A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

Inclusion Criteria:

• Study participant must be ≥16 years of age, unless restricted by local regulation,at the time of signing the Informed Consent form (ICF)

• Study participants who have moderate to severe disease activity due to eitherpersisting active systemic lupus erythematosus (SLE) or due to an acute worsening ofSLE in the scope of frequent relapsing-remitting SLE despite stable standard ofcare(SOC) medication defined as: a. Diagnosed with SLE at least 24 weeks before the Screening Visit by a qualifiedphysician b. Classified by 2019 SLE European League Against Rheumatism/AmericanCollege of Rheumatology (EULAR/ACR) classification criteria for SLE c. Withserological evidence for SLE at Screening as demonstrated by at least 1 of thefollowing: i) Evidence for anti-dsDNA (defined as evidence for anti-dsDNA antibodiesin central laboratory) ii) Either complement C3 <lower limit of normal (LLN) ORcomplement C4 <LLN as measured by central laboratory iii) Antinuclear antibodieswith a titer of at least 1:80 confirmed by central laboratory in combination withevidence of at least 1 of the following SLE typical autoantibodies:

1. Anti-Smith (anti-Sm) antibodies (central laboratory or source verifiablehistory)

2. Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndromeantibody B (anti-SSB) (La) autoantibodies (central laboratory)

3. Historical evidence for anti-dsDNA antibodies

4. Anti-ribonucleoprotein (RNP) autoantibodies (central laboratory) d. Moderatelyto severely active defined as:

• British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG

2004. Grade B in ≥2 organ systems and/or a BILAG 2004 Grade A in ≥1 organsystems at Screening and Baseline Visit AND

• Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 atthe Screening Visit AND
• SLEDAI-2K without labs ≥4 at Baseline Visit e. Receiving the followingstandard of care (SOC) medications at stable dose:
• Antimalarial treatment in combination with corticosteroids and/orimmunosuppressants or as stand-alone treatment if justified OR
• Treatment with corticosteroids and/or immunosuppressants if antimalarialtreatment is not appropriate (ie, there is documented intolerance inmedical history, documented lack of efficacy, contraindications, or lackof availability)

Exclusion Criteria:

• Study participant has any medical or psychiatric condition (including conditions dueto neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardizeor would compromise the study participant's ability to participate in this study.This includes study participants with a life-threatening condition

• Study participant has a history of an anaphylactic reaction to parenteraladministration of contrast agents, human or murine proteins, or monoclonalantibodies. This includes systemic reactions due to latex allergy

• Study participant has a history of malignancy, except the following treated cancers:cervical carcinoma in situ (after complete resection [eg, curettage,electrodesiccation] not later than 4 weeks prior to the Screening Visit [V1]), basalcell carcinoma, or dermatological squamous cell carcinoma

• Study participant has an increased risk for thromboembolic events due to an ongoingheart disease or due to a medical device, including but not limited to vasculargraft, valvular heart disease, atrial fibrillation, or a heart rhythm disorder

• Study participant has a mixed connective tissue disease, scleroderma, and/or overlapsyndrome of these diseases with SLE

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

• Study participant has clinically significant active or latent infection

• Study participant had a reactivated latent infection (eg, cytomegalovirus, herpessimplex virus, or herpes zoster infection) or opportunistic infection (including butnot limited to, pneumocystis, cytomegalovirus, or severe herpes zoster infection)within 12 weeks prior to the first study medication infusion (Visit 2) or iscurrently receiving suppressive therapy for an opportunistic infection

• Study participants who have received live/live attenuated vaccines within 6 weeksprior to the first study medication infusion

• Study participant has used the prohibited medications defined in the Protocol

• Study participant has previously been randomized within this study or has previouslybeen assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP

• Study participant has participated in another study of an investigational medicinalproduct (IMP) within the previous 12 weeks or 5 half-lives of the IMP whatever islonger, or is currently participating in another study of an IMP

• Study participant has chronic kidney failure stage 4, manifested by estimatedglomerular filtration rate (eGFR) <30 mL/min/1.73m2, or serum creatinine >2.5 mg/dL,or participant has proteinuria >3g/day, or protein:creatinine ratio >340 mg/mmol atthe Screening Visit