Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MedImmune LLC
With
AstraZeneca
This is a Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of escalating single subcutaneous doses of MEDI-570 in adult subjects with moderately to severely active SLE.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
