Clinical trial NCT05851443: A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Moderate to Severe Asthma
Keywords: Asthma
Moderate to Severe
INCB54707
Povorcitinib
ICS-LABA
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2023-05-09
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Primary outcomes:
measure: Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1)
timeFrame: Baseline ; Week 24
Secondary outcomes:
measure: Number of asthma exacerbations during the Placebo Controlled (PC) period
timeFrame: Up to 28 weeks
measure: Absolute change from baseline in pre-BD FEV1 at each visit
timeFrame: Up to 14 months
measure: Percent change from baseline in pre-BD FEV1 at each visit
timeFrame: Up to 14 months
measure: Absolute change from baseline in post-BD FEV1 at week 24
timeFrame: Baseline; Week 24
measure: Percent change from baseline in post-BD FEV1 at week 24
timeFrame: Baseline; Week 24
measure: Absolute change from baseline in pre-BD FVC at each visit
timeFrame: Up to 14 months
measure: Percent change from baseline in pre-BD FVC at each visit
timeFrame: Up to 14 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Allervie Clinical Research
state: Alabama
city: Bakersfield
country: United States
facility: Kern Allergy Medical Clinic, Inc
state: California
city: Upland
country: United States
facility: Integrated Research of Inland, Inc
state: California
city: Hialeah
country: United States
facility: Qway Research
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Miami
country: United States
facility: Care Research Inc
state: Florida
city: Miami
country: United States
facility: Verus Clinical Research Corp
state: Florida
city: Miami
country: United States
facility: Dr. de Armas Research Center, Llc
state: Florida
city: Miami
country: United States
facility: Care Research Center, Inc
state: Florida
city: Orlando
country: United States
facility: Anderson Allergy and Asthma
state: Florida
city: Orlando
country: United States
facility: Heuer Md Research Inc
state: Florida
city: Atlanta
country: United States
facility: Advanced Clinical Research Atlanta
state: Georgia
city: East Point
country: United States
facility: Covenant Pulmonary Critical Care
state: Georgia
city: Glenview
country: United States
facility: Northshore Medical Group
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Flint
country: United States
facility: Aa Medical Research Center
state: Michigan
city: Southfield
country: United States
facility: Revive Research Institute
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center (Mmc)
state: New York
city: New Hyde Park
country: United States
facility: Northwell Health Physician Partners
state: New York
city: New York
country: United States
facility: Pioneer Clinical Research Ny
state: New York
city: Charlotte
country: United States
facility: Onsite Clinical Solutions, Llc Charlotte Central Office
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
city: Austin
country: United States
facility: Howland Allergy and Asthma Pllc Dba Orion Clinical Research
state: Texas
city: Pearland
country: United States
facility: Linq Research, Llc
state: Texas
city: San Antonio
country: United States
facility: Quality Assurance Research Center
state: Texas
city: Buenos Aires
country: Argentina
facility: Fundacion Respirar
city: Buenos Aires
country: Argentina
facility: Fundacion Cidea
city: Caba
country: Argentina
facility: Mautalen Salud E Investigacion
city: Caba
country: Argentina
facility: Care: Centro de Alergia Y Enfermedades Respiratorias
city: Capitalfederal
country: Argentina
facility: INAER
city: Concepcion Del Uruguay
country: Argentina
facility: Centro de Medicina Respiratoria
city: Cordoba
country: Argentina
facility: Instituto de Medicina Respiratoria - Imer
city: Florencio Varela
country: Argentina
facility: Ierim Instituto de Enfermedades Respiratorias E Investigacion Medica
city: Lanus ESTE
country: Argentina
facility: CIMEL
city: Mar Del Plata
country: Argentina
facility: Fundacion Enfisema
city: Mendoza
country: Argentina
facility: Office of Pedro Carlos Elias, Md
city: Mendoza
country: Argentina
facility: Polo de Salud Vistalba
city: Mendoza
country: Argentina
facility: Fundacion Scherbovsky
city: Mendoza
country: Argentina
facility: Centro Medico Dharma
city: Quilmes
country: Argentina
facility: Centro Respiratorio Quilmes
city: Rosario
country: Argentina
facility: Centro Respiratorio Infantil
city: Rosario
country: Argentina
facility: Instituto de Diagnostico Abc
city: Rosario
country: Argentina
facility: Instituto Especialidades de La Salud Rosario
city: Rosario
country: Argentina
facility: Instituto Medico de La Fundacion Estudios Clinicos
city: San Fernando
country: Argentina
facility: Centro Medico Respire
city: San Miguel de Tucuman
country: Argentina
facility: Cimer - Centro Integral de Medicina Respiratoria Srl
city: San Miguel de Tucumán
country: Argentina
facility: Ipr Instituto de Patologias Respiratorias
city: Santa Fe
country: Argentina
facility: Iba Medica
city: Sherwood Park
country: Canada
facility: Synergy Respiratory Care
state: Alberta
city: Vancouver
country: Canada
facility: Centre For Lung Health
state: British Columbia
city: Ajax
country: Canada
facility: Dynamic Drug Advancement
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corporation
state: Ontario
city: Waterloo
country: Canada
facility: S. Fikry Medicine Professional Corporation
state: Ontario
city: Windsor
country: Canada
facility: Dr. Syed Anees Medicine Professional Corporation
state: Ontario
city: Bendorf
country: Germany
facility: Pneumologische Gemeinschaftspraxis Kroker-Schaeben-Schmidt
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn Aoer
city: Frankfurt Am Main
country: Germany
facility: Ikf Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
city: Hannover
country: Germany
facility: Hannover Medical School
city: Mainz
country: Germany
facility: Ikf Pneumologie Mainz
city: Chuo-ku
country: Japan
facility: Nihonbashi Medical and Allergy Clinic
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
city: Fukuoka City
country: Japan
facility: National Hospital Organization Fukuoka National Hospital
city: Kishiwada
country: Japan
facility: Kishiwada City Hospital
city: Kitakyushu-shi
country: Japan
facility: Kirigaoka Tsuda Hospital
city: Mizunami-shi
country: Japan
facility: Tohno Chuo Clinic
city: Osaka-shi
country: Japan
facility: Kyosokai Amc Nishi-Umeda Clinic
city: Osaka-shi
country: Japan
facility: Lee Clinic
city: Sakaide-shi
country: Japan
facility: Sakaide City Hospital
city: Sapporo
country: Japan
facility: Idaimae Minami Yojo Int Clinic
city: Shinagawa-ku
country: Japan
facility: Tokyo Shinagawa Hospital
city: Tokyo
country: Japan
facility: Takahashi Medical Clinic
city: Toshima-ku
country: Japan
facility: Kouwa Clinic
city: Yokkaichi-shi
country: Japan
facility: Local Independent Administrative Institution Mie Prefectural General Medical Center
city: Yokohama
country: Japan
facility: Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
city: Bialystok
country: Poland
facility: Allergy Clinic Homeo Medicus
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Krakow
country: Poland
facility: Nzoz Atopia
city: Lubin
country: Poland
facility: Szpital Specjalistyczny Cdt Medicus
city: Ostrowiec Swietokrzyski
country: Poland
facility: Ostrowieckie Centrum Medyczne Spka Cywilna Anna Olech-Cudzik Krzysztof Cudzik
city: Warszawa
country: Poland
facility: Pim Mswia
city: Barcelona
country: Spain
facility: Giromed Institute/ Clinica Tres Torrres
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona Main
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela
Study officials:
References: