A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Lupus Erythematosus, Systemic

In brief

The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).

Key facts

Study ID

NCT01127321

Run by

MedImmune LLC

People needed

44

Starts

2010-05-01

Expected to finish

2012-07-01

Last updated by the study team

2014-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet or have met at least 4 of the 11 revised American College of Rheumatology (ACR) classification criteria for systemic lupus erythematosus (SLE)
• Score greater than or equal to (>=) 6 points on the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Screening
• Ability to complete the study period, including follow-up period through Day 169
• Willingness to forego other forms of experimental treatment during the study.

You may not qualify if…

• History of cancer except basal cell carcinoma treated with apparent success with curative therapy >=1 year before randomization into the study
• Evidence of active or latent tuberculosis (TB)
• History of primary immunodeficiency
• Evidence of infection at any time with hepatitis B or C virus or human immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at Screening
• History of sepsis or serious, recurrent, chronic infection, current signs and symptoms of clinically significant chronic infection, or recent (within 6 months before Baseline visit) serious infection
• Any history or evidence of opportunistic infection within 6 months of Screening including severe cytomegalovirus (CMV) or herpetic infections (such as disseminated herpes, herpes encephalitis, ophthalmic herpes)
• Receipt of cyclophosphamide (intravenous or oral) within 6 months of Screening
• Have any absolute contraindications to skin punch biopsies, for example, a history of coagulation disorders.

Where it is running

• Research Site — Long Beach, California, United States
• Research Site — San Leandro, California, United States
• Research Site — Fort Lauderdale, Florida, United States
• Research Site — Ocala, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Lansing, Michigan, United States
• Research Site — New York, New York, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Columbus, Ohio, United States
• Research Site — London, Ontario, Canada
• Research Site — Chihuahua City, Mexico
• Research Site — Guadalajara, Mexico
• Research Site — México, Mexico
• Research Site — Lima, Peru
• Research Site — Trujillo, Peru
• Research Site — Cape Town, South Africa
• Research Site — Johannesburg, South Africa

Full record on ClinicalTrials.gov

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