Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma

August 7, 2017 updated by: Novartis Pharmaceuticals

A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of 52 Weeks Treatment With QGE031 Subcutaneous (s.c). in Asthma Patients Not Adequately Controlled by Medium- or High-dose Inhaled Corticosteroid (ICS) Plus Long Acting β2-agonist (LABA) With or Without Oral Corticosteroid (OCS)

This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Erpent, Belgium, 5100
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 3A9
        • Novartis Investigative Site
    • Quebec
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Novartis Investigative Site
  • France
      • Le Kremlin Bicetre, France, 94275
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 12099
        • Novartis Investigative Site
      • Frankfurt, Germany, 60596
        • Novartis Investigative Site
      • Hamburg, Germany, 20354
        • Novartis Investigative Site
      • Leipzig, Germany, 04103
        • Novartis Investigative Site
      • Marburg, Germany, 35037
        • Novartis Investigative Site
      • Münster, Germany, 48145
        • Novartis Investigative Site
    • Sachsen
      • Cottbus, Sachsen, Germany, 03050
        • Novartis Investigative Site
  • Hungary
      • Balassagyarmat, Hungary, 2660
        • Novartis Investigative Site
    • HUN
      • Miskolc, HUN, Hungary, 3529
        • Novartis Investigative Site
  • Italy
    • PI
      • Pisa, PI, Italy, 56124
        • Novartis Investigative Site
  • Japan
    • Hokkaido
      • Sapporo-city, Hokkaido, Japan, 064-0804
        • Novartis Investigative Site
    • Kagawa
      • Sakaide-city, Kagawa, Japan, 762-8550
        • Novartis Investigative Site
    • Kanagawa
      • Sagamihara-city, Kanagawa, Japan, 228-8522
        • Novartis Investigative Site
      • Yokohama-city, Kanagawa, Japan, 232-0024
        • Novartis Investigative Site
      • Yokohama-city, Kanagawa, Japan, 234-8503
        • Novartis Investigative Site
    • Osaka
      • Habikino-city, Osaka, Japan, 583-8588
        • Novartis Investigative Site
      • Kishiwada-city, Osaka, Japan, 596-8501
        • Novartis Investigative Site
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 103-0027
        • Novartis Investigative Site
      • Edogawa-ku, Tokyo, Japan, 134-0083
        • Novartis Investigative Site
      • Itabashi-ku, Tokyo, Japan, 173-8610
        • Novartis Investigative Site
      • Ota-ku, Tokyo, Japan, 143-0023
        • Novartis Investigative Site
      • Ota-ku, Tokyo, Japan, 140-0063
        • Novartis Investigative Site
      • Shinagawa-ku, Tokyo, Japan, 142-8666
        • Novartis Investigative Site
      • Toshima-ku, Tokyo, Japan, 171-0014
        • Novartis Investigative Site
  • Netherlands
      • Harderwijk, Netherlands, 3840 AC
        • Novartis Investigative Site
      • Leiden, Netherlands, 2333 ZA
        • Novartis Investigative Site
  • Slovakia
      • Zvolen, Slovakia, 960 01
        • Novartis Investigative Site
    • Slovak Republic
      • Bojnice, Slovak Republic, Slovakia, 972 01
        • Novartis Investigative Site
      • Liptovsky Hradok, Slovak Republic, Slovakia, 033 01
        • Novartis Investigative Site
      • Nitra, Slovak Republic, Slovakia, 949 01
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Novartis Investigative Site
    • Texas
      • Kingwood, Texas, United States, 77339
        • Novartis Investigative Site
      • Plano, Texas, United States, 75093
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • A diagnosis of allergic asthma, uncontrolled on current medication.
  • History of at least 2 asthma exacerbations during the last 1 year
  • Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted normal value; reversibility following administration of bronchodilator.

Key Exclusion Criteria:

  • Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
  • Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QGE031 240 mg
QGE031 240 mg subcutaneous injection every 4 weeks
Drug: QGE031
QGE031 120 mg per 1 mL liquid in vial
Experimental: QGE031 72 mg
QGE031 72 mg subcutaneous injection every 4 weeks
Drug: QGE031
QGE031 120 mg per 1 mL liquid in vial
Experimental: QGE031 24 mg
QGE031 24 mg subcutaneous injection every 4 weeks
Drug: QGE031
QGE031 120 mg per 1 mL liquid in vial
Placebo Comparator: Placebo to QGE031
Placebo subcutaneous injection every 4 weeks
Drug: Placebo
Placebo to QGE031 0 mg per 1 mL liquid in vial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
Time Frame: Week 52
Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
QGE031 Compared to Placebo in All Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
Time Frame: Week 52
Week 52
QGE031 Compared to Placebo in Non-atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
Time Frame: Week 52
Week 52
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on the Reduction in Rate of Asthma Exacerbations (by Severity)
Time Frame: Week 52
Week 52
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Time to First Asthma Exacerbations (by Severity)
Time Frame: Week 52
Week 52
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Questionnaire (ACQ)
Time Frame: Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)
Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Diary (ACD)
Time Frame: Over 52 weeks (Treatment) and 20 weeks (follow-up)
Over 52 weeks (Treatment) and 20 weeks (follow-up)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)
Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Peak Expiratory Flow (PEF) in the Morning and Evening
Time Frame: Over 52 weeks (Treatment) and 20 weeks (follow-up)
Over 52 weeks (Treatment) and 20 weeks (follow-up)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Total Daily Symptom Score
Time Frame: Over 52 weeks (Treatment) and 20 weeks (follow-up)
Over 52 weeks (Treatment) and 20 weeks (follow-up)
Response to QGE031 Between Atopic Asthma and Non-atopic Asthma
Time Frame: Over 52 weeks (treatment) and 20 weeks (follow up)
Over 52 weeks (treatment) and 20 weeks (follow up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

January 8, 2015

First Posted (Estimate)

January 13, 2015

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQGE031B2204
  • 2014-003155-57 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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