A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma
Phase 2
Recruiting
- Conditions
- Moderate to Severe Asthma
- Interventions
- Registration Number
- NCT05851443
- Lead Sponsor
- Incyte Corporation
- Brief Summary
The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ICS-LABA + povorcitinib Dose 1 ICS-LABA Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 1 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks ICS-LABA + povorcitinib Dose 2 povorcitinib Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 2 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo placebo Participants will receive stable background therapy with ICS-LABA in combination with placebo once daily (QD) for 24 weeks during the placebo-controlled period. Participants will be allocated to 1 of 3 doses of povorcitinib during the extension period of 28 weeks Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo ICS-LABA Participants will receive stable background therapy with ICS-LABA in combination with placebo once daily (QD) for 24 weeks during the placebo-controlled period. Participants will be allocated to 1 of 3 doses of povorcitinib during the extension period of 28 weeks ICS-LABA + povorcitinib Dose 2 ICS-LABA Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 2 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks ICS-LABA + povorcitinib Dose 3 povorcitinib Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 3 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks ICS-LABA + povorcitinib Dose 1 povorcitinib Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 1 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks ICS-LABA + povorcitinib Dose 3 ICS-LABA Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 3 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
- Primary Outcome Measures
Name Time Method Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1) Baseline ; Week 24 To assess the effect of povorcitinib on lung function (pre-BD FEV1) between baseline and week 24
- Secondary Outcome Measures
Name Time Method Percent change from baseline in pre-BD FEV1 at each visit Up to 14 months Number of asthma exacerbations during the Placebo Controlled (PC) period Up to 28 weeks Defined as a worsening of asthma
Absolute change from baseline in pre-BD FEV1 at each visit Up to 14 months Percent change from baseline in post-BD FEV1 at week 24 Baseline; Week 24 Percent change from baseline in pre-BD FVC at each visit Up to 14 months Absolute change from baseline in post-BD FEV1 at week 24 Baseline; Week 24 Absolute change from baseline in pre-BD FVC at each visit Up to 14 months
Trial Locations
- Locations (84)
INSARES
🇦🇷Mendoza, Argentina
Allervie Clinical Research
🇺🇸Birmingham, Alabama, United States
Kern Allergy Medical Clinic, Inc
🇺🇸Bakersfield, California, United States
Integrated Research of Inland, Inc
🇺🇸Upland, California, United States
Qway Research
🇺🇸Hialeah, Florida, United States
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
Care Research Inc
🇺🇸Miami, Florida, United States
Verus Clinical Research Corp
🇺🇸Miami, Florida, United States
Dr. de Armas Research Center, Llc
🇺🇸Miami, Florida, United States
Care Research Center, Inc
🇺🇸Miami, Florida, United States
Scroll for more (74 remaining)INSARES🇦🇷Mendoza, Argentina