A Study of DS-7011a in Patients With Systemic Lupus Erythematosus

Inclusion Criteria:

• Male and female participants must be of 18 years or more with definite SLE for atleast 6 months prior to Screening, defined according to the 2019 European LeagueAgainst Rheumatism (EULAR)/American College of Rheumatology (ACR) classificationcriteria for SLE, including documented history of positivity for antinuclearantibody (titer ≥1:80).

• Body mass index (BMI) ≥18 kg/m^2 and body weight ≥45 kg.

• Presence of active CLE (acute, subacute, and chronic cutaneous lupus), with activeskin involvement and a CLASI-A score of 4 or higher at the time of screening andrandomization as recognized by 2 adjudicators, ie, the investigator in the peripheryat the site and a centrally located arbiter contracted ad hoc (in case ofdisagreement between these 2 adjudicators, a third adjudicator, also centrallylocated and contracted ad hoc, will solve the disagreement and provide a finaldecision), despite adequate use of conventional therapies (either topicalcorticosteroids or antimalarial agents used for at least 12 weeks prior toScreening) or because of the requirement to discontinue these therapies due to sideeffects or poor tolerability.

• Participants must be willing to have skin tape harvests collected from the affectedskin area (skin tape stripping done on the target lesion).

• Participants must agree not to participate in any other investigational study duringthe study Treatment Period and for 3 months after the last dose of study drug.

• Participants must give written informed consent to participation in the study priorto Screening.

• Participants must be vaccinated against COVID-19

Exclusion Criteria:

• Active lupus nephritis (LN) on induction therapy, or induction therapy completedwithin 12 weeks prior to Screening (stable maintenance therapy with mycophenolate orazathioprine allowed).

• Active neuropsychiatric SLE, including, but not limited to, the following: seizure,new or worsening impaired level of consciousness, psychosis, delirium or confusionalstate, aseptic meningitis, ascending or transverse myelitis, chorea, cerebellarataxia, mononeuritis multiplex, or demyelinating syndromes.

• Primary diagnosis of autoimmune or rheumatic disease other than SLE (secondarySjögren's syndrome or autoimmune thyroiditis are not exclusionary) or drug-inducedlupus.

• History of chronic, recurrent (3 or more of the same type of infection in 1 year) orrecent serious infection, including viral infections, as determined by theinvestigator, or requiring anti-infective treatment within 12 weeks prior toScreening.

• History of severe herpes infection or signs of herpes or varicella zoster viralinfection within 12 weeks prior to Screening.

• Positive COVID-19 molecular test at Screening or symptoms suggestive of SARS-CoV-2infection or close contact with an individual with SARS-CoV-2 infection within 2weeks prior to randomization.

• History of malignant disease within the 2 years before Screening or ongoing at thetime of Screening, except basal cell carcinomas and squamous cell carcinomas of theskin, or completely excised carcinoma in situ of the cervix

• Chronic kidney disease with significant proteinuria (ie, >2 g/24 h or urine proteinto creatinine ratio >200 mg/g) or decreased renal function (estimated glomerularfiltration rate [eGFR] <30 mL/min).

• New York Heart Association class III or IV congestive heart failure.

• Concomitant disease or condition that could interfere with, or treatment of whichmight interfere with, the conduct of the study, or that would, in the opinion of theinvestigator, pose an unacceptable risk to the participant in this study.

• History or positive test result for human immunodeficiency virus at Screening.

• Active hepatitis B virus (HBV) infection determined at Screening as positive testresult for hepatitis B surface antigen.

• Active hepatitis C virus (HCV) infection determined at Screening as HCV ribonucleicacid (RNA) above the limit of detection in subjects with positive HCV antibodytiter.

• History of, or ongoing, active tuberculosis (TB) or untreated latent TB infection (LTBI) at Screening. Participants with documented previously completed appropriateLTBI treatment and without evidence of re-exposure will not be required to betested.

• Any other significant condition that according to the investigator's judgment wouldprevent compliance with study protocol and full study participation.

• Participants must not be participating in another investigational study or haveparticipated in an investigational study within the past 30 days prior torandomization (Day 1).

• History of or current inflammatory skin disease other than SLE that in the opinionof the investigator could interfere with the inflammatory skin assessments andconfound the disease activity assessments.

• History of any non-SLE disease that had required treatment with oral or parenteralcorticosteroids for more than a total of 2 weeks within the last 24 weeks prior torandomization