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The Role of IL-22/IL-22BP Axis in Atopic Dermatitis (DA/IL-22BP)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biopsy
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Atopic Dermatitis focused on measuring Atopic dermatitis, eczema, interleukin 22

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with AD according to UK Working Party criteria
  • Patients affiliated to French social security system
  • Patients who gave written consent after reading the protocol
  • Moderate to severe AD (SCORAD score>25)
  • Presence of at least one lesional and one non-lesional skin area in the area covered by the clothing
  • No immunosuppressive systemic treatment in progress for at least 3 months or biologics for at least 4 months

Exclusion Criteria:

  • Minor patients
  • Pregnant and/or breastfeeding women
  • Patients under guardianship or tutorship
  • Inability to understand information and instructions
  • Patients undergoing systemic immunosuppressive treatment for at least 3 months or biologics for at least 4 months
  • Patient included in a clinical trial
  • Documented allergy to the anesthetic (xylocain)

Sites / Locations

  • Nantes University Hospital

Outcomes

Primary Outcome Measures

Expression levels of IL-22 at the transcriptomic level
To compare the expression levels of IL-22 at the transcriptomic level in non lesional and lesional skin between the different groups of AD patients included in the study. Three groups of patients will be defined based on the SCORAD score . The score is out of 103 and is higher the greater the severity of the disease: Group 1: SCORAD score between ]25-50] Group 2: SCORAD between ]50; 65] Group 3: SCORAD greater than 65.

Secondary Outcome Measures

IL-22 expression levels in lesional skin at the protein level
To compare IL-22 expression levels in lesional skin at the protein level between the different AD patient groups included in the study.
expression levels of IL-22BP at the transcriptome level in in lesional skin
To compare the expression levels of IL-22BP at the transcriptome level in in lesional skin between the different groups of AD patients included in the study.
expression levels of IL-22BP at the protein level in lesional
To compare the expression levels of IL-22BP at the protein level in lesional skin between the different groups of AD patients included in the study.
level of IL22 gene expression in lesional and non lesional skin
To compare the level of IL22 gene expression in lesional and non lesional skin within each patient group
level of IL22BP gene expression in in lesional and non lesional
To compare the level of IL22BP gene expression in in lesional and non lesional in each patient group.
level of IL22R gene expression in lesional skin
To compare the level of IL22R gene expression in lesional skin between different groups of patients.
the level of IL22 receptor (IL22R ) gene expression in in lesional and non lesional skin
Compare the level of IL22 receptor (IL22R ) gene expression in in lesional and non lesional skin within each patient group
The level of expression of the following IL-22-induced genes
To compare the level of expression of the following IL-22-induced genes in injured skin between different groups of AD patients: S100A8, involucrin, loricrin
The level of IL-22-induced gene expression in lesional and non-lesional skin
To compare the level of IL-22-induced gene expression in lesional and non-lesional skin in each patient group: S100A8, involucrin, loricrin...
Level of IL-22BP and IL-22 proteins in serum
Measuring the level of IL-22BP and IL-22 proteins in serum
Locating IL-22 Binding protein (BP)
Locating IL-22 Binding protein (BP) producing cells in the lesional skin of patients with a SCORAD>50 (n = 10) (qualitative)
Characterizing IL-22 Binding protein (BP)
Characterizing (phenotype) IL-22 Binding protein (BP) producing cells in the lesional skin of patients with a SCORAD>50 (n = 10) (qualitative)

Full Information

First Posted
March 6, 2020
Last Updated
December 9, 2022
Sponsor
Nantes University Hospital
Collaborators
Plateforme CIMNA, Laboratoire d'Immunologie, Nantes University Hospital, UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT04310189
Brief Title
The Role of IL-22/IL-22BP Axis in Atopic Dermatitis
Acronym
DA/IL-22BP
Official Title
The Role of IL-22/IL-22BP Axis in Atopic Dermatitis. A Cross Sectional Monocentric Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
November 29, 2022 (Actual)
Study Completion Date
November 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
Plateforme CIMNA, Laboratoire d'Immunologie, Nantes University Hospital, UCB Biopharma SRL

