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

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
QGE031
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, allergic asthma, QGE031, open-label, IgE, long-term safety

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

QGE031 every 4 weeks (q4w)

Arm Description

QGE031 240 mg subcutaneously q4w

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 27, 2014
Last Updated
August 7, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02075008
Brief Title
Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
The study was prematurely terminated after core study CQGE031B2201 failed to meet the primary objective of demonstrating superiority for QGE031 versus placebo.
Study Start Date
March 27, 2014 (Actual)
Primary Completion Date
March 22, 2016 (Actual)
Study Completion Date
March 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, allergic asthma, QGE031, open-label, IgE, long-term safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QGE031 every 4 weeks (q4w)
Arm Type
Experimental
Arm Description
QGE031 240 mg subcutaneously q4w
Intervention Type
Drug
Intervention Name(s)
QGE031
Intervention Description
QGE031 120 mg/mL solution for subcutaneous injection
Primary Outcome Measure Information:
Title
Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability
Description
Safety was monitored throughout the study.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Novartis Investigative Site
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Novartis Investigative Site
City
Waldorf
State/Province
Maryland
ZIP/Postal Code
20602
Country
United States
Facility Name
Novartis Investigative Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Novartis Investigative Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1122AAK
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Capital Federal
ZIP/Postal Code
C1430CKE
Country
Argentina
Facility Name
Novartis Investigative Site
City
Santa Fe
State/Province
Rosario
ZIP/Postal Code
S2000DBS
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000AII
Country
Argentina
Facility Name
Novartis Investigative Site
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1125ABE
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mendoza
ZIP/Postal Code
M5500CBA
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mendoza
ZIP/Postal Code
M5500FIK
Country
Argentina
Facility Name
Novartis Investigative Site
City
Santa Fe
ZIP/Postal Code
S3000FIL
Country
Argentina
Facility Name
Novartis Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4G2
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1L5
Country
Canada
Facility Name
Novartis Investigative Site
City
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Facility Name
Novartis Investigative Site
City
Trutnov
State/Province
Czech Republic
ZIP/Postal Code
541 01
Country
Czechia
Facility Name
Novartis Investigative Site
City
Teplice
State/Province
CZE
ZIP/Postal Code
415 01
Country
Czechia
Facility Name
Novartis Investigative Site
City
Breclav
ZIP/Postal Code
690 02
Country
Czechia
Facility Name
Novartis Investigative Site
City
Brno
ZIP/Postal Code
615 00
Country
Czechia
Facility Name
Novartis Investigative Site
City
Tabor
ZIP/Postal Code
390 01
Country
Czechia
Facility Name
Novartis Investigative Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Novartis Investigative Site
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Novartis Investigative Site
City
Le Kremlin
ZIP/Postal Code
94275
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier
ZIP/Postal Code
34059
Country
France
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04275
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novartis Investigative Site
City
Rudersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Novartis Investigative Site
City
Pecs
ZIP/Postal Code
7635
Country
Hungary
Facility Name
Novartis Investigative Site
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Novartis Investigative Site
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Novartis Investigative Site
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Novartis Investigative Site
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Novartis Investigative Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Novartis Investigative Site
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Novartis Investigative Site
City
Messina
State/Province
ME
ZIP/Postal Code
98125
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20123
Country
Italy
Facility Name
Novartis Investigative Site
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
State/Province
PI
ZIP/Postal Code
56124
Country
Italy
Facility Name
Novartis Investigative Site
City
Verona
State/Province
VR
ZIP/Postal Code
37126
Country
Italy
Facility Name
Novartis Investigative Site
City
Cheongju-si
State/Province
Chungcheongbuk-do
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Bucheon-Si
State/Province
Gyeonggi-Do
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Novartis Investigative Site
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Novartis Investigative Site
City
Coimbra
ZIP/Postal Code
3041-853
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1749-035
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4100-180
Country
Portugal
Facility Name
Novartis Investigative Site
City
Bucharest
State/Province
ROM
ZIP/Postal Code
12071
Country
Romania
Facility Name
Novartis Investigative Site
City
Brasov
ZIP/Postal Code
500112
Country
Romania
Facility Name
Novartis Investigative Site
City
Brasov
ZIP/Postal Code
500281
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
ZIP/Postal Code
030317
Country
Romania
Facility Name
Novartis Investigative Site
City
Cluj-Napoca
ZIP/Postal Code
400371
Country
Romania
Facility Name
Novartis Investigative Site
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Nizhny Novgorod
ZIP/Postal Code
603018
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Bratislava
State/Province
Slovak Republic
ZIP/Postal Code
831 03
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Nitra
State/Province
Slovak Republic
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kosice
ZIP/Postal Code
04001
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Prievidza
ZIP/Postal Code
97101
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Ruzomberok
ZIP/Postal Code
034 26
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Berea
State/Province
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Novartis Investigative Site
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Novartis Investigative Site
City
Istanbul
ZIP/Postal Code
34854
Country
Turkey
Facility Name
Novartis Investigative Site
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Novartis Investigative Site
City
Mersin
ZIP/Postal Code
33079
Country
Turkey
Facility Name
Novartis Investigative Site
City
Bradford
State/Province
West Yorkshire
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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