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

Asthma Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02336425
• Other study ID #: CQGE031B2204
• Secondary ID: 2014-003155-57
• Status: Terminated
• Phase: Phase 2
• First received: January 8, 2015
• Last updated: August 7, 2017
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• QGE031
QGE031 120 mg per 1 mL liquid in vial
• Placebo
Placebo to QGE031 0 mg per 1 mL liquid in vial

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Erpent
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Trois-Rivières	Quebec
France	Novartis Investigative Site	Le Kremlin Bicetre
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Cottbus	Sachsen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Münster
Hungary	Novartis Investigative Site	Balassagyarmat
Hungary	Novartis Investigative Site	Miskolc	HUN
Italy	Novartis Investigative Site	Pisa	PI
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Edogawa-ku	Tokyo
Japan	Novartis Investigative Site	Habikino-city	Osaka
Japan	Novartis Investigative Site	Itabashi-ku	Tokyo
Japan	Novartis Investigative Site	Kishiwada-city	Osaka
Japan	Novartis Investigative Site	Ota-ku	Tokyo
Japan	Novartis Investigative Site	Ota-ku	Tokyo
Japan	Novartis Investigative Site	Sagamihara-city	Kanagawa
Japan	Novartis Investigative Site	Sakaide-city	Kagawa
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Toshima-ku	Tokyo
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Netherlands	Novartis Investigative Site	Harderwijk
Netherlands	Novartis Investigative Site	Leiden
Slovakia	Novartis Investigative Site	Bojnice	Slovak Republic
Slovakia	Novartis Investigative Site	Liptovsky Hradok	Slovak Republic
Slovakia	Novartis Investigative Site	Nitra	Slovak Republic
Slovakia	Novartis Investigative Site	Zvolen
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Kingwood	Texas
United States	Novartis Investigative Site	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Hungary,  Italy,  Japan,  Netherlands,  Slovakia, 

Outcome

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

External Links

•   Results for CQGE031B2204 from the Novartis Clinical Trials Website