Long-term safety study of QGE031 in patients with allergic asthma who completed study CQGE031B2201

• Register: EUCTR
• Last refreshed on: 4 July 2016
• Main ID: EUCTR2013-003683-31-DE
• Date of registration: 03/03/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Long-term safety study of QGE031 in patients with allergic asthma who completed study CQGE031B2201
• Scientific 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
• Date of first enrolment: 08/04/2014
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003683-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Canada, Czech Republic, Finland, Germany, Hungary, Israel, Italy, Korea, Republic of, Mexico, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, Turkey, United Kingdom, United States

Contacts

• Name: Medical Competence Center (MCC)
• Affiliation: Novartis Pharma GmbH, Medizinischer Infoservice

• Name: Medical Competence Center (MCC)
• Affiliation: Novartis Pharma GmbH, Medizinischer Infoservice

Key inclusion & exclusion criteria

Inclusion criteria:
Key Inclusion Criteria:
- FEV1 > 40% predicted
- patients who completed CQGE031B2201 study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion criteria:
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Asthma
MedDRA version: 18.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Product Code: QGE031
Pharmaceutical Form: Solution for injection
INN or Proposed INN: not established
CAS Number: not establis
Current Sponsor code: QGE031
Other descriptive name: QGE031
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Every 4 weeks (as patient visits site every 4 weeks) as described in protocol.

Main Objective: To assess long-term safety and tolerability of QGE031 given every 4 weeks s.c.

Secondary Objective:

Primary end point(s): Adverse events and serious adverse events

Secondary ID(s)

2013-003683-31-SK

CQGE031B2201E1

Source(s) of Monetary Support

Novartis Pharma Services AG