Dupilumab impact on skin resident memory T cells

Phase 1

• Conditions: Atopic Dermatitis; MedDRA version: 20.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-004073-27-FR
• Lead Sponsor: ARCI (trade name LYON RECHERCHE CLINIQUE : LyREC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-14
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

•Subject over 18 years of age
•For woman with childbearing potential ;
•Use of a highly effective method of birth control from at least 1 month prior to study enrollment until the last visit
•Negative urine pregnancy test at inclusion visit
•Subject diagnosed with moderate-to-severe AD, defined as SCORAD=20 and/or EASI=7 (Eichenfield et al., 2014)
•Subject with I, II, III or IV skin phototype (according to Fitzpatrick scale)
•Subject accepting skin prick-tests and skin biopsies
•Subject having a least one non lesional area on the body (off head and neck, feet and hands)
•Subject eligible for systemic treatment
•Failure, intolerance or contraindication to available systemic treatments (i.e. cyclosporine/ methotrexate)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

•Pregnancy or breast-feeding women, or planning to become pregnant or breastfeed during the study
•Subject currently experiencing or having a history of other concomitant skin conditions that would interfere with evaluation of AD
•History of allergic reaction to local anesthetic product
•History of wound healing disorders (e.g. hypertrophic scars, keloids)
•Subject with known active infection to HBV, HCV or HIV
•Subject with known blood dyscrasia
•Subject having an allergen immunotherapy within 3 months before study
•Subject treated by antihistamine 5 days before study. Please note, antihistamine administered to treat allergic rhino conjunctivitis is allowed after V1.
•Subject treated with an investigational drug within 8 weeks or within 5 half-life (if known), whichever is longer, before the baseline visit
•Subject treated with cyclosporine, methotrexate oral corticosteroids, azathioprine, mycophenolate-mofetil, and/or any other systemic immunosupperessor/immunomodulator within 4 weeks before the study
•Subject treated by a biologic therapy within 5 half-life before the study
•Subject treated with ultraviolet therapy within 4 weeks before study
•Subject treated with a live (attenuated) vaccine within 12 weeks before baseline visit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified