An Open Label, Single Arm Study to Assess the Safety and Immunogenicity of Omalizumab Liquid Administered Subcutaneously to Male and Female Adolescents and Adults With Persistent Allergic Asthma

CompletadoFase 3ClinicalTrials.gov

ID: NCT00500539Tipo: INTERVENTIONALInicio: 1 de jul de 2007Fin estimado: 1 de sept de 2008

Cardiología Neumología Pediatría Alergia e Inmunología

Traducción no disponible, mostrando original

Resumen

The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary objective of this study is to assess the safety of the liquid formulation of omalizumab in the same patients.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Patients 12 years old or above with moderate to severe allergic asthma
Body weight greater than 30kg and less than 150 kg and total serum IgE level greater than 30 to less than 700 IU/ml
Diagnosis of allergic asthma greater than 1 year duration, according to the American Thoracic Society criteria (14) and at screening, a history consistent with clinical features of moderate to severe persistent asthma.
Positive skin prick test (diameter of wheel is greater than 3mm) to at least one perennial allergen within the previous one year to visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
No clinically significant asthma exacerbations that required treatment with systemic corticosteroids during the four weeks immediately prior to screening visit (Visit 1) and during screening period (between Visit 1 and 2)
Demonstrated evidence of inadequate asthma symptom control, despite treatment with ICS according to clinical features of moderate to severe persistent asthma.

Criterios de exclusión

Previous exposure to omalizumab
Previous exposure to other humanized proteins or monoclonal antibodies
Known HAHA to other monoclonal antibodies
History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
Known hypersensitivity to any ingredients, including excipients of the study medication or drugs related to omalizumab (e.g. monoclonal antibodies, polyclonal gamma globulin)
Active lung disease other than allergic asthma (e.g. cystic fibrosis, bronchiectasis)
Elevated serum IgE levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis)

Intervenciones

drug

omalizumab

The liquid formulation of omalizumab was packaged in a pre-filled safety syringe containing either 75 mg (0.5ml) or 150 mg (1.0 ml) of drug. The syringes were clearly marked so that the health care provider could differentiate between the 75 mg or 150 mg syringe.

Ubicaciones

Novartis Investigative Site,

Buenos Aires, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site,

Corrientes, Argentina

Novartis Investigative Site,

Mendoza, Argentina

Patrocinadores

PrincipalNovartis

ColaboradorGenentech, Inc.

ColaboradorTanox

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