Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients (ADAMUNE)

Not Applicable

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Other: Blood sample

• Registration Number: NCT05868824
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-21
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-22
• Study Start: 2023-06-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2025-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main Cohort	Blood sample	-

Primary Outcome Measures

Name	Time	Method
Compare the dynamic blood cytokines profile by stimulating blood with immune ligands	After 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Compare cytokine dosage according to the different phenotypes of patients with atopic dermatitis.	6 months	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.

Trial Locations

Locations (1)

Nice University Hospital; 🇫🇷 Nice, France