Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients (ADAMUNE)

NCT05868824 | Active Not Recruiting

• 1 other identifier: 22-AOIP-05
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Compare cytokine dosage according to the different phenotypes of patients with atopic dermatitis.

  6 months

Study Arms (1)

Main Cohort

EXPERIMENTAL

Other: Blood sample

Interventions

Blood sample OTHER

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.

Main Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice University Hospital

Nice, France, 06200, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Blood Specimen Collection

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)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Thomas Hubiche

  CHu Nice dermatologie Hôpital Archet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 22, 2023
• Study Start: June 1, 2023
• Primary Completion: February 3, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)