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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Allergic Asthma	Drug: QGE031; Drug: omalizumab; Drug: placebo	Phase 1; Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	37 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	November 2012
Actual Primary Completion Date :	October 2013
Actual Study Completion Date :	October 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 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.	Drug: QGE031; Drug administered by subcutaneous injection
Active Comparator: 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.	Drug: omalizumab; Drug administered by subcutaneous injection
Placebo Comparator: placebo; During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses).	Drug: placebo; Drug administered by subcutaneous injection

Outcome Measures

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Primary Outcome Measures :

1. Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1) [ Time Frame: Baseline, 12 weeks ]

Secondary Outcome Measures :

1. 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 [ Time Frame: Baseline, 12 weeks ]
2. QGE031 blood concentrations [ Time Frame: 24 weeks ]
3. Number of participants with adverse events or other safety concerns [ Time Frame: 24 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Canada, Alberta
Novartis Investigative Site
Calgary, Alberta, Canada, T2N 4N1
Novartis Investigative Site
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Novartis Investigative Site
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Novartis Investigative Site
Ste-Foy, Quebec, Canada, G1V 4G5
Canada, Saskatchewan
Novartis Investigative Site
Saskatoon, Saskatchewan, Canada, S7N 0W8
Canada
Novartis Investigative Site
Vancouver, Canada
Sweden
Novartis Investigative Site
Stockholm, Sweden, S-171 76

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01703312 History of Changes
Other Study ID Numbers:	CQGE031B2203
First Posted:	October 10, 2012
Last Update Posted:	April 20, 2016
Last Verified:	April 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Allergies, asthma, IgE

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate	Hypersensitivity; Immune System Diseases; Omalizumab; Anti-Allergic Agents; Anti-Asthmatic Agents; Respiratory System Agents