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A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma

A Randomized, Double-blind, Placebo- and Comparator-controlled Study Evaluating the Effect of Multiple Doses of QGE031 Compared to Omalizumab in Asthma Induced by Allergen Bronchial Provocation

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01703312
Enrollment
37
Registered
2012-10-10
Start date
2012-11-30
Completion date
2013-10-31
Last updated
2016-04-20

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

Conditions

Allergic Asthma

Keywords

Allergies, asthma, IgE

Brief summary

This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at 12 weeks compared to baseline will be evaluated.

Interventions

DRUGQGE031

Drug administered by subcutaneous injection

DRUGomalizumab

Drug administered by subcutaneous injection

DRUGplacebo

Drug administered by subcutaneous injection

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Adult patients 18 to 65 years Positive skin prick test to one or more common airborne allergens Presence of airway hyperresponsiveness documented by a provocative concentration of methacholine causing a 20% fall in FEV1 (PC20 FEV1) of less than or equal to 16 mg/mL Presence of an early asthmatic response demonstrated by an allergen challenge at screening and including a 15% fall in the FEV1 Patients with a body weight and total IgE in a range specified by local country prescribing information for omalizumab

Exclusion criteria

Pregnant or nursing (lactating) women Women of child-bearing potential unless they are using a highly effective method of birth control (as further defined in the study protocol) Smokers Patients with poorly controlled asthma or patients who have had an asthma exacerbation within the past year Other protocol-defined inclusion/

Design outcomes

Primary

MeasureTime frame
Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1)Baseline, 12 weeks

Secondary

MeasureTime frame
Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1) following treatment with placebo and various doses of QGE031Baseline, 12 weeks
QGE031 blood concentrations24 weeks
Number of participants with adverse events or other safety concerns24 weeks

Countries

Canada, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026