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Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma

NCT01716754 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 471

Last updated 2017-08-11

Study results available
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Summary

This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.

Conditions

Interventions

DRUG

QGE031

QGE031 was supplied as 120 mg liquid in vial per 1 mL

DRUG

Omalizumab

Omalizumab was supplied as 150 mg lyophilisate in vial

DRUG

Placebo

Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL

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
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States
  • Argentina
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Guatemala
  • Hungary
  • India
  • Israel
  • Italy
  • Mexico
  • Panama
  • Poland
  • Portugal
  • Romania
  • Russia
  • Singapore
  • Slovakia
  • South Africa
  • South Korea
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01716754 on ClinicalTrials.gov