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Trial record 1 of 3 for:    CQGE031B2201
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Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02075008
Recruitment Status : Terminated (The study was prematurely terminated after core study CQGE031B2201 failed to meet the primary objective of demonstrating superiority for QGE031 versus placebo.)
First Posted : March 3, 2014
Results First Posted : April 25, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma patients who completed study CQGE031B2201.

Condition or disease Intervention/treatment Phase
Asthma Drug: QGE031 Phase 2

Detailed Description:
This study planned to assess long-term safety and tolerability of QGE031 administered every 4 weeks for an additional 12 months in patients with allergic asthma who previously completed study CQGE031B2201. The study was terminated early due to the efficacy results from an interim analysis of the Phase II study CQGE031B2201.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center, Extension Study to Evaluate the Long-term Safety of Subcutaneous 240mg QGE031 Given Every 4 Weeks for 52 Weeks in Allergic Asthma Patients Who Completed Study CQGE031B2201
Actual Study Start Date : March 27, 2014
Actual Primary Completion Date : March 22, 2016
Actual Study Completion Date : March 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: QGE031 every 4 weeks (q4w)
QGE031 240 mg subcutaneously q4w
Drug: QGE031
QGE031 120 mg/mL solution for subcutaneous injection




Primary Outcome Measures :
  1. Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability [ Time Frame: 52 weeks ]
    Safety was monitored throughout the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • forced Expiratory Volume in one second ( FEV1) >= 40% predicted
  • patients who completed CQGE031B2201 study

Key Exclusion Criteria:

  • life-threatening asthma attack, intubation, respiratory arrest during or after completion of CQGE031B2201 study
  • new malignancy
  • ongoing SAE from CQGE031B2201 that was assessed as related to study drug
  • patient experienced platelets drop to < 75,000/uL
  • patient experienced one unexpected grade 4 or two unexpected grade 3 hypersensitivity reactions
  • patient is pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02075008


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02075008    
Other Study ID Numbers: CQGE031B2201E1
2013-003683-31 ( EudraCT Number )
First Posted: March 3, 2014    Key Record Dates
Results First Posted: April 25, 2017
Last Update Posted: August 11, 2017
Last Verified: August 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
asthma
allergic asthma
QGE031
open-label
IgE
long-term safety
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases