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A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 1)

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Trial Profile

A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 1)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2024

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At a glance

  • Drugs Delgocitinib (Primary)
  • Indications Eczema
  • Focus Registrational; Therapeutic Use
  • Acronyms DELTA 1
  • Sponsors LEO Pharma

    • Most Recent Events

    • 26 Jul 2024 According to a LEO Pharma media release, the positive opinion by CHMP will be reviewed by the European Commission (EC) and, the final decision is pending. The authorization of delgocitinib cream will be valid in all EU member states, Iceland, Norway, and Liechtenstein. Regulatory filings in other markets are underway.
    • 26 Jul 2024 According to a LEO Pharma media release, as a latest step towards marketing authorization in the European Union (EU), the company has received a positive CHMP opinion of Anzupgo for the treatment of Moderate to Severe Chronic Hand Eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate, based on results from the DELTA phase 3 program comprising DELTA-1,2 and 3 trials.
    • 25 Jul 2024 Results from DELTA 1 and DELTA 2 trials published in The Lancet.

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