NCT05851443 A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma
| NCT ID | NCT05851443 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Incyte Corporation |
| Condition | Moderate to Severe Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-07-11 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 240 participants in total. It began in 2023-07-11 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05851443 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Moderate to Severe Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05851443 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05851443 currently recruiting?
Yes, NCT05851443 is actively recruiting participants. Contact the research team at medinfo@incyte.com for enrollment information.
Where is the NCT05851443 trial being conducted?
This trial is being conducted at Birmingham, United States, Bakersfield, United States, Upland, United States, Hialeah, United States and 11 additional locations.
Who is sponsoring the NCT05851443 clinical trial?
NCT05851443 is sponsored by Incyte Corporation. The trial plans to enroll 240 participants.
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