebo
37.5 mg BID dexpramipexole
Active Comparator group
Description:
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Treatment:
Drug: Dexpramipexole
75 mg BID dexpramipexole
Active Comparator group
Description:
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Treatment:
Drug: Dexpramipexole
150 mg BID dexpramipexole
Active Comparator group
Description:
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Treatment:
Drug: Dexpramipexole

Trial documents
2

Trial contacts and locations

36

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Data sourced from clinicaltrials.gov

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