The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function
Eligibility
Sex
ALL
Min age
18 Years
Max age
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
Primary outcome measure(s)
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
Trial sites (82)
Facility
City
Region
Status
Allervie Clinical Research
Birmingham
Alabama
Kern Allergy Medical Clinic, Inc
Bakersfield
California
Integrated Research of Inland, Inc
Upland
California
Qway Research
Hialeah
Florida
Direct Helpers Research Center
Hialeah
Florida
Care Research Inc
Miami
Florida
Verus Clinical Research Corp
Miami
Florida
Dr. de Armas Research Center, Llc
Miami
Florida
Care Research Center, Inc
Miami
Florida
Anderson Allergy and Asthma
Orlando
Florida
Heuer Md Research Inc
Orlando
Florida
Advanced Clinical Research Atlanta
Atlanta
Georgia
Covenant Pulmonary Critical Care
East Point
Georgia
Northshore Medical Group
Glenview
Illinois
Henry Ford Hospital
Detroit
Michigan
Aa Medical Research Center
Flint
Michigan
Revive Research Institute
Southfield
Michigan
Northwell Health Physician Partners
New Hyde Park
New York
Pioneer Clinical Research Ny
New York
New York
Montefiore Medical Center (Mmc)
The Bronx
New York
Onsite Clinical Solutions, Llc Charlotte Central Office
Charlotte
North Carolina
Temple University Hospital
Philadelphia
Pennsylvania
Clinical Research of Rock Hill
Rock Hill
South Carolina
Howland Allergy and Asthma Pllc Dba Orion Clinical Research
Austin
Texas
Linq Research, Llc
Pearland
Texas
Quality Assurance Research Center
San Antonio
Texas
Fundacion Respirar
Buenos Aires
Argentina
Fundacion Cidea
Buenos Aires
Argentina
Mautalen Salud E Investigacion
Buenos Aires
Argentina
Care: Centro de Alergia Y Enfermedades Respiratorias
CABA
Argentina
INAER
Capitalfederal
Argentina
Centro de Medicina Respiratoria
Concepción del Uruguay
Argentina
Instituto de Medicina Respiratoria - Imer
Córdoba
Argentina
Fundacion Enfisema
Mar del Plata
Argentina
Centro Medico Dharma
Mendoza
Argentina
Polo de Salud Vistalba
Mendoza
Argentina
Fundacion Scherbovsky
Mendoza
Argentina
INSARES
Mendoza
Argentina
Centro Respiratorio Quilmes
Quilmes
Argentina
Centro Respiratorio Infantil
Rosario
Argentina
+ 42 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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