Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
EMD Serono Research & Development Institute, Inc.
With
Merck KGaA, Darmstadt, Germany
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) \>= 8
Active SLE with presence of: CLASI-A \>= 8 and BILAG 2004 1B, C, D (that is \[i.e.\], No BILAG 2004 A and No BILAG 2004 \>= 2B) or BILAG 2004 \>= 1A or 2B and 1 or 2 of the following: Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI \>= 6 at Screening Visit and confirmed clinical hybrid SELENA-SLEDAI \>= 4 (excluding laboratory parameters) at Day 1 Visit and/or CLASI-A \>= 8
Receiving a stable dose of at least one of the following standards of care therapies for lupus: Immunomodulator/immunosuppressant, oral corticosteroids, and/or topical corticosteroids
You may not be if
Autoimmune or rheumatic disease other than SLE or CLE
Dermatological diseases other than cutaneous manifestations of SLE or CLE
Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder
Ongoing or active clinically significant viral, bacterial, or fungal infection
History of uncontrolled seizures or other neurological disorder
History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
