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Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients (ADAMUNE)

Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05868824
Enrollment
11
Registered
2023-05-22
Start date
2023-06-01
Completion date
2027-03-01
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

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.

Interventions

OTHERBlood 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.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Compare the dynamic blood cytokines profile by stimulating blood with immune ligandsAt baselineCytokines 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.

Secondary

MeasureTime frameDescription
Compare cytokine dosage according to the different phenotypes of patients with atopic dermatitis.6 monthsCytokines 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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORThomas Hubiche

CHu Nice dermatologie Hôpital Archet

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026