Deciphering IL-17-dependant Inflammatory Response in Bullous Pemphigoid
NCT Number: NCT06479018
Acronym: BP-IL17RB
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bullous Pemphigoid
Interventions: BIOLOGICAL: Blood sampling|BIOLOGICAL: Liquid bubble sampling|PROCEDURE: Cutaneous biopsy
Sponsor: CHU de Reims
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-02-10
Completion Date: 2026-01-10
Locations: Chu Reims, Reims, 51092, France

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.

Primary Outcome Measures: 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, 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, 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, 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, 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, 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, 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, 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, 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, Day 60
Secondary Outcome Measures: Measurement of IL-17B concentrations in sera, Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique, Day 1|Measurement of IL-17B concentrations in sera, Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique, Day 30|Measurement of IL-17B concentrations in sera, Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique, Day 60|Measurement of IL-17B concentrations in sera, Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique, Day 90|Measurement of IL-17B concentrations in sera, Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique, Day 150|Measurement of IL-17B concentrations in sera, Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique, Day 270|Measurement of IL-17B concentrations in sera, Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique, Day 365