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A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma

NCT05851443 · Incyte Corporation
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Official title
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
About this study
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
Study design
Enrollment target: 240 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-07-11
Estimated completion: 2027-01-31
Last updated: 2026-04-14
Interventions
Drug: povorcitinibOther: placeboDrug: ICS-LABA
Primary outcomes
  • Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1) (Baseline ; Week 24)
Sponsor
Incyte Corporation · industry
Contacts & investigators
ContactIncyte Corporation Call Center (US) · contact · medinfo@incyte.com · 1.855.463.3463
ContactIncyte Corporation Call Center (ex-US) · contact · eumedinfo@incyte.com · +800 00027423
All locations (83)
Allervie Clinical ResearchCompleted
Birmingham, Alabama, United States
Kern Allergy Medical Clinic, IncRecruiting
Bakersfield, California, United States
Integrated Research of Inland, IncCompleted
Upland, California, United States
Qway ResearchRecruiting
Hialeah, Florida, United States
Direct Helpers Research CenterRecruiting
Hialeah, Florida, United States
Care Research IncRecruiting
Miami, Florida, United States
Verus Clinical Research CorpRecruiting
Miami, Florida, United States
Dr. de Armas Research Center, LlcCompleted
Miami, Florida, United States
Care Research Center, IncCompleted
Miami, Florida, United States
Anderson Allergy and AsthmaCompleted
Orlando, Florida, United States
Heuer Md Research IncCompleted
Orlando, Florida, United States
Advanced Clinical Research AtlantaCompleted
Atlanta, Georgia, United States
Covenant Pulmonary Critical CareCompleted
East Point, Georgia, United States
Northshore Medical GroupCompleted
Glenview, Illinois, United States
Henry Ford HospitalCompleted
Detroit, Michigan, United States
Aa Medical Research CenterCompleted
Flint, Michigan, United States
Revive Research InstituteCompleted
Southfield, Michigan, United States
Northwell Health Physician PartnersCompleted
New Hyde Park, New York, United States
Pioneer Clinical Research NyCompleted
New York, New York, United States
Montefiore Medical Center (Mmc)Completed
The Bronx, New York, United States
Onsite Clinical Solutions, Llc Charlotte Central OfficeCompleted
Charlotte, North Carolina, United States
Temple University HospitalCompleted
Philadelphia, Pennsylvania, United States
Clinical Research of Rock HillCompleted
Rock Hill, South Carolina, United States
Howland Allergy and Asthma Pllc Dba Orion Clinical ResearchRecruiting
Austin, Texas, United States
Linq Research, LlcRecruiting
Pearland, Texas, United States
Quality Assurance Research CenterCompleted
San Antonio, Texas, United States
Fundacion RespirarRecruiting
Buenos Aires, Argentina
Fundacion CideaRecruiting
Buenos Aires, Argentina
Mautalen Salud E InvestigacionRecruiting
Buenos Aires, Argentina
Care: Centro de Alergia Y Enfermedades RespiratoriasRecruiting
CABA, Argentina
INAERRecruiting
Capitalfederal, Argentina
Centro de Medicina RespiratoriaRecruiting
Concepción del Uruguay, Argentina
Instituto de Medicina Respiratoria - ImerRecruiting
Córdoba, Argentina
Fundacion EnfisemaRecruiting
Mar del Plata, Argentina
Centro Medico DharmaRecruiting
Mendoza, Argentina
Polo de Salud VistalbaRecruiting
Mendoza, Argentina
Fundacion ScherbovskyRecruiting
Mendoza, Argentina
INSARESRecruiting
Mendoza, Argentina
Centro Respiratorio QuilmesRecruiting
Quilmes, Argentina
Centro Respiratorio InfantilRecruiting
Rosario, Argentina
Instituto de Diagnostico AbcRecruiting
Rosario, Argentina
Instituto Especialidades de La Salud RosarioRecruiting
Rosario, Argentina
Instituto Medico de La Fundacion Estudios ClinicosRecruiting
Rosario, Argentina
Centro Medico RespireRecruiting
San Fernando, Argentina
Ierim Instituto de Enfermedades Respiratorias E Investigacion MedicaRecruiting
San Juan Bautista, Argentina
Ipr Instituto de Patologias RespiratoriasRecruiting
San Miguel de Tucumán, Argentina
Cimer - Centro Integral de Medicina Respiratoria SrlRecruiting
San Miguel de Tucumán, Argentina
Iba MedicaRecruiting
Santa Fe, Argentina
Synergy Respiratory CareRecruiting
Sherwood Park, Alberta, Canada
Centre For Lung HealthCompleted
Vancouver, British Columbia, Canada
Dynamic Drug AdvancementRecruiting
Ajax, Ontario, Canada
Hamilton AllergyWithdrawn
Hamilton, Ontario, Canada
Ottawa Allergy Research CorporationCompleted
Ottawa, Ontario, Canada
S. Fikry Medicine Professional CorporationRecruiting
Waterloo, Ontario, Canada
Dr. Syed Anees Medicine Professional CorporationRecruiting
Windsor, Ontario, Canada
Pneumologische Gemeinschaftspraxis Kroker-Schaeben-SchmidtRecruiting
Bendorf, Germany
Universitatsklinikum Bonn AoerRecruiting
Bonn, Germany
Ikf Pneumologie Frankfurt, Clinical Research Center Respiratory DiseasesRecruiting
Frankfurt am Main, Germany
Hannover Medical SchoolRecruiting
Hanover, Germany
Ikf Pneumologie MainzRecruiting
Mainz, Germany
Nihonbashi Medical and Allergy ClinicCompleted
Chūōku, Japan
Fukuwa ClinicRecruiting
Chūōku, Japan
National Hospital Organization Fukuoka National HospitalRecruiting
Fukuoka, Japan
Kishiwada City HospitalRecruiting
Kishiwada, Japan
Kirigaoka Tsuda HospitalRecruiting
Kitakyushu-shi, Japan
Tohno Chuo ClinicRecruiting
Mizunami-shi, Japan
Kyosokai Amc Nishi-Umeda ClinicCompleted
Osaka, Japan
Lee ClinicCompleted
Osaka, Japan
Sakaide City HospitalRecruiting
Sakaide-shi, Japan
Idaimae Minami Yojo Int ClinicCompleted
Sapporo, Japan
Tokyo Shinagawa HospitalRecruiting
Shinagawa-ku, Japan
Takahashi Medical ClinicCompleted
Tokyo, Japan
Kouwa ClinicCompleted
Toshima-ku, Japan
Local Independent Administrative Institution Mie Prefectural General Medical CenterRecruiting
Yokkaichi-shi, Japan
Kaiseikai Kita Shin Yokohama Internal Medicine ClinicCompleted
Yokohama, Japan
Allergy Clinic Homeo MedicusRecruiting
Bialystok, Poland
Uniwersyteckie Centrum KliniczneRecruiting
Gdansk, Poland
Nzoz AtopiaRecruiting
Krakow, Poland
Szpital Specjalistyczny Cdt MedicusCompleted
Lubin, Poland
Ostrowieckie Centrum Medyczne Spka Cywilna Anna Olech-Cudzik Krzysztof CudzikRecruiting
Ostrowiec Świętokrzyski, Poland
Pim MswiaCompleted
Warsaw, Poland
Giromed Institute/ Clinica Tres TorrresRecruiting
Barcelona, Spain
Hospital Clinic Barcelona MainRecruiting
Barcelona, Spain
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma · TrialPath