search
Back to results

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
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring Asthma, VAK694, QAX576, QBX258, pharmacokinetics

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 29, 2012
Last Updated
December 17, 2020
Sponsor
Novartis Pharmaceuticals
search

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

We'll reach out to this number within 24 hrs