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

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT01479595

Run by

Novartis Pharmaceuticals

People needed

65

Starts

2012-02-01

Expected to finish

2015-02-01

Last updated by the study team

2016-08-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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