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

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Incyte

Status and phase

Enrolling
Phase 2

Conditions

Moderate to Severe Asthma

Treatments

Drug: ICS-LABA
Other: placebo
Drug: povorcitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05851443
INCB54707-208

Details and patient eligibility

About

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

Enrollment

240 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

240 participants in 4 patient groups, including a placebo group

Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo
Placebo Comparator group
Description:
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
Treatment:
Other: placebo
Drug: ICS-LABA
ICS-LABA + povorcitinib Dose 1
Experimental group
Description:
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
Treatment:
Drug: povorcitinib
Drug: ICS-LABA
ICS-LABA + povorcitinib Dose 2
Experimental group
Description:
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
Treatment:
Drug: povorcitinib
Drug: ICS-LABA
ICS-LABA + povorcitinib Dose 3
Experimental group
Description:
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
Treatment:
Drug: povorcitinib
Drug: ICS-LABA

Trial contacts and locations

85

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Central trial contact

Incyte Corporation Call Center (ex-US); Incyte Corporation Call Center (US)

Data sourced from clinicaltrials.gov

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