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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01716754
First received: October 19, 2012
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

This study will assess 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 will also be assessed. Comparison will be to placebo and omalizumab. Information from this study will inform the design of future studies.


Condition Intervention Phase
Asthma
Drug: QGE031
Drug: Omalizumab
Drug: Placebo to QGE031
Drug: Placebo to omalizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo and Active-Controlled Study With Exploratory DR to Investigate the Efficacy and Safety of 16 Wks Treatment With s.c. QGE031 in Asthma Patients Not Adequately Controlled With High-dose Inhaled Corticosteroids and Long Acting β2-agonists

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • QGE031 ACQ response rate compared to placebo [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QGE031 ACQ response rate compared to omalizumab [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in Asthma Control Questionnaire score at different time points [ Time Frame: Baseline, Weeks 4, 8, 12,16 and 28 ] [ Designated as safety issue: No ]
  • Percentage of patients with a change from baseline in Asthma Control Questionnaire less than -1.1 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in Asthma Quality of Life Questionnaire score [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Total daily rescue medication use [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Comparison of injection site reactions across all groups [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events and serious adverse events [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 457
Study Start Date: December 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 QGE031 2qW Drug: QGE031
Experimental: Dose 1 QGE031 4qW Drug: QGE031
Experimental: Dose 2 QGE031 2qW Drug: QGE031
Experimental: Dose 3 QGE031 2qW Drug: QGE031
Experimental: Dose 4 QGE031 2qW Drug: QGE031
Experimental: Dose 5 QGE031 2qW Drug: QGE031
Active Comparator: omalizumab (as per dosing table) Drug: Omalizumab
Other Name: Xolair
Placebo Comparator: Placebo to Dose 1 QGE031 2qW Drug: Placebo to QGE031
Placebo Comparator: Placebo to Dose 1 QGE031 4qW Drug: Placebo to QGE031
Placebo Comparator: Placebo to Dose 2 QGE031 2qW Drug: Placebo to QGE031
Placebo Comparator: Placebo to Dose 3 QGE031 2qW Drug: Placebo to QGE031
Placebo Comparator: Placebo to Dose 4 QGE031 2qW Drug: Placebo to QGE031
Placebo Comparator: Placebo to Dose 5 QGE031 2qW Drug: Placebo to QGE031
Placebo Comparator: Placebo to omalizumab Drug: Placebo to omalizumab

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • A diagnosis of allergic asthma , uncontrolled on current medication.
  • History of at least 1 asthma exacerbation 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 must also be demonstrated (historical positive reversibility or bronchoprovocation result can be used).

Key Exclusion Criteria:

  • Baseline IgE levels or body weight outside the omalizumab dosing table.
  • Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
  • Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716754

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 169 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01716754     History of Changes
Other Study ID Numbers: CQGE031B2201, 2012-002298-69
Study First Received: October 19, 2012
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
asthma
asthma control
allergy
atopic
IgE
double-blind
placebo
omalizumab

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 16, 2014