A Multicentre Randomised Double-blind Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | NYU Langone Health

A Multicentre Randomised Double-blind Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

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 years - 150 years
Gender: Male or Female

Other Inclusion Criteria:
1. Subjects who have qualified for and received investigational product (anifrolumab or placebo) and completed the treatment period in Studies D3461C00004 or D3461C00005 (through Week 52)
2. Subjects able to provide written consent and any locally required authorization
3. Subjects able to understand the consent form and protocol required assessments
4. Subjects have adequate peripheral venous access
5. Females of childbearing potential must use 2 effective methods of avoiding pregnancy, only 1 of which is a barrier method and the other is a highly effective intrauterine device or hormonal method
6. All males (sterilized or non-sterilized) who are sexually active must use a condom for contraception with a woman of child bearing potential
7. Females with an intact cervix must have a Pap smear completed and without documented malignancy
8. Subjects must be willing to forego other forms of experimental treatment during the study
9. Subjects must meet the TB criteria as per the study protocol

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

1. Subjects with any condition that would interfere with the evaluation of the investigational product or interpretation of subject safety or study results
2. Subjects concurrently enrolled in another clinical study with an investigational product
3. Subjects who are pregnant or planning to become pregnant
4. Subjects with alcohol, drug or chemical abuse
5. Subjects who received any of the following within the last 60 days prior to Day 1:
  - Azathioprine >200 mg/day
  - Mycophenolate mofetil >2.0 g/day /mycophenolic acid >1.44 g/day
  - Oral, subcutaneous, or intramuscular methotrexate >25 mg/week
  - Mizoribine >150 mg/day
6. Subjects receiving any investigational product within 4 weeks prior to Day 1.
7. Subjects receiving any live or attenuated vaccine within 8 weeks or the BCG Vaccine between the end of the studies D3461C00004 or D3461C00005 and Day 1
8. Subjects who have active severe SLE-driven renal or neuropsychiatric disease
9. Subjects with HIV, Hepatitis B, or opportunistic infection requiring hospitalization or parenteral antimicrobial treatment within 3 years of Day 1/Visit 1
10. Subjects taking any medications from the restricted medication list as per the protocol