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

Launched by INCYTE CORPORATION · May 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called povorcitinib to see how well it works and how safe it is for people with moderate to severe asthma that is not well controlled with current treatments. The researchers want to find out if different doses of this medication can improve lung function in participants. The trial is currently looking for volunteers aged 18 and older who have been diagnosed with asthma and have been using specific asthma treatments for at least a year. To qualify, potential participants should have had asthma attacks requiring medical attention in the past year, and their lung function tests should show a certain level of impairment.

Participants in this trial can expect to be monitored closely by healthcare professionals as they receive the medication. They will undergo various tests to check their lung function and overall health. It’s important to know that some people may not be eligible for this trial if they have certain health conditions, are current smokers, or are pregnant or breastfeeding. This study aims to discover new ways to help people manage their asthma better, which could lead to more effective treatments in the future.

Gender

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Eligibility 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