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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01534403
First received: February 13, 2012
Last updated: April 11, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Systemic Lupus Erythematosus Biological: Epratuzumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome 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 Outcome 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 ]

Enrollment: 17
Study Start Date: January 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epratuzumab 4x600 mg every 12 weeks Group 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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534403

Locations
Japan
10
Fukuoka, Japan
11
Fukuoka, Japan
9
Fukuoka, Japan
3
Kitakyusyu, Japan
1
Tokyo, Japan
8
Tokyo, Japan
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01534403     History of Changes
Other Study ID Numbers: SL0027
Study First Received: February 13, 2012
Last Updated: April 11, 2016

Keywords provided by UCB Pharma:
Lupus
Monoclonal antibody
B-cell immunotherapy
Epratuzumab

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2017