Nipocalimab in Moderate to Severe Sjogren's Disease

Inclusion Criteria:-

• Medically stable on the basis of physical examination, medical history, vital signs,clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed atscreening

• Meets criteria for diagnosis of SjD by the 2016 American College ofRheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR)classification criteria

• Seropositive for antibodies to Ro/SSA (Ro60 and/or Ro52) at screening

• Total ClinESSDAI score greater than or equal to (>=) 5 at screening

• Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0prior to randomization

Exclusion Criteria:

• Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal,renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletaldisorder, hypertension, and/or any other medical or uncontrolled autoimmune disorderor clinically significant abnormalities in screening laboratory

• Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipientsor excipients used in the placebo formulation

• Has any confirmed or suspected clinical immunodeficiency syndrome not related totreatment of his/her SjD or has a family history of congenital or hereditaryimmunodeficiency

• Has shown a previous severe immediate hypersensitivity reaction, such asanaphylaxis, to therapeutic proteins (for example [e.g.], monoclonal antibodies,intravenous immunoglobulin)

• Has any unstable or progressive manifestation of SjD that is likely to warrantescalation in therapy beyond permitted background medications