NCT00995449

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Humanigen, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	KB003	KB003 IV x5 doses
OTHER	Placebo Comparator	Placebo IV x5 doses

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-03-01
• Completion: 2012-02-01
• First posted: 2009-10-15
• Last updated: 2014-06-09
• Results posted: 2012-09-25

Locations

11 sites across 1 country: United States