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

April 19, 2016 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, 12 weeks
QGE031 blood concentrations
Time Frame: 24 weeks
24 weeks
Number of participants with adverse events or other safety concerns
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

October 5, 2012

First Submitted That Met QC Criteria

October 5, 2012

First Posted (ESTIMATE)

October 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQGE031B2203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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