Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma

Novartis

Status and phase: Terminated; Phase 2

Conditions: Asthma

Treatments: Drug: QGE031; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02336425

2014-003155-57 (EudraCT Number)

CQGE031B2204

Details and patient eligibility

About

This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• A diagnosis of allergic asthma, uncontrolled on current medication.
• History of at least 2 asthma exacerbations during the last 1 year
• Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted normal value; reversibility following administration of bronchodilator.

Key Exclusion Criteria:

• Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
• Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 4 patient groups, including a placebo group

QGE031 240 mg

Experimental group

Description:

QGE031 240 mg subcutaneous injection every 4 weeks

Treatment:

Drug: QGE031

QGE031 72 mg

Experimental group

Description:

QGE031 72 mg subcutaneous injection every 4 weeks

Treatment:

Drug: QGE031

QGE031 24 mg

Experimental group

Description:

QGE031 24 mg subcutaneous injection every 4 weeks

Treatment:

Drug: QGE031

Placebo to QGE031

Placebo Comparator group

Description:

Placebo subcutaneous injection every 4 weeks

Treatment:

Drug: Placebo