A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Chronic Obstructive Pulmonary Disease and a History of Exacerbations

CompletadoFase 2ClinicalTrials.gov

ID: NCT02546700Tipo: INTERVENTIONALInicio: 30 de sept de 2015Fin estimado: 25 de nov de 2016

Traducción no disponible, mostrando original

Resumen

Phase II, randomized, double-blind, placebo-controlled, parallel-group clinical trial of lebrikizumab in participants with COPD and a history of exacerbations who are treated with inhaled corticosteroid (ICS) and at least one long-acting bronchodilator inhaler medication. This study will be conducted to assess the safety, efficacy, and patient-reported outcome (PRO) measures.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Post-bronchodilator FEV1/FVC less than (\<) 0.70 at Visit 1 or 2
Post bronchodilator FEV1 \<80% predicted at Visit 1 or 2
Documented history of COPD greater than or equal to (\>/=) 12 months prior to Visit 1
Documented history of one or more acute COPD exacerbations requiring treatment with systemic corticosteroids and/or antibiotics or hospitalization within 12 months prior to Visit 1
Current tobacco smoker or former smoker (having stopped smoking for at least 6 months prior to Visit 1) with a history of smoking \>/=10 pack-years (20 cigarettes/day for 10 years)
On inhaled corticosteroids (ICS) therapy for \>/=6 months prior to Visit 1
On an eligible bronchodilator medication for \>/=6 months prior to Visit 1
Chest X-ray or computed tomography (CT) scan within 6 months prior to Visit 1 or chest X-ray prior to Visit 2 that confirms absence of clinically significant lung disease besides COPD
Demonstrated adherence with background COPD inhaler medication during screening period
For female participants of childbearing age, use of single or combined contraceptive methods for the duration of the study

Criterios de exclusión

History of severe allergic reaction or anaphylactic reaction to biologic agent or known hypersensitivity to lebrikizumab injection
History of clinically significant pulmonary disease other than COPD
Diagnosis of alpha-1-antitrypsin deficiency
Lung volume reduction surgery or procedure within 12 months prior to Visit 1
Supplemental oxygen requirement \>2 liters/minute (L/min) at rest or with exertion
Current diagnosis of asthma
Participants participating in, or scheduled for, an intensive COPD rehabilitation program
Maintenance oral corticosteroid therapy
Treatment with systemic corticosteroids within 4 weeks prior to Visit 1 or during screen period
Unstable ischemic heart disease or other relevant cardiovascular disorders
Use of an immunomodulatory or immunosuppressive therapy including monoclonal antibodies (includes anti-interleukin-13 (IL) or anti-IL-4/IL-13 therapy)
Body weight \<40 kg
Any infection that resulted in hospital admission for \>/= 24 hours and/or treatment with oral, intravenous (IV), or intramuscular (IM) antibiotics within 4 weeks prior to Visit 1 or during screening
Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening
Active parasitic or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
Received a live attenuated vaccine within 4 weeks prior to Visit 1 or during screening
Active tuberculosis requiring treatment within 12 months prior to Visit 1
Human immunodeficiency virus (HIV) or other known immunodeficiency
Hepatitis or known liver cirrhosis
Aspartate Aminotransferase (AST), Alanine Aminotransferase (ATL), or total bilirubin elevation \>/=2.0 x upper limit of normal (ULN) during screening
Clinically significant abnormality on screening electrocardiogram (ECG) or laboratory tests
History of alcohol or drug abuse
Pregnant or lactating

Intervenciones

drug

Lebrikizumab

Lebrikizumab 125 milligrams (mg) will be administered subcutaneously once in every 4 weeks.

drug

Placebo

Matching placebo will be administered subcutaneously once in every 4 weeks.

Ubicaciones

Centro Médico Dra de Salvo

Buenos Aires, Argentina

Instituto Ave Pulmo

Mar del Plata, Argentina

Centro Respiratorio Quilmes

Quilmes, Argentina

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, Argentina

Instituto Del Buen Aire

Santa Fe, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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