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

Phase 1

• Conditions: 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]

• Registration Number: EUCTR2012-002298-69-GB
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-04
• Study Completion: 2016-01-21
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 471

Inclusion Criteria

1) A diagnosis of allergic asthma, uncontrolled on current medication.
2) History of at least 1 asthma exacerbation(s) during the last 1 year.
3) 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

1) Baseline IgE levels or BW outside the omalizumab dosing table.
2) Use of tobacco products within the previous 6 months (social occasional smokers may be included).
3) 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;<br> 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<br> ;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
<br> 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<br> ;<br> 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<br>