Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis

NCT ID: NCT00995449

Last Updated: 2014-06-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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KB003 70 mg

Group Type EXPERIMENTAL

KB003

Intervention Type BIOLOGICAL

KB003 IV x5 doses

KB003 200 mg

Group Type EXPERIMENTAL

KB003

Intervention Type BIOLOGICAL

KB003 IV x5 doses

KB003 600 mg

Group Type EXPERIMENTAL

KB003

Intervention Type BIOLOGICAL

KB003 IV x5 doses

Placebo

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type OTHER

Placebo IV x5 doses

Interventions

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KB003

KB003 IV x5 doses

Intervention Type BIOLOGICAL

Placebo Comparator

Placebo IV x5 doses

Intervention Type OTHER

Other Intervention Names

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Recombinant anti-GM-CSF IgG1K monoclonal antibody

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Humanigen, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nestor A. Molfino, MD, MSC

Role: STUDY_CHAIR

Humanigen, Inc.

Locations

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Stanford, California, United States

Site Status

Westlake Village, California, United States

Site Status

Miami, Florida, United States

Site Status

Honolulu, Hawaii, United States

Site Status

Frederick, Maryland, United States

Site Status

Wheaton, Maryland, United States

Site Status

St Louis, Missouri, United States

Site Status

St Louis, Missouri, United States

Site Status

Wilmington, North Carolina, United States

Site Status

Tulsa, Oklahoma, United States

Site Status

Oak Creek, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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KB003-02

Identifier Type: -

Identifier Source: org_study_id

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