Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000554460
Ethics application status
Approved
Date submitted
24/10/2007
Date registered
29/10/2007
Date last updated
20/08/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and pharmacodynamics of KB002, an anti granulocyte monocyte colony stimulating factor (GM-CSF) monoclonal antibody, in patients with persistent symptomatic asthma
Scientific title
A Randomized Placebo-Controlled Safety and Pharmacodynamic Study of KB002, an Anti-GM-CSF Monoclonal Antibody, in Patients with Persistent Symptomatic Asthma
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent symptomatic asthma 2497 0
Condition category
Condition code
Respiratory 2532 2532 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
200mL infusion of 5.0mg/kg KB002 in 0.9% sodium chloride over 1 hour
Intervention code [1] 2151 0
Treatment: Drugs
Comparator / control treatment
200mL infusion of placebo (0.9% Sodium Chloride) over 1 hour
Control group
Placebo

Outcomes
Primary outcome [1] 3433 0
Safety and tolerability of a single dose of KB002 in adults with persistent symptomatic asthma
Timepoint [1] 3433 0
Day 42
Secondary outcome [1] 5704 0
Changes in selected markers of inflammation
Timepoint [1] 5704 0
Day 42
Secondary outcome [2] 5705 0
Changes in lung function and asthma symptoms as assessed by diary
Timepoint [2] 5705 0
Day 42
Secondary outcome [3] 5706 0
Assessment of pharmacokinetics and immunogenicity of KB002
Timepoint [3] 5706 0
Day 42
Secondary outcome [4] 5707 0
4. To evaluate the pharmacokinetics and immunogenicity of KB002 in this patient population
Timepoint [4] 5707 0
Day 42

Eligibility
Key inclusion criteria
1. Aged 18 – 75 years inclusive at screening 2. Males and females. Females of childbearing age may participate only if they have a negative pregnancy test, are non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study 3. An established diagnosis of asthma for at least 2 years at screening 4. Astthma control questionaire score of >0.75 at screening 5. Have persistent asthma as defined as being symptomatic despite being treated with >/= 500 µg/day beclomethasone (BDP) equivalent of inhaled and/or >/= 7.5mg prednisolone equivalent oral corticosteroids
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Acute asthma attack or lower respiratory tract infection within 1 month prior to baseline (Day 0)
2. History of life threatening asthma with admission to the intensive care unit requiring the use of mechanical ventilation within the past three years
3. History of any cardiovascular, neurological, hepatic, renal, or other medical conditions that in the Investigator’s opinion may interfere with the interpretation of data or the patient’s participation in the study
4. History of smoking within the past year or a greater than 20 pack year history of smoking
5. History of alcohol or drug abuse
6. Omalizumab (Xolair) therapy within 2 months prior to baseline (Day 0)
7. Participation in another research trial within 1 month prior to baseline (Day 0)
8. Inability to give consent and/or unwillingness/inability to comply with study procedures

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?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 616 0
New Zealand
State/province [1] 616 0
Christchurch

Funding & Sponsors
Funding source category [1] 2681 0
Commercial sector/Industry
Name [1] 2681 0
Kalobios Pharmaceuticals Inc.
Country [1] 2681 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Kalobios Pharmaceuticals Inc.
Address
260 East Grand Avenue, South San Francisco, California, 94080
Country
United States of America
Secondary sponsor category [1] 2422 0
Commercial sector/Industry
Name [1] 2422 0
Novotech Pty Ltd
Address [1] 2422 0
Level 3
19 Harris Street
Pyrmont NSW 2009
Country [1] 2422 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4663 0
Ethics committee address [1] 4663 0
Ethics committee country [1] 4663 0
Date submitted for ethics approval [1] 4663 0
24/10/2007
Approval date [1] 4663 0
Ethics approval number [1] 4663 0

Summary
Brief summary
The purpose of this study is to look at the safety and effectiveness of a drug called KB002. KB002 is a monoclonal antibody which specifically target parts of the immune system that lead to inflammation, which can contribute to asthma. This study will help decide if KB002 may be safe at reducing the symptoms of asthma.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28093 0
Address 28093 0
Country 28093 0
Phone 28093 0
Fax 28093 0
Email 28093 0
Contact person for public queries
Name 11250 0
Michael Flashner
Address 11250 0
260 East Grand Avenue, South San Francisco, California, 94080
Country 11250 0
United States of America
Phone 11250 0
+1 650 243 3100
Fax 11250 0
+1 650 243 3260
Email 11250 0
[email protected]
Contact person for scientific queries
Name 2178 0
Tillman Pearce
Address 2178 0
260 East Grand Avenue, South San Francisco, California, 94080
Country 2178 0
United States of America
Phone 2178 0
+1 650 243 3100
Fax 2178 0
Email 2178 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.