About this trial
The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Physician-diagnosed asthma requiring treatment with medium- to high-dose ICS-LABA for at least 12 months prior to screening.
Pre-BD FEV1 < 80% predicted according to central over read value at Visit 2.
Documented historical post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL in FEV1.
At least 2 documented asthma exacerbations (requiring treatment with systemic CS, hospitalization, or emergency department visit) within 12 months prior to screening but not within the past 4 weeks prior to screening
Disqualifiers
Maintenance use of asthma controllers other than ICS-LABA.
Have undergone bronchial thermoplasty.
Current smokers or participants with a smoking history of ≥ 10 pack-years and participants using vaping products, including electronic cigarettes.
Women who are pregnant (or who are considering pregnancy) or breastfeeding.
Trial design
Parallel
Treatments tested in this trial
povorcitinib
Drugpovorcitinib
placebo
Other interventionplacebo
ICS-LABA
DrugBackground Therapy
Treatment groups
Trial outcomes
Primary outcomes
Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1)
To assess the effect of povorcitinib on lung function (pre-BD FEV1) between baseline and week 24
Secondary outcomes
Number of asthma exacerbations during the Placebo Controlled (PC) period
Defined as a worsening of asthma
Absolute change from baseline in pre-BD FEV1 at each visit
Percent change from baseline in pre-BD FEV1 at each visit
Absolute change from baseline in post-BD FEV1 at week 24
Sponsors and contacts
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