Status:
RECRUITING
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma
Lead Sponsor:
Incyte Corporation
Conditions:
Moderate to Severe Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function
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
Key Trial Info
Start Date :
July 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05851443
Start Date
July 11 2023
End Date
January 31 2027
Last Update
April 14 2026
Active Locations (83)
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1
Allervie Clinical Research
Birmingham, Alabama, United States, 35209
2
Kern Allergy Medical Clinic, Inc
Bakersfield, California, United States, 93301
3
Integrated Research of Inland, Inc
Upland, California, United States, 91786
4
Qway Research
Hialeah, Florida, United States, 33010