A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma

Korábbi kezelés

• Recipient of an organ transplant that requires continued immunosuppression.
• Receipt of any biologic drugs used for asthma < 12 weeks or 5 half-lives (if known), whichever is longer, prior to screening

Más betegség

• Current smokers or participants with a smoking history of ≥ 10 pack-years and participants using vaping products, including electronic cigarettes.
• Current conditions or history of other diseases, as follows:
• 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.
• Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
• Any malignancies or history of malignancies.
• Chronic or recurrent infectious disease.

Laborértékek

• Clinically important pulmonary disease other than asthma ,Thrombocytopenia, coagulopathy, or platelet dysfunction.

Egyéb

• Maintenance use of asthma controllers other than ICS-LABA.
• Have undergone bronchial thermoplasty.
• Women who are pregnant (or who are considering pregnancy) or breastfeeding.

• 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.