The primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

The patient is male or female, 12 years of age and older, with a previous diagnosis of asthma.
Written informed consent is obtained.
The patient requires daily maintenance dose of prednisone or equivalent for asthma of between 5 and 40 mg during the 3 months prior to screening.
The patient has a documented elevated blood eosinophils at screening or during the previous 12 months.
The patient has required high dose ICS plus another asthma controller for at least 6 months prior to screening.
The patient has FEV1 reversibility to inhaled SABA or historical reversibility within the previous 24 months.
Other criteria may apply, please contact the investigator for more information.

Criterios de exclusión

The patient has any clinically significant, uncontrolled medical condition that would interfere with the study schedule or procedures and interpretation of efficacy results or would compromise the patient's safety.
The patient has another confounding underlying lung disorder.
The patient has a known hypereosinophilic syndrome.
The patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
The patient is pregnant or intends to become pregnant during the study or is lactating.
The patient required treatment for an asthma exacerbation within 4 weeks of screening.
The patient is a current smoker or has a smoking history ≥10 pack-years.
The patient is currently using any systemic immunosuppressive or immunomodulatory biologic except maintenance OCS for the treatment of asthma.
The patient participated in a clinical study within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
The patient was previously exposed to benralizumab within 12 months of screening.
The patient was previously exposed to reslizumab.
The patient has a history of immunodeficiency disorder including human immunodeficiency virus.
The patient has current suspected drug and/or alcohol abuse.
The patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening.
The patient has a history of allergic reactions or hypersensitivity to any component of the study drug.
Other criteria may apply, please contact the investigator for more information.

Intervenciones

drug

Reslizumab

Reslizumab 110 mg was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.

drug

Placebo

Placebo was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.

drug

Non-Oral Corticosteroid (non-OCS) Asthma Medication

Participants continue using their non-OCS background asthma medications without change during the study's treatment period.

drug

Oral Corticosteroid (OCS)

After screening and prior to study start, the participant's OCS dose was adjusted to determine the minimal effective OCS requirement.

Ubicaciones

Teva Investigational Site 20059

Buenos Aires, Argentina

Teva Investigational Site 20058

Buenos Aires, Argentina

Teva Investigational Site 20056

Buenos Aires, Argentina

Teva Investigational Site 20057

Buenos Aires, Argentina

Teva Investigational Site 20052

Córdoba, Argentina

Teva Investigational Site 20055

Mendoza, Argentina

Teva Investigational Site 20050

Mendoza, Argentina

Teva Investigational Site 20087

Rosario, Argentina

Teva Investigational Site 20051

San Miguel de Tucumán, Argentina

Teva Investigational Site 20066

San Rafael, Argentina

A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 Weeks) in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Reslizumab

Placebo

Non-Oral Corticosteroid (non-OCS) Asthma Medication

Oral Corticosteroid (OCS)

Ubicaciones

Teva Investigational Site 20059

Teva Investigational Site 20058

Teva Investigational Site 20056

Teva Investigational Site 20057

Teva Investigational Site 20052

Teva Investigational Site 20055

Teva Investigational Site 20050

Teva Investigational Site 20087

Teva Investigational Site 20051

Teva Investigational Site 20066

Patrocinadores