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

UCB

Status and phase: Completed; Phase 2; Phase 1

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: Epratuzumab 600 mg; Biological: Epratuzumab 100 mg; Biological: Epratuzumab 400 mg; Biological: Epratuzumab 1200 mg; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01449071

SL0026

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive Anti-nuclear Antibody (ANA) at Screening (Visit 1)
• Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria
• Active moderate to severe SLE activity as demonstrated by British Isles Lupus Assessment Group Index (BILAG)
• Active moderate to severe SLE disease as demonstrated by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score on stable SLE treatment

Exclusion criteria

• Subjects who are breastfeeding, pregnant, or plan to become pregnant
• Subjects with active, severe SLE disease activity which involves the renal system and active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A
• Serious infections

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 5 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Treatment:

Biological: Placebo

Epratuzumab 600 mg Group

Experimental group

Treatment:

Biological: Epratuzumab 600 mg

Epratuzumab 100 mg Group

Experimental group

Treatment:

Biological: Epratuzumab 100 mg

Epratuzumab 400 mg Group

Experimental group

Treatment:

Biological: Epratuzumab 400 mg

Epratuzumab 1200 mg Group

Experimental group

Treatment:

Biological: Epratuzumab 1200 mg