A study to establish the efficacy of QBX258 in patients with moderate to severe asthma.

A randomized double-blind multiple-dose placebo-controlled trial to establish the efficacy of QBX258 (combination of VAK694 and QAX576) in asthma that is inadequately controlled with inhaled corticosteroids and long acting beta agonists.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003066-32-GB

Enrollment

Registered

2011-09-28

Start date

2012-02-09

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Patients with asthma that are inadequately controlled with inhaled corticosteroids and long acting beta agonists MedDRA version: 17.0 Level: LLT Classification code 10049106 Term: Asthma chronic System Organ Class: 100000004855

Interventions

Product Code: QAX576 Pharmaceutical Form: Powder for solution for infusion Current Sponsor code: QAX576 Concentration unit: mg milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * Patients with atopic asthma >1 year duration diagnosed according to the GINA guidelines. * Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 39 kg/m2. * Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of > 1.5. * FEV1 40 to 90% of predicted. Other inclusion criteria are listed in the clinical study protocol. 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: * Diagnosed with COPD as defined by the GOLD guidelines * Subjects who have had a respiratory tract infection within 4 weeks prior to screening.Patients should not have symptoms of an active respiratory tract infection at the time of randomization. * Women of child-bearing potential must use highly effective methods of contraception during dosing and for at least 18 weeks after last study drug administration Other inclusion criteria are listed in the clinical study protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: Change in Asthma Control Questionnaire score; Secondary Objective: * Change in Forced Expiratory Volume in one second (FEV1) * Change in Asthma Quality of Life Questionnaire score * Morning and evening peak expiratory flow rate ; Primary end point(s): Measure: Change in Asthma Control Questionnaire score ; Timepoint(s) of evaluation of this end point: Time Frame: 12 weeks	—

Secondary

Measure	Time frame
Secondary end point(s): 1) Measure: Change in Forced Expiratory Volume in one second (FEV1) 2) Measure: Change in Asthma Quality of Life Questionnaire score 3) Measure: Morning and evening peak expiratory flow rate ; Timepoint(s) of evaluation of this end point: 1) Time Frame: 26 weeks 2) Time Frame: 12 weeks 3) Time Frame: 26 weeks	—

Countries

Germany, United Kingdom, United States

Contacts

Public ContactMedical Information Services

Novartis Pharmaceutical UK Ltd

medinfo.uk@novartis.com+4401276698370

Outcome results

None listed

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