Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients (ADAMUNE)

Study Overview
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Brief Summary
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This is a prospective, single-center, class 2 study to better characterize the immune response in immune response in the blood of atopic dermatitis. Investigators are following in the referral center of Nice, 100 patients with atopic dermatitis. Investigators plan to include 30 patients. Blood samples will be collected to assess cytokine levels after non-specific immune stimulation. immune stimulation. Whole blood will be collected and stimulated with immune ligands (anti-CD3 T-cell stimulating ligands associated with Thymic Stromal LymphoPoietin (TSLP) or TLR agonist R848 7/8 agonist stimulating NK (natural killer) lymphocytes and promoting T cell response) on lyophilized freeze-dried spheres (LyoSphere, Qiagen) within 8 hours of blood collection.

Official Title
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Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Other: Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged ≥ 18 years. Patient with clinically diagnosed atopic dermatitis according to the criteria of Hanifin and Rajka. Moderate to severe defined by an Investigator's Global Assessment ³3 and eligible to systemic treatment. If the subject is a woman of childbearing potential, she has a negative urine pregnancy test. Subject is non-pregnant, non-lactating and is not planning for pregnancy during the study period. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair his/her evaluation or which exposes the subject to an unacceptable risk by study participation. Subject is able to comprehend and willing to sign an Informed Consent and/or Assent Form. Affiliation to a social security scheme. Signed informed consent Exclusion Criteria: Vulnerable person: pregnant or nursing woman, minor, adult under guardianship or deprived of liberty Patient with an infection Patient with other systemic inflammatory disease Patient with anti-inflammatory or immunosuppressive therapy Patient with a contraindication to JAK inhibitors Participants in other clinical therapeutic studies involving a drug that may interfere with the present evaluation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main Cohort<br> | Other: Blood sample<br>* A blood sample for assessing cytokines will be performed at baseline and at follow-up visit 3 months after initiation of treatment. The blood sample will be performed as part of blood tests done for standard AD follow up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the dynamic blood cytokines profile by stimulating blood with immune ligands | Cytokines dosage, measured by ELISA, in blood sample before and after in vitro stimulation with immune ligands at baseline. Responders are defined by an Investigator's Global Assessment score £ 1, and by 2 or more points improvement. | At baseline | 
| Compare the dynamic blood cytokines profile by stimulating blood with immune ligands | Cytokines dosage, measured by ELISA, in blood sample before and after in vitro stimulation with immune ligands after 3 months of treatment. Responders are defined by an Investigator's Global Assessment score £ 1, and by 2 or more points improvement. | After 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare cytokine dosage according to the different phenotypes of patients with atopic dermatitis. | Cytokines dosage, measured by ELISA, in blood sample before and after in vitro stimulation with immune ligands according to clinical phenotypes: moderate, severe, very severe defined by SCORAD, ethnic origin, the presence of specific clinical signs (head and neck dermatitis, dirty neck, orbital darkening, perleche, Herthoge sign, nummular eczema, hand eczema, keratosis pilaris) or the presence of atopic comorbidities (asthma, conjunctivitis, allergic rhinitis, food allergy) in untreated patients. | 6 months |