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Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients (ADAMUNE)

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nice University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Main Cohort

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 21, 2023
Last Updated
September 5, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05868824
Brief Title
Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients (ADAMUNE)
Official Title
Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Main Cohort
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
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 Outcome Measure Information:
Title
Compare the dynamic blood cytokines profile by stimulating blood with immune ligands
Description
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
Title
Compare the dynamic blood cytokines profile by stimulating blood with immune ligands
Description
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 Outcome Measure Information:
Title
Compare cytokine dosage according to the different phenotypes of patients with atopic dermatitis.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HUBICHE Thomas
Phone
04 92 03 64 88
Ext
+33
Email
hubiche.t@chu-nice.fr
Facility Information:
Facility Name
Nice University Hospital
City
Nice
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HUBICHE Thomas
Phone
0492036488
Email
hubiche.t@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Hubiche Thomas

12. IPD Sharing Statement

Plan to Share IPD
No

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Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients (ADAMUNE)

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