Clinical trial NCT06479018: Deciphering IL-17-dependant Inflammatory Response in Bullous Pemphigoid
Official title: Identification and Functional Characterization of the Cellular and Molecular Actors of the IL-17B/IL-17RB Axis in Bullous Pemphigoid
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bullous Pemphigoid
Keywords: Bullous pemphigoid
IL-17 family
inflammatory response
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. 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:

1. To confirm IL-17B concentrations in sera at diagnosis as predictive biomarker of BP outcome under local corticotherapy
2. To study the expression kinetics of IL-17B and its receptor IL-17RB in BP patients under treatment
3. To study the implication of IL-17B/IL-17RB axis in BP relapse
4. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
timeFrame: Day 1
measure: Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
timeFrame: Day 30
measure: Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
timeFrame: Day 60
measure: Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
timeFrame: Day 90
measure: Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
timeFrame: Day 150
measure: Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
timeFrame: Day 270
measure: Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
timeFrame: Day 365
measure: Identification of IL-17RB-expressing cells at the lesional site
timeFrame: Day 1
measure: Identification of IL-17RB-expressing cells at the lesional site
timeFrame: Day 60
Secondary outcomes:
measure: Measurement of IL-17B concentrations in sera
timeFrame: Day 1
measure: Measurement of IL-17B concentrations in sera
timeFrame: Day 30
measure: Measurement of IL-17B concentrations in sera
timeFrame: Day 60
measure: Measurement of IL-17B concentrations in sera
timeFrame: Day 90
measure: Measurement of IL-17B concentrations in sera
timeFrame: Day 150
measure: Measurement of IL-17B concentrations in sera
timeFrame: Day 270
measure: Measurement of IL-17B concentrations in sera
timeFrame: Day 365
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References: