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

Phase 1

• 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-PL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-01
• Last Update Posted: 23 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 457

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

Not provided

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