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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Moderate to Severe Asthma

In brief

The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function

Key facts

Study ID

NCT05851443

Run by

Incyte Corporation

People needed

247

Starts

2023-07-11

Expected to finish

2027-07-05

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Kouwa Clinic — Toshima-ku, Japan
• Allervie Clinical Research — Birmingham, Alabama, United States
• Kern Allergy Medical Clinic, Inc — Bakersfield, California, United States
• Integrated Research of Inland, Inc — Upland, California, United States
• Qway Research — Hialeah, Florida, United States
• Direct Helpers Research Center — Hialeah, Florida, United States
• Care Research Inc — Miami, Florida, United States
• Verus Clinical Research Corp — Miami, Florida, United States
• Dr. de Armas Research Center, Llc — Miami, Florida, United States
• Care Research Center, Inc — Miami, Florida, United States
• Anderson Allergy and Asthma — Orlando, Florida, United States
• Heuer Md Research Inc — Orlando, Florida, United States
• Advanced Clinical Research Atlanta — Atlanta, Georgia, United States
• Covenant Pulmonary Critical Care — East Point, Georgia, United States
• Northshore Medical Group — Glenview, Illinois, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Aa Medical Research Center — Flint, Michigan, United States
• Revive Research Institute — Southfield, Michigan, United States
• Northwell Health Physician Partners — New Hyde Park, New York, United States
• Pioneer Clinical Research Ny — New York, New York, United States
• Montefiore Medical Center (Mmc) — The Bronx, New York, United States
• Onsite Clinical Solutions, Llc Charlotte Central Office — Charlotte, North Carolina, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Clinical Research of Rock Hill — Rock Hill, South Carolina, United States
• Takahashi Medical Clinic — Tokyo, Japan

Full record on ClinicalTrials.gov

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