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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Asthma

Treatments: Drug: QGE031

Study type: Interventional

Funder types: Industry

Identifiers

NCT02075008

2013-003683-31 (EudraCT Number)

CQGE031B2201E1

Details and patient eligibility

About

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

Full description

This study planned to 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. The study was terminated early due to the efficacy results from an interim analysis of the Phase II study CQGE031B2201.

Enrollment: 270 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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270 participants in 1 patient group

QGE031 every 4 weeks (q4w)

Experimental group

Description:

QGE031 240 mg subcutaneously q4w

Treatment:

Drug: QGE031