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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01703312
First received: October 5, 2012
Last updated: January 27, 2014
Last verified: January 2014
  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:


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

ClinicalTrials.gov processed this record on July 28, 2014