ong-term safety study of QGE031 in patients with allergic asthma who completed study CQGE031B2201

Phase 1

• Conditions: Asthma; MedDRA version: 18.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-003683-31-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-03
• Last Update Posted: 4 July 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Key Inclusion Criteria:
- FEV1 > 40% predicted
- patients who completed CQGE031B2201 study

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 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess long-term safety and tolerability of QGE031 given every 4 weeks s.c.;Secondary Objective: ;Primary end point(s): Adverse events and serious adverse events<br>;Timepoint(s) of evaluation of this end point: Every 4 weeks (as patient visits site every 4 weeks) as described in protocol.