A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Sponsored by Janssen Research & Development, LLC
About this study
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).
Where this study is enrolling (3)
- I'm interested
Atlanta Research Center for Rheumatology
Marietta, Georgia
- I'm interested
Clinical Research Philadelphia
Philadelphia, Pennsylvania
- I'm interested
Fort Bend Rheumatology Associates PLLC
Sugar Land, Texas
Who can participate
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
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.