Authorised Therapeutic confirmatory (Phase III) Systemic Lupus Erythematosus

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

EU CTIS ID: 2025-523552-31-00

What this study is testing

To evaluate the efficacy of nipocalimab compared with placebo on SLE disease activity

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Adult participants at the time of informed consent
  • Diagnoses of SLE and at least 1 positive autoantibody
  • SLEDAI-2K score
  • BILAG Score

You likely can't join if

  • Any condition for which, participation would not be in the best interest of the participant
  • Any clinically significant laboratory abnormality that is not considered appropriate or reasonable for the population under study.
  • Comorbidities requiring systemic GCs
  • Inflammatory diseases
  • Major surgical procedure prior to screening

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom
  • Switzerland
  • Hong Kong
  • United States
  • Georgia
  • Colombia
  • Chile
  • Peru
  • Serbia
  • Turkey
  • Taiwan
  • Thailand
  • Australia
  • South Africa
  • Canada
  • Brazil
  • Argentina

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom; Switzerland; Hong Kong; United States; Georgia; Colombia and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.