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

Overview

The study is an open-labeled extension study to continue to assess the safety and tolerability of Epratuzumab in moderate to severe SLE subjects who have previously participated in SL0026 [NCT01449071] phase I/II trial.

Full Title of Study: “A Phase 2, Multicenter, Open-label, Long-term, Extension Study to Assess the Safety of Epratuzumab Treatment in Japanese Subjects With Systemic Lupus Erythematosus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2015

Interventions

  • Biological: Epratuzumab
    • Epratuzumab 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) 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, 49, 50, 51, 60, 61, 62, 63, 72, 73, 74, 75, 84, 85, 86, and 87)

Arms, Groups and Cohorts

  • Experimental: Epratuzumab 4×600 mg every 12 weeks Group

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change from Baseline in levels of Monocyte in the peripheral blood circulation at Week 96
    • Time Frame: From Baseline (Week 0) to 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
  • Number of subjects reporting anti-Epratuzumab in plasma at Week 96
    • Time Frame: Week 96

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UCB Pharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • UCB Clinical Trial Call Center, Study Director, +1 877 822 9493 (UCB)

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