Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma
Status and phase
Completed
Phase 2
Conditions
Asthma
Treatments
Drug: Placebo
Drug: Omalizumab
Drug: QGE031
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.
Enrollment
471 patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion 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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
471 participants in 14 patient groups, including a placebo group
QGE031 240 mg every 2 weeks (q2w)
Experimental group
Description:
Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks.
Treatment:
Drug: QGE031
QGE031 240 mg q4w
Experimental group
Description:
Participants received QGE031 240 mg s.c. q4w for 16 weeks.
Treatment:
Drug: QGE031
QGE031 180 mg q2w
Experimental group
Description:
Participants received QGE031 180 mg s.c. q2w for 16 weeks.
Treatment:
Drug: QGE031
QGE031 120 mg q2w
Experimental group
Description:
Participants received QGE031 120 mg s.c. q2w for 16 weeks.
Treatment:
Drug: QGE031
QGE031 36 mg q2w
Experimental group
Description:
Participants received QGE031 36 mg s.c. q2w for 16 weeks.
Treatment:
Drug: QGE031
QGE031 12 mg q2w
Experimental group
Description:
Participants received QGE031 12 mg s.c. q2w for 16 weeks.
Treatment:
Drug: QGE031
Omalizumab (as per locally approved dosing table)
Active Comparator group
Description:
Participants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks.
Treatment:
Drug: Omalizumab
Placebo to QGE031 240 mg q2w
Placebo Comparator group
Description:
Participants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks.
Treatment:
Drug: Placebo
Placebo to QGE031 240 mg q4w
Placebo Comparator group
Description:
Participants received placebo to QGE031 240 mg s.c. q2w for 16 weeks.
Treatment:
Drug: Placebo
Placebo to QGE031 180 mg q2w
Placebo Comparator group
Description:
Participants received QGE031 180 mg s.c. q2w for 16 weeks.
Treatment:
Drug: Placebo
Placebo to QGE031 120 mg q2w
Placebo Comparator group
Description:
Participants received QGE031 120 mg s.c. q2w for 16 weeks.
Treatment:
Drug: Placebo
Placebo to QGE031 36 mg q2w
Placebo Comparator group
Description:
Participants received QGE031 36 mg s.c. q2w for 16 weeks.
Treatment:
Drug: Placebo
Placebo to QGE031 12 mg q2w
Placebo Comparator group
Description:
Participants received QGE031 12 mg s.c. q2w for 16 weeks.
Treatment:
Drug: Placebo
Placebo to omalizumab
Placebo Comparator group
Description:
Participants received placebo to omalizumab s.c. q2w or q4w for 16 weeks.
Treatment:
Drug: Placebo
Trial contacts and locations
150
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Data sourced from clinicaltrials.gov
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