To Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 in Patients With Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VAK694
VAK694 placebo
QAX576
QAX576 placebo
Sponsored by

About this trial
This is an interventional other trial for Asthma focused on measuring Asthma, VAK694, QAX576, QBX258, pharmacokinetics
Eligibility 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.
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
VAK694
VAK694 Placebo
QAX576
QAX576 placebo
Arm Description
VAK694 was administered as a 1 hour intravenous infusion
VAK694 placebo was administered as a one hour intravenous infusion
QAX576 was administered intravenously as a 2 hour infusion
QAX576 placebo was administered as a 2 hour intravenous infusion
Outcomes
Primary Outcome Measures
Number of patients with adverse events
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
Blood will be collected to determine concentrations if anti-VAK964 antibodies
Concentration of serum anti-QAX576 antibodies
Blood will be collected to determine concentrations if anti-QAX576 antibodies
Area under the serum concentration curve for VAK694
Blood will be collected for the measurement of VAK694 serum concentrations
Area under the serum concentration curve for QAX576
Blood will be collected for the measurement of QAX576 concentrations
Change in interleukin concentrations
Blood samples will be collected to measure interleukin concetrations.
Full Information
NCT ID
NCT01568762
First Posted
March 29, 2012
Last Updated
December 17, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01568762
Brief Title
To Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 in Patients With Asthma
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, VAK694, QAX576, QBX258, pharmacokinetics
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VAK694
Arm Type
Experimental
Arm Description
VAK694 was administered as a 1 hour intravenous infusion
Arm Title
VAK694 Placebo
Arm Type
Placebo Comparator
Arm Description
VAK694 placebo was administered as a one hour intravenous infusion
Arm Title
QAX576
Arm Type
Experimental
Arm Description
QAX576 was administered intravenously as a 2 hour infusion
Arm Title
QAX576 placebo
Arm Type
Placebo Comparator
Arm Description
QAX576 placebo was administered as a 2 hour intravenous infusion
Intervention Type
Drug
Intervention Name(s)
VAK694
Intervention Description
Intravenous infusion
Intervention Type
Drug
Intervention Name(s)
VAK694 placebo
Intervention Description
Intravenous infusion
Intervention Type
Drug
Intervention Name(s)
QAX576
Intervention Description
Intravenous infusion
Intervention Type
Drug
Intervention Name(s)
QAX576 placebo
Intervention Description
Intravenous infusion
Primary Outcome Measure Information:
Title
Number of patients with adverse events
Description
Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs
Time Frame
100 days
Secondary Outcome Measure Information:
Title
Concentration of serum anti-VAK694 antibodies
Description
Blood will be collected to determine concentrations if anti-VAK964 antibodies
Time Frame
Pre-dose, Day 71, 85 and 100
Title
Concentration of serum anti-QAX576 antibodies
Description
Blood will be collected to determine concentrations if anti-QAX576 antibodies
Time Frame
Pre-dose, Day 71, 85 and 100
Title
Area under the serum concentration curve for VAK694
Description
Blood will be collected for the measurement of VAK694 serum concentrations
Time Frame
Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
Title
Area under the serum concentration curve for QAX576
Description
Blood will be collected for the measurement of QAX576 concentrations
Time Frame
Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
Title
Change in interleukin concentrations
Description
Blood samples will be collected to measure interleukin concetrations.
Time Frame
Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6763
Description
Results forCQBX258X2101 can be found on the Novartis Clinical Trial Results Website
Learn more about this trial
To Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 in Patients With Asthma
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