Dupilumab and House Dust Mite Immunotherapy in Patients With Atopic Dermatitis

NCT06509243 | Completed

• 1 other identifier: KNW-1-131/N/9/K
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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

Atopic Dermatitis

Keywords

atopic dermatitis; biologics; allergen immunotherapy

Outcome Measures

Primary Outcomes (3)

• Changes in EASI (the Eczema Area and Severity Index) scale

  objective improvement of skin lesions in the course of atopic dermatitis based on assessment using standardized questionnaire tests EASI. The EASI assessed disease extent on a scale of 0 to 6 in 4 defined body regions plus an assessment of erythema, infiltration, and/or population; excoriation; and lichenification, each on a scale of 0 to 3. A formula was then used to calculate the total score for each of the 4 regions, which were then added together. Interpretation of the EASI result: 0 = no change, 0.1-1.0 = almost no change, 1.1-7.0 = mild in intensity, 7.1-21.0 = moderate intensity, 21.1-50.0 = high intensity, 50.1-72.0 = very severe (points)

  12 months

• Changes in BSA% (Body Surface Area) scale

  Ii atopic dermatitis, %BSA was categorised according to severity bands: clear (0%), mild (\> 0 to \< 16%), moderate (16 to \< 40%), and severe (40-100%) (percentage)

  12 months

• Changes in IsGA (investigator global assessment) scale

  The IsGA is a doctor-assessed outcome that evaluates overall AD severity on a 5-point scale ranging from clear (0) to severe (4) or very severe (5).

  12 months

Secondary Outcomes (5)

• Significant reduction in IsGA scale

  12 months

• changes in DLQI (Dermatology Life Quality Index ) questionnaire

  12 months

• exacerbations of atopic dermatitis

  12 months

• changes in serum concentration of IgG4 against D. pteronyssinus

  12 months

• changes in serum concentration of IgE against D. pteronyssinus

  12 months

Study Arms (4)

SLIT HDM

ACTIVE COMPARATOR

Patients received sublingual allergen immunotherapy (Acarizax), adding to symptomatic therapy for atopic dermatitis (according to recommendations).

Biological: tablets Acarizax

biologic

ACTIVE COMPARATOR

Patients received dupilumab, added to symptomatic therapy for atopic dermatitis (according to recommendations.)

Biological: dupilumab

Combi therapy

ACTIVE COMPARATOR

Patients received sublingual allergen immunotherapy (Acarizax) and dupilumab, added to symptomatic therapy for atopic dermatitis (according to recommendations).

Biological: tablets Acarizax; Biological: dupilumab

cyclosporine

PLACEBO COMPARATOR

Patients received cyclosporine added to symptomatic therapy for atopic dermatitis (according to recommendations).

Drug: cyclosporine

Interventions

tablets Acarizax BIOLOGICAL

sublingual immunotherapy to house dust mites

Combi therapy; SLIT HDM

dupilumab BIOLOGICAL

dupilumab - biologic therapy for atopic dermatitis

Combi therapy; biologic

cyclosporine DRUG

cyclosporine used in atopic dermatitis

cyclosporine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosed with AD a minimum of one year before the study (documented one year of therapy for AD)
• between 18 and 45 years of age
• severe AD with an Eczema Area and Severity Index (EASI) \>20 points, a %BSA (body surface area) \>10 points, an IsGA (Investigator Global Assessment) = 4 points, a positive skin prick test (SPT)
• a positive result for specific immunoglobulin E (sIgE) to extracts of D. pteronyssinus and D. farinae and to Der p 1;
• negative results for SPT and sIgE to other inhalant allergens;
• no symptoms of allergic asthma and/or allergic rhinitis

You may not qualify if:

• other active dermatoses, systemic immunosuppressant treatment up to 7 months before the study, other chronic diseases,
• contraindications to sublingual immunotherapy or dupilumab,
• lack of written consent

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

SUM

Zabrze, Poland

Location

Related Publications (1)

• Bogacz-Piaseczynska A, Bozek A. The Effectiveness of Allergen Immunotherapy in Adult Patients with Atopic Dermatitis Allergic to House Dust Mites. Medicina (Kaunas). 2022 Dec 21;59(1):15. doi: 10.3390/medicina59010015.

  PMID: 36676639 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab; Cyclosporine

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Andrzej Bozek, Prof

  Medical University of Silesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, placebo-controlled, double-blind 12-month trial

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: July 19, 2024
• Study Start: February 10, 2023
• Primary Completion: March 12, 2024
• Study Completion: April 10, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-06

Locations

PL (1)