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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • povorcitinib

    Drug

    povorcitinib

  • placebo

    Other intervention

    placebo

  • ICS-LABA

    Drug

    Background Therapy

Treatment groups

240 Participants
are divided into 4 treatment groups
Group A: Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placeboPlacebo comparator 2 interventions
Group B: ICS-LABA + povorcitinib Dose 1Experimental treatment 2 interventions
Group C: ICS-LABA + povorcitinib Dose 2Experimental treatment 2 interventions
Group D: ICS-LABA + povorcitinib Dose 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1)

To assess the effect of povorcitinib on lung function (pre-BD FEV1) between baseline and week 24

Time frame
Baseline ; Week 24

Secondary outcomes

1

Number of asthma exacerbations during the Placebo Controlled (PC) period

Defined as a worsening of asthma

Time frame
Up to 28 weeks
2

Absolute change from baseline in pre-BD FEV1 at each visit

Time frame
Up to 14 months
3

Percent change from baseline in pre-BD FEV1 at each visit

Time frame
Up to 14 months
4

Absolute change from baseline in post-BD FEV1 at week 24

Time frame
Baseline; Week 24

Other outcomes

Sponsors and contacts

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