A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Investigate the Efficacy and Safety of Daxdilimab Subcutaneous Injection in Reducing Disease Activity in Adult Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus (RECAST DLE)

  • STATUS
    Recruiting
  • End date
    Dec 10, 2024
  • participants needed
    99
  • sponsor
    Horizon Therapeutics Ireland DAC
Updated on 10 November 2022

Summary

A Phase 2, double-blind, randomized, placebo-controlled parallel-group study to evaluate the efficacy and safety of daxdilimab in participants with moderate-to-severely active primary Discoid Lupus Erythematosus (DLE) refractory to standard of care.

Description

Approximately 99 participants will be enrolled to receive daxdilimab or placebo administered subcutaneously over 48 weeks. After week 24 all subjects will be receiving daxbilimab, including those assigned to the placebo arm, for the remainder of the 48 week treatment period. The maximum trial duration per participant is approximately 60 weeks including screening, the 48 weeks for the treatment period where participants will receive daxdilimab or placebo, and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study.

Details
Condition Discoid Lupus Erythematosus
Treatment Daxdilimab, Placebo/Daxdilimab
Clinical Study IdentifierNCT05591222
SponsorHorizon Therapeutics Ireland DAC
Last Modified on10 November 2022

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