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Study of Dupilumab to Demonstrate Efficacy in Subjects With Nummular Eczema

Study acronym: DUPINUM
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date changed from estimate of Jan 31, 2026 to Sep 1, 2025v10
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v9
  3. Primary completion date: Jan 31, 2025 to Jan 31, 2026
    • Study completion date: Jan 31, 2025 to Jan 31, 2027
    v8
  4. Eligibility criteria expanded, about 3 wordsv7
  5. Primary completion date: Jan 31, 2023 to Jan 31, 2025
    • Study completion date: Jan 31, 2024 to Jan 31, 2025
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Mar 15, 2021 to Mar 30, 2021v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v4
  3. Start date: Jan 15, 2021 to Mar 15, 2021v3
  4. Eligibility criteria revised
    • Secondary endpoints: details revised at 2 of 10 entries
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Nummular eczema (NE) is an idiopathic chronic inflammatory skin disease that occurs throughout all life periods. Diagnosis is made primarily clinically in correlation with histological findings. Treatment of NE is difficult. Standard treatment consists of the use of emollients, topical as well as systemic corticosteroids and phototherapy. Nevertheless, remission is hard to achieve and relapse occurs often. Patients usually suffer from severe pruritus and reduced quality of life. Therefore, new therapeutic strategies are urgently needed. Dupilumab (Dupixent®), a monoclonal antibody inhibiting the IL-4 and IL-13 pathway by targeting the IL-4-receptor, has been approved for the treatment of moderate-to-severe atopic dermatitis (AD). Since there is an overlap between AD and NE with both being caused by impaired epidermal barrier, broad immune-mediated inflammation and microbial skin colonization, using Dupilumab in NE seems to be promising.
Trial Details
NCT Number NCT04600362
Lead Sponsor Technical University of Munich
Collaborators: University Hospital Munich
Conditions
(from sponsor)		 Nummular Eczema
Related terms Dermatitis, Skin Diseases
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov