Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 16 March 2015
• Main ID: NCT01534403
• Date of registration: 13/02/2012
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects
• Scientific title: A Phase 2, Multicenter, Open-label, Long-term, Extension Study to Assess the Safety of Epratuzumab Treatment in Japanese Subjects With Systemic Lupus Erythematosus
• Date of first enrolment: January 2012
• Target sample size: 17
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01534403
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Japan

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject has completed the double-blind study SL0026 [NCT01449071] or terminated
prematurely at Week 8 or later in SL0026 [NCT01449071] due to lack of efficacy

- Women of childbearing potential must agree to use an acceptable method of birth
control/Written Informed Consent

Exclusion Criteria:

- Subjects with active, severe SLE disease activity which involves the renal system and
active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring
British Isles Lupus Assessment Group Index (BILAG) level A

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

- Substance abuse or dependence

- Significant hematologic abnormalities

- 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: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Biological: Epratuzumab

Primary Outcome(s)

Change from Baseline in levels of total B Cells in the peripheral blood circulation at Week 96 [Time Frame: From Baseline (Week 0) to Week 96]

Number of subjects reporting at least 1 Adverse Event (AE) during the Treatment Period (maximum 100 weeks) [Time Frame: up to Week 100]

Secondary Outcome(s)

Change from Baseline in levels of Monocyte in the peripheral blood circulation at Week 96 [Time Frame: From Baseline (Week 0) to Week 96]

Number of subjects reporting anti-Epratuzumab in plasma at Week 96 [Time Frame: Week 96]

Change from Baseline in levels of NK-Cells (Natural Killer-Cells) in the peripheral blood circulation at Week 96 [Time Frame: From Baseline (Week 0) to Week 96]

Change from Baseline in levels of total T Cells in the peripheral blood circulation at Week 96 [Time Frame: From Baseline (Week 0) to Week 96]

Epratuzumab plasma concentration at Week 96 [Time Frame: Week 96]

Secondary ID(s)

SL0027

Source(s) of Monetary Support

Please refer to primary and secondary sponsors