A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND DOSING REGIMENS OF MEMP1972A IN ADULTS WITH ALLERGIC ASTHMA WHO ARE INADEQUATELYCONTROLLED ON INHALED CORTICOSTEROIDS AND A SECOND CONTROLLER (COSTA) - COSTA

GENENTECH, Inc.0 个研究点目标入组 560 人开始时间: 2012年10月19日最近更新: 2015年9月28日

研究概览

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•- Age 18-75 years
•- Body weight = 40 kg
•- Normal CXR
•- Diagnosis of asthma for at least 12 months
•- Evidence of documented bronchodilator reversibility
•- Prebronchodilator FEV1 = 40% and = 80% predicted
•- Daily use of ICS and second controller for a minimum of 3 consecutive months prior to screen
•- History of at least one protocol-defined asthma exacerbation in the 18 months prior to screen
•- Inadequately controlled asthma despite compliance with asthma controller therapy documented by daily diary and ACQ
•- Positive aeroallergen-specific IgE OR a total serum IgE = 75 IU/mL
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 540
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•- Asthma exacerbation requiring systemic steroids in the 30 days prior to randomization
•- Have pre-existing active lung disease other than asthma
•- Any infection including chronic or latent infections or infections requiring treatment during screening
•- Clinically significant medical disease that is uncontrolled despite treatment
•- Any condition that contraindicates the use of an investigational drug
•- History of significant exposure to water-borne parasites and/or have recent diarrheal illness of indeterminate etiology
•- Former smoker with >10 pack year history or current smoker
•- History of anaphylaxis or allergic reaction during the use of a monoclonal antibody
•- Use of any excluded concomitant therapies
•- Men and women who are not willing to use highly effective method of contraception
•- Women who are pregnant or lactating

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