A Multi-Center, Open-Label, Continuation Trial of LymphoStat-B Antibody (Monoclonal Anti-BLyS Antibody) in Subjects with Systemic Lupus Erthematosus (SLE) Who Completed the Phase 2 Protocol LBSL02, Clinical Protocol LBSL99

Study ID
STU 062010-049

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Azza Badr
214-648-7219
azza.mutwally@utsouthwestern.edu

Principal Investigator
David Karp

Summary

This is a multi-center, open label, continuation trial of LymphoStat-B in SLe subjects who achieved a satisfactory response in the Phase 2 study LBSL02. Subjects receive 10 mg/kg of LymphoStat-B every 28 days intravenously (iV) over a period of 1 to 2 hours. Subjects have laboratory assessments every eight weeks, a physical exam and joint exam every eight weeks and an infusion every four weeks. Study visits last from 1-2 hours. The number of study visits per year is 12; the estimated length of the study is ten years or until the sponsor discontinues the study or the study agent is marketed for an approximate number of study visits 67 including the two follow-up study visits. Should HGS decide to terminate the LymphoStat-B SLe program, this study will be terminated. Subjects will be required to complete an exit visit at the time of termination and return for 8- and 24-week follow-up visits.

Participant Eligibility


* Have completed the LBSL02 trial through Day 532 of the 24-week extension period.

* Have achieved a satisfactory response at the Day 532 or Day 476 visit of the 24-week extension period of LBSL02 compared to either Day 364 (Week 52) of the treatment period of Day 0 (baseline) in LBSL02. A satisfactory response is defined as:

* An improvement in the Physician[Single Quote]s Global Disease Assessment (PGA) at either Day 532 or Day 476 as compared with either Day 364 or Day 0.
And

* Absence of an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99. (See exclusion criterion #2).

* Any women with an intact uterus, regardless of age, must have a negative urine pregnancy test. Women with total hysterectomies or post-menopausal women with documented FSH levels >35mIU/ml are exempt from pregnancy testing.

* Over the course of the study and for 16 weeks after the last dose of the study agent, any woman with an intact uterus who is not post-menopausal must agree to practice a medically accepted method of contraception.

* Be able to receive the 1st dose of LymphoStat-B in LBSL99 4 weeks ((+ or -) 2 weeks) after the last (Day 532) dose in LBSL02.

* Demonstrate compliance with study procedures for LBSL02, and are willing to comply with LBSL99 study protocol procedures (including required study visits).

* Provide written informed consent, including consent for the use and disclosure of research-related health information.