Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis

This study has been terminated.
(Program refocus)
Sponsor:
Information provided by (Responsible Party):
KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00995449
First received: October 5, 2009
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: KB003
Other: Placebo Comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by KaloBios Pharmaceuticals:

Primary Outcome Measures:
  • This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety. [ Time Frame: Weeks 14 & 30 ] [ Designated as safety issue: Yes ]
    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)


Enrollment: 9
Study Start Date: January 2010
Study Completion Date: February 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KB003 70 mg Biological: KB003
KB003 IV x5 doses
Other Name: Recombinant anti-GM-CSF IgG1K monoclonal antibody
Experimental: KB003 200 mg Biological: KB003
KB003 IV x5 doses
Other Name: Recombinant anti-GM-CSF IgG1K monoclonal antibody
Experimental: KB003 600 mg Biological: KB003
KB003 IV x5 doses
Other Name: Recombinant anti-GM-CSF IgG1K monoclonal antibody
Placebo Comparator: Placebo Other: Placebo Comparator
Placebo IV x5 doses

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995449

Locations
United States, California
Stanford, California, United States, 94304
Westlake Village, California, United States, 91361
United States, Florida
Miami, Florida, United States, 33143
United States, Hawaii
Honolulu, Hawaii, United States, 96813
United States, Maryland
Frederick, Maryland, United States, 21702
Wheaton, Maryland, United States, 20902
United States, Missouri
St. Louis, Missouri, United States, 63141
St. Louis, Missouri, United States, 63117
United States, North Carolina
Wilmington, North Carolina, United States, 28401
United States, Oklahoma
Tulsa, Oklahoma, United States, 74135
United States, Wisconsin
Oak Creek, Wisconsin, United States, 53154
Sponsors and Collaborators
KaloBios Pharmaceuticals
Investigators
Study Chair: Nestor A. Molfino, MD, MSC KaloBios Pharmaceuticals
  More Information

No publications provided

Responsible Party: KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00995449     History of Changes
Other Study ID Numbers: KB003-02
Study First Received: October 5, 2009
Results First Received: May 7, 2012
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by KaloBios Pharmaceuticals:
Rheumatoid Arthritis
Biologics-Inadequate
KB003
GM-CSF

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014