To Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 in Patients With Asthma - Full Text View

Purpose

This study is designed to compare the safety, tolerability, and pharmacokinetics of QBX258 (sequential administration of a fixed dose of VAK694 and single ascending doses of QAX576) in patients with well-controlled mild to moderate asthma.

Condition	Intervention	Phase
Asthma	Drug: VAK694 Drug: VAK694 placebo Drug: QAX576 Drug: QAX576 placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator)
Official Title:	A Randomized, Double-blind, Placebo Controlled Study to Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 (Sequential Administration of a Fixed Dose of VAK694 and Single Ascending Doses of QAX576) in Patients With Well-controlled Mild to Moderate Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Number of patients with adverse events [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs

Secondary Outcome Measures:

Concentration of serum anti-VAK694 antibodies [ Time Frame: Pre-dose, Day 71, 85 and 100 ] [ Designated as safety issue: No ]
Blood will be collected to determine concentrations if anti-VAK964 antibodies
Concentration of serum anti-QAX576 antibodies [ Time Frame: Pre-dose, Day 71, 85 and 100 ] [ Designated as safety issue: No ]
Blood will be collected to determine concentrations if anti-QAX576 antibodies
Area under the serum concentration curve for VAK694 [ Time Frame: Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100 ] [ Designated as safety issue: No ]
Blood will be collected for the measurement of VAK694 serum concentrations
Area under the serum concentration curve for QAX576 [ Time Frame: Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100 ] [ Designated as safety issue: No ]
Blood will be collected for the measurement of QAX576 concentrations
Change in interleukin concentrations [ Time Frame: Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100 ] [ Designated as safety issue: No ]
Blood samples will be collected to measure interleukin concetrations.

Enrollment:	50
Study Start Date:	October 2010
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: VAK694 VAK694 was administered as a 1 hour intravenous infusion	Drug: VAK694 Intravenous infusion
Placebo Comparator: VAK694 Placebo VAK694 placebo was administered as a one hour intravenous infusion	Drug: VAK694 placebo Intravenous infusion
Experimental: QAX576 QAX576 was administered intravenously as a 2 hour infusion	Drug: QAX576 Intravenous infusion
Placebo Comparator: QAX576 placebo QAX576 placebo was administered as a 2 hour intravenous infusion	Drug: QAX576 placebo Intravenous infusion

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female subjects age 18-60 years (inclusive)
Well controlled mild to moderate atopic asthma
Female subjects must be post-menopausal or surgically sterile
Male subjects must be using two methods of contraception
Subjects must have a positive skin prick test to one or more common airborne allergen

Exclusion Criteria:

Participation in any clinical investigation or use of other investigational drugs at time of enrollment
A history of clinically significant ECG abnormalities
History of malignancy of any organ system
Smokers (use of tobacco products in the previous 3 months)
Use of prescription drugs other than those required for control and relief of asthma
Use of oral steroids within 12 weeks prior to dosing
FEVI < 80% predicted at screening or baseline
Use of albuterol more than twice a week for relief of asthma
Patients suffering from active hay fever at baseline or likely to require treatment during the study
History of chronic respiratory disease other than asthma or chronic allergic rhinitis
Emergency room visit within 6 weeks of screening due to asthma
Hospitalization for asthma in the last year
History of intubation/assisted ventilation for asthma in the last 5 years
Administration of live vaccines within the preceding month

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568762

Locations

United States, North Carolina
Novartis Investigative Site
Raleigh, North Carolina, United States, 27607

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01568762 History of Changes
Other Study ID Numbers:	CQBX258X2101
Study First Received:	March 29, 2012
Last Updated:	March 30, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Asthma
VAK694
QAX576
QBX258
pharmacokinetics

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013