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

NCT04310189 | Completed

• 1 other identifier: RC19_0320
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; eczema; interleukin 22

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• IL-22 expression levels in lesional skin at the protein level

  1 day

• expression levels of IL-22BP at the transcriptome level in in lesional skin

  1 day

• expression levels of IL-22BP at the protein level in lesional

  1 day

• level of IL22 gene expression in lesional and non lesional skin

  1 day

• level of IL22BP gene expression in in lesional and non lesional

  1 day

Interventions

Biopsy PROCEDURE

All patients will have a blood sample and 2 skin biopsies (2 mm diameter) in lesional and non lesional area

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nantes University Hospital: lead
• Plateforme CIMNA, Laboratoire d'Immunologie, Nantes University Hospital: collaborator
• UCB Biopharma SRL: collaborator

Study Sites (1)

Nantes University Hospital

Nantes, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Sébastien BARBAROT

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 17, 2020
• Study Start: December 2, 2020
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

FR (1)