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NCT Number: NCT05868824

Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients (ADAMUNE)

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nice University Hospital

Nice, France, 06200

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Compare the dynamic blood cytokines profile by stimulating blood with immune ligands

    Time frame: At baseline

    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.

  2. Compare the dynamic blood cytokines profile by stimulating blood with immune ligands

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 22, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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