NCT01534403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2012

Typical duration for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 6, 2016

Status Verified

April 1, 2016

Enrollment Period

3.1 years

First QC Date

February 13, 2012

Last Update Submit

April 11, 2016

Conditions

Systemic Lupus Erythematosus

Keywords

LupusMonoclonal antibodyB-cell immunotherapyEpratuzumab

Outcome Measures

Primary Outcomes (2)

  • 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 (5)

  • 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

Study Arms (1)

Epratuzumab 4x600 mg every 12 weeks Group

EXPERIMENTAL
Biological: Epratuzumab

Interventions

EpratuzumabBIOLOGICAL

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)

Epratuzumab 4x600 mg every 12 weeks Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

10

Fukuoka, Japan

Location

11

Fukuoka, Japan

Location

9

Fukuoka, Japan

Location

3

Kitakyushu, Japan

Location

1

Tokyo, Japan

Location

8

Tokyo, Japan

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

epratuzumab

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2012

First Posted

February 16, 2012

Study Start

January 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

May 6, 2016

Record last verified: 2016-04

Locations

JP(6)