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
Interleukin 22 (IL-22) is known to be regulated by IL-22 binding protein (IL-22BP), a soluble, inhibitory receptor. The potential role of IL-22BP in atopic dermatitis (AD) is mostly unknown and deserves further investigation. The main objective of this study is to better understand the potential protective role of IL-22BP through the assessment of its expression at the Messenger Ribonucleic Acid (mRNA) and protein levels in skin and serum which will be correlated to the severity of the diseases and through the identification of its cellular sources in lesions. The results of this study will help to correctly interpret the levels of IL-22 in AD and will potentially allow identifying biomarkers for patient stratification and predicting clinical outcomes to targeted therapeutic agents.
Detailed Description
This is a single-visit study. All patients will have a blood sample and 2 skin biopsies (2 mm diameter) in lesional and non lesional area . It is planned to include 45 patients (15 patients per severity group: SCORAD ]25-50] , ]50-65]; 50-65; >65).The first 20 patients included will be group 2 and 3 patients (SCORAD > 50). The patients will be adults with AD recruited from the cohort of patients followed up in the Dermatology department of Nantes University Hospital. A refusal rate of 4/5 is expected. Recruitment can therefore be envisaged in 18 months (2.5 patients/month). Patients will be recruited during follow-up consultations or at the first consultation in the department. Recruitment will be coordinated by the clinical research team (CRT). Blood samples will be taken by the CRT Nurse. The skin and blood samples will be sent to the CIMNA/ Immunology Laboratory Nantes University hospital

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, eczema, interleukin 22

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Biopsy
Intervention Description
All patients will have a blood sample and 2 skin biopsies (2 mm diameter) in lesional and non lesional area
Primary Outcome Measure Information:
Title
Expression levels of IL-22 at the transcriptomic level
Description
To compare the expression levels of IL-22 at the transcriptomic level in non lesional and lesional skin between the different groups of AD patients included in the study. Three groups of patients will be defined based on the SCORAD score . The score is out of 103 and is higher the greater the severity of the disease: Group 1: SCORAD score between ]25-50] Group 2: SCORAD between ]50; 65] Group 3: SCORAD greater than 65.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
IL-22 expression levels in lesional skin at the protein level
Description
To compare IL-22 expression levels in lesional skin at the protein level between the different AD patient groups included in the study.
Time Frame
1 day
Title
expression levels of IL-22BP at the transcriptome level in in lesional skin
Description
To compare the expression levels of IL-22BP at the transcriptome level in in lesional skin between the different groups of AD patients included in the study.
Time Frame
1 day
Title
expression levels of IL-22BP at the protein level in lesional
Description
To compare the expression levels of IL-22BP at the protein level in lesional skin between the different groups of AD patients included in the study.
Time Frame
1 day
Title
level of IL22 gene expression in lesional and non lesional skin
Description
To compare the level of IL22 gene expression in lesional and non lesional skin within each patient group
Time Frame
1 day
Title
level of IL22BP gene expression in in lesional and non lesional
Description
To compare the level of IL22BP gene expression in in lesional and non lesional in each patient group.
Time Frame
1 day
Title
level of IL22R gene expression in lesional skin
Description
To compare the level of IL22R gene expression in lesional skin between different groups of patients.
Time Frame
1 day
Title
the level of IL22 receptor (IL22R ) gene expression in in lesional and non lesional skin
Description
Compare the level of IL22 receptor (IL22R ) gene expression in in lesional and non lesional skin within each patient group
Time Frame
1 day
Title
The level of expression of the following IL-22-induced genes
Description
To compare the level of expression of the following IL-22-induced genes in injured skin between different groups of AD patients: S100A8, involucrin, loricrin
Time Frame
1 day
Title
The level of IL-22-induced gene expression in lesional and non-lesional skin
Description
To compare the level of IL-22-induced gene expression in lesional and non-lesional skin in each patient group: S100A8, involucrin, loricrin...
Time Frame
1 day
Title
Level of IL-22BP and IL-22 proteins in serum
Description
Measuring the level of IL-22BP and IL-22 proteins in serum
Time Frame
1 day
Title
Locating IL-22 Binding protein (BP)
Description
Locating IL-22 Binding protein (BP) producing cells in the lesional skin of patients with a SCORAD>50 (n = 10) (qualitative)
Time Frame
1 day
Title
Characterizing IL-22 Binding protein (BP)
Description
Characterizing (phenotype) IL-22 Binding protein (BP) producing cells in the lesional skin of patients with a SCORAD>50 (n = 10) (qualitative)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with AD according to UK Working Party criteria Patients affiliated to French social security system Patients who gave written consent after reading the protocol Moderate to severe AD (SCORAD score>25) Presence of at least one lesional and one non-lesional skin area in the area covered by the clothing No immunosuppressive systemic treatment in progress for at least 3 months or biologics for at least 4 months Exclusion Criteria: Minor patients Pregnant and/or breastfeeding women Patients under guardianship or tutorship Inability to understand information and instructions Patients undergoing systemic immunosuppressive treatment for at least 3 months or biologics for at least 4 months Patient included in a clinical trial Documented allergy to the anesthetic (xylocain)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien BARBAROT
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Role of IL-22/IL-22BP Axis in Atopic Dermatitis

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