NCT01703312

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2012

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

October 5, 2012

Last Update Submit

April 19, 2016

Conditions

Allergic Asthma

Keywords

Allergies, asthma, IgE

Outcome Measures

Primary Outcomes (1)

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

    Baseline, 12 weeks

Secondary Outcomes (3)

  • 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

  • QGE031 blood concentrations

    24 weeks

  • Number of participants with adverse events or other safety concerns

    24 weeks

Study Arms (3)

QGE031

EXPERIMENTAL

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

omalizumab

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

QGE031DRUG

Drug administered by subcutaneous injection

QGE031
omalizumabDRUG

Drug administered by subcutaneous injection

omalizumab
placeboDRUG

Drug administered by subcutaneous injection

placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Novartis Investigative Site

Calgary, Alberta, T2N 4N1, Canada

Location

Novartis Investigative Site

Edmonton, Alberta, T6G 2B7, Canada

Location

Novartis Investigative Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

Novartis Investigative Site

Ste-Foy, Quebec, G1V 4G5, Canada

Location

Novartis Investigative Site

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Novartis Investigative Site

Vancouver, Canada

Location

Novartis Investigative Site

Stockholm, S-171 76, Sweden

Location

MeSH Terms

Conditions

HypersensitivityAsthmaEpilepsy, Idiopathic Generalized

Interventions

ligelizumabOmalizumab

Condition Hierarchy (Ancestors)

Immune System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2012

First Posted

October 10, 2012

Study Start

November 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

SE(1)CA(6)