Study Stopped
Program refocus
Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis
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
1 other identifier
interventional
9
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 rheumatoid-arthritis
Started Jan 2010
Typical duration for phase_2 rheumatoid-arthritis
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2009
CompletedFirst Posted
Study publicly available on registry
October 15, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
September 25, 2012
CompletedJune 9, 2014
June 1, 2014
1.2 years
October 5, 2009
May 7, 2012
June 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Weeks 14 & 30
Study Arms (4)
KB003 70 mg
EXPERIMENTALKB003 200 mg
EXPERIMENTALKB003 600 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
KB003 IV x5 doses
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unstable medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Humanigen, Inc.lead
Study Sites (11)
Unknown Facility
Stanford, California, 94304, United States
Unknown Facility
Westlake Village, California, 91361, United States
Unknown Facility
Miami, Florida, 33143, United States
Unknown Facility
Honolulu, Hawaii, 96813, United States
Unknown Facility
Frederick, Maryland, 21702, United States
Unknown Facility
Wheaton, Maryland, 20902, United States
Unknown Facility
St Louis, Missouri, 63117, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Wilmington, North Carolina, 28401, United States
Unknown Facility
Tulsa, Oklahoma, 74135, United States
Unknown Facility
Oak Creek, Wisconsin, 53154, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated upon completion of safety run-in due to program refocus.
Results Point of Contact
- Title
- Nestor A. Molfino, MD., MSc
- Organization
- KaloBios Pharmaceuticals, Inc.
Study Officials
- STUDY CHAIR
Nestor A. Molfino, MD, MSC
Humanigen, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2009
First Posted
October 15, 2009
Study Start
January 1, 2010
Primary Completion
March 1, 2011
Study Completion
February 1, 2012
Last Updated
June 9, 2014
Results First Posted
September 25, 2012
Record last verified: 2014-06