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

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2012-002298-69-FR
• Date of registration: 18/06/2015
• Prospective Registration: No
• 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: 28/11/2014
• 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: yes; 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, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Hungary, India, Israel, Italy, Korea, Republic of, Mexico, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, Turkey, United Kingdom, United States

Contacts

• Name: Information&Communication Médicales
• Affiliation: Novartis Pharma S.A.S

• Name: Information&Communication Médicales
• Affiliation: Novartis Pharma S.A.S

Key inclusion & exclusion criteria

Inclusion criteria:
-A diagnosis of allergic asthma , uncontrolled on current medication.
-History of at least 1 asthma exacerbation during the last 1 year
-Forced Expiratory Volume in one second (FEV1) of = 40% and = 80% of the predicted normal value;
- reversibility following administration of bronchodilator must also be demonstrated (historical positive reversibility or bronchoprovocation result can be used).

Other inclusion criteria are listed in the clinical study protocol
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:
-Baseline IgE levels or body weight outside the omalizumab dosing table.
-Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
-Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.

Other exclusion criteria are listed in the clinical study protocol


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: 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 (Omalizumab)
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)

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

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

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

Main Objective: Responder rate compared to placebo

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)

2012-002298-69-FI

CQGE031B2201

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 03/02/2017
• Date Completed: 21/01/2016
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-002298-69/results