Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis

Humanigen

Status and phase: Terminated; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Biological: KB003; Other: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00995449

KB003-02

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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9 participants in 4 patient groups, including a placebo group

KB003 70 mg

Experimental group

Treatment:

Biological: KB003

KB003 200 mg

Experimental group

Treatment:

Biological: KB003

KB003 600 mg

Experimental group

Treatment:

Biological: KB003

Placebo

Placebo Comparator group

Treatment:

Other: Placebo Comparator