Spotlight on: The EMBODY Program
Watch an interview with two researchers who are involved with the EMBODY clinical trial discuss the purpose of this Phase 3 study to evaluate the efficacy and safety of Epratuzumab in people with moderate to severe Systemic Lupus Erythematosus. See who may be eligible and how you can participate.
|Listen to an audio podcast featuring Theresa Lawrence Ford, M.D., Medical Director, North Georgia Rheumatology Group, Lawrenceville, Georgia, discussing the EMBODY Program.|
Study Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects with Moderate to Severe Disease
Sponsor: UCB, Inc.
Purpose: To confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)
Eligibility criteria: Men and women, at least 18 years old
Key Inclusion Criteria - Individuals may be eligible if they are:
• Diagnosed with systemic lupus erythematosus
• Available for 27 study visits over a period up to 1 year
Key Exclusion Criteria - Individuals may be excluded if they:
• Are breastfeeding, pregnant, or plan to become pregnant
• Have active, severe SLE disease activity which involves the renal system
• Have active, severe neuropsychiatric SLE
• Are in an immunosuppressive state
• Have a history of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma
• Have a history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
• Have received treatment with other anti-B cell antibodies within 12 months prior to screening (visit 1)
Study Type: Interventional - Participants will receive study treatment with the investigational study drug or an inactive placebo up to 16 times. The investigational study drug or placebo will be administered by intravenous infusion. Each infusion will last about 1 hour.
Locations: 30 physician offices for EMBODY 1 and 30 physician offices for EMBODY 2 throughout the United States.
EMBODY Study (PDF)