A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma
- 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
- 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.
- 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)
Centro Medico Dharma
🇦🇷Mendoza, Argentina
Idaimae Minami Yojo Int Clinic
🇯🇵Sapporo, Japan
Tokyo Shinagawa Hospital
🇯🇵Shinagawa-ku, Japan
Takahashi Medical Clinic
🇯🇵Tokyo, Japan
Kouwa Clinic
🇯🇵Toshima-ku, Japan
Local Independent Administrative Institution Mie Prefectural General Medical Center
🇯🇵Yokkaichi-shi, Japan
Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
🇯🇵Yokohama, Japan
Allergy Clinic Homeo Medicus
🇵🇱Bialystok, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Nzoz Atopia
🇵🇱Krakow, Poland
Szpital Specjalistyczny Cdt Medicus
🇵🇱Lubin, Poland
Ostrowieckie Centrum Medyczne Spka Cywilna Anna Olech-Cudzik Krzysztof Cudzik
🇵🇱Ostrowiec Swietokrzyski, Poland
Pim Mswia
🇵🇱Warszawa, Poland
Giromed Institute/ Clinica Tres Torrres
🇪🇸Barcelona, Spain
Hospital Clinic Barcelona Main
🇪🇸Barcelona, Spain
Complejo Hospitalario Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, Spain
Instituto de Medicina Respiratoria - Imer
🇦🇷Cordoba, Argentina
National Hospital Organization Fukuoka National Hospital
🇯🇵Fukuoka City, Japan
Kishiwada City Hospital
🇯🇵Kishiwada, Japan
Kirigaoka Tsuda Hospital
🇯🇵Kitakyushu-shi, Japan
Tohno Chuo Clinic
🇯🇵Mizunami-shi, Japan
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
Anderson Allergy and Asthma
🇺🇸Orlando, Florida, United States
Heuer Md Research Inc
🇺🇸Orlando, Florida, United States
Advanced Clinical Research Atlanta
🇺🇸Atlanta, Georgia, United States
Covenant Pulmonary Critical Care
🇺🇸East Point, Georgia, United States
Northshore Medical Group
🇺🇸Glenview, Illinois, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Aa Medical Research Center
🇺🇸Flint, Michigan, United States
Revive Research Institute
🇺🇸Southfield, Michigan, United States
Montefiore Medical Center (Mmc)
🇺🇸Bronx, New York, United States
Northwell Health Physician Partners
🇺🇸New Hyde Park, New York, United States
Pioneer Clinical Research Ny
🇺🇸New York, New York, United States
Onsite Clinical Solutions, Llc Charlotte Central Office
🇺🇸Charlotte, North Carolina, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Research of Rock Hill
🇺🇸Rock Hill, South Carolina, United States
Howland Allergy and Asthma Pllc Dba Orion Clinical Research
🇺🇸Austin, Texas, United States
Linq Research, Llc
🇺🇸Pearland, Texas, United States
Quality Assurance Research Center
🇺🇸San Antonio, Texas, United States
Fundacion Respirar
🇦🇷Buenos Aires, Argentina
Fundacion Cidea
🇦🇷Buenos Aires, Argentina
Mautalen Salud E Investigacion
🇦🇷Caba, Argentina
Care: Centro de Alergia Y Enfermedades Respiratorias
🇦🇷Caba, Argentina
INAER
🇦🇷Capitalfederal, Argentina
Centro de Medicina Respiratoria
🇦🇷Concepcion Del Uruguay, Argentina
Ierim Instituto de Enfermedades Respiratorias E Investigacion Medica
🇦🇷Florencio Varela, Argentina
CIMEL
🇦🇷Lanus ESTE, Argentina
Fundacion Enfisema
🇦🇷Mar Del Plata, Argentina
Office of Pedro Carlos Elias, Md
🇦🇷Mendoza, Argentina
Polo de Salud Vistalba
🇦🇷Mendoza, Argentina
Fundacion Scherbovsky
🇦🇷Mendoza, Argentina
Centro Respiratorio Quilmes
🇦🇷Quilmes, Argentina
Centro Respiratorio Infantil
🇦🇷Rosario, Argentina
Instituto de Diagnostico Abc
🇦🇷Rosario, Argentina
Instituto Especialidades de La Salud Rosario
🇦🇷Rosario, Argentina
Instituto Medico de La Fundacion Estudios Clinicos
🇦🇷Rosario, Argentina
Centro Medico Respire
🇦🇷San Fernando, Argentina
Cimer - Centro Integral de Medicina Respiratoria Srl
🇦🇷San Miguel de Tucuman, Argentina
Ipr Instituto de Patologias Respiratorias
🇦🇷San Miguel de Tucumán, Argentina
Iba Medica
🇦🇷Santa Fe, Argentina
Synergy Respiratory Care
🇨🇦Sherwood Park, Alberta, Canada
Centre For Lung Health
🇨🇦Vancouver, British Columbia, Canada
Dynamic Drug Advancement
🇨🇦Ajax, Ontario, Canada
Ottawa Allergy Research Corporation
🇨🇦Ottawa, Ontario, Canada
S. Fikry Medicine Professional Corporation
🇨🇦Waterloo, Ontario, Canada
Dr. Syed Anees Medicine Professional Corporation
🇨🇦Windsor, Ontario, Canada
Pneumologische Gemeinschaftspraxis Kroker-Schaeben-Schmidt
🇩🇪Bendorf, Germany
Universitatsklinikum Bonn Aoer
🇩🇪Bonn, Germany
Ikf Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
🇩🇪Frankfurt Am Main, Germany
Hannover Medical School
🇩🇪Hannover, Germany
Ikf Pneumologie Mainz
🇩🇪Mainz, Germany
Nihonbashi Medical and Allergy Clinic
🇯🇵Chuo-ku, Japan
Fukuwa Clinic
🇯🇵Chuo-ku, Japan
Kyosokai Amc Nishi-Umeda Clinic
🇯🇵Osaka-shi, Japan
Lee Clinic
🇯🇵Osaka-shi, Japan
Sakaide City Hospital
🇯🇵Sakaide-shi, Japan