A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma
Moderate to Severe AsthmaThe study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 to 65
Participation Criteria
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
Study Location
Centre For Lung Health
Centre For Lung HealthVancouver, British Columbia
Canada
Contact Study Team
Dr. Syed Anees Medicine Professional Corporation
Dr. Syed Anees Medicine Professional CorporationWindsor, Ontario
Canada
Contact Study Team
Synergy Respiratory Care
Synergy Respiratory CareSherwood Park, Alberta
Canada
Contact Study Team
S. Fikry Medicine Professional Corporation
S. Fikry Medicine Professional CorporationWaterloo, Ontario
Canada
Contact Study Team
Dynamic Drug Advancement
Dynamic Drug AdvancementAjax, Ontario
Canada
Contact Study Team
Ottawa Allergy Research Corporation
Ottawa Allergy Research CorporationOttawa, Ontario
Canada
Contact Study Team
- Study Sponsored By
- Incyte Corporation
- Participants Required
- More Information
- Study ID:
NCT05851443