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NCT02075008 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02075008
Other study ID # CQGE031B2201E1
Secondary ID 2013-003683-31
Status Terminated
Phase Phase 2
First received February 27, 2014
Last updated August 7, 2017
Start date March 27, 2014
Est. completion date March 22, 2016

Study information
Verified date August 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 270
Est. completion date March 22, 2016
Est. primary completion date March 22, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 76 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• QGE031
QGE031 120 mg/mL solution for subcutaneous injection

Locations
Country Name City State
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Caba Capital Federal
Argentina Novartis Investigative Site Mar del Plata Buenos Aires
Argentina Novartis Investigative Site Mendoza
Argentina Novartis Investigative Site Mendoza
Argentina Novartis Investigative Site Rosario Santa Fe
Argentina Novartis Investigative Site San Miguel de Tucuman Tucuman
Argentina Novartis Investigative Site Santa Fe
Argentina Novartis Investigative Site Santa Fe Rosario
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Ottawa Ontario
Canada Novartis Investigative Site Quebec
Czechia Novartis Investigative Site Breclav
Czechia Novartis Investigative Site Brno
Czechia Novartis Investigative Site Tabor
Czechia Novartis Investigative Site Teplice CZE
Czechia Novartis Investigative Site Trutnov Czech Republic
Finland Novartis Investigative Site Tampere
Finland Novartis Investigative Site Turku
France Novartis Investigative Site Le Kremlin
France Novartis Investigative Site Montpellier
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Mainz
Germany Novartis Investigative Site Rudersdorf
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Pecs
Hungary Novartis Investigative Site Torokbalint
Israel Novartis Investigative Site Jerusalem
Israel Novartis Investigative Site Jerusalem
Israel Novartis Investigative Site Kfar Saba
Israel Novartis Investigative Site Petach Tikva
Israel Novartis Investigative Site Rehovot
Italy Novartis Investigative Site Messina ME
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Padova PD
Italy Novartis Investigative Site Pisa PI
Italy Novartis Investigative Site Verona VR
Korea, Republic of Novartis Investigative Site Bucheon-Si Gyeonggi-Do
Korea, Republic of Novartis Investigative Site Cheongju-si Chungcheongbuk-do
Korea, Republic of Novartis Investigative Site Gwangju
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul Korea
Korea, Republic of Novartis Investigative Site Suwon Gyeonggi-do
Mexico Novartis Investigative Site Guadalajara Jalisco
Poland Novartis Investigative Site Bialystok
Poland Novartis Investigative Site Lodz
Portugal Novartis Investigative Site Coimbra
Portugal Novartis Investigative Site Lisboa
Portugal Novartis Investigative Site Porto
Romania Novartis Investigative Site Brasov
Romania Novartis Investigative Site Brasov
Romania Novartis Investigative Site Bucharest
Romania Novartis Investigative Site Bucharest ROM
Romania Novartis Investigative Site Cluj-Napoca
Russian Federation Novartis Investigative Site Barnaul
Russian Federation Novartis Investigative Site Nizhny Novgorod
Russian Federation Novartis Investigative Site Ryazan
Russian Federation Novartis Investigative Site Saint Petersburg
Russian Federation Novartis Investigative Site Saint Petersburg
Russian Federation Novartis Investigative Site Yaroslavl
Slovakia Novartis Investigative Site Bratislava Slovak Republic
Slovakia Novartis Investigative Site Bratislava
Slovakia Novartis Investigative Site Kosice
Slovakia Novartis Investigative Site Nitra Slovak Republic
Slovakia Novartis Investigative Site Prievidza
Slovakia Novartis Investigative Site Ruzomberok
South Africa Novartis Investigative Site Berea Durban
Turkey Novartis Investigative Site Istanbul
Turkey Novartis Investigative Site Istanbul
Turkey Novartis Investigative Site Izmir
Turkey Novartis Investigative Site Mersin
United Kingdom Novartis Investigative Site Bradford West Yorkshire
United Kingdom Novartis Investigative Site Southampton
United States Novartis Investigative Site Evansville Indiana
United States Novartis Investigative Site Fairfax Virginia
United States Novartis Investigative Site Minneapolis Minnesota
United States Novartis Investigative Site Owensboro Kentucky
United States Novartis Investigative Site Waldorf Maryland

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Czechia,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Korea, Republic of,  Mexico,  Poland,  Portugal,  Romania,  Russian Federation,  Slovakia,  South Africa,  Turkey,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability Safety was monitored throughout the study. 52 weeks
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