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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIncyte Corporation

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • povorcitinib
  • placebo
  • ICS-LABA

Treatment groups

240 Participants
are divided into 4 treatment groups

Sponsors and collaborators