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Phase IIb randomized double-blind placebo-controlled study of MEMP1972A in adults with allergic asthma inadequately controlled on high-dose inhaled corticosteroids and a second controller
2011-003997-10Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2012
- Countries
- 1
- Sponsor
- Genentech
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Drugs
- quilizumab
- Conditions
- allergic asthmaasthma
01
Overview
Phase 2, randomised, double-blind trial of quilizumab in allergic asthma and asthma (4 arms), sponsored by Genentech. Primary endpoint: Protocol-defined asthma exacerbation rate. Started Jun 2012; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
MEMP1972A regimen 1
One of three dosing regimens of MEMP1972A administered for 36 weeks in addition to high-dose inhaled corticosteroids and a second controller.
MEMP1972A regimen 2
Alternative dosing regimen of MEMP1972A administered for 36 weeks in addition to high-dose inhaled corticosteroids and a second controller.
MEMP1972A regimen 3
Third dosing regimen of MEMP1972A administered for 36 weeks in addition to high-dose inhaled corticosteroids and a second controller.
Placebo
Placebo administered for 36 weeks in addition to high-dose inhaled corticosteroids and a second controller.
03
Who it enrols
Adults 18–75 years with allergic asthma inadequately controlled despite high-dose inhaled corticosteroids (≥400 µg/day fluticasone propionate or equivalent) plus a second controller, without recent exacerbations requiring systemic steroids in the 30 days prior to randomization.
04
Endpoints
Primary
Protocol-defined asthma exacerbation rate
Secondary
Treatment-emergent adverse events
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