Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MedImmune LLC
This is an open-label extension study to evaluate long-term safety and tolerability of intravenous (IV) anifrolumab in adult participants with moderately-to-severely active SLE. Participants must have completed the qualifying Phase 2 study and meet this study criteria in order to be eligible.
Age
18–68
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must be willing to use 2 methods of effective contraception
Must have venous access
Must be willing to forego participation in other clinical trials for SLE.
You may not be if
Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
Major surgery within 8 weeks before signing informed consent form (ICF)
Elective major surgery planned during the study period
Concomitant Medications within the last 12 weeks: Azathioprine \> 200 mg/day, Mycophenolate mofetil/mycophenolic acid \> 2.0 g/day, oral, subcutaneous, or intramuscular methotrexate \> 25 mg/week
A live or attenuated vaccine within 4 weeks of signing the ICF
Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of ICF