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

Conditions: asthma
MedDRA version: 19.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2012-002298-69-DE

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 457

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.
- Recent asthma attack/exacerbation or asthma worsening/respiratory infection.
Other exclusion criteria are listed in the clinical study protocol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Responder rate compared to placebo;Secondary Objective: 1) Responder rate compared to omalizumab<br>2) ACQ score<br>3) Change from baseline in ACQ score less than -1.1<br>4) AQLQ score;Primary end point(s): Responder rate compared to placebo;Timepoint(s) of evaluation of this end point: Baseline, Week 16

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Responder rate compared to omalizumab<br>2) ACQ score<br>3) Change from baseline in ACQ score less than -1.1<br>4) AQLQ score;Timepoint(s) of evaluation of this end point: 1) Baseline, Week 16<br>2) Baseline, Week 4, Week 8, Week 12, Week 16 and Week 28<br>3) Baseline, Week 16<br>4) Baseline, Week 16