Phase 3 Randomized Double-blind Placebo-controlled Study of Nipocalimab in Adults with Moderate to Severe Systemic Lupus Erythematosus

The primary objective is to evaluate the efficacy of systemic lupus erythematosus disease activity with nipocalimab compared with placebo, which is clinically relevant for determining whether treatment reduces overall inflammatory disease burden. No secondary objectives were provided.

The trial enrolled 329 participants with systemic lupus erythematosus. The study population included both female and male patients, and the age range corresponded to adult participants. Participants were selected from the patient population and were required to be adults at the time of informed consent, with a diagnosis of SLE and at least 1 positive autoantibody. Additional eligibility was based on SLE disease activity assessments, including SLEDAI-2K and BILAG scores. No information was provided on general health status beyond the disease condition, and no lifestyle details such as diet, physical activity, or habits were reported.

This systemic lupus erythematosus study is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating nipocalimab compared with placebo in adults with moderate to severe disease. The main objective is to assess efficacy on disease activity, with the primary endpoint defined as SRI-4 composite response at Week 52. Study participation includes an inclusion screening visit to confirm eligibility, including adult status at informed consent, diagnosis of SLE with at least 1 positive autoantibody, and assessment by SLEDAI-2K and BILAG scores. Eligible participants then enter the treatment period and undergo follow-up visits during the study to monitor disease activity and study outcomes. An end-of-study visit is performed at completion of the trial period. The overall trial duration is estimated from 2026-05-31 to 2031-02-21, and participant involvement is expected to continue through the study period unless early termination occurs because of ineligibility identified at screening, withdrawal of consent, or other study discontinuation criteria determined by the protocol.

The investigational treatment was nipocalimab, administered as a solution for injection by subcutaneous use. The product was identified as JNJ-80202135. The dosage was recorded as 0 in the source data. Administration frequency was not specified. Participant compliance monitoring was not described in the source data.

The non-experimental treatment was a placebo administered subcutaneously without nipocalimab. The placebo was listed as a subcutaneous product with no active substance. The pharmaceutical form, dosage, route, and frequency were not specified in the source data.

Efficacy will be assessed by comparing Systemic Lupus Erythematosus disease activity between nipocalimab and placebo. The primary efficacy endpoint is the SRI-4 composite response at Week 52.