Clinical Trials in the USA / 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 USA tracker
Condition(s) studied
Moderate to Severe Asthma
Investigational drug(s) / intervention(s)
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
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.
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Recruiting
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 the USA