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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

Recruiting
99 years or below
All
Phase 2
4 participants needed
1 Location

Brief description of study

PURPOSE: Phase 2 study to evaluate effect of daxdilimab vs placebo to reduce DLE activity in adults 18-75 yo with DLE. 60 wks 99 pts multiple sites 3 trx grps: placebo; daxdilimab 150 mg; daxdilimab 300 mg. Randomize 1:1:1 sc injections q 4 wks Screening--4 wks; Treatment--48 wks; Follow-Up--8 wks. Check eligibility, ICF signed, meds, ECG, vital signs, PEs, safety + specialty+ research labs, skin swab, pregnancy testing, clinical assessments, questionnaires, photos, optional future, genetic research.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Medical Research
  • Age: 99 years or below
  • Gender: All
Updated on 12 Apr 2023. Study ID: 852348

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