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

This study is currently recruiting participants.
Verified October 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01479595
First received: November 22, 2011
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Asthma
Drug: QBX258
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in Asthma Control Questionnaire score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: February 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QBX258 - Active Drug: QBX258
QBX258 intravenous infusion every 4 weeks for up to 4 doses total
Placebo Comparator: Placebo Drug: Placebo
Placebo to QBX258 intravenous infusion every 4 weeks up to 4 doses total

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479595

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, California
Novartis Investigative Site Not yet recruiting
Anaheim, California, United States, 92801
Novartis Investigative Site Not yet recruiting
Riverside, California, United States, 92506
Novartis Investigative Site Not yet recruiting
Rolling Hills Estates, California, United States, 90274
Novartis Investigative Site Not yet recruiting
San Marino, California, United States, 91108
United States, Colorado
Novartis Investigative Site Not yet recruiting
Denver, Colorado, United States, 80230
United States, Florida
Novartis Investigative Site Recruiting
Aventura, Florida, United States, 33180
United States, Massachusetts
Novartis Investigative Site Not yet recruiting
Boston, Massachusetts, United States, 02115
United States, Missouri
Novartis Investigative Site Not yet recruiting
St. Louis, Missouri, United States, 63110
United States, Nevada
Novartis Investigative Site Not yet recruiting
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Novartis Investigative Site Withdrawn
Berlin, New Jersey, United States, 08009
United States, North Carolina
Novartis Investigative Site Not yet recruiting
Raleigh, North Carolina, United States, 27607
Novartis Investigative Site Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Novartis Investigative Site Not yet recruiting
Marion, Ohio, United States, 43302
United States, Oregon
Novartis Investigative Site Not yet recruiting
Medford, Oregon, United States, 97504-8741
United States, South Carolina
Novartis Investigative Site Not yet recruiting
Spartanburg, South Carolina, United States, 29303
United Kingdom
Novartis Investigative Site Not yet recruiting
Belfast, Northern Ireland, United Kingdom, BT9 6AD
Novartis Investigative Site Not yet recruiting
London, United Kingdom, SE11YR
Novartis Investigative Site Not yet recruiting
London, United Kingdom, SW3 6PH
Novartis Investigative Site Not yet recruiting
London, United Kingdom, E2 9JX
Novartis Investigative Site Not yet recruiting
London, United Kingdom, W2 1PG
Novartis Investigative Site Not yet recruiting
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01479595     History of Changes
Other Study ID Numbers: CQBX258X2201, 2011-003066-32
Study First Received: November 22, 2011
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Asthma
Interleukin
QBX258
QAX576
VAK694

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014