NCT01449071

Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)

A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Pharmacokinetics of One 12 Week Treatment Cycle of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects With Moderate to Severe Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of Epratuzumab in Japanese subjects with moderate to severe general SLE as add on to standard of care treatment during the trial.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	Placebo infusions at study weeks 0, 1, 2, and 3.
BIOLOGICAL	Epratuzumab 400 mg	Epratuzumab 400 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
BIOLOGICAL	Epratuzumab 1200 mg	Epratuzumab 1200 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
BIOLOGICAL	Epratuzumab 100 mg	Epratuzumab 100 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
BIOLOGICAL	Epratuzumab 600 mg	Epratuzumab 600 mg infusions at study weeks 0, 1, 2, and 3.

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-10-07
• Last updated: 2014-02-12

Locations

7 sites across 1 country: Japan