Clinical trial

Identification and Functional Characterization of the Cellular and Molecular Actors of the IL-17B/IL-17RB Axis in Bullous Pemphigoid

Name
PO21096
Description
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.
Trial arms
Trial start
2022-02-10
Estimated PCD
2025-01-10
Trial end
2026-01-10
Status
Recruiting
Treatment
Blood sampling
Venous blood sampling will be carried out for each patient included in the study.
Arms:
Control subjects, Patients with Bullous Pemphigoid
Liquid bubble sampling
Liquid bubble sampling will be carried out for each patients with Bullous Pemphigoid included in the study.
Arms:
Patients with Bullous