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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Systemic Lupus Erythematosus
Interventions
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.

Trial Locations (7)

Unknown

09, Fukuoka

10, Fukuoka

11, Fukuoka

03, Kitakyushu

01, Tokyo

08, Tokyo

12, Urayasu

Sponsors

Lead Sponsor

All Listed Sponsors
lead

UCB Pharma

INDUSTRY