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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01603277
Registration number
NCT01603277
Ethics application status
Date submitted
16/05/2012
Date registered
22/05/2012
Date last updated
2/02/2015
Titles & IDs
Public title
Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids
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Scientific title
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
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Secondary ID [1]
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KB003-04
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Universal Trial Number (UTN)
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Trial acronym
KB003-04
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Moderate-to-Severe Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Anti-GM-CSF Monoclonal Antibody 400mg
Other interventions - Placebo
Experimental: Anti-GM-CSF Monoclonal Antibody 400mg -
Placebo Comparator: Normal Saline -
Other interventions: Anti-GM-CSF Monoclonal Antibody 400mg
Anti-GM-CSF Monoclonal Antibody 400mg
Other interventions: Placebo
Normal Saline
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Percent Predicted FEV1 at Week 24
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Assessment method [1]
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Timepoint [1]
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Baseline to Week 24
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Secondary outcome [1]
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To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate
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Assessment method [1]
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF)
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Assessment method [2]
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Timepoint [2]
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Week 24
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Secondary outcome [3]
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To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments
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Assessment method [3]
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Timepoint [3]
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Week 24
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Eligibility
Key inclusion criteria
Key
- 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
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Minimum age
16
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2014
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Sample size
Target
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Accrual to date
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Final
160
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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Recruitment hospital [1]
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- Cairns
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Recruitment hospital [2]
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- Woolonggabba
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Recruitment hospital [3]
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- Bedford Park
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Recruitment hospital [4]
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- Woodville
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Recruitment hospital [5]
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- Box Hill
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Recruitment hospital [6]
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- Frankston
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Recruitment hospital [7]
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- Melbourne
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Recruitment hospital [8]
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- Nedlands
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Recruitment postcode(s) [1]
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4870 - Cairns
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Recruitment postcode(s) [2]
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4102 - Woolonggabba
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Recruitment postcode(s) [3]
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5042 - Bedford Park
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Recruitment postcode(s) [4]
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5011 - Woodville
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Recruitment postcode(s) [5]
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3128 - Box Hill
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Recruitment postcode(s) [6]
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3199 - Frankston
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Recruitment postcode(s) [7]
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3050 - Melbourne
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Recruitment postcode(s) [8]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Alabama
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Colorado
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Connecticut
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Marseille
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France
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Rennes
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Slaski
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Biala Rawska
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Piasta
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Kyiv
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Odessa
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Simferopol
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Vinnytsya
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Ukraine
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Yalta
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Ukraine
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Zaporizhzhya
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Lanarkshire
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West Yorkshire
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United Kingdom
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Humanigen, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the safety, tolerability and efficacy of a single dose level of
KB003 in subjects with inadequately controlled asthma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01603277
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Nestor A. Molfino, MD, MSc
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Address
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KaloBios Pharmaceuticals, Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01603277
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