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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003683-31-SK

Enrollment

300

Registered

2013-12-10

Start date

2014-01-23

Completion date

Unknown

Last updated

2016-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 18.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Code: QGE031 Pharmaceutical Form: Solution for injection INN or Proposed INN: do not established yet Current Sponsor code: QGE031 Other descriptive name: QGE031 Concentration unit: mg/ml milli

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess long-term safety and tolerability of QGE031 given every 4 weeks s.c.;Secondary Objective: as per protocol there is no secondary objective in trial;Primary end point(s): Adverse events and serious adverse events ;Timepoint(s) of evaluation of this end point: Every 4 weeks (as patient visits site every 4 weeks) as described in protocol.	—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Argentina, Canada, Czech Republic, Finland, Germany, Hungary, Israel, Italy, Korea, Republic of, Mexico, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, Turkey, United Kingdom, United States

Contacts

Public ContactDRA dept.

Novartis Slovakia s.r.o.

DRA.Slovakia@novartis.com+421250706111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026