A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus

Inclusion Criteria:

- Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by SLICC
classification criteria

- Moderate to severe SLE disease activity

- Evidence for at least 1 of the following SLE markers:

- Anti-dsDNA antibodies confirmed by central laboratory or

- Low complement confirmed by central laboratory or

- Antinuclear antibody (ANA) titer of >= 1:80 in combination with at least 1 of the
following: Historical positivity for anti-dsDNA or Positivity for anti-ENA
confirmed by central laboratory

- The subject is receiving stable SLE standard-of-care medication

Exclusion Criteria:

- Mixed connective tissue disease, scleroderma, and/or overlap syndromes of SLE

- Subjects with severe neuropsychiatric SLE or other neurological symptoms that in the
opinion of the Investigator, would prevent the subject from completing protocol
required procedures and assessments.

- New or worsening Class III or IV lupus nephritis

- Chronic kidney failure stage 3b

- Evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell
deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or
during the study

- Clinically significant active or latent infection (eg. chronic viral hepatitis B or C)

- Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent
TB (LTB) infection

- Live/live attenuated vaccines within 6 weeks prior to the first study drug infusion
(Visit 2) or who plan to receive these vaccines during the study or 12 weeks after the
final dose of study drug

- History of thromboembolic events within 12 months of screening

- Subject has used protocol defined prohibited medications