Last updated 24 days ago

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

240 patients around the world
Available in Argentina
Incyte Corporation
17Research sites
240Patients around the world

This study is for people with

Asthma

Requirements for the patient

To 65 Years
All Gender

Medical requirements

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 within 12 months prior to screening OR Post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL in FEV1 according to central over read value at Visit 2.
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.
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. Note: Participants with cured nonmetastatic basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy or cancers from which the participant has been disease-free for > 1 year after treatment with curative intent are eligible.
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

Sites

Polo de Salud Vistalba
Polo de Salud Vistalba
Recruiting
Guardia Vieja 1428, Vistalba, Lujan de Cuyo
Centro Respiratorio Quilmes - Buenos Aires
Centro Respiratorio Quilmes - Buenos Aires
Recruiting
Hipolito Yrigoyen 856, Quilmes, Buenos Aires
Servicio de Investigación de Patologías Alérgicas del Instituto ABC
Servicio de Investigación de Patologías Alérgicas del Instituto ABC
Recruiting
Salta 2668, Rosario, Santa Fe
Instituto de Especialidades de la Salud Rosario Clínica del Tórax
Recruiting
España 931, Rosario, Santa Fe
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Italia 428, Rosario - Santa Fe
Fundación CIDEA - Buenos Aires
Fundación CIDEA - Buenos Aires
Recruiting
Paraguay 2035, C1121ABE Cdad. Autónoma de Buenos Aires, Argentina
Mautalen - Salud e Investigación - CABA
Azcuénaga 1860, CABA, Buenos Aires
Instituto de Medicina Respiratoria IMER - Córdoba
Recruiting
Av. Colon 2057, Córdoba
Centro Médico Cimel Chahin Chahin S.A.
Recruiting
Tucumán 1314, Lanús, Buenos Aires
Fundación Enfisema - Instituto Ave Pulmo
Recruiting
Carlos Alvear 3345, B7602DCK Mar del Plata, Provincia de Buenos Aires, Argentina
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