Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000248561
Ethics application status
Approved
Date submitted
15/06/2006
Date registered
20/06/2006
Date last updated
2/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase 1 randomised double blind, placebo-controlled, single dose, dose escalation study of KB002, a chimeric monoclonal antibody which binds to granulocyte macrophage-colony stimulating factor (GM-CSF), in patients with rheumatoid arthritis
Scientific title
A phase 1 randomised double blind, placebo-controlled, single dose, dose escalation study of the safety and tolerability profile of KB002, a chimeric monoclonal antibody which binds to granulocyte macrophage-colony stimulating factor (GM-CSF), in patients with rheumatoid arthritis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 1227 0
Condition category
Condition code
Inflammatory and Immune System 1310 1310 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single dose of KB002 administered intravenously over one hour to patients with rheumatiod arthritis.
Intervention code [1] 863 0
Treatment: Drugs
Comparator / control treatment
A single dose of placebo (0.9% sodium chloride for infection) administered intravenously over one hour to patients with rheumatiod arthritis.
Control group
Placebo

Outcomes
Primary outcome [1] 1791 0
The safety profile of KB002 in patients with rheumatoid arthritis
Timepoint [1] 1791 0
At day 29
Primary outcome [2] 1792 0
The tolerability profile of KB002 in patients with rheumatoid arthritis
Timepoint [2] 1792 0
At day 29
Secondary outcome [1] 3147 0
Efficacy and pharmacokinetics of KB002.
Timepoint [1] 3147 0
At Day 29.

Eligibility
Key inclusion criteria
Active rheumatoid arthritisCurrently receiving treatment with methotrexateStable doses of disease modifying anti-rheumatic drugs (DMARDs) for at least 8 weeksSwollen joint count of at least 6 (using 66 joint count)Tender joint count of at least 6 (using 68 joint count)Two out of three of the following:Erythrocyte sedimentation rate (ESR) greater than or equal to 20 mm/hrC-reactive protein (CRP) greater than or equal to 15 mg/dLEarly morning stiffness of greater than or equal to 45 minutes.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Concurrent treatment with approved or investigational biological rheumatoid arthritis therapiesWhite blood cell (WBC) < 3.5 x 10^9/LAny major surgical operation or infrction within the last 8 weeks History of solid or haematological malignancy within the past 10 yearsFemales who are pregnant or breastfeedingMales or females unable to practice effective methods of birth control for 3 months after the infusion of study drugCurrent or past history of severe cardiac diseaseCurrent respiratory disease or a past history of chronic respiratory diseasePartial pressure of oxygen in arterial blood (PaO2) < 95% on room airCurrent smokers or a greater than or equal to 10 pack year history for ex-smokersImmune deficiency, chronic infections or chronic imflammatory conditiond other than rheumatoid arthritisDemylinating neurological disordersFelty's syndrome or myasthenia gravisAny other illness Current or past treatmant with granulocyte macrophage-colony stimulating factor (GM-CSF) or granulocyte-colony stimulating factor (G-CSF)Previous treatment with an investigational agent within the last 90 daysVaccination within the last 30 days.

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)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 264 0
United States of America
State/province [1] 264 0

Funding & Sponsors
Funding source category [1] 1436 0
Commercial sector/Industry
Name [1] 1436 0
KaloBios Pharmaceuticals, Inc.
Country [1] 1436 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
KaloBios Pharmaceuticals, Inc.
Address
3427 Hillview Avenue, Suite 200
Palo Alto, CA 94304
Country
United States of America
Secondary sponsor category [1] 1270 0
Commercial sector/Industry
Name [1] 1270 0
Kendle R&D Pty Limited
Address [1] 1270 0
156 - 158 Drummond Street
Oakleigh Victoria 3166
Australia
Country [1] 1270 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2811 0
Repatriation General Hospital
Ethics committee address [1] 2811 0
Ethics committee country [1] 2811 0
Australia
Date submitted for ethics approval [1] 2811 0
Approval date [1] 2811 0
24/05/2006
Ethics approval number [1] 2811 0
09/06

Summary
Brief summary
The primary purpose of the study is to investigate the safety and the pharmacokinetics of KB002 in patients with rheumatoid arthritis. Patients will be randomly assigned 3:1 to KB002 or placebo. The study is double-blinded, with only the pharmacist unblinded. The investigator, study coordinator, patient, clinical research orgination (CRO) and sponsor are blinded to the treatment assignment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36328 0
Address 36328 0
Country 36328 0
Phone 36328 0
Fax 36328 0
Email 36328 0
Contact person for public queries
Name 10052 0
Catherine Howard
Address 10052 0
3427 Hillview Avenue, Suite 200
Palo Alto, CA 94304
Country 10052 0
United States of America
Phone 10052 0
+1 650 8431897
Fax 10052 0
+1 650 8431896
Email 10052 0
choward@kalobios.com
Contact person for scientific queries
Name 980 0
Tillman Pearce, MD
Address 980 0
3427 Hillview Avenue, Suite 200
Palo Alto CA 94304
Country 980 0
United States of America
Phone 980 0
+1 650 8431897
Fax 980 0
+1 650 8431896
Email 980 0
slight@kalobios.com

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.