Treatment of Adult Allergic Asthma Patients with MEMP1972A

Conditions: Allergic Asthma
MedDRA version: 17.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2011-003997-10-DE

Lead Sponsor: GENENTECH, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 560

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objectives of this study are to evaluate the efficacy and safety of MEMP1972A in adult patients with allergic asthma inadequately controlled despite high dose inhaled corticosteroids ( ICS) (= 400 µg/day total daily dose of fluticasone propionate [FP] or equivalent) and a second controller after 36 weeks of treatment.;Secondary Objective: • To compare the efficacy and safety profiles of three dosing regimens of MEMP1972A in patients with asthma not controlled on high dose ICS and a second controller<br>• To evaluate the pharmacokinetics of MEMP1972A;Primary end point(s): Rate of protocol-defined asthma exacerbations resulting in use of systemic steroids or hospitalization over 36 weeks;Timepoint(s) of evaluation of this end point: Baseline through week 36

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Incidence and severity of treatment-emergent adverse events<br>- Change in asthma symptoms;Timepoint(s) of evaluation of this end point: - From consent through last study visit <br>- Baseline through week 36