A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma
NCT ID: NCT01479595
Last Updated: 2016-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2012-02-29
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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QBX258
Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
QBX258
QBX258 infusion, a combination of VAK694 and QAX576, was supplied to the Investigator as open label bulk medication. The planned dose of VAK694 (lyophilisate in vial, 150 mg/vial), was 3 mg/kg. The planned dose of QAX576 (lyophilisate in vial, 150 mg/vial), was 6 mg/kg.
Placebo
Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
Placebo
The placebo infusion was an equal volume of 5% dextrose for infusion and was provided by the clinical site.
Interventions
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QBX258
QBX258 infusion, a combination of VAK694 and QAX576, was supplied to the Investigator as open label bulk medication. The planned dose of VAK694 (lyophilisate in vial, 150 mg/vial), was 3 mg/kg. The planned dose of QAX576 (lyophilisate in vial, 150 mg/vial), was 6 mg/kg.
Placebo
The placebo infusion was an equal volume of 5% dextrose for infusion and was provided by the clinical site.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis
Locations
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Novartis Investigative Site
Anaheim, California, 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
Denver, Colorado, United States
Novartis Investigative Site
Denver, Colorado, United States
Novartis Investigative Site
Aventura, Florida, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Minneapolis, Minnesota, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Raleigh, North Carolina, United States
Novartis Investigative Site
Winston-Salem, North Carolina, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Medford, Oregon, United States
Novartis Investigative Site
Spartanburg, South Carolina, United States
Novartis Investigative Site
Wiesbaden, Germany, Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
London, United Kingdom, United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Countries
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Other Identifiers
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2011-003066-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQBX258X2201
Identifier Type: -
Identifier Source: org_study_id
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