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

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
QGE031
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

QGE031 240 mg

QGE031 72 mg

QGE031 24 mg

Placebo to QGE031

Arm Description

QGE031 240 mg subcutaneous injection every 4 weeks

QGE031 72 mg subcutaneous injection every 4 weeks

QGE031 24 mg subcutaneous injection every 4 weeks

Placebo subcutaneous injection every 4 weeks

Outcomes

Primary Outcome Measures

QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations

Secondary Outcome Measures

QGE031 Compared to Placebo in All Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
QGE031 Compared to Placebo in Non-atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on the Reduction in Rate of Asthma Exacerbations (by Severity)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Time to First Asthma Exacerbations (by Severity)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Questionnaire (ACQ)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Diary (ACD)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Forced Expiratory Volume in 1 Second (FEV1)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Peak Expiratory Flow (PEF) in the Morning and Evening
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Total Daily Symptom Score
Response to QGE031 Between Atopic Asthma and Non-atopic Asthma

Full Information

First Posted
January 8, 2015
Last Updated
August 7, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02336425
Brief Title
Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
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).
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QGE031 240 mg
Arm Type
Experimental
Arm Description
QGE031 240 mg subcutaneous injection every 4 weeks
Arm Title
QGE031 72 mg
Arm Type
Experimental
Arm Description
QGE031 72 mg subcutaneous injection every 4 weeks
Arm Title
QGE031 24 mg
Arm Type
Experimental
Arm Description
QGE031 24 mg subcutaneous injection every 4 weeks
Arm Title
Placebo to QGE031
Arm Type
Placebo Comparator
Arm Description
Placebo subcutaneous injection every 4 weeks
Intervention Type
Drug
Intervention Name(s)
QGE031
Intervention Description
QGE031 120 mg per 1 mL liquid in vial
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to QGE031 0 mg per 1 mL liquid in vial
Primary Outcome Measure Information:
Title
QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
QGE031 Compared to Placebo in All Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
Time Frame
Week 52
Title
QGE031 Compared to Placebo in Non-atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
Time Frame
Week 52
Title
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
Title
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
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
Response to QGE031 Between Atopic Asthma and Non-atopic Asthma
Time Frame
Over 52 weeks (treatment) and 20 weeks (follow up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Novartis Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Novartis Investigative Site
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Facility Name
Novartis Investigative Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Novartis Investigative Site
City
Erpent
ZIP/Postal Code
5100
Country
Belgium
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
Novartis Investigative Site
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Novartis Investigative Site
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Novartis Investigative Site
City
Cottbus
State/Province
Sachsen
ZIP/Postal Code
03050
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12099
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Novartis Investigative Site
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Novartis Investigative Site
City
Miskolc
State/Province
HUN
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Novartis Investigative Site
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
Novartis Investigative Site
City
Pisa
State/Province
PI
ZIP/Postal Code
56124
Country
Italy
Facility Name
Novartis Investigative Site
City
Sapporo-city
State/Province
Hokkaido
ZIP/Postal Code
064-0804
Country
Japan
Facility Name
Novartis Investigative Site
City
Sakaide-city
State/Province
Kagawa
ZIP/Postal Code
762-8550
Country
Japan
Facility Name
Novartis Investigative Site
City
Sagamihara-city
State/Province
Kanagawa
ZIP/Postal Code
228-8522
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
234-8503
Country
Japan
Facility Name
Novartis Investigative Site
City
Habikino-city
State/Province
Osaka
ZIP/Postal Code
583-8588
Country
Japan
Facility Name
Novartis Investigative Site
City
Kishiwada-city
State/Province
Osaka
ZIP/Postal Code
596-8501
Country
Japan
Facility Name
Novartis Investigative Site
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Novartis Investigative Site
City
Edogawa-ku
State/Province
Tokyo
ZIP/Postal Code
134-0083
Country
Japan
Facility Name
Novartis Investigative Site
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Novartis Investigative Site
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
140-0063
Country
Japan
Facility Name
Novartis Investigative Site
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
143-0023
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Novartis Investigative Site
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
171-0014
Country
Japan
Facility Name
Novartis Investigative Site
City
Harderwijk
ZIP/Postal Code
3840 AC
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Bojnice
State/Province
Slovak Republic
ZIP/Postal Code
972 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Liptovsky Hradok
State/Province
Slovak Republic
ZIP/Postal Code
033 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Nitra
State/Province
Slovak Republic
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Zvolen
ZIP/Postal Code
960 01
Country
Slovakia

12. IPD Sharing Statement

Learn more about this trial

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

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