Efficacy and safety of QGE031 versus placebo and Omalizumab in patients aged 18-75 years with asthma

• Register: EUCTR
• Last refreshed on: 23 May 2016
• Main ID: EUCTR2012-002298-69-PL
• Date of registration: 01/02/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Efficacy and safety of QGE031 versus placebo and Omalizumab in patients aged 18-75 years with asthma
• Scientific title: A Multi-Center, Randomized, Double Blind, Placebo and Active-Controlled study with exploratory dose-ranging, to investigate the efficacy and safety of 16 weeks treatment with subcutaneous QGE031 in asthma patients not adequately controlled with high-dose inhaled corticosteroids and long acting ß2-agonists
• Date of first enrolment: 11/04/2013
• Target sample size: 457
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002298-69
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 14
• 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, France, Germany, Hungary, Israel, Italy, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Turkey, United Kingdom, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma Services AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma Services AG

Key inclusion & exclusion criteria

Inclusion criteria:
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 366
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 91

Exclusion criteria:


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

Health Condition(s) or Problem(s) studied

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

asthma
MedDRA version: 19.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Code: QGE031
Pharmaceutical Form: Concentrate for solution for injection
Current Sponsor code: QGE031
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: Xolair
Product Name: Xolair
Product Code: IGE025
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: OMALIZUMAB
CAS Number: 242138-07-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: Responder rate compared to placebo

Timepoint(s) of evaluation of this end point: Baseline, Week 16

Primary end point(s): Responder rate compared to placebo

Secondary Objective: 1) Responder rate compared to omalizumab
2) ACQ score
3) Change from baseline in ACQ score less than -1.1
4) AQLQ score

Secondary Outcome(s)

Secondary end point(s): 1) Responder rate compared to omalizumab
2) ACQ score
3) Change from baseline in ACQ score less than -1.1
4) AQLQ score

Timepoint(s) of evaluation of this end point: 1) Baseline, Week 16
2) Baseline, Week 4, Week 8, Week 12, Week 16 and Week 28
3) Baseline, Week 16
4) Baseline, Week 16

Secondary ID(s)

CQGE031B2201

2012-002298-69-FI

Source(s) of Monetary Support

Novartis Pharma Services AG