Flora to provide confirmation: "A study evaluating the efficacy of QGE031 compared to omalizumab in patients with allergic asthma."

A randomized, double-blind, placebo- and comparator-controlled study evaluating the effect of multiple doses of QGE031 compared to omalizumab in asthma induced by allergen bronchial provocation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003350-84-SE

Enrollment

Registered

2012-10-19

Start date

2013-01-16

Completion date

Unknown

Last updated

2014-10-27

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

Conditions

asthma MedDRA version: 14.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Code: QGE031 Pharmaceutical Form: Concentrate for solution for injection/infusion Current Sponsor code: QGE031 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients 18 to 65 years Positive skin prick test to one or more common airborne allergens Presence of airway hyperresponsiveness documented by a provocative concentration of methacholine causing a 20% fall in FEV1 (PC20 FEV1) of less than or equal to 16 mg/mL Presence of an early asthmatic response demonstrated by an allergen challenge at screening and including a 15% fall in the FEV1 Patients with a body weight and total IgE in a range specified by local country prescribing information for omalizumab Additional inclusion criteria may apply. 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnant or nursing (lactating) women. Women of child-bearing potential unless they are using a highly effective method of birth control (as further defined in the study protocol) Smokers Patients with poorly controlled asthma or patients who have had an asthma exacerbation within the past year Additional exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effects of treatment every two weeks with 240 mg QGE031 versus omalizumab in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at 12 weeks compared to baseline ;Secondary Objective: To compare the effects between QGE031 24 mg and 72 mg treatments versus omalizumab, and between QGE031 treatments versus placebo in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the FEV1 (PC15FEV1) at 12 weeks compared to baseline To evaluate the pharmacokinetics of six 2-weekly doses of QGE031 in subjects with mild atopic asthma To evaluate the safety and tolerability of six 2-weekly doses of QGE031 in subjects with mild atopic asthma ;Primary end point(s): Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1);Timepoint(s) of evaluation of this end point: Baseline, 12 weeks	—

Measure

Time frame

Main Objective: To compare the effects of treatment every two weeks with 240 mg QGE031 versus omalizumab in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at 12 weeks compared to baseline ;Secondary Objective: To compare the effects between QGE031 24 mg and 72 mg treatments versus omalizumab, and between QGE031 treatments versus placebo in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the FEV1 (PC15FEV1) at 12 weeks compared to baseline To evaluate the pharmacokinetics of six 2-weekly doses of QGE031 in subjects with mild atopic asthma To evaluate the safety and tolerability of six 2-weekly doses of QGE031 in subjects with mild atopic asthma ;Primary end point(s): Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1);Timepoint(s) of evaluation of this end point: Baseline, 12 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): 1.Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1) following treatment with placebo and various doses of QGE031 2.QGE031 blood concentrations 3.Number of participants with adverse events or other safety concerns ;Timepoint(s) of evaluation of this end point: 1.Baseline, 12 weeks	—

Countries

Canada, Sweden

Contacts

Public ContactMedical information

Novartis Sverige AB

medinfo.se@novartis.com+4687323200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026