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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 21 (83 locations)

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

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