RECRUITING

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

Conditions

Moderate to Severe Asthma Asthma Moderate to Severe INCB54707 Povorcitinib ICS-LABA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-07-11

Study Completion:2026-05-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05851443

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463

medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423

eumedinfo@incyte.com

Study Locations (Sites)

Allervie Clinical Research

Birmingham, Alabama, 35209

United States

Kern Allergy Medical Clinic, Inc

Bakersfield, California, 93301

United States

Integrated Research of Inland, Inc

Upland, California, 91786

United States

Qway Research

Hialeah, Florida, 33010

United States

Direct Helpers Research Center

Hialeah, Florida, 33012

United States

Care Research Inc

Miami, Florida, 33130

United States

Verus Clinical Research Corp

Miami, Florida, 33135

United States

Dr. de Armas Research Center, Llc

Miami, Florida, 33174

United States

Care Research Center, Inc

Miami, Florida, 33175

United States

Anderson Allergy and Asthma

Orlando, Florida, 32806

United States

Heuer Md Research Inc

Orlando, Florida, 32819

United States

Advanced Clinical Research Atlanta

Atlanta, Georgia, 30309

United States

Covenant Pulmonary Critical Care

East Point, Georgia, 30344

United States

Northshore Medical Group

Glenview, Illinois, 60026

United States

Henry Ford Hospital

Detroit, Michigan, 48202

United States

Aa Medical Research Center

Flint, Michigan, 48504

United States

Revive Research Institute

Southfield, Michigan, 48075

United States

Montefiore Medical Center (Mmc)

Bronx, New York, 10461

United States

Northwell Health Physician Partners

New Hyde Park, New York, 11040

United States

Pioneer Clinical Research Ny

New York, New York, 10016

United States

Onsite Clinical Solutions, Llc Charlotte Central Office

Charlotte, North Carolina, 28277

United States

Temple University Hospital

Philadelphia, Pennsylvania, 19140

United States

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732

United States

Howland Allergy and Asthma Pllc Dba Orion Clinical Research

Austin, Texas, 78759

United States

Linq Research, Llc

Pearland, Texas, 77584

United States

Quality Assurance Research Center

San Antonio, Texas, 78207

United States

Collaborators and Investigators

Sponsor: Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-11

Study Completion Date2026-05-29

Study Record Updates

Study Start Date2023-07-11

Study Completion Date2026-05-29

Terms related to this study

Keywords Provided by Researchers

Asthma
Moderate to Severe
INCB54707
Povorcitinib
ICS-LABA

Additional Relevant MeSH Terms

Moderate to Severe Asthma