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

ReclutandoFase 2ClinicalTrials.gov

ID: NCT05851443Tipo: INTERVENTIONALInicio: 11 de jul de 2023Fin estimado: 31 de ene de 2027

Neumología

Traducción no disponible, mostrando original

Resumen

The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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

Intervenciones

drug

povorcitinib

other

placebo

drug

ICS-LABA

Background Therapy

Ubicaciones

Fundacion Respirar

Buenos Aires, Argentina

RECRUITING

Fundacion Cidea

Buenos Aires, Argentina

RECRUITING

Mautalen Salud E Investigacion

Buenos Aires, Argentina

RECRUITING

INAER

Buenos Aires, Argentina

RECRUITING

Care: Centro de Alergia Y Enfermedades Respiratorias

CABA, Argentina

RECRUITING

Centro de Medicina Respiratoria

Concepción del Uruguay, Argentina

RECRUITING

Instituto de Medicina Respiratoria - Imer

Córdoba, Argentina

RECRUITING

CIMEL

Lanús, Argentina

NOT_YET_RECRUITING

Fundacion Enfisema

Mar del Plata, Argentina

RECRUITING

Centro Medico Dharma

Mendoza, Argentina

RECRUITING

Polo de Salud Vistalba

Mendoza, Argentina

RECRUITING

Fundacion Scherbovsky

Mendoza, Argentina

RECRUITING

INSARES

Mendoza, Argentina

RECRUITING

Centro Respiratorio Quilmes

Quilmes, Argentina

RECRUITING

Centro Respiratorio Infantil

Rosario, Argentina

RECRUITING

Instituto de Diagnostico Abc

Rosario, Argentina

RECRUITING

Instituto Especialidades de La Salud Rosario

Rosario, Argentina

RECRUITING

Instituto Medico de La Fundacion Estudios Clinicos

Rosario, Argentina

RECRUITING

Centro Medico Respire

San Fernando, Argentina

RECRUITING

Ierim Instituto de Enfermedades Respiratorias E Investigacion Medica

San Juan Bautista, Argentina

RECRUITING

Ipr Instituto de Patologias Respiratorias

San Miguel de Tucumán, Argentina

RECRUITING

Cimer - Centro Integral de Medicina Respiratoria Srl

San Miguel de Tucumán, Argentina

RECRUITING

Iba Medica

Santa Fe, Argentina

RECRUITING

Patrocinadores

PrincipalIncyte Corporation

Contactos

Incyte Corporation Call Center (US)

CONTACT

medinfo@incyte.com 1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

eumedinfo@incyte.com +800 00027423

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