Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Systemic Lupus Erythematosus
• Age: Between 18 Year(s) - 70 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Age 18 to 70 years inclusive
  2. Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
  3. Weigh =40.0 kg (88 lbs)
  4. Diagnosis of pediatric or adult Systemic lupus erythematosus (SLE) for =24 weeks prior to signing the ICF
  5. Must be receiving at least one of the following standard of care (SOC) regimens at Screening:
     1. Oral prednisone (or equivalent) monotherapy:
        1. Start date: minimum daily dose: =7.5 mg/day for at least 8 weeks prior to Day 1 (randomization)
        2. Must be stable for >2 weeks before Day 1 (randomization)
        3. Maximum daily dose: =40 mg/day
     2. Immunosuppressant(s) with or without oral corticosteroids (OCS):
        1. Permitted medications include: antimalarials, azathioprine, mycophenolate mofetil / mycophenolic acid, methotrexate, mizoribine
        2. Start date: = 12 weeks prior to signing the ICF
        3. Must be stable = 8 weeks prior to signing the ICF
        4. Maximum daily dose:
           - Azathioprine: =200mg/day
           - Mycophenolate mofetil =2g/day or mycophenolic acid =1.44g/day
           - Oral, subcutaneous (SC), or intramuscular methotrexate =25mg/week
           - Mizoribine =150mg/day
     3. Oral prednisone (or equivalent) plus immunosuppressant(s):
        1. Start dates for OCS and immunosuppressants must be met
        2. Stability requirements for each medication must be met
        3. No minimum daily dose for OCS when in combination with immunosuppressants
        4. Maximum daily dosages for each medication in (a) and (b) must not exceeded

  
  

You may not be eligible for this study if the following are true:

• 1. Concurrent enrolment in another clinical study with an investigational product
  2. Individuals involved with the conduct of the study, their employees, or immediate family members of such individuals
  3. Spontaneous or induced abortion, still or live birth, or pregnancy =4 weeks prior to signing the informed consent form (ICF)
  4. Lactating or pregnant females or females who intend to become pregnant anytime from initiation of Screening until the 10-week safety follow-up period following last dose of investigational product
  5. Current alcohol, drug or chemical abuse, or a history of such abuse within 1 year before randomisation.
  6. Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period
  7. Prior receipt of anifrolumab
  8. Any change in route of administration of oral, SC, or intramuscular methotrexate anytime within the 8 weeks prior to signing of the informed consent through Day 1