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A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Lupus Erythematosus, Systemic

Interventions: Nipocalimab, Placebo, Standard of care treatment

Countries: United States, Argentina, Australia, Brazil, Bulgaria, China, Czechia, Denmark

The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:-

* Medically stable on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening
* Clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to (\>=) 24 weeks prior to screening and meeting european league against rheumatism/american college of rheumatology (EULAR/ACR) classification criteria
* Must have a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score \>= 6 and a clinical SLEDAI-2K \>= 4 at screening, AND a clinical SLEDAI-2K score \>= 4 points at Week 0. For eligibility, points attributed to "lupus headache," "alopecia," and "organic brain syndrome" are excluded
* 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 prior to randomization
* Has at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores observed at screening

Exclusion Criteria:

* 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
* Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications
* 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
* Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins
* Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation

Locations (231)

Beverly Hills, California, United States
Fullerton, California, United States
Hemet, California, United States
La Palma, California, United States
San Leandro, California, United States
Torrance, California, United States
Tustin, California, United States
Upland, California, United States
Aventura, Florida, United States
Clearwater, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami Gardens, Florida, United States
Miami Lakes, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
Marietta, Georgia, United States
Willowbrook, Illinois, United States
Lake Charles, Louisiana, United States
Sterling Heights, Michigan, United States
Voorhees Township, New Jersey, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Fayetteville, North Carolina, United States
Middleburg Heights, Ohio, United States
Philadelphia, Pennsylvania, United States
Jackson, Tennessee, United States
Amarillo, Texas, United States
Frisco, Texas, United States
Katy, Texas, United States
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