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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus

Trial Profile

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus

Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2019

At a glance

  • Drugs Ustekinumab (Primary) ; Ustekinumab (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Registrational; Therapeutic Use
  • Acronyms LOTUS
  • Sponsors Janssen Pharmaceutical KK; Janssen Research & Development; Janssen-Cilag
  • Most Recent Events

    • 23 Oct 2018 Janssen will collaborate with the Lupus Foundation of America (LFA) to incorporate the Rapid Evaluation of Activity in Lupus (LFA-REAL™) instrument into the study.
    • 03 Oct 2018 Planned primary completion date changed from 21 Jan 2021 to 22 Jan 2021.
    • 08 Aug 2018 Planned End Date changed from 30 Jun 2023 to 31 Aug 2028.
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