A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma - Full Text View

Purpose

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	Intervention	Phase
Allergic Asthma	Drug: QGE031 Drug: omalizumab Drug: placebo	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Omalizumab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
QGE031 blood concentrations [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Number of participants with adverse events or other safety concerns [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]


Enrollment:	37
Study Start Date:	November 2012
Study Completion Date:	October 2013
Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703312

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

No publications provided


Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01703312 History of Changes
Other Study ID Numbers:	CQGE031B2203
Study First Received:	October 5, 2012
Last Updated:	January 27, 2014
Health Authority:	Canada: Health Canada Sweden: Medical Products Agency

Keywords provided by Novartis:


Allergies, asthma, IgE

Additional relevant MeSH terms:


Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity	Respiratory Tract Diseases Omalizumab Anti-Allergic Agents Anti-Asthmatic Agents Pharmacologic Actions Respiratory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015