Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01408576
• Date of registration: 01/08/2011
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus EMBODY4
• Scientific title: A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects
• Date of first enrolment: July 2011
• Target sample size: 1250
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01408576
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Czechia, Estonia, France, Germany, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Lithuania, Mexico, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: UCB Pharma

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject has completed the double-blind study SL0009 (NCT01262365) or SL0010
(NCT01261793) or terminated prematurely at Week 16 or later in SL0009 or SL0010 due to
lack of efficacy and would, in the opinion of the investigator, continue to benefit
from continued epratuzumab treatment

- Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881),
and would, in the opinion of the investigator, continue to benefit from continued
epratuzumab treatment

- Women of childbearing potential must agree to use an acceptable method of birth
control

Exclusion Criteria:

- Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric
element scoring British Isles Lupus Assessment Group Index (BILAG) level A disease

- Subjects with active, severe SLE disease activity which involves the renal system

- Subjects with concurrent relevant medical conditions like defined chronic infections
or high risk of new significant infections

- Substance abuse or dependence

- History of malignant cancer

- Subjects with any other condition which, in the investigator's judgment, would make
the subject unsuitable for inclusion



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Epratuzumab

Primary Outcome(s)

Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks) [Time Frame: During the treatment period (through Week 96)]

Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks) [Time Frame: During the treatment period (through Week 96)]

Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) [Time Frame: During the treatment period (through Week 96)]

Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) [Time Frame: During the treatment period (through Week 96)]

Secondary Outcome(s)

The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index [Time Frame: Week 96]

Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index [Time Frame: At Week 48]

Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index [Time Frame: Week 48]

Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index [Time Frame: Week 96]

Secondary ID(s)

SL0012

2010-020859-30

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01408576