Dupilumab and House Dust Mite Immunotherapy in Patients With Atopic Dermatitis

NCT06509243 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2024-07-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

tablets Acarizax

sublingual immunotherapy to house dust mites

BIOLOGICAL

dupilumab

dupilumab - biologic therapy for atopic dermatitis

DRUG

cyclosporine

cyclosporine used in atopic dermatitis

Sponsors & Collaborators

  • Medical University of Silesia

    lead OTHER

Principal Investigators

  • Andrzej Bozek, Prof · Medical University of Silesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-10
Primary Completion
2024-03-12
Completion
2024-04-10

Countries

  • Poland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06509243 on ClinicalTrials.gov