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

NCT ID: NCT02336425

Last Updated: 2017-08-11

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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QGE031 240 mg

QGE031 240 mg subcutaneous injection every 4 weeks

Group Type EXPERIMENTAL

QGE031

Intervention Type DRUG

QGE031 120 mg per 1 mL liquid in vial

QGE031 72 mg

QGE031 72 mg subcutaneous injection every 4 weeks

Group Type EXPERIMENTAL

QGE031

Intervention Type DRUG

QGE031 120 mg per 1 mL liquid in vial

QGE031 24 mg

QGE031 24 mg subcutaneous injection every 4 weeks

Group Type EXPERIMENTAL

QGE031

Intervention Type DRUG

QGE031 120 mg per 1 mL liquid in vial

Placebo to QGE031

Placebo subcutaneous injection every 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to QGE031 0 mg per 1 mL liquid in vial

Interventions

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QGE031

QGE031 120 mg per 1 mL liquid in vial

Intervention Type DRUG

Placebo

Placebo to QGE031 0 mg per 1 mL liquid in vial

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Birmingham, Alabama, United States

Site Status

Novartis Investigative Site

Kingwood, Texas, United States

Site Status

Novartis Investigative Site

Plano, Texas, United States

Site Status

Novartis Investigative Site

Erpent, , Belgium

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Trois-Rivières, Quebec, Canada

Site Status

Novartis Investigative Site

Le Kremlin-Bicêtre, , France

Site Status

Novartis Investigative Site

Cottbus, Saxony, Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Frankfurt, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Leipzig, , Germany

Site Status

Novartis Investigative Site

Marburg, , Germany

Site Status

Novartis Investigative Site

Münster, , Germany

Site Status

Novartis Investigative Site

Miskolc, HUN, Hungary

Site Status

Novartis Investigative Site

Balassagyarmat, , Hungary

Site Status

Novartis Investigative Site

Pisa, PI, Italy

Site Status

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status

Novartis Investigative Site

Sakaidechō, Kagawa-ken, Japan

Site Status

Novartis Investigative Site

Sagamihara, Kanagawa, Japan

Site Status

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status

Novartis Investigative Site

Habikino, Osaka, Japan

Site Status

Novartis Investigative Site

Kishiwada, Osaka, Japan

Site Status

Novartis Investigative Site

Chuo-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Edogawa-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Itabashi-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Ōta-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Ōta-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Shinagawa-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Toshima-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Harderwijk, , Netherlands

Site Status

Novartis Investigative Site

Leiden, , Netherlands

Site Status

Novartis Investigative Site

Bojnice, Slovak Republic, Slovakia

Site Status

Novartis Investigative Site

Liptovský Hrádok, Slovak Republic, Slovakia

Site Status

Novartis Investigative Site

Nitra, Slovak Republic, Slovakia

Site Status

Novartis Investigative Site

Zvolen, , Slovakia

Site Status

Countries

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United States Belgium Canada France Germany Hungary Italy Japan Netherlands Slovakia

Other Identifiers

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2014-003155-57

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQGE031B2204

Identifier Type: -

Identifier Source: org_study_id

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