A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma
This study is currently recruiting participants.
Verified March 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01479595
First received: November 22, 2011
Last updated: March 18, 2013
Last verified: March 2013
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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: | June 2014 |
| Estimated Primary Completion Date: | June 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 | |
| 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, 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, South Carolina | |
| Novartis Investigative Site | Not yet recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| United Kingdom | |
| Novartis Investigative Site | Not yet recruiting |
| London, United Kingdom, SE11YR | |
| Novartis Investigative Site | Not yet recruiting |
| London, United Kingdom, E2 9JX | |
| Novartis Investigative Site | Not yet recruiting |
| London, United Kingdom, SW3 6PH | |
| 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: | March 18, 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 May 19, 2013