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
Status: Recruiting
Location: See all (83) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Allervie Clinical Research
COMPLETED
Birmingham
California
Kern Allergy Medical Clinic, Inc
RECRUITING
Bakersfield
Integrated Research of Inland, Inc
COMPLETED
Upland
Florida
Direct Helpers Research Center
RECRUITING
Hialeah
Qway Research
RECRUITING
Hialeah
Care Research Center, Inc
COMPLETED
Miami
Care Research Inc
RECRUITING
Miami
Dr. de Armas Research Center, Llc
COMPLETED
Miami
Verus Clinical Research Corp
RECRUITING
Miami
Anderson Allergy and Asthma
COMPLETED
Orlando
Heuer Md Research Inc
COMPLETED
Orlando
Georgia
Advanced Clinical Research Atlanta
COMPLETED
Atlanta
Covenant Pulmonary Critical Care
COMPLETED
East Point
Illinois
Northshore Medical Group
COMPLETED
Glenview
Michigan
Henry Ford Hospital
COMPLETED
Detroit
Aa Medical Research Center
COMPLETED
Flint
Revive Research Institute
COMPLETED
Southfield
North Carolina
Onsite Clinical Solutions, Llc Charlotte Central Office
COMPLETED
Charlotte
New York
Northwell Health Physician Partners
COMPLETED
New Hyde Park
Pioneer Clinical Research Ny
COMPLETED
New York
Montefiore Medical Center (Mmc)
COMPLETED
The Bronx
Pennsylvania
Temple University Hospital
COMPLETED
Philadelphia
South Carolina
Clinical Research of Rock Hill
COMPLETED
Rock Hill
Texas
Howland Allergy and Asthma Pllc Dba Orion Clinical Research
RECRUITING
Austin
Linq Research, Llc
RECRUITING
Pearland
Quality Assurance Research Center
COMPLETED
San Antonio
Other Locations
Argentina
Fundacion Cidea
RECRUITING
Buenos Aires
Fundacion Respirar
RECRUITING
Buenos Aires
Mautalen Salud E Investigacion
RECRUITING
Buenos Aires
Care: Centro de Alergia Y Enfermedades Respiratorias
RECRUITING
Caba
INAER
RECRUITING
Capitalfederal
Centro de Medicina Respiratoria
RECRUITING
Concepción Del Uruguay
Instituto de Medicina Respiratoria - Imer
RECRUITING
Córdoba
Fundacion Enfisema
RECRUITING
Mar Del Plata
Centro Medico Dharma
RECRUITING
Mendoza
Fundacion Scherbovsky
RECRUITING
Mendoza
INSARES
RECRUITING
Mendoza
Polo de Salud Vistalba
RECRUITING
Mendoza
Centro Respiratorio Quilmes
RECRUITING
Quilmes
Centro Respiratorio Infantil
RECRUITING
Rosario
Instituto de Diagnostico Abc
RECRUITING
Rosario
Instituto Especialidades de La Salud Rosario
RECRUITING
Rosario
Instituto Medico de La Fundacion Estudios Clinicos
RECRUITING
Rosario
Centro Medico Respire
RECRUITING
San Fernando
Ierim Instituto de Enfermedades Respiratorias E Investigacion Medica
RECRUITING
San Juan Bautista
Cimer - Centro Integral de Medicina Respiratoria Srl
RECRUITING
San Miguel De Tucumán
Ipr Instituto de Patologias Respiratorias
RECRUITING
San Miguel De Tucumán
Iba Medica
RECRUITING
Santa Fe
Canada
Dynamic Drug Advancement
RECRUITING
Ajax
Hamilton Allergy
WITHDRAWN
Hamilton
Ottawa Allergy Research Corporation
COMPLETED
Ottawa
Synergy Respiratory Care
RECRUITING
Sherwood Park
Centre For Lung Health
COMPLETED
Vancouver
S. Fikry Medicine Professional Corporation
RECRUITING
Waterloo
Dr. Syed Anees Medicine Professional Corporation
RECRUITING
Windsor
Germany
Pneumologische Gemeinschaftspraxis Kroker-Schaeben-Schmidt
RECRUITING
Bendorf
Universitatsklinikum Bonn Aoer
RECRUITING
Bonn
Ikf Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
RECRUITING
Frankfurt Am Main
Hannover Medical School
RECRUITING
Hanover
Ikf Pneumologie Mainz
RECRUITING
Mainz
Japan
Fukuwa Clinic
RECRUITING
Chūōku
Nihonbashi Medical and Allergy Clinic
COMPLETED
Chūōku
National Hospital Organization Fukuoka National Hospital
RECRUITING
Fukuoka
Kishiwada City Hospital
RECRUITING
Kishiwada
Kirigaoka Tsuda Hospital
RECRUITING
Kitakyushu-shi
Tohno Chuo Clinic
RECRUITING
Mizunami-shi
Kyosokai Amc Nishi-Umeda Clinic
COMPLETED
Osaka
Lee Clinic
COMPLETED
Osaka
Sakaide City Hospital
RECRUITING
Sakaide-shi
Idaimae Minami Yojo Int Clinic
COMPLETED
Sapporo
Tokyo Shinagawa Hospital
RECRUITING
Shinagawa-ku
Takahashi Medical Clinic
COMPLETED
Tokyo
Kouwa Clinic
COMPLETED
Toshima-ku
Local Independent Administrative Institution Mie Prefectural General Medical Center
RECRUITING
Yokkaichi-shi
Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
COMPLETED
Yokohama
Poland
Allergy Clinic Homeo Medicus
RECRUITING
Bialystok
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Nzoz Atopia
RECRUITING
Krakow
Szpital Specjalistyczny Cdt Medicus
COMPLETED
Lubin
Ostrowieckie Centrum Medyczne Spka Cywilna Anna Olech-Cudzik Krzysztof Cudzik
RECRUITING
Ostrowiec Świętokrzyski
Pim Mswia
COMPLETED
Warsaw
Spain
Giromed Institute/ Clinica Tres Torrres
RECRUITING
Barcelona
Hospital Clinic Barcelona Main
RECRUITING
Barcelona
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Backup
Incyte Corporation Call Center (ex-US)
eumedinfo@incyte.com
+800 00027423
Time Frame
Start Date: 2023-07-11
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 240
Treatments
Placebo_comparator: 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
Experimental: 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
Experimental: 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
Experimental: 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
Related Therapeutic Areas
Sponsors
Leads: Incyte Corporation