A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma

Asthma Clinical Trial

Official title:

A Randomized Double-blind Multiple-dose Placebo-controlled Trial to Establish the Efficacy of QBX258 (Combination of VAK694 and QAX576) in Asthma That is Inadequately Controlled With Inhaled Corticosteroids and Long Acting Beta Agonists

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479595
• Other study ID #: CQBX258X2201
• Secondary ID: 2011-003066-32
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2011
• Last updated: January 8, 2016
• Start date: January 2012
• Est. completion date: February 2015

Study information

• Verified date: January 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This study is designed to investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with atopic asthma >1 year duration diagnosed according to the GINA guidelines.

• Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 39 kg/m2.

• Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of > 1.5.

• FEV1 40 to 90% of predicted.

Exclusion Criteria:

• Diagnosed with COPD as defined by the GOLD guidelines

• Subjects who have had a respiratory tract infection within 4 weeks prior to screening.

• Women of child-bearing potential must use highly effective methods of contraception during dosing and for at least 18 weeks after last study drug administration

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• QBX258
QBX258 intravenous infusion every 4 weeks for up to 4 doses total
• Placebo
Placebo to QBX258 intravenous infusion every 4 weeks up to 4 doses total

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Wiesbaden
United Kingdom	Novartis Investigative Site	London
United States	Novartis Investigative Site	Anaheim	California
United States	Novartis Investigative Site	Aventura	Florida
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Medford	Oregon
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigative Site	Riverside	California
United States	Novartis Investigative Site	Rolling Hills Estates	California
United States	Novartis Investigative Site	San Marino	California
United States	Novartis Investigative Site	Spartanburg	South Carolina
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Asthma Control Questionnaire score		Baseline and 12 weeks	No
Secondary	Change in Forced Expiratory Volume in one second (FEV1)		Baseline and 26 weeks	No
Secondary	Change in Asthma Quality of Life Questionnaire score		Baseline and 12 weeks	No
Secondary	Morning and evening peak expiratory flow rate		Baseline and 26 weeks	No