Bullous PemphigoidBP-IL17RBNCT06479018
Deciphering IL-17-dependant Inflammatory Response in Bullous Pemphigoid
A study testing Blood sampling, Liquid bubble sampling and Cutaneous biopsy in people with Bullous Pemphigoid, run by CHU de Reims at 1 site in France.
Trial summary
Bullous pemphigoid (BP) is the most frequent autoimmune skin disease and mainly affects elderly individuals. BP classically manifests with tense blisters over urticarial plaques on the trunk and extremities accompanied by intense itches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bullous Pemphigoid
- What is being tested?
- Blood sampling, Liquid bubble sampling and Cutaneous biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2022to 10 Jan 2026
- 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 Bullous Pemphigoid (BP) using the following criteria: clinical features typical of BP with presence of at least three out of four well-established criteria by Vaillant et al.47; subepidermal blister on skin biopsy; and deposits of IgG and/or C3 in a linear pattern along the epidermal basement membrane zone by direct IF.
- patient agreed to participate to the study
- patient affiliated to the French Healthcare System
Who cannot join
- patient that does not have the ability to give its written informed consent before inclusion in the study
- patient with a pemphigoid gestationis
- patient with a relapse of Bullous Pemphigoid
- patient with Bullous Pemphigoid that already received local superpotent corticotherapy during the last 14 days before inclusion or systemic corticoid treatment during the last 28 days before inclusion
- anemic patient (hemoglobin < 10 g/dL)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Reims
Reims, 51092
Damien JOLLY, Pr., 326788472 ext. 33, djolly@chu-reims.fr
About this study
Official title: Identification and Functional Characterization of the Cellular and Molecular Actors of the IL-17B/IL-17RB Axis in Bullous Pemphigoid
Bullous pemphigoid (BP) is the most frequent autoimmune skin disease and mainly affects elderly individuals. BP classically manifests with tense blisters over urticarial plaques on the trunk and extremities accompanied by intense itches. However, BP is characterized by a large spectrum of clinical presentations allowing to distinguish between typical (with blisters) and atypical forms (non bullous, mucosal damage).
High potency topical steroids and systemic steroids are the current first line intention treatments. While very efficient, these therapies are non-targeted and cause numerous side-effects, especially in these elderly patients that are the most affected. Furthermore, around 30% of BP patients will relapse during the first year of treatment when corticotherapy is decreased or stopped.
The investigators and others have highlighted the presence of Il-17 family belonging-inflammatory cytokines in BP patients. Their functions in the amplification of the inflammatory response and in the mechanisms of relapse have to be precisely determined in order to develop innovative therapeutic approaches and to move forwards precision medicine.
Read the detailed description
This is a pathophysiological study with prospective and monocentric inclusion.
90 patients with bullous phemphigoid will be recruited from the department of dermatology at the Reims University Hospital.
The main objectives of this study are to identify the cellular and molecular actors of the IL-17B/IL-17RB axis at diagnosis in patients with bullous pemphigoid and to determine their functions in the pathophysiological mechanisms associated with BP at systemic and in situ levels.
The secondary aims of this research are:
- To confirm IL-17B concentrations in sera at diagnosis as predictive biomarker of BP outcome under local corticotherapy
- To study the expression kinetics of IL-17B and its receptor IL-17RB in BP patients under treatment
- To study the implication of IL-17B/IL-17RB axis in BP relapse
- To establish inflammatory cell composition profile in skin and blood issued from clinical variants of BP as well as from BP patients during the first year of treatment.
- Conditions
- Bullous Pemphigoid
- Being tested
- Blood sampling, Liquid bubble sampling, Cutaneous biopsy
- Keywords
- Bullous pemphigoid, IL-17 family, inflammatory response
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Venous blood sampling will be carried out for each patient included in the study.
Liquid bubble samplingBiological
Liquid bubble sampling will be carried out for each patients with Bullous Pemphigoid included in the study.
Cutaneous biopsyProcedure or surgery
At least the first cutaneous biopsy will be carried out for each patients with Bullous Pemphigoid included in the study.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Bullous Pemphigoid | Experimental | Not described Receives: Biological: Blood sampling; Biological: Liquid bubble sampling; Procedure: Cutaneous biopsy |
| Control subjects | Experimental | Not described Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry
Measured: Day 1
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry
Measured: Day 30
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry
Measured: Day 60
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry
Measured: Day 90
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry
Measured: Day 150
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry
Measured: Day 270
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry
Measured: Day 365
Identification of IL-17RB-expressing cells at the lesional site
Identification of IL-17RB-expressing cells at the lesional site from BP skin biopsy specimen harvested using histocytometry
Measured: Day 1
Identification of IL-17RB-expressing cells at the lesional site
Identification of IL-17RB-expressing cells at the lesional site from BP skin biopsy specimen harvested using histocytometry
Measured: Day 60
Secondary outcomes (7)
Measurement of IL-17B concentrations in sera
Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique
Measured: Day 1
Measurement of IL-17B concentrations in sera
Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique
Measured: Day 30
Measurement of IL-17B concentrations in sera
Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique
Measured: Day 60
Measurement of IL-17B concentrations in sera
Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique
Measured: Day 90
Measurement of IL-17B concentrations in sera
Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique
Measured: Day 150
Measurement of IL-17B concentrations in sera
Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique
Measured: Day 270
Measurement of IL-17B concentrations in sera
Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique
Measured: Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start10 Feb 2022
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous PemphigoidStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479018
- Sponsor's protocol ID
- PO21096
- Acronym
- BP-IL17RB
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Functional Characterization of the Cellular and Molecular Actors of the IL-17B/IL-17RB Axis in Bullous Pemphigoid
- ClinicalTrials.gov ID
- NCT06479018
- Acronym / sponsor ID
- BP-IL17RB / PO21096
- Conditions
- Bullous Pemphigoid
- Keywords
- Bullous pemphigoid, IL-17 family, inflammatory response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 27 Jun 2024 (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.
