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A Single-Ascending-Dose and Multiple-Ascending-Dose Study of BIIB059 in Healthy Volunteers and Subjects With Systemic Lupus Erythematosus

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Trial Profile

A Single-Ascending-Dose and Multiple-Ascending-Dose Study of BIIB059 in Healthy Volunteers and Subjects With Systemic Lupus Erythematosus

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 03 Feb 2023

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At a glance

  • Drugs Litifilimab (Primary) ; Litifilimab (Primary)
  • Indications Cutaneous lupus erythematosus; Discoid lupus erythematosus; Systemic lupus erythematosus
  • Focus Adverse reactions; First in man; Pharmacodynamics
  • Sponsors Biogen

    • Most Recent Events

    • 08 Nov 2017 Results assessing safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical efficacy of single and multiple ascending doses (SAD-MAD) of BIIB059 in HV and SLE subjects, were presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting.
    • 17 Jun 2017 Results (n=12) presented at the 18th Annual Congress of the European League Against Rheumatism
    • 17 Jun 2017 Results from part I of the trial in healthy volunteers (n=54), presented at the 18th Annual Congress of the European League Against Rheumatism
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