Article Text

Download PDFPDF

PO.6.137 Design of a phase 2, multicenter, randomized, placebo-controlled, parallel-group, double-blind study to assess the efficacy and safety of nipocalimab in adults with active systemic lupus erythematosus
  1. F Liu-Walsh1,
  2. B Van Hartingsveldt2,
  3. Q Zuraw3,
  4. RW Hoffman1,
  5. T Rooney1,
  6. S Gao1,
  7. R Gordon1,
  8. JH Leu1,
  9. A Berhanu Debella1,
  10. C Calderon1,
  11. F Zazzetti3 and
  12. G Vratsanos1
  1. 1Janssen Research and Development, LLC ~ Spring House ~ USA
  2. 2Janssen Biologics Europe ~ Leiden ~ Netherlands
  3. 3Janssen-Cilag Argentina ~ Buenos Aries ~ Argentina


Objective Systemic lupus erythematosus (SLE) is a chronic, complex autoimmune disease characterized by pathogenic autoantibodies and tissue damage to multiple organ systems. Approved treatments are few and associated with limitations including suboptimal response for many patients. Nipocalimab is a novel high affinity, fully human, aglycosylated, effectorless IgG1 monoclonal antibody that selectively targets the neonatal Fc receptor (FcRn). Clinical studies conducted with nipocalimab in healthy volunteers (NCT02828046) and in adult generalized myasthenia gravis patients (NCT03896295) demonstrated rapid and durable serum IgG and pathogenic autoantibody reductions, which may be therapeutic across a broad range of autoantibody-mediated immune disorders including SLE. This abstract describes the protocol of a Phase 2 study evaluating efficacy and safety of nipocalimab in patients with active SLE (NCT04882878).

Methods This is a phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study enrolling adults with active, autoantibody-positive SLE with an inadequate response to ≥1 standard of care (SoC) treatments. The study consists of a ≤6-week screening period, a 52-week double-blind treatment period, and a 6-week follow-up period (figure 1). Approximately 225 participants will be randomized in a 1:1:1 ratio to receive nipocalimab dose 1, dose 2 or placebo intravenously every 2 weeks through Week 50.

Results The primary efficacy endpoint is the percentage of participants achieving an SLE Responder Index (SRI)-4 composite response at Week 24. Secondary efficacy endpoints assessed at Week 24 include the percentage of participants achieving: ≥50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity score (CLASI), ≥50% reduction in active joints, ≥4 points improvement in SLE Disease Activity Index 2000 (SLEDAI 2K), and British Isles Lupus Assessment Group Composite Lupus Assessment response (BICLA); time to first disease flare; and reduction in corticosteroid use. Percentage of participants achieving an SRI-4 composite response at Week 52 will also be assessed. Safety endpoints include adverse events (AEs), serious AEs, AEs of special interest (severe infections, grade ≥3 hypoalbuminemia), and AEs leading to treatment discontinuation through Week 58.

Abstract PO.6.137 Figure 1

Study design

Conclusion This ongoing phase 2 study will evaluate the safety and efficacy of nipocalimab in adults with active SLE, using multiple clinical outcome measures.

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.