NCT03983460

Dupilumab Impact on Skin Resident Memory T Cells

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Association pour la Recherche Clinique et Immunologique · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study consists in characterizing the immune cells that are present/persist in the skin and the blood of atopic dermatitis (AD) patients treated with Dupilumab, as well as with potent/very potent topical corticosteroids (TCS: betamethasone valerate cream 0.1% or clobetasol propionate cream 0.05%). A specific attention will be paid on the presence/persistence of skin Trm and ILCs. The study population will consist of 20 adult patients suffering from moderate to severe Atopic Dermatitis and eligible for Dupilumab treatment. (Patients should have inadequate response, intolerance or contraindication to systemic anti-inflammatory treatments). This is an exploratory, prospective, single-site, randomized, open labeled study. There is a treatment period of 168 days (24 weeks) and a post-treatment follow-up period of maximum 102 days.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Dupilumab	Each single used prefilled syringe contains 300 mg of Dupilumab in 2 mL solution (150mg/mL) Dupilumab is a fully human monoclonal antibody against interleukin (IL)-4 receptor alpha that inhibits IL-4/IL-13 signaling, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
DRUG	Optimized TCS treatment	Application of betamethasone valerate 0.1% (Betneval 0.1% cream), a potent topical corticosteroid, and if not active, application of clobetasol propionate 0.05% (Dermoval 0.05% cream), a very potent topical corticosteroid. TCS treatment will be associated with a personal therapeutic education for treatment optimization.
PROCEDURE	Biopsies	Four skin biopsies (5 mm diameter) and ten microbiopsies (2 \& 3 mm diameter) will be performed according the following schedule: * Day 0 * a 5 mm section biopsy from a non-lesional skin * a 5 mm section biopsy from an active lesion * a 3 mm section microbiopsies from a non-lesional skin * a 3 mm section microbiopsies from an active lesion * a 2 mm section microbiopsies from a non-lesional skin * a 2 mm section microbiopsies from an active lesion * Day 28 * a 5 mm section biopsy on improved/healed lesion * a 3 mm section microbiopsies on improved/healed lesion * a 2 mm section microbiopsies from non lesional skin identified at V1 * a 2 mm section microbiopsies on improved/healed lesion * Day 168 * a 5 mm section biopsy on improved/healed lesion * a 3 mm section microbiopsies on improved/healed lesion * a 2 mm section microbiopsies from non-lesional skin identified at V1 * a 2 mm section microbiopsies on improved/healed lesion
PROCEDURE	Skin prick-test	Skin prick test is a method for medical diagnosis of allergy consisting in introducing a small amount of an allergen into the patient's skin. The allergen penetrates the epidermis by pricking the skin with a pin. Skin Prick test for Derp and Derf will be performed at Day 0, preferentially on the forearms, avoiding lesional areas. For the results interpretation, the two allergen Derp/Derf will be compared to 2 controls: * Negative control : saline solution * Positive control : histamine solution Positive criteria of prick tests results are: * Positive control's diameter ≥ 3mm * And negative control's diameter \< 3 mm * And tested allergen with wheal ≥ positive control, i.e. 3mm
PROCEDURE	Blood sample collection	A 50ml blood sample will be collected by venipuncture at Day 0, Day 28 and Day 168. More specifically a 40 ml blood sample will be drawn on heparinized tubes for immunophenotyping and a 10 mL on serum blood collection tube for analysis of AD biomarkers by mass cytometry and ELISA.

Timeline

• Start date: 2020-03-09
• Primary completion: 2021-06-01
• Completion: 2021-09-01
• First posted: 2019-06-12
• Last updated: 2020-03-24

Locations

1 site across 1 country: France