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

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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
1253
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from 91732
Tulsa, OK
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1932
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Ann Arbor, MI
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2002
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Ashville, NC
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825
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Aurora, CO
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1784
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Birmingham, AL
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2473
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from 91732
Bridgeport, CT
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Charleston, South Carolina 29412
2184
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Charleston, SC
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1225
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Dallas, TX
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2187
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Daytona Beach, FL
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1924
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Decatur, GA
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218
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Henderson, NV
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1813
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Louisville, KY
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1722
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Milwaukee, WI
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2423
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Newark, NJ
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316
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Santa Clara, CA
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1333
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from 91732
St. Joseph, MO
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2560
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from 91732
Warwick, RI
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