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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Humanigen, Inc.
- Enrollment
- 9
- Primary Endpoint
- This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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)