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

Primary Purpose

Allergic Asthma

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

QGE031

omalizumab

placebo

About this trial

This is an interventional treatment trial for Allergic Asthma focused on measuring Allergies, asthma, IgE

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

QGE031

omalizumab

placebo

Arm Description

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.

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.

During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses).

Outcomes

Primary Outcome Measures

Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1)

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

QGE031 blood concentrations

Number of participants with adverse events or other safety concerns

Full Information

NCT ID

NCT01703312

First Posted

October 5, 2012

Last Updated

April 19, 2016

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01703312

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Asthma

Keywords

Allergies, asthma, IgE

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QGE031

Arm Type

Experimental

Arm Description

Arm Title

omalizumab

Arm Type

Active Comparator

Arm Description

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses).

Intervention Type

Drug

Intervention Name(s)

QGE031

Intervention Description

Drug administered by subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

omalizumab

Intervention Description

Drug administered by subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Drug administered by subcutaneous injection

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

Title

QGE031 blood concentrations

Time Frame

24 weeks

Title

Number of participants with adverse events or other safety concerns

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N1

Country

Canada

Facility Name

Novartis Investigative Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Novartis Investigative Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

Novartis Investigative Site

City

Ste-Foy

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Novartis Investigative Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 0W8

Country

Canada

Facility Name

Novartis Investigative Site

City

Vancouver

Country

Canada

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

S-171 76

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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