Moderate to Severe Asthma
Conditions
Keywords
Asthma, Moderate to Severe, INCB54707, Povorcitinib, ICS-LABA
Brief summary
The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function
Interventions
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 * ACQ-6 ≥ 1.5 at screening.
Exclusion criteria
* 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. * Current conditions or history of other diseases, as follows: * Clinically important pulmonary disease other than asthma ,Thrombocytopenia, coagulopathy, or platelet dysfunction. * Venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, moderate to severe heart failure (NYHA Class III or IV), cerebrovascular accident, myocardial infarction, coronary stenting, or CABG surgery. * Diagnosis of other significant cardiovascular diseases, including but not limited to angina, peripheral arterial disease, or uncontrolled arrhythmias such as atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, and forms of carditis. * Recipient of an organ transplant that requires continued immunosuppression. * Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome). * Any malignancies or history of malignancies. * Chronic or recurrent infectious disease. * Receipt of any biologic drugs used for asthma \< 12 weeks or 5 half-lives (if known), whichever is longer, prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1) | Baseline ; Week 24 | To assess the effect of povorcitinib on lung function (pre-BD FEV1) between baseline and week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of asthma exacerbations during the Placebo Controlled (PC) period | Up to 28 weeks | Defined as a worsening of asthma |
| Absolute change from baseline in pre-BD FEV1 at each visit | Up to 14 months | — |
| Percent change from baseline in pre-BD FEV1 at each visit | Up to 14 months | — |
| Absolute change from baseline in post-BD FEV1 at week 24 | Baseline; Week 24 | — |
| Percent change from baseline in post-BD FEV1 at week 24 | Baseline; Week 24 | — |
| Absolute change from baseline in pre-BD FVC at each visit | Up to 14 months | — |
| Percent change from baseline in pre-BD FVC at each visit | Up to 14 months | — |
Countries
Argentina, Canada, Germany, Japan, Poland, Spain, United States
Contacts
CONTACTIncyte Corporation Call Center (US)
CONTACTIncyte Corporation Call Center (ex-US)
Outcome results
None listed