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

NCT01534403 — Phase 2, Completed, 17 participants, UCB Pharma

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT01534403
Status	Completed
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	17 (Actual)
Sponsor	UCB Pharma (Industry)
Conditions	Systemic Lupus Erythematosus
Interventions	Epratuzumab (Biological)
Dates	start 2012-01-01, primary completion 2015-02-01, completion 2015-02-01, first posted 2012-02-16, last updated 2016-05-06
Locations	6 sites in Japan

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Epratuzumab 4x600 mg every 12 weeks Group	Experimental	Biological: Epratuzumab

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)

+Outcome measures

Primary outcomes

Number of subjects reporting at least 1 Adverse Event (AE) during the Treatment Period (maximum 100 weeks) [up to Week 100]
Change from Baseline in levels of total B Cells in the peripheral blood circulation at Week 96 [From Baseline (Week 0) to Week 96]

Secondary outcomes

Change from Baseline in levels of Monocyte in the peripheral blood circulation at Week 96 [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 [From Baseline (Week 0) to Week 96]
Change from Baseline in levels of total T Cells in the peripheral blood circulation at Week 96 [From Baseline (Week 0) to Week 96]
Epratuzumab plasma concentration at Week 96 [Week 96]
Number of subjects reporting anti-Epratuzumab in plasma at Week 96 [Week 96]

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (6)

Facility	City	Country
10	Fukuoka	Japan
11	Fukuoka	Japan
9	Fukuoka	Japan
3	Kitakyushu	Japan
1	Tokyo	Japan
8	Tokyo	Japan

+Investigators

UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)