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

Allergic Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703312
• Other study ID #: CQGE031B2203
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 5, 2012
• Last updated: April 19, 2016
• Start date: November 2012
• Est. completion date: October 2013

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Drug:
• QGE031
Drug administered by subcutaneous injection
• omalizumab
Drug administered by subcutaneous injection
• placebo
Drug administered by subcutaneous injection

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	Saskatoon	Saskatchewan
Canada	Novartis Investigative Site	Ste-Foy	Quebec
Canada	Novartis Investigative Site	Vancouver
Sweden	Novartis Investigative Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Canada,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1)		Baseline, 12 weeks	No
Secondary	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	No
Secondary	QGE031 blood concentrations		24 weeks	No
Secondary	Number of participants with adverse events or other safety concerns		24 weeks	Yes