drugset / Trial / NCT01582503

A Study of MEMP1972A in Patients With Allergic Asthma Inadequately Controlled on Inhaled Steroids And A Second Controller (COSTA)

NCT01582503 ↗

Phase 2 Completed 578 enrolled Genentech, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of 3 dosing regimens of MEMP1972A in patients with allergic asthma who remain inadequately controlled on chronic therapy with high dose inhaled corticosteroids and a second controller medication.Patients will be randomized to 4 Arms to receive subcutaneous repeating dose of either MEMP1972A 150 mg, 300 mg, or 450 mg, or placebo. Patients will continue their usual asthma medication throughout the study. Anticipated time on study treatment is 36 weeks, with a 48-week follow-up.

Timeline

Start
2012-04
Primary completion
2014-05
Completion
2014-11

Outcome

Missed primary endpoint

paper a 19.6 % reduction (p = 0.38) in the asthma exacerbation rate relative to placebo, but this was neither statistically nor clinically significant. PMID 26993628 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Quilizumab Monoclonal antibody 150 mg Subcutaneous
Subject Quilizumab Monoclonal antibody 300 mg Subcutaneous
Subject Quilizumab Monoclonal antibody 450 mg Subcutaneous

Indications