Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma
Asthma

About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma, asthma control, allergy, atopic, IgE, double-blind, placebo, omalizumab
Eligibility Criteria
Key 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).
Key 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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
QGE031 240 mg every 2 weeks (q2w)
QGE031 240 mg q4w
QGE031 180 mg q2w
QGE031 120 mg q2w
QGE031 36 mg q2w
QGE031 12 mg q2w
Omalizumab (as per locally approved dosing table)
Placebo to QGE031 240 mg q2w
Placebo to QGE031 240 mg q4w
Placebo to QGE031 180 mg q2w
Placebo to QGE031 120 mg q2w
Placebo to QGE031 36 mg q2w
Placebo to QGE031 12 mg q2w
Placebo to omalizumab
Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks.
Participants received QGE031 240 mg s.c. q4w for 16 weeks.
Participants received QGE031 180 mg s.c. q2w for 16 weeks.
Participants received QGE031 120 mg s.c. q2w for 16 weeks.
Participants received QGE031 36 mg s.c. q2w for 16 weeks.
Participants received QGE031 12 mg s.c. q2w for 16 weeks.
Participants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks.
Participants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks.
Participants received placebo to QGE031 240 mg s.c. q2w for 16 weeks.
Participants received QGE031 180 mg s.c. q2w for 16 weeks.
Participants received QGE031 120 mg s.c. q2w for 16 weeks.
Participants received QGE031 36 mg s.c. q2w for 16 weeks.
Participants received QGE031 12 mg s.c. q2w for 16 weeks.
Participants received placebo to omalizumab s.c. q2w or q4w for 16 weeks.