To Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 in Patients With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01568762
First received: March 29, 2012
Last updated: March 30, 2012
Last verified: March 2012
  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:


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 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 April 17, 2014