A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus (GARDENIA-SLE)

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 3

Conditions: Lupus Erythematosus, Systemic

Treatments: Drug: Nipocalimab; Drug: Standard of care treatment; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07438496

80202135SLE3001 (Other Identifier)

2025

2025-523552-31-00 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 2 patient groups, including a placebo group

Nipocalimab

Experimental group

Description:

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 from both studies 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.

Treatment:

Drug: Standard of care treatment

Drug: Nipocalimab

Placebo

Placebo Comparator group

Description:

Participants will receive placebo up to Week 52 in the double blind treatment period along with standard of care treatment. At Week 52, eligible participants from both studies will have the option to enter an OLE period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.

Treatment:

Drug: Placebo

Drug: Standard of care treatment

Drug: Nipocalimab