Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis

June 4, 2014 updated by: Humanigen, Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94304
      • Westlake Village, California, United States, 91361
    • Florida
      • Miami, Florida, United States, 33143
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
    • Maryland
      • Frederick, Maryland, United States, 21702
      • Wheaton, Maryland, United States, 20902
    • Missouri
      • St. Louis, Missouri, United States, 63141
      • St. Louis, Missouri, United States, 63117
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
    • Wisconsin
      • Oak Creek, Wisconsin, United States, 53154

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo Comparator
Placebo IV x5 doses
Experimental: KB003 70 mg
Biological: KB003
KB003 IV x5 doses
Other Names:
  • Recombinant anti-GM-CSF IgG1K monoclonal antibody
Experimental: KB003 200 mg
Biological: KB003
KB003 IV x5 doses
Other Names:
  • Recombinant anti-GM-CSF IgG1K monoclonal antibody
Experimental: KB003 600 mg
Biological: KB003
KB003 IV x5 doses
Other Names:
  • Recombinant anti-GM-CSF IgG1K monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Weeks 14 & 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanigen, Inc.

Investigators

  • Study Chair: Nestor A. Molfino, MD, MSC, Humanigen, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

October 5, 2009

First Submitted That Met QC Criteria

October 14, 2009

First Posted (Estimate)

October 15, 2009

Study Record Updates

Last Update Posted (Estimate)

June 9, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB003-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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