A Study of Dexpramipexole in adolescents and adults with eosinophilic asthma (EXHALE-4)

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The company Areteia Therapeutics is commencing recruitment for the clinical trial of the A 24-week Clinical Trial to Study the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma.

The trial that takes place in several serearch sites in the USA officially began on the January 30, 2023 and is planned to complete on July 2024.

The purpose of this study is to evaluate dexpramipexole as an add-on oral therapy in participants with inadequately controlled eosinophilic asthma to evaluate improvements in lung function, asthma control, and quality of life. In addition, the study will further evaluate the safety and tolerability of dexpramipexole in participants with eosinophilic asthma.

The population that can be enrolled into this study includes: 

  1. Male or female ≥12 years of age at randomization who signed a written infromed consent to participate.

    Asthma-related criteria

  2. Documented physician diagnosis of asthma for ≥12 months.
  3. Participants requiring at a minimum daily low dose inhaled corticosteroids (ICS; ≥100 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per GINA 2021), plus one or more additional daily maintenance asthma controller medications, eg, long-acting β2 agonist (LABA), leukotriene antagonist, theophylline, long-acting muscarinic antagonists, cromolyn/nedocromil. Use of daily ICS must be for at least 12 weeks prior to Screening Visit 1 and the doses of all controller medications must be stable for at least 4 weeks prior to Screening Visit 1.
  4. Pre-BD FEV1 ≥40% and <80% of predicted at Screening.
  5. Bronchodilator reversibility, as evidenced by ≥12% and ≥200 mL improvement in FEV1, 15 to 30 minutes following inhalation of 400 μg (four puffs) of albuterol/salbutamol (≥12% and ≥160 mL for ages 12 to 17).Participants who do not meet the bronchodilator reversibility inclusion criterion but have ≥10% and ≥160 mL reversibility, may repeat the reversibility spirometry assessment once during the Screening Period, at an unscheduled visit at least 7 days prior to baseline.
  6. ACQ-6 ≥1.5 at Screening.
  7. Eosinophil count of ≥0.30x10⁹/L at Screening Visit 1. If the initial value is between 0.250x10⁹/L to 0.299x10⁹/L, then this may be repeated once at an unscheduled visit (prior to Screening Visit 2).
  8. Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at Screening and Baseline.

 

For exclusion criteria and research sites contact details kindly follow the link: https://ichgcp.net/clinical-trials-registry/NCT05748600

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