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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014