Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00995449
Recruitment Status : Terminated (Program refocus)
First Posted : October 15, 2009
Results First Posted : September 25, 2012
Last Update Posted : June 9, 2014
Information provided by (Responsible Party):
Humanigen, Inc.

October 5, 2009
October 15, 2009
May 7, 2012
September 25, 2012
June 9, 2014
January 2010
March 2011   (Final data collection date for primary outcome measure)
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)
American College of Rheumatology 20% improvement criteria (ACR20) Response [ Time Frame: Week 14 ]
Complete list of historical versions of study NCT00995449 on Archive Site
Not Provided
  • DAS28 (Disease Activity Score) [ Time Frame: Week 14 ]
  • Disease response based on European League Against Rheumatism (EULAR) criteria [ Time Frame: Week 14 ]
  • Serum concentrations of KB003 (Pharmacokinetics) [ Time Frame: Week 30 ]
  • Adverse events [ Time Frame: Week 30 ]
Not Provided
Not Provided
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
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Biological: KB003
    KB003 IV x5 doses
    Other Name: Recombinant anti-GM-CSF IgG1K monoclonal antibody
  • Other: Placebo Comparator
    Placebo IV x5 doses
  • Experimental: KB003 70 mg
    Intervention: Biological: KB003
  • Experimental: KB003 200 mg
    Intervention: Biological: KB003
  • Experimental: KB003 600 mg
    Intervention: Biological: KB003
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2012
March 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Humanigen, Inc.
Humanigen, Inc.
Not Provided
Study Chair: Nestor A. Molfino, MD, MSC Humanigen, Inc.
Humanigen, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP