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NCT Number: NCT05851443

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fundacion Cidea, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Povorcitinib

Drug

povorcitinib

Other names: INCB54707

Placebo

Other

placebo

ICS-LABA

Drug

Background Therapy

Primary outcomes

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

    Time frame: Baseline ; Week 24

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

Secondary outcomes

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

    Time frame: Up to 28 weeks

    Defined as a worsening of asthma

  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

  5. Percent change from baseline in post-BD FEV1 at week 24

    Time frame: Baseline; Week 24

  6. Absolute change from baseline in pre-BD FVC at each visit

    Time frame: Up to 14 months

  7. Percent change from baseline in pre-BD FVC at each visit

    Time frame: Up to 14 months

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 9, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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