Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201

August 7, 2017 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1125ABE
        • Novartis Investigative Site
      • Mendoza, Argentina, M5500CBA
        • Novartis Investigative Site
      • Mendoza, Argentina, M5500FIK
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000FIL
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1122AAK
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1426ABP
        • Novartis Investigative Site
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Novartis Investigative Site
    • Capital Federal
      • Caba, Capital Federal, Argentina, C1430CKE
        • Novartis Investigative Site
    • Rosario
      • Santa Fe, Rosario, Argentina, S2000DBS
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000AII
        • Novartis Investigative Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • Novartis Investigative Site
  • Canada
      • Quebec, Canada, G1V 4W2
        • Novartis Investigative Site
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4G2
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H3G 1L5
        • Novartis Investigative Site
  • Czechia
      • Breclav, Czechia, 690 02
        • Novartis Investigative Site
      • Brno, Czechia, 615 00
        • Novartis Investigative Site
      • Tabor, Czechia, 390 01
        • Novartis Investigative Site
    • CZE
      • Teplice, CZE, Czechia, 415 01
        • Novartis Investigative Site
    • Czech Republic
      • Trutnov, Czech Republic, Czechia, 541 01
        • Novartis Investigative Site
  • Finland
      • Tampere, Finland, 33520
        • Novartis Investigative Site
      • Turku, Finland, 20521
        • Novartis Investigative Site
  • France
      • Le Kremlin, France, 94275
        • Novartis Investigative Site
      • Montpellier, France, 34059
        • Novartis Investigative Site
  • Germany
      • Frankfurt, Germany, 60596
        • Novartis Investigative Site
      • Hamburg, Germany, 20354
        • Novartis Investigative Site
      • Leipzig, Germany, 04103
        • Novartis Investigative Site
      • Leipzig, Germany, 04275
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
      • Rudersdorf, Germany, 15562
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1121
        • Novartis Investigative Site
      • Pecs, Hungary, 7635
        • Novartis Investigative Site
      • Torokbalint, Hungary, 2045
        • Novartis Investigative Site
  • Israel
      • Jerusalem, Israel, 91031
        • Novartis Investigative Site
      • Jerusalem, Israel, 9112001
        • Novartis Investigative Site
      • Kfar Saba, Israel, 4428164
        • Novartis Investigative Site
      • Petach Tikva, Israel, 49100
        • Novartis Investigative Site
      • Rehovot, Israel, 7610001
        • Novartis Investigative Site
  • Italy
    • ME
      • Messina, ME, Italy, 98125
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20123
        • Novartis Investigative Site
    • PD
      • Padova, PD, Italy, 35128
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italy, 56124
        • Novartis Investigative Site
    • VR
      • Verona, VR, Italy, 37126
        • Novartis Investigative Site
  • Korea, Republic of
      • Gwangju, Korea, Republic of, 501-757
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 120-752
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 156-755
        • Novartis Investigative Site
    • Chungcheongbuk-do
      • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
        • Novartis Investigative Site
    • Gyeonggi-Do
      • Bucheon-Si, Gyeonggi-Do, Korea, Republic of, 14584
        • Novartis Investigative Site
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 08308
        • Novartis Investigative Site
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44130
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland, 15-276
        • Novartis Investigative Site
      • Lodz, Poland, 90-153
        • Novartis Investigative Site
  • Portugal
      • Coimbra, Portugal, 3041-853
        • Novartis Investigative Site
      • Lisboa, Portugal, 1749-035
        • Novartis Investigative Site
      • Porto, Portugal, 4100-180
        • Novartis Investigative Site
  • Romania
      • Brasov, Romania, 500112
        • Novartis Investigative Site
      • Brasov, Romania, 500281
        • Novartis Investigative Site
      • Bucharest, Romania, 030317
        • Novartis Investigative Site
      • Cluj-Napoca, Romania, 400371
        • Novartis Investigative Site
    • ROM
      • Bucharest, ROM, Romania, 12071
        • Novartis Investigative Site
  • Russian Federation
      • Barnaul, Russian Federation, 656045
        • Novartis Investigative Site
      • Nizhny Novgorod, Russian Federation, 603018
        • Novartis Investigative Site
      • Ryazan, Russian Federation, 390026
        • Novartis Investigative Site
      • Saint Petersburg, Russian Federation, 197022
        • Novartis Investigative Site
      • Saint Petersburg, Russian Federation, 194354
        • Novartis Investigative Site
      • Yaroslavl, Russian Federation, 150003
        • Novartis Investigative Site
  • Slovakia
      • Bratislava, Slovakia, 826 06
        • Novartis Investigative Site
      • Kosice, Slovakia, 04001
        • Novartis Investigative Site
      • Prievidza, Slovakia, 97101
        • Novartis Investigative Site
      • Ruzomberok, Slovakia, 034 26
        • Novartis Investigative Site
    • Slovak Republic
      • Bratislava, Slovak Republic, Slovakia, 831 03
        • Novartis Investigative Site
      • Nitra, Slovak Republic, Slovakia, 949 01
        • Novartis Investigative Site
  • South Africa
    • Durban
      • Berea, Durban, South Africa, 4001
        • Novartis Investigative Site
  • Turkey
      • Istanbul, Turkey, 34098
        • Novartis Investigative Site
      • Istanbul, Turkey, 34854
        • Novartis Investigative Site
      • Izmir, Turkey, 35040
        • Novartis Investigative Site
      • Mersin, Turkey, 33079
        • Novartis Investigative Site
  • United Kingdom
      • Southampton, United Kingdom, SO16 6YD
        • Novartis Investigative Site
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
        • Novartis Investigative Site
  • United States
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Novartis Investigative Site
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Novartis Investigative Site
    • Maryland
      • Waldorf, Maryland, United States, 20602
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Novartis Investigative Site
    • Virginia
      • Fairfax, Virginia, United States, 22030
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2014

Primary Completion (Actual)

March 22, 2016

Study Completion (Actual)

March 22, 2016

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQGE031B2201E1
  • 2013-003683-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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