Atopic DermatitisDA/IL-22BPNCT04310189
The Role of IL-22/IL-22BP Axis in Atopic Dermatitis
A study testing Biopsy in people with Atopic Dermatitis, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2020to 29 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Atopic Dermatitis
- Being tested
- Biopsy
- Keywords
- Atopic dermatitis, eczema, interleukin 22
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
All patients will have a blood sample and 2 skin biopsies (2 mm diameter) in lesional and non lesional area
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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...
Measured: 1 day
Level of IL-22BP and IL-22 proteins in serum
Measuring the level of IL-22BP and IL-22 proteins in serum
Measured: 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)
Measured: 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)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start2 Dec 2020
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Plateforme CIMNA, Laboratoire d'Immunologie, Nantes University Hospital, UCB Biopharma SRL
- Responsible party
- Sponsor
- Investigators
- Sébastien BARBAROT, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310189
- Sponsor's protocol ID
- RC19_0320
- Acronym
- DA/IL-22BP
- Status last verified
- Dec 2022
- First submitted
- 6 Mar 2020
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of IL-22/IL-22BP Axis in Atopic Dermatitis. A Cross Sectional Monocentric Pilot Study
- ClinicalTrials.gov ID
- NCT04310189
- Acronym / sponsor ID
- DA/IL-22BP / RC19_0320
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, eczema, interleukin 22
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Plateforme CIMNA, Laboratoire d'Immunologie, Nantes University Hospital, UCB Biopharma SRL
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyAll patients will have a blood sample and 2 skin biopsies (2 mm diameter) in lesional and non lesional area | Procedure or surgery | – |
Primary outcome
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.
12 secondary outcomes
IL-22 expression levels in lesional skin at the protein level
Time frame: 1 day
expression levels of IL-22BP at the transcriptome level in in lesional skin
Time frame: 1 day
expression levels of IL-22BP at the protein level in lesional
Time frame: 1 day
level of IL22 gene expression in lesional and non lesional skin
Time frame: 1 day
level of IL22BP gene expression in in lesional and non lesional
Time frame: 1 day
level of IL22R gene expression in lesional skin
Time frame: 1 day
the level of IL22 receptor (IL22R ) gene expression in in lesional and non lesional skin
Time frame: 1 day
The level of expression of the following IL-22-induced genes
Time frame: 1 day
The level of IL-22-induced gene expression in lesional and non-lesional skin
Time frame: 1 day
Level of IL-22BP and IL-22 proteins in serum
Time frame: 1 day
Locating IL-22 Binding protein (BP)
Time frame: 1 day
Characterizing IL-22 Binding protein (BP)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien BARBAROT principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Atopic Dermatitis, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression levels of IL-22 at the transcriptomic level (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.