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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01703312
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • QGE031 — DRUG
    Drug administered by subcutaneous injection
  • omalizumab — DRUG
    Drug administered by subcutaneous injection
  • placebo — DRUG
    Drug administered by subcutaneous injection

Study Details

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.

Key Dates

Start date
Nov 30, 2012
Status verified
Apr 2016
Primary completion
Oct 31, 2013
Completion
Oct 31, 2013

Study Design

Enrollment
37 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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).

Primary Outcome Measure

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 ]

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