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Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis

This study has been terminated.
(Program refocus)
Sponsor:
Information provided by (Responsible Party):
KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00995449
First received: October 5, 2009
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
Results First Received: May 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Biological: KB003
Other: Placebo Comparator

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a two-part study with a safety run-in. The primary objective of the main portion of the study was to evaluate the safety, PK, and efficacy of selected repeat-dose regimens of KB003 in subjects with active moderate to severe rheumatoid arthritis who had an inadequate treatment outcome from prior biologic therapy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The safety run-in portion was conducted in a small cohort of 7 active and 2 placebo subjects to evaluate the acceptability of repeat-dose safety. KB003 was administered by intravenous (IV) infusion as a 600 mg dose at wks 0, 2, 4, 8, and 12, with primary safety being evaluated at wk 14 and a follow-up (end of study) safety assessment at wk 30.

Reporting Groups
  Description
KB003 70mg Dose group not evaluated in this portion of study
KB003 200 mg Dose group not evaluated in this portion of study
KB003 600 mg 600 mg, KB003 a monoclonal antibody
Placebo Placebo comparator

Participant Flow:   Overall Study
    KB003 70mg     KB003 200 mg     KB003 600 mg     Placebo  
STARTED     0     0     7     2  
COMPLETED     0     0     5     2  
NOT COMPLETED     0     0     2     0  



  Baseline Characteristics
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Reporting Groups
  Description
KB003 70mg Dose group not evaluated in this portion of study
KB003 200 mg Dose group not evaluated in this portion of study
KB003 600 mg 600 mg, KB003 a monoclonal antibody
Placebo Placebo comparator
Total Total of all reporting groups

Baseline Measures
    KB003 70mg     KB003 200 mg     KB003 600 mg     Placebo     Total  
Number of Participants  
[units: participants]
 		  0     0     7     2     9  
Age  
[units: participants]
 		         
<=18 years             0     0     0  
Between 18 and 65 years             5     2     7  
>=65 years             2     0     2  
Gender  
[units: participants]
 		         
Female             4     1     5  
Male             3     1     4  
Region of Enrollment  
[units: participants]
 		         
United States             7     2     9  



  Outcome Measures

1.  Primary:   This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.   [ Time Frame: Weeks 14 & 30 ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated upon completion of safety run-in due to program refocus.  


Results Point of Contact:  
Name/Title: Nestor A. Molfino, MD., MSc
Organization: KaloBios Pharmaceuticals, Inc.
phone: 650-243-3103
e-mail: nmolfino@kalobios.com


No publications provided


Responsible Party: KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00995449     History of Changes
Other Study ID Numbers: KB003-02
Study First Received: October 5, 2009
Results First Received: May 7, 2012
Last Updated: February 1, 2013
Health Authority: United States: Food and Drug Administration