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Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00995449
Recruitment Status : Terminated (Program refocus)
First Posted : October 15, 2009
Results First Posted : September 25, 2012
Last Update Posted : June 9, 2014
Sponsor:
Information provided by (Responsible Party):
Humanigen, Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of various repeat-dose regimens of KB003 in subjects with active Rheumatoid Arthritis (RA) who have had an inadequate prior treatment outcome from biologic therapy.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: KB003 Other: Placebo Comparator Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of the Anti-GM-CSF Monoclonal Antibody KB003 in Subjects With Active Rheumatoid Arthritis and Inadequate Prior Treatment Outcome From Biologic Therapy
Study Start Date : January 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : February 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: KB003 70 mg Biological: KB003
KB003 IV x5 doses
Other Name: Recombinant anti-GM-CSF IgG1K monoclonal antibody
Experimental: KB003 200 mg Biological: KB003
KB003 IV x5 doses
Other Name: Recombinant anti-GM-CSF IgG1K monoclonal antibody
Experimental: KB003 600 mg Biological: KB003
KB003 IV x5 doses
Other Name: Recombinant anti-GM-CSF IgG1K monoclonal antibody
Placebo Comparator: Placebo Other: Placebo Comparator
Placebo IV x5 doses


Outcome Measures
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Primary Outcome Measures :
  1. This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety. [ Time Frame: Weeks 14 & 30 ]
    KB003 was administered by intravenous (IV) infusion as a 600 mg dose at weeks 0, 2, 4, 8, and 12, with primary safety being evaluated at week 14 and a follow-up (end of study) safety assessment at week 30. Safety was evaluated by number of participants with treatment-emergent (TE) adverse events (AEs). (TE is defined as ocurring during the 14 week treatment and week 30 follow-up periods)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 6 swollen and at least 6 tender joints
  • C-reactive Protein (CRP) > Upper Limit Normal (ULN)
  • Prior inadequate response from biologic therapy
  • Stable regimens of concomitant RA therapies

Exclusion Criteria:

  • Unstable medical conditions
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995449


Locations
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United States, California
Stanford, California, United States, 94304
Westlake Village, California, United States, 91361
United States, Florida
Miami, Florida, United States, 33143
United States, Hawaii
Honolulu, Hawaii, United States, 96813
United States, Maryland
Frederick, Maryland, United States, 21702
Wheaton, Maryland, United States, 20902
United States, Missouri
St. Louis, Missouri, United States, 63117
St. Louis, Missouri, United States, 63141
United States, North Carolina
Wilmington, North Carolina, United States, 28401
United States, Oklahoma
Tulsa, Oklahoma, United States, 74135
United States, Wisconsin
Oak Creek, Wisconsin, United States, 53154
Sponsors and Collaborators
Humanigen, Inc.
Investigators
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Study Chair: Nestor A. Molfino, MD, MSC Humanigen, Inc.
More Information
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Responsible Party: Humanigen, Inc.
ClinicalTrials.gov Identifier: NCT00995449    
Other Study ID Numbers: KB003-02
First Posted: October 15, 2009    Key Record Dates
Results First Posted: September 25, 2012
Last Update Posted: June 9, 2014
Last Verified: June 2014
Keywords provided by Humanigen, Inc.:
Rheumatoid Arthritis
Biologics-Inadequate
KB003
GM-CSF
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases