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

Description

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

Conditions

Moderate to Severe Asthma

Study Overview

Study Details

Study overview

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

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma

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

Condition
Moderate to Severe Asthma
Intervention / Treatment

-

Contacts and Locations

Birmingham

Allervie Clinical Research, Birmingham, Alabama, United States, 35209

Bakersfield

Kern Allergy Medical Clinic, Inc, Bakersfield, California, United States, 93301

Upland

Integrated Research of Inland, Inc, Upland, California, United States, 91786

Hialeah

Qway Research, Hialeah, Florida, United States, 33010

Hialeah

Direct Helpers Research Center, Hialeah, Florida, United States, 33012

Miami

Care Research Inc, Miami, Florida, United States, 33130

Miami

Verus Clinical Research Corp, Miami, Florida, United States, 33135

Miami

Dr. de Armas Research Center, Llc, Miami, Florida, United States, 33174

Miami

Care Research Center, Inc, Miami, Florida, United States, 33175

Orlando

Anderson Allergy and Asthma, Orlando, Florida, United States, 32806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Incyte Corporation,

Study Record Dates

2026-05-29