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

Purpose

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

Condition

  • Moderate to Severe Asthma

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo 		Participants will receive stable background therapy with ICS-LABA in combination with placebo once daily (QD) for 24 weeks during the placebo-controlled period. Participants will be allocated to 1 of 3 doses of povorcitinib during the extension period of 28 weeks
  • Other: placebo
    placebo
  • Drug: ICS-LABA
    Background Therapy
Experimental
ICS-LABA + povorcitinib Dose 1 		Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 1 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
  • Drug: povorcitinib
    povorcitinib
    Other names:
    • INCB54707
  • Drug: ICS-LABA
    Background Therapy
Experimental
ICS-LABA + povorcitinib Dose 2 		Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 2 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
  • Drug: povorcitinib
    povorcitinib
    Other names:
    • INCB54707
  • Drug: ICS-LABA
    Background Therapy
Experimental
ICS-LABA + povorcitinib Dose 3 		Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 3 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
  • Drug: povorcitinib
    povorcitinib
    Other names:
    • INCB54707
  • Drug: ICS-LABA
    Background Therapy

Recruiting Locations

Kern Allergy Medical Clinic, Inc
Bakersfield 5325738, California 5332921 93301

Qway Research
Hialeah 4158476, Florida 4155751 33010

Direct Helpers Research Center
Hialeah 4158476, Florida 4155751 33012

Care Research Inc
Miami 4164138, Florida 4155751 33130

Verus Clinical Research Corp
Miami 4164138, Florida 4155751 33135

Howland Allergy and Asthma Pllc Dba Orion Clinical Research
Austin 4671654, Texas 4736286 78759

Linq Research, Llc
Pearland 4718097, Texas 4736286 77584

Quality Assurance Research Center
San Antonio 4726206, Texas 4736286 78212

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com