A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With Lupus

Completed · Phase 2 · Has a placebo group

Conditions studied: Lupus Erythematosus, Systemic, Lupus

In brief

The primary objective of this study is to evaluate the safety and tolerability of multiple doses of MEDI-545 in subjects with moderately to severely active Lupus.

Key facts

Study ID

NCT00657189

Run by

MedImmune LLC

People needed

87

Starts

2008-07-01

Expected to finish

2010-05-01

Last updated by the study team

2016-08-09

Who can join

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

You may qualify if…

• Male or female subjects ≥ 18 years at the time of the first dose of study drug;
• Written informed consent and HIPAA authorization (applies to covered entities in the US only) obtained from the subject or subject's legal representative;
• Meet at least 4 of the 11 revised ACR classification criteria for SLE
• Have positive antinuclear antibody test (ANA) at ≥ 1:80 serum dilution documented in the past or at screening;
• Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score ≥ 6;
• Treatment for SLE with antimalarials, oral prednisone or another systemic corticosteroid, mycophenolate mofetil, methotrexate, leflunomide, azathioprine, or dapsone;
• Women, unless surgically sterile or at least 2 years post-menopausal, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal, or implanted contraceptives, intrauterine device, diaphragm with spermicide, cervical cap, abstinence, or sterile sexual partner) in addition to the use of condoms (male or female condoms with spermicide) from screening through the end of the study. Cessation of birth control after this point should be discussed with a responsible physician. Men unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide or abstinence) from Study Day 0 through the end of the study;
• Ability to complete the study period, including the follow-up period through Study Day 168; and
• Willing to forego other forms of experimental treatment during the study.

You may not qualify if…

• Have received MEDI-545 within 120 days prior to screening;
• History of allergy or reaction to any component of the study drug formulation;
• Have received the following medications within 28 days before randomization:
• Systemic cyclophosphamide at any dose
• Cyclosporine at any dose
• Thalidomide at any dose
• Hydroxychloroquine > 600 mg/day
• Mycophenolate mofetil > 3 g/day
• Methotrexate > 25 mg/week
• Azathioprine > 3 mg/kg/day
• Have received fluctuating doses of the following within 28 days before randomization:
• Antimalarials
• Mycophenolate mofetil
• Methotrexate
• Leflunomide
• Azathioprine
• Dapsone
• Have received Leflunomide > 20mg/day in the 6 months prior to Study Day 0;
• Have received prednisone > 20 mg/day or in fluctuating doses within 14 days before randomization;
• Have received fluctuating doses of non-steroidal anti-inflammatory drugs within 14 days before randomization;
• Treatment with any investigational drug therapy within 28 days before randomization into the study, B cell-depleting therapies within 12 months before randomization, or biologic therapies within 30 days or 5 half-lives of the biologic agent, whichever is longer, before randomization into the study;
• In the investigator's opinion, evidence of clinically significant active infection, including ongoing, chronic infection, within 28 days before randomization;
• A history of severe viral infection as judged by the investigators, including severe infections of either cytomegalovirus or the herpes family such as disseminated herpes, herpes encephalitis, ophthalmic herpes;
• Herpes zoster infection within 3 months before randomization;
• Evidence of infection 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

Where it is running

• Research Site — Anniston, Alabama, United States
• Research Site — Huntington Beach, California, United States
• Research Site — Upland, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Farmington, Connecticut, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Ocala, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Marrietta, Georgia, United States
• Research Site — West Fayetteville, Georgia, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Lansing, Michigan, United States
• Research Site — Brooklyn, New York, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Charleston, South Carolina, United States
• Research Site — Columbia, South Carolina, United States
• Research Site — Houston, Texas, United States
• Research Site — Sugarland, Texas, United States
• Research Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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