Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201

Status:	Completed
Conditions:	Asthma
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - 76
Updated:	8/4/2016
Start Date:	March 2014
End Date:	March 2016

An Open-label, Multi-center, Extension Study to Evaluate the Long-term Safety of Subcutaneous 240mg QGE031 Given Every 4 Weeks for 52 Weeks in Allergic Asthma Patients Who Completed Study CQGE031B2201

This study will assess long-term safety of QGE031 during 12 months treatment in asthma
patients who completed study CQGE031B2201.

This study will assess long-term safety and tolerability of QGE031 administered every 4
weeks for an additional 12 months in patients with allergic asthma who previously completed
study CQGE031B2201.

Key Inclusion Criteria:

- forced Expiratory Volume in one second ( FEV1) > 40% predicted

- patients who completed CQGE031B2201 study

Key Exclusion Criteria:

- life-threatening asthma attack, intubation, respiratory arrest during or after
completion of CQGE031B2201 study

- new malignancy

- ongoing SAE from CQGE031B2201 that was assessed as related to study drug

- patient experienced platelets drop to < 75,000/uL

- patient experienced one unexpected grade 4 or two unexpected grade 3 hypersensitivity
reactions

- patient is pregnant

We found this trial at

sites

Novartis Investigative Site

Caba, Buenos Aires

from

Caba,