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

Recruiting

• Conditions: Moderate to Severe Asthma

• Registration Number: jRCT2031230185
• Lead Sponsor: Incyte Biosciences Japan G.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-27
• Study Start: 2023-07-21
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Physician-diagnosed asthma requiring treatment with medium- to high-dose ICS-LABA for at least 12 months prior to screening. 2.Pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1) < 80% predicted according to central over read value at Visit 2.
2. Documented historical post-BD reversibility of FEV1 >= 12% and >= 200 mL in FEV1.
3. At least 2 documented asthma exacerbations (requiring treatment with systemic corticosteroid (CS), hospitalization, or emergency department visit) within 12 months prior to screening but not within the past 4 weeks prior to screening.
4. ACQ-6 >= 1.5 at screening.

Exclusion Criteria

1. Maintenance use of asthma controllers other than ICS-LABA.
2. Have undergone bronchial thermoplasty.
3. Current smokers or participants with a smoking history of >= 10 pack-years and participants using vaping products, including electronic cigarettes.
4. Women who are pregnant (or who are considering pregnancy) or breastfeeding.
5. 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.

6. Receipt of any biologic drugs used for asthma < 12 weeks or 5 half-lives (if known), whichever is longer, prior to screening.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		Absolute change in pre-BD FEV1 [ Time Frame: Baseline ; Week 24 ]