Bullous pemphigoid (BP) is the most frequent autoimmune skin disease and mainly affects elderly individuals. BP classically manifests with tense blisters over urticarial plaques on the trunk and extremities accompanied by intense itches. However, BP is characterized by a large spectrum of clinical presentations allowing to distinguish between typical (with blisters) and atypical forms (non bullous, mucosal damage).
High potency topical steroids and systemic steroids are the current first line intention treatments. While very efficient, these therapies are non-targeted and cause numerous side-effects, especially in these elderly patients that are the most affected. Furthermore, around 30% of BP patients will relapse during the first year of treatment when corticotherapy is decreased or stopped.
The investigators and others have highlighted the presence of Il-17 family belonging-inflammatory cytokines in BP patients. Their functions in the amplification of the inflammatory response and in the mechanisms of relapse have to be precisely determined in order to develop innovative therapeutic approaches and to move forwards precision medicine.
Detailed description
This is a pathophysiological study with prospective and monocentric inclusion.
90 patients with bullous phemphigoid will be recruited from the department of dermatology at the Reims University Hospital.
The main objectives of this study are to identify the cellular and molecular actors of the IL-17B/IL-17RB axis at diagnosis in patients with bullous pemphigoid and to determine their functions in the pathophysiological mechanisms associated with BP at systemic and in situ levels.
The secondary aims of this research are:
- To confirm IL-17B concentrations in sera at diagnosis as predictive biomarker of BP outcome under local corticotherapy
- To study the expression kinetics of IL-17B and its receptor IL-17RB in BP patients under treatment
- To study the implication of IL-17B/IL-17RB axis in BP relapse
- To establish inflammatory cell composition profile in skin and blood issued from clinical variants of BP as well as from BP patients during the first year of treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Bullous Pemphigoid | Experimental | Biological: Blood sampling, Biological: Liquid bubble sampling, Procedure: Cutaneous biopsy |
| Control subjects | Experimental | Biological: Blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with Bullous Pemphigoid (BP) using the following criteria: clinical features typical of BP with presence of at least three out of four well-established criteria by Vaillant et al.47; subepidermal blister on skin biopsy; and deposits of IgG and/or C3 in a linear pattern along the epidermal basement membrane zone by direct IF.
- patient agreed to participate to the study
- patient affiliated to the French Healthcare System
Key exclusion criteria (5 listed)
- patient that does not have the ability to give its written informed consent before inclusion in the study
- patient with a pemphigoid gestationis
- patient with a relapse of Bullous Pemphigoid
- patient with Bullous Pemphigoid that already received local superpotent corticotherapy during the last 14 days before inclusion or systemic corticoid treatment during the last 28 days before inclusion
- anemic patient (hemoglobin < 10 g/dL)
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 |
|---|---|---|
| Blood samplingVenous blood sampling will be carried out for each patient included in the study. | Biological | Control subjects, Patients with Bullous Pemphigoid |
| Liquid bubble samplingLiquid bubble sampling will be carried out for each patients with Bullous Pemphigoid included in the study. | Biological | Patients with Bullous Pemphigoid |
| Cutaneous biopsyAt least the first cutaneous biopsy will be carried out for each patients with Bullous Pemphigoid included in the study. | Procedure or surgery | Patients with Bullous Pemphigoid |
Primary outcome
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Time frame: Day 1
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Time frame: Day 30
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Time frame: Day 60
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Time frame: Day 90
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Time frame: Day 150
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Time frame: Day 270
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Time frame: Day 365
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry
Identification of IL-17RB-expressing cells at the lesional site
Time frame: Day 1
Identification of IL-17RB-expressing cells at the lesional site from BP skin biopsy specimen harvested using histocytometry
Identification of IL-17RB-expressing cells at the lesional site
Time frame: Day 60
Identification of IL-17RB-expressing cells at the lesional site from BP skin biopsy specimen harvested using histocytometry
7 secondary outcomes
Measurement of IL-17B concentrations in sera
Time frame: Day 1
Measurement of IL-17B concentrations in sera
Time frame: Day 30
Measurement of IL-17B concentrations in sera
Time frame: Day 60
Measurement of IL-17B concentrations in sera
Time frame: Day 90
Measurement of IL-17B concentrations in sera
Time frame: Day 150
Measurement of IL-17B concentrations in sera
Time frame: Day 270
Measurement of IL-17B concentrations in sera
Time frame: Day 365
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling, Liquid bubble sampling and Cutaneous biopsy in people with Bullous Pemphigoid, run by CHU de Reims 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuelle VIGUIER, Pr. (03.10.73.66.76, mviguier@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood (time frame: Day 1). The study lists 9 primary outcomes in all. 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 27 Jun 2024.