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

The Role of IL-22/IL-22BP Axis in Atopic Dermatitis. A Cross Sectional Monocentric Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Procedure: Biopsy

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

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day
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.	1 day
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.	1 day
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	1 day
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.	1 day
level of IL22R gene expression in lesional skin	To compare the level of IL22R gene expression in lesional skin between different groups of patients.	1 day
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	1 day
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	1 day
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...	1 day
Level of IL-22BP and IL-22 proteins in serum	Measuring the level of IL-22BP and IL-22 proteins in serum	1 day
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)	1 day
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)	1 day

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: UCB Biopharma SRL; Plateforme CIMNA, Laboratoire d'Immunologie, Nantes University Hospital
• Investigators: Principal Investigator: Sébastien BARBAROT, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Actual): November 29, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: eczema; Atopic dermatitis; interleukin 22
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: RC19_0320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No