Back to resultsStudy of KB003 In Biologics-Inadequate Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
KB003
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Biologics-Inadequate, KB003, GM-CSF
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
KB003 70 mg
KB003 200 mg
KB003 600 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00995449
Brief Title
Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis
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 Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
Program refocus
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Humanigen, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Biologics-Inadequate, KB003, GM-CSF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KB003 70 mg
Arm Type
Experimental
Arm Title
KB003 200 mg
Arm Type
Experimental
Arm Title
KB003 600 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
KB003
Other Intervention Name(s)
Recombinant anti-GM-CSF IgG1K monoclonal antibody
Intervention Description
KB003 IV x5 doses
Intervention Type
Other
Intervention Name(s)
Placebo Comparator
Intervention Description
Placebo IV x5 doses
Primary Outcome Measure Information:
Title
This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.
Description
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)
Time Frame
Weeks 14 & 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nestor A. Molfino, MD, MSC
Organizational Affiliation
Humanigen, Inc.
Official's Role
Study Chair
Facility Information:
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
City
Oak Creek
State/Province
Wisconsin
ZIP/Postal Code
53154
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis
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