Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alpine Immune Sciences Inc, A Subsidiary of Vertex
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
SLE onset ≥ 6 months prior to Screening
Positive ANA and/or elevated anti-dsDNA and/or elevated anti-Smith antibody test
Active lupus at Screening and Baseline, as defined per-protocol and confirmed by the study's medical monitor, including a SLEDAI score at Screening of ≥ 6 and a clinical score at Baseline of ≥ 4
Standard lupus medications must be stable prior to Screening
You may not be if
Life-threatening or organ system-threatening lupus activity that is anticipated to require increased treatment during the study
Proteinuria consistent with nephrotic syndrome
Active lupus-related neuropsychiatric disease
Drug-induced lupus
Recent or serious ongoing infection; risk or history of serious infection
Receipt of live vaccination within 8 weeks of Day 1, or expected to require live vaccination during the study
Prior diagnosis of, or fulfills diagnostic criteria for, another rheumatic disease that overlaps with lupus or another autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study
Diagnosis of, or fulfills diagnostic criteria for fibromyalgia
Functional class IV
Serious lupus disease activity, which warrants immediate immunosuppressive therapy not appropriate for the study or which makes the possibility of receiving placebo or investigational agent an inappropriate risk
