Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis

Phase 2TerminatedNCT00995449

Humanigen, Inc.9 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

KB003BIOLOGICAL

KB003 IV x5 doses

Placebo ComparatorOTHER

Placebo IV x5 doses

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Unnamed facility

Stanford, California, United States

Unnamed facility

Westlake Village, California, United States

Unnamed facility

Miami, Florida, United States

Unnamed facility

Honolulu, Hawaii, United States

Outcomes

Primary Outcomes

This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.

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)

Time frame: Weeks 14 & 30

Data from ClinicalTrials.gov

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