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A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Baricitinib in Combination With Topical Corticosteroids in Adult Patients With Moderate-to-Severe Atopic Dermatitis Who Have Experienced Failure to Cyclosporine or Are Intolerant to, or Have Contraindication to, Cyclosporine

Trial Profile

A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Baricitinib in Combination With Topical Corticosteroids in Adult Patients With Moderate-to-Severe Atopic Dermatitis Who Have Experienced Failure to Cyclosporine or Are Intolerant to, or Have Contraindication to, Cyclosporine

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

Latest Information Update: 06 Oct 2021

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At a glance

  • Drugs Baricitinib (Primary) ; Corticosteroid; Hydrocortisone; Triamcinolone
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms BREEZE-AD4
  • Sponsors Eli Lilly and Company
  • Most Recent Events

    • 23 Apr 2021 According to an Eli Lilly media release, these results are being presented virtually at the American Academy of Dermatology's Virtual Meeting Experience (AAD VMX), April 23-25, 2021.
    • 23 Apr 2021 Results of Extended safety analysis of baricitinib 2 mg in the AD clinical program (NCT02576938; NCT03334396; NCT03334422; NCT03428100; NCT03435081; NCT03733301; NCT03334435; NCT03559270), published in the Eli lilly Media Release
    • 07 Apr 2021 Extended safety analysis of baricitinib 2 mg in the AD clinical program (NCT02576938; NCT03334396; NCT03334422; NCT03428100; NCT03435081; NCT03733301; NCT03334435; NCT03559270), Results published in the American Journal of Clinical Dermatology.
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