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NCT Number: NCT04310189

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital

Nantes, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Biopsy

Procedure

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

Primary outcomes

  1. Expression levels of IL-22 at the transcriptomic level

    Time frame: 1 day

    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 outcomes

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

    Time frame: 1 day

    To compare IL-22 expression levels in lesional skin at the protein level between the different AD patient groups included in the study.

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

    Time frame: 1 day

    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.

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

    Time frame: 1 day

    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.

  4. level of IL22 gene expression in lesional and non lesional skin

    Time frame: 1 day

    To compare the level of IL22 gene expression in lesional and non lesional skin within each patient group

  5. level of IL22BP gene expression in in lesional and non lesional

    Time frame: 1 day

    To compare the level of IL22BP gene expression in in lesional and non lesional in each patient group.

  6. level of IL22R gene expression in lesional skin

    Time frame: 1 day

    To compare the level of IL22R gene expression in lesional skin between different groups of patients.

  7. the level of IL22 receptor (IL22R ) gene expression in in lesional and non lesional skin

    Time frame: 1 day

    Compare the level of IL22 receptor (IL22R ) gene expression in in lesional and non lesional skin within each patient group

  8. The level of expression of the following IL-22-induced genes

    Time frame: 1 day

    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

  9. The level of IL-22-induced gene expression in lesional and non-lesional skin

    Time frame: 1 day

    To compare the level of IL-22-induced gene expression in lesional and non-lesional skin in each patient group: S100A8, involucrin, loricrin...

  10. Level of IL-22BP and IL-22 proteins in serum

    Time frame: 1 day

    Measuring the level of IL-22BP and IL-22 proteins in serum

  11. Locating IL-22 Binding protein (BP)

    Time frame: 1 day

    Locating IL-22 Binding protein (BP) producing cells in the lesional skin of patients with a SCORAD>50 (n = 10) (qualitative)

  12. Characterizing IL-22 Binding protein (BP)

    Time frame: 1 day

    Characterizing (phenotype) IL-22 Binding protein (BP) producing cells in the lesional skin of patients with a SCORAD>50 (n = 10) (qualitative)

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DA/IL-22BP

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2020
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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