Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus (CLEan)

  • STATUS
    Not Recruiting
  • days left to enroll
    88
  • participants needed
    78
  • sponsor
    Sanofi
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Updated on 31 March 2023
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Summary

Primary Objective:

  • Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE)

Secondary Objectives:

  • Assess the effect of SAR443122 on the physician's global assessment of disease activity (PhysGA - disease activity)
  • Assess the effect of SAR443122 on CLE induced itch and overall pain
  • Assess the effect of SAR443122 on the proportion of disease activity responders compared to placebo
  • Assess the effect of SAR443122 on the CLASI components score
  • Assess the effect of SAR443122 on the Investigator's global assessment for CLE (IGA-CLE)
  • Assess oral cavities for patients with oral lesions
  • Assess the disease specific quality of life (QoL)
  • Assess the safety and tolerability of SAR443122 in patients with CLE
  • Assess the pharmacokinetics (PK) exposure of SAR443122 in patients with CLE

Description

Total study duration per participant will be up 20 weeks including:

  • A screening period of up to 4 weeks
  • A treatment period of 12 weeks
  • A post treatment follow-up period of 4 weeks

Details
Condition Cutaneous Lupus Erythematosus
Treatment Placebo, SAR443122
Clinical Study IdentifierNCT04781816
SponsorSanofi
Last Modified on31 March 2023

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