Last updated 7 days ago
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
600 patients around the world
Available in United States, Brazil
Janssen Research & Development, LLC
1Research sites
600Patients around the world
This study is for people with
Lupus
Systemic lupus erythematosus
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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 according to 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, excluding points attributed to 'lupus headache,' 'alopecia,' and 'organic brain syndrome.'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.
- 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.
Sites
Centro Universitário Faculdade de Medicina do ABC (FMABC)
Recruiting
StudyGARDENIA
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Systemic lupus erythematosus
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07438496
