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Evaluating the effects of povorcitinib on asthma control

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

Phase 2 Interventional Incyte Corporation · NCT05851443

This study is testing if a new medication called povorcitinib can help people with moderate to severe asthma breathe better and manage their symptoms more effectively than their current treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorIncyte Corporation Industry-sponsored
Drugs / interventionspovorcitinib
Locations83 sites (Birmingham, Alabama and 82 other locations)
Trial IDNCT05851443 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of povorcitinib in patients with inadequately controlled moderate to severe asthma. Participants will receive one of three dosing regimens of povorcitinib or a placebo, alongside their standard treatment of medium- to high-dose ICS-LABA. The primary focus is on assessing improvements in pulmonary function as measured by FEV1. The study aims to determine if povorcitinib can provide better asthma control compared to existing treatments.

Who should consider this trial

Good fit: Ideal candidates are individuals with physician-diagnosed moderate to severe asthma requiring medium- to high-dose ICS-LABA treatment and experiencing frequent exacerbations.

Not a fit: Patients who are currently using other asthma controllers or have undergone bronchial thermoplasty may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve asthma control and quality of life for patients with moderate to severe asthma.

How similar studies have performed: Other studies have shown promise with similar approaches in targeting asthma management, but the specific use of povorcitinib is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 82 other locations

+33 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Moderate to Severe AsthmaAsthmaModerate to SevereINCB54707PovorcitinibICS-LABA
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.