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Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis

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Trial Profile

Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 20 Oct 2022

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At a glance

  • Drugs Valziflocept (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Adverse reactions
  • Acronyms SMILE
  • Sponsors SuppreMol

    • Most Recent Events

    • 12 Jul 2019 This trial has been completed in United Kingdom, according to European Clinical Trials Database.
    • 04 Mar 2015 According to a Baxter International and SuppreMol GmbH media release, results were presented at the American College of Rheumatology, 2014 annual meeting.
    • 04 Mar 2015 Results published in a Baxter International and SuppreMol GmbH media release.

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