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

Phase 1

Completed

• Conditions: Allergic Asthma
• Interventions: Drug: omalizumab; Drug: placebo; Drug: QGE031

• Registration Number: NCT01703312
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-05
• Study First Submitted QC: 2012-10-05
• Study First Posted: 2012-10-10
• Study Start: 2012-11
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
omalizumab	omalizumab	During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses) or once every four weeks (total of three doses). The dose that a participant receives will depend upon the participant's body weight and IgE level; dosage will be determined based upon local omalizumab dosing charts.
placebo	placebo	During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses).
QGE031	QGE031	During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses). Three dose levels of QGE031 will be offered during the study: low, medium, and high. Participants will be randomized to receive one of these dose levels for all dosing visits.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
QGE031 blood concentrations	24 weeks
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 QGE031	Baseline, 12 weeks
Number of participants with adverse events or other safety concerns	24 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇸🇪 Stockholm, Sweden