Phase 2
N=65
A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01479595 ↗Enrolled (actual)
65
Serious AEs
3.1%
Results posted
Aug 2016
Primary outcome: Primary: Change From Baseline in Asthma Control Questionnaire (ACQ) Score — -0.513; 0.001 score on a scale — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- QBX258 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Asthma Control Questionnaire (ACQ) Score |
-0.513; 0.001 | 0.005 sig |
| SECONDARY Change in Forced Expiratory Volume in One Second (FEV1) |
0.076; 0.050 | — |
| SECONDARY Change in Asthma Quality of Life Questionnaire (AQLQ) Score |
0.580; 0.468 | — |
| SECONDARY Morning and Evening Peak Expiratory Flow (PEF) Rate |
— | — |
| SECONDARY Change From Baseline in Maximum Expiratory Flow |
0.099; 0.025 | — |
| SECONDARY Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies |
2; 2 | — |
| SECONDARY Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the QAX576 Analyte |
169000; 184000; 176000 | — |
| SECONDARY Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the VAK694 Analyte |
56.7; 58.6; 57.6 | — |
| SECONDARY Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the QAX576 Analyte |
37500; 32200; 35000 | — |
| SECONDARY Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the VAK694 Analyte |
10.7; 9.83; 10.3 | — |
| SECONDARY Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) |
-3.67; 2.21 | — |
Summary
This study is designed to investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma.
Eligibility 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.
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.
- 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
Data sourced from ClinicalTrials.gov (NCT01479595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.