Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 16 - 75 |
Updated: | 5/27/2013 |
Start Date: | July 2012 |
End Date: | March 2014 |
Contact: | Josh Pelham |
Email: | jpelham@kalobios.com |
Phone: | 650-243-3125 |
A Phase 2, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids
This study will evaluate the safety, tolerability and efficacy of a single dose level of
KB003 in subjects with inadequately controlled asthma.
Key Inclusion Criteria:
- A diagnosis of asthma established for at least 2 years
- Symptomatic asthma as defined by the Juniper Asthma Control Questionnaire
- Symptomatic asthma despite stable treatment with inhaled corticosteroids fluticasone
or budesonide, or other corticosteroids, for at least 12 weeks
- Currently receiving inhaled long-acting beta agonist (LABA) or previously documented
LABA intolerability or lack of responsiveness
- At least 2 exacerbations (no more than 6) in the previous 12 months that required
systemic corticosteroids or at least a doubling of daily oral dose
Key Exclusion Criteria:
- Acute asthma worsening (requiring emergency room visit, hospitalization, urgent care,
physician visit, or change in asthma medications) or lower respiratory tract
infection requiring the use of antibiotics, within 4 weeks prior to Screening Visit.
- History of life-threatening asthma with admission to the intensive care unit
requiring the use of mechanical ventilation within the past 12 months
- Use of any immunosuppressive or immunomodulatory agents within 12 weeks or an
investigational agent within 4 weeks prior to Screening Visit
- History of any cardiovascular, neurological, hepatic, or renal condition
- History of smoking within the past 12 months
We found this trial at
17
sites
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