Clinical trial NCT01479595: A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Interleukin
QBX258
QAX576
VAK694
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-11-24
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline in Asthma Control Questionnaire (ACQ) Score
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline and 12 weeks
measure: Change in Asthma Quality of Life Questionnaire (AQLQ) Score
timeFrame: Baseline and 12 weeks
measure: Morning and Evening Peak Expiratory Flow (PEF) Rate
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Maximum Expiratory Flow
timeFrame: Baseline and 12 weeks
measure: Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies
timeFrame: 12 weeks
measure: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the QAX576 Analyte
timeFrame: days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183
measure: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the VAK694 Analyte
timeFrame: days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183
measure: Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the QAX576 Analyte
timeFrame: days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183
measure: Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the VAK694 Analyte
timeFrame: days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183
measure: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Novartis Investigative Site
state: California
city: Riverside
country: United States
facility: Novartis Investigative Site
state: California
city: Rolling Hills Estates
country: United States
facility: Novartis Investigative Site
state: California
city: San Marino
country: United States
facility: Novartis Investigative Site
state: California
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Aventura
country: United States
facility: Novartis Investigative Site
state: Florida
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Raleigh
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Medford
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Spartanburg
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: