Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus

Status:	Completed
Conditions:	Lupus
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 70
Updated:	1/6/2019
Start Date:	November 13, 2014
End Date:	November 30, 2017

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus

Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic
lupus erythematosus in male and female adults. Patients who qualify will be randomized to
either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the
initial 24 weeks of treatment and who are responding to therapy will have the option to
continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and
safety will be assessed over the course of the study through laboratory values, various
rating scales accepted in systemic lupus erythematosus studies and patient self reporting.

1. Subjects completing Day 169 (24 weeks) on study medication may be eligible to enter an
optional LTE period

2. The LTE period will remain blinded but will no longer have a placebo arm:

- Subjects will remain on their originally assigned treatment arm unless they were on
placebo

- Subjects initially randomized to placebo arm will be automatically re-randomized
into one of the existing active arms at Day 169 (24 weeks)

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Male or female aged between 18 to 70 (included)

- Diagnosed with active systemic lupus erythematosus by a doctor

- Disease must be in patient's joints or on the skin at a minimum

- Taking other medications is allowed but some are excluded

Exclusion Criteria:

- Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis

- Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus

We found this trial at

sites

Heartland Research Associates, LLC

1709 S Rock Rd
Wichita, Kansas 67207

316-689-6629

Phone: 316-612-4815

from

Wichita, KS