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611 Efficacy and safety of nipocalimab in adult patients with active systemic lupus erythematosus: design of a phase 2 study
  1. Fang Liu-Walsh1,
  2. Bart van Hartingsveldt2,
  3. Qing Zuraw1,
  4. Robert W Hoffman1,
  5. Terence Rooney1,
  6. Sheng Gao1,
  7. Robert Gordon1,
  8. Jocelyn H Leu1,
  9. Cesar Calderon1,
  10. Federico Zazzetti3,
  11. Anne M Stevens1 and
  12. George Vratsanos1
  1. 1Janssen Research and Development, LLC, Spring House, PA, USA
  2. 2Janssen Biologics Europe, Leiden, the Netherlands
  3. 3Janssen-Cilag Argentina, Buenos Aires, Argentina


Background Autoantibody-mediated diseases, such as systemic lupus erythematosus (SLE), are caused by pathogenic antibodies that can damage tissues or organs. Approved treatments are few and associated with limitations including suboptimal response. Nipocalimab is a novel high affinity, fully human, aglycosylated, effectorless IgG1 monoclonal antibody that selectively blocks 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. Here we describe the protocol of a Phase 2 study evaluating the efficacy and safety of nipocalimab in patients with active SLE (NCT04882878).

Methods A phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study enrolling adults with active, autoantibody-positive SLE with an inadequate response to one or more standard of care treatments. The study consists of a ≤6-week screening period, a 52-week double-blind treatment period, and a 6-week follow-up period. A target of approximately 225 participants will be enrolled. 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. Additional assessments include pharmacokinetic, pharmacodynamic, and immunogenicity evaluations.

Conclusions 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: .

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