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Clinical Trials in Poland / NCT05851443
Active, not recruiting Phase 2

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

NCT05851443 · tracked via the Priya Life Science Poland tracker
Phase
Phase 2
Started
2023-07-11
Last updated
2026-07-07

Condition(s) studied

Moderate to Severe Asthma

Investigational drug(s) / intervention(s)

povorcitinib →placeboICS-LABA →

povorcitinib: povorcitinib

placebo: placebo

ICS-LABA: Background Therapy

Study summary

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)

Trial sites (82)

FacilityCityRegionStatus
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.

More Incyte Corporation trials in Poland

Official registry record

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.

View NCT05851443 on ClinicalTrials.gov ↗ ← All trials in Poland