A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic… (NCT05763121) | Clinical Trial Compass
TerminatedPhase 3
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.
Stopped: Program stopped due to the benefit risk profile no longer supports further development in the intended patient population.
United States1,061 participantsStarted 2023-01-30
Plain-language summary
This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an eosinophilic phenotype and a history of asthma exacerbations.
Who can participate
Age range12 Years – 99 Years
SexALL
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Inclusion criteria
✓. Signed informed consent form and assent form, as appropriate
✓. Male or female ≥12 years of age at Screening Visit 1
✓. Documented physician diagnosis of asthma for ≥12 months prior to Screening Visit 1.
✓. Treatment of asthma, participants must satisfy all the below (items a to c):
✓. Participants who have received asthma controller medication with medium or high dose inhaled corticosteroids (ICS; ≥500 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per Global Initiative for Asthma (GINA) 2021) on a regular basis for at least 12 months prior to Screening Visit 1.
✓. Documented treatment with a stable dose of either medium or high dose ICS for at least 3 months prior to Screening Visit 1. The ICS may be contained within an ICS/LABA (long-acting β2 agonist) combination product. Daily oral corticosteroids are an allowed concomitant medication; participants on daily oral corticosteroids must be on a stable dose for 3 months before Screening Visit 1.
✓. Use of one of more additional daily maintenance asthma controller medications according to standard practice of care is required. Use of a stable dose of any additional asthma controller medications must be documented for at least 3 months prior to Screening Visit 1.
✓. Pre-bronchodilator forced expiratory volume (Pre-BD FEV₁) ≥40% and \<80% (\<90% for participants 12 to 17 years of age) of predicted at Screening Visit 2.
Exclusion criteria
✕. A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids) at any time from 4 weeks prior to Screening Visit.
What they're measuring
1
Annualized rate of severe asthma exacerbations over 52 weeks.
Timeframe: Day 1 (baseline, pre-dose) through Week 52
✕. Current diagnosis of diseases which may confound interpretation of this study's findings such as allergic bronchopulmonary aspergillosis, eosinophilic granulomatosis with polyangiitis, eosinophilic gastrointestinal diseases, hypereosinophilic syndrome, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis.
✕. Respiratory infection: Upper or lower respiratory tract, sinus, or middle ear infection within the 4 weeks before Screening Visit 1.
✕. For participants aged 12 to 17 years old, AEC of \<0.15x10⁹/L at Screening Visit 1.
✕. Treatment with a biologic investigational drug in the last 5 months prior to Screening Visit 1. Treatment with non-biologic investigational drugs in the previous 30 days or five-half-lives prior to Screening Visit 1, whichever is longer. Treatment with GSK3511294 (long-acting anti-IL-5) in the past 12 months.
✕. Treatment with any of the following monoclonal antibody therapies within 120 days prior to Baseline Visit: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab.
✕. Treatment with pramipexole (Mirapex®) within 30 days of Baseline Visit.
✕. Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days prior to Screening Visit 1.