Dupilumab and House Dust Mite Immunotherapy in Patients With Atopic Dermatitis

Sponsor
Medical University of Silesia
Study ID
NCT06509243
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • tablets Acarizax — BIOLOGICAL
    sublingual immunotherapy to house dust mites
  • dupilumab — BIOLOGICAL
    dupilumab - biologic therapy for atopic dermatitis
  • cyclosporine — DRUG
    cyclosporine used in atopic dermatitis

Study Details

Severe atopic dermatitis (AD) is a complex disease requiring systemic treatment. This study aimed to assess the effectiveness of combined therapy consisting of dupilumab and sublingual dust mite allergen immunotherapy (SLIT-HDM) in patients with severe AD and HDM allergies. Methods: Patients diagnosed with severe AD were included in a randomized, placebo-controlled, double-blind 12-month trial; they received SLIT to HDM and/or dupilumab for 12 months and were compared to patients on cyclosporine. EASI, %BSA, and IsGA changes were analyzed in the different treatment arms from the beginning to the end of the 12th month. The secondary outcomes were the proportion of patients who achieved IsGA success and reduced medication scores.

Key Dates

Start date
Feb 10, 2023
Status verified
Jun 2024
Primary completion
Mar 12, 2024
Completion
Apr 10, 2024

Study Design

Enrollment
132 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: SLIT HDM
    Patients received sublingual allergen immunotherapy (Acarizax), adding to symptomatic therapy for atopic dermatitis (according to recommendations).
  • Active Comparator: biologic
    Patients received dupilumab, added to symptomatic therapy for atopic dermatitis (according to recommendations.)
  • Active Comparator: Combi therapy
    Patients received sublingual allergen immunotherapy (Acarizax) and dupilumab, added to symptomatic therapy for atopic dermatitis (according to recommendations).
  • Placebo Comparator: cyclosporine
    Patients received cyclosporine added to symptomatic therapy for atopic dermatitis (according to recommendations).

Primary Outcome Measure

Changes in EASI (the Eczema Area and Severity Index) scale [ Time Frame: 12 months ]

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