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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
KB003-04
Universal Trial Number (UTN)
Trial acronym
KB003-04
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate-to-Severe Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Anti-GM-CSF Monoclonal Antibody 400mg
Other interventions - Placebo

Experimental: Anti-GM-CSF Monoclonal Antibody 400mg -

Placebo comparator: Normal Saline -


Treatment: Other: Anti-GM-CSF Monoclonal Antibody 400mg
Anti-GM-CSF Monoclonal Antibody 400mg

Other interventions: Placebo
Normal Saline
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Percent Predicted FEV1 at Week 24
Timepoint [1] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF)
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments
Timepoint [3] 0 0
Week 24

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

Key
Minimum age
16 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2014
Sample size
Target
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Cairns
Recruitment hospital [2] 0 0
- Woolonggabba
Recruitment hospital [3] 0 0
- Bedford Park
Recruitment hospital [4] 0 0
- Woodville
Recruitment hospital [5] 0 0
- Box Hill
Recruitment hospital [6] 0 0
- Frankston
Recruitment hospital [7] 0 0
- Melbourne
Recruitment hospital [8] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
4870 - Cairns
Recruitment postcode(s) [2] 0 0
4102 - Woolonggabba
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
3050 - Melbourne
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Kentucky
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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Nevada
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United States of America
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New Jersey
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United States of America
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North Carolina
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United States of America
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Oklahoma
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United States of America
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Texas
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United States of America
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Wisconsin
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France
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Marseille
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France
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Montpellier
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France
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Rennes
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France
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Strasbourg
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France
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Tours
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Poland
State/province [23] 0 0
Podlaskie
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Poland
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Slaskie
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Poland
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Slaski
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Poland
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Biala Rawska
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Poland
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Bydgoszcz
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Poland
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Krakow
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Poland
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Lodz
Country [30] 0 0
Poland
State/province [30] 0 0
Lublin
Country [31] 0 0
Poland
State/province [31] 0 0
Piasta
Country [32] 0 0
Ukraine
State/province [32] 0 0
Dnipropetrovsk
Country [33] 0 0
Ukraine
State/province [33] 0 0
Donetsk
Country [34] 0 0
Ukraine
State/province [34] 0 0
Kharkiv
Country [35] 0 0
Ukraine
State/province [35] 0 0
Kyiv
Country [36] 0 0
Ukraine
State/province [36] 0 0
Odessa
Country [37] 0 0
Ukraine
State/province [37] 0 0
Simferopol
Country [38] 0 0
Ukraine
State/province [38] 0 0
Vinnytsya
Country [39] 0 0
Ukraine
State/province [39] 0 0
Yalta
Country [40] 0 0
Ukraine
State/province [40] 0 0
Zaporizhzhya
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Lanarkshire
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Middlesex
Country [43] 0 0
United Kingdom
State/province [43] 0 0
West Yorkshire
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Humanigen, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01603277
Trial related presentations / publications
Molfino NA, Kuna P, Leff JA, Oh CK, Singh D, Chernow M, Sutton B, Yarranton G. Phase 2, randomised placebo-controlled trial to evaluate the efficacy and safety of an anti-GM-CSF antibody (KB003) in patients with inadequately controlled asthma. BMJ Open. 2016 Jan 6;6(1):e007709. doi: 10.1136/bmjopen-2015-007709.
Public notes

Contacts
Principal investigator
Name 0 0
Nestor A. Molfino, MD, MSc
Address 0 0
KaloBios Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01603277