Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients (ADAMUNE)

Atopic Dermatitis Clinical Trial

Official title:

Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868824
• Other study ID #: 22-AOIP-05
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: June 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: HUBICHE Thomas
• Phone: 04 92 03 64 88
• Email: hubiche.t[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Blood sample
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.

Locations

Country	Name	City	State
France	Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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