A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma
NCT ID: NCT05851443
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2023-07-11
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + 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
placebo
placebo
ICS-LABA
Background Therapy
ICS-LABA + povorcitinib Dose 1
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
povorcitinib
povorcitinib
ICS-LABA
Background Therapy
ICS-LABA + povorcitinib Dose 2
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
povorcitinib
povorcitinib
ICS-LABA
Background Therapy
ICS-LABA + povorcitinib Dose 3
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
povorcitinib
povorcitinib
ICS-LABA
Background Therapy
Interventions
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povorcitinib
povorcitinib
placebo
placebo
ICS-LABA
Background Therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Locations
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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
Northwell Health Physician Partners
New Hyde Park, New York, United States
Pioneer Clinical Research Ny
New York, New York, United States
Montefiore Medical Center (Mmc)
The Bronx, 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
Buenos Aires, , Argentina
INAER
Buenos Aires, , Argentina
Care: Centro de Alergia Y Enfermedades Respiratorias
CABA, , Argentina
Centro de Medicina Respiratoria
Concepción del Uruguay, , Argentina
Instituto de Medicina Respiratoria - Imer
Córdoba, , Argentina
CIMEL
Lanús, , Argentina
Fundacion Enfisema
Mar del Plata, , Argentina
Centro Medico Dharma
Mendoza, , Argentina
Polo de Salud Vistalba
Mendoza, , Argentina
Fundacion Scherbovsky
Mendoza, , Argentina
INSARES
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
Ierim Instituto de Enfermedades Respiratorias E Investigacion Medica
San Juan Bautista, , Argentina
Ipr Instituto de Patologias Respiratorias
San Miguel de Tucumán, , Argentina
Cimer - Centro Integral de Medicina Respiratoria Srl
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
Hanover, , Germany
Ikf Pneumologie Mainz
Mainz, , Germany
Nihonbashi Medical and Allergy Clinic
Chūōku, , Japan
Fukuwa Clinic
Chūōku, , Japan
National Hospital Organization Fukuoka National Hospital
Fukuoka, , Japan
Kishiwada City Hospital
Kishiwada, , Japan
Kirigaoka Tsuda Hospital
Kitakyushu-shi, , Japan
Tohno Chuo Clinic
Mizunami-shi, , Japan
Kyosokai Amc Nishi-Umeda Clinic
Osaka, , Japan
Lee Clinic
Osaka, , Japan
Sakaide City Hospital
Sakaide-shi, , Japan
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 Świętokrzyski, , Poland
Pim Mswia
Warsaw, , 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
Countries
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Central Contacts
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Related Links
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A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma
Other Identifiers
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INCB54707-208
Identifier Type: -
Identifier Source: org_study_id
2022-502570-16-00
Identifier Type: REGISTRY
Identifier Source: secondary_id