Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma

A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of 52 Weeks Treatment With QGE031 s.c. in Asthma Patients Not Adequately Controlled by Medium- or High-dose ICS Plus LABA With or Without OCS

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223065

Enrollment

Registered

2016-01-07

Start date

2016-01-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

investigational material(s) Generic name etc : QGE031 INN of investigational material : Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational materia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *A diagnosis of allergic asthma, uncontrolled on current medication *History of at least 2 asthma exacerbations 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

Exclusion criteria

Exclusion criteria: *Use of tobacco products within the previous 6 months (Social occasional smokers may be included). *Recent asthma attack/exacerbation or asthma worsening/ respiratory infection. Other protocol defined inclusion/exclusion may apply

Design outcomes

Primary

Measure	Time frame
QGE031 compared to placebo in atopic asthma patients on the reduction in rate of severe asthma exacerbations [ Time Frame: Week 52 ]	—

Secondary

Measure	Time frame
QGE031 compared to placebo in all asthma patients on the reduction in rate of severe asthma exacerbations [ Time Frame: Week 52 ] QGE031 compared to placebo in non-atopic asthma patients on the reduction in rate of severe asthma exacerbations [ Time Frame: Week 52 ]	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026