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A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

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Trial Profile

A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 15 Jan 2025

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At a glance

  • Drugs Nipocalimab (Primary)
  • Indications Sjogren's syndrome
  • Focus Therapeutic Use
  • Acronyms DAHLIAS
  • Sponsors Janssen Research & Development; Janssen-Cilag

    • Most Recent Events

    • 14 Nov 2024 According to a Janssen Cilag Media Release, data from this study were included in a plenary session presentation (Abstract #2527) and two posters (Abstract #s 1427 and 2294) and are among the Company's 43 oral and poster presentations at the American College of Rheumatology (ACR) Convergence 2024 taking place from November 14 to November 19 in Washington, D.C.
    • 14 Nov 2024 Results published in the Janssen Cilag Media Release
    • 11 Nov 2024 According to a Johnson & Johnson Media Release,company announced that the U.S. Food and Drug Administration (FDA) has granted nipocalimab Breakthrough Therapy designation (BTD) for the treatment of adults living with moderate-to-severe Sjogren disease (SjD) which is supported by data from this trial

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