A Phase III, randomised, double-blind, placebo-controlled, multicentre study of nipocalimab in adults with moderate to severe systemic lupus erythematosus
Systemic lupus erythematosus
Experimental: Nipocalimab Participants will receive nipocalimab up to Week 52 in the double-blind treatment period along with standard of care treatments. At Week 52, eligible participants will have the option to enter an open-label long-term extension (OLE) period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued. Placebo Comparator: Placebo Participants will receive a placebo up to Week 52 in the double-blind treatment period along with standard of care treatment. At Week 52, eligible participants will have the option to enter an open-label extension period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.
1. Aged 18 to 75 years old 2. Male or female 3. Medically stable on the basis of physical examination, medical history, vital signs and a 12-lead electrocardiogram (ECG) performed at screening 4. A clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to 24 weeks before screening. This diagnosis should be made according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria. 5. Participants must have a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than or equal to 6 and a Clinical SLEDAI-2K greater than or equal to 4 at screening, AND a clinical SLEDAI-2K score greater than or equal to 4 points at Week 0, excluding points attributed to “lupus headache,” “alopecia,” and “organic brain syndrome”. 6. Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test at screening and a negative urine (β- hCG) test at Week 0 before randomisation 7. Participants must have at least one BILAG#2004 (British Isles Lupus Assessment Group#2004) A score or two BILAG#2004 B scores observed at screening
1. History of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder (s) or clinically significant abnormalities in screening laboratory tests 2. Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications 3. Confirmed or suspected clinical immunodeficiency syndrome not related to treatment of SLE or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant 4. Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins 5. Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation