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

NCT01703312 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2016-04-20

No results posted yet for this study

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.

Conditions

  • Allergic Asthma

Interventions

DRUG

QGE031

Drug administered by subcutaneous injection

DRUG

omalizumab

Drug administered by subcutaneous injection

DRUG

placebo

Drug administered by subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Canada
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01703312 on ClinicalTrials.gov