Clinical trial NCT01534403: Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Monoclonal antibody
B-cell immunotherapy
Epratuzumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-02-16
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number of subjects reporting at least 1 Adverse Event (AE) during the Treatment Period (maximum 100 weeks)
timeFrame: up to Week 100
measure: Change from Baseline in levels of total B Cells in the peripheral blood circulation at Week 96
timeFrame: From Baseline (Week 0) to Week 96
Secondary outcomes:
measure: Change from Baseline in levels of Monocyte in the peripheral blood circulation at Week 96
timeFrame: From Baseline (Week 0) to Week 96
measure: Change from Baseline in levels of NK-Cells (Natural Killer-Cells) in the peripheral blood circulation at Week 96
timeFrame: From Baseline (Week 0) to Week 96
measure: Change from Baseline in levels of total T Cells in the peripheral blood circulation at Week 96
timeFrame: From Baseline (Week 0) to Week 96
measure: Epratuzumab plasma concentration at Week 96
timeFrame: Week 96
measure: Number of subjects reporting anti-Epratuzumab in plasma at Week 96
timeFrame: Week 96
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: 10
city: Fukuoka
country: Japan
facility: 11
city: Fukuoka
country: Japan
facility: 9
city: Kitakyusyu
country: Japan
facility: 3
city: Tokyo
country: Japan
facility: 1
city: Tokyo
country: Japan
facility: 8
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: