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NCT Number: NCT01534403

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

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

10, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epratuzumab

Biological

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)

Primary outcomes

  1. Number of subjects reporting at least 1 Adverse Event (AE) during the Treatment Period (maximum 100 weeks)

    Time frame: up to Week 100

  2. 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 outcomes

  1. Change from Baseline in levels of Monocyte in the peripheral blood circulation at Week 96

    Time frame: From Baseline (Week 0) to Week 96

  2. 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

  3. 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

  4. Epratuzumab plasma concentration at Week 96

    Time frame: Week 96

  5. Number of subjects reporting anti-Epratuzumab in plasma at Week 96

    Time frame: Week 96

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 16, 2012
Registry last updated
May 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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