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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01479595
First received: November 22, 2011
Last updated: May 21, 2014
Last verified: May 2014

November 22, 2011
May 21, 2014
February 2012
April 2015   (final data collection date for primary outcome measure)
Change in Asthma Control Questionnaire score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01479595 on ClinicalTrials.gov Archive Site
  • Change in Forced Expiratory Volume in one second (FEV1) [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
  • Change in Asthma Quality of Life Questionnaire score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Morning and evening peak expiratory flow rate [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: QBX258
    QBX258 intravenous infusion every 4 weeks for up to 4 doses total
  • Drug: Placebo
    Placebo to QBX258 intravenous infusion every 4 weeks up to 4 doses total
  • Experimental: QBX258 - Active
    Intervention: Drug: QBX258
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   Germany,   United Kingdom
 
NCT01479595
CQBX258X2201, 2011-003066-32
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis
Novartis
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP