CClinicalTrials.gg
Active, not recruitingNCT05868824Updated Mar 18, 2026

Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients (ADAMUNE)

An interventional study of Blood sample in Atopic Dermatitis, sponsored by Centre Hospitalier Universitaire de Nice. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Atopic Dermatitis

Browse trials for

03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 11 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Main Cohort

    Other: Blood sample

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline

  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 after 3 months of treatment. Responders are defined by an Investigator's Global Assessment score £ 1, and by 2 or more points improvement.

    Time frame: After 3 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

1 site
  • Nice University Hospital
    Nice, France 06200, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05868824
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
May 22, 2023
Start date
Jun 1, 2023
Primary completion
Feb 3, 2026
Completion
Mar 1, 2027 (estimated)
Last update
Mar 18, 2026

Study contacts

Thomas Hubiche
principal investigator · CHu Nice dermatologie Hôpital Archet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion