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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: VAK694; Drug: VAK694 placebo; Drug: QAX576; Drug: QAX576 placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with adverse events	Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs	100 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of serum anti-VAK694 antibodies	Blood will be collected to determine concentrations if anti-VAK964 antibodies	Pre-dose, Day 71, 85 and 100
Concentration of serum anti-QAX576 antibodies	Blood will be collected to determine concentrations if anti-QAX576 antibodies	Pre-dose, Day 71, 85 and 100
Area under the serum concentration curve for VAK694	Blood will be collected for the measurement of VAK694 serum concentrations	Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
Area under the serum concentration curve for QAX576	Blood will be collected for the measurement of QAX576 concentrations	Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
Change in interleukin concentrations	Blood samples will be collected to measure interleukin concetrations.	Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results forCQBX258X2101 can be found on the Novartis Clinical Trial Results Website

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: March 29, 2012
• First Submitted That Met QC Criteria: March 30, 2012
• First Posted (ESTIMATE): April 2, 2012

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Asthma; pharmacokinetics; QBX258; VAK694; QAX576
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CQBX258X2101