A Study to Evaluate the Safety and Tolerability of Epratuzumab in Patients With Systemic Lupus Erythematosus.

A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000298819

Acronym

EMBODY 4

Enrollment

1400

Registered

2012-03-15

Start date

2011-07-20

Completion date

Unknown

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a Phase 3, multicenter, open-label, extension study to evaluate the safety, tolerability, efficacy, and immunogenicity of long-term epratuzumab treatment in subjects with SLE. Subjects who complete 1 of the Phase 3, double-blind, placebo controlled studies, SL0009 or SL0010, or terminate prematurely (at Week 16 or later) due to lack of efficacy, are eligible to enroll in SL0012. The study consists of an Open-Label Treatment Period and a Safety Follow-Up Visit. During the Open-Label Treatment Period, all subjects will receive epratuzumab 600mg delivered QW via slow iv infusion for a total of 4 consecutive weeks (CMD 2400mg) over eight 12 week treatment cycles (ie, Weeks 0, 1, 2, 3, 12, 13, 14, 15, 24, 25, 26, 27, 36, 37, 38, 39, 48 (Year 1), 49, 50, 51, 60, 61, 62, 63, 72, 73, 74, 75, 84, 85, 86, and 87 (Year 2) [96 weeks total duration]). A Safety Follow-Up Visit will occur approximately 4 weeks after Week 96 (ie, no later than Week 100) for subjects who complete the study, or 13 weeks after the final dose of study drug for subjects who discontinue early. Study drug treatment is in addition to the subjects’ existing standard care of oral corticosteroids and any immunosuppressants or antimalarials continued from Baseline in the subjects’ prior study.

Interventions

Epratuzumab 600mg intravenous infusions delivered once a week (QW) via slow infusion for a total of 4 consecutive weeks (cumulative dose (CMD) 2400mg) over eight 12-week treatment cycles

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

The subject has completed double-blind study SL0009 (ACTRN12611000464965) or SL0010, or the subject has terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy, as described in the respective protocols and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment in SL0012. The subject has maintained the eligibility requirements (including concomitant medication restrictions) throughout their participation in the prior study Woman of childbearing potential using an acceptable method of birth control

Exclusion criteria

Subject has active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease Subject has active, severe, SLE disease activity which involves the renal system defined by BILAG renal level A activity Evidence of an immunosuppressive state Subjects with a history of chronic infections, including but not limited to subjects with concurrent acute or chronic viral hepatitis B or C Subjects with substance abuse/dependence or other concurrent medical conditions Subjects with significant hematologic abnormalities History of malignant cancer Subject has used the prohibited medications

Outcome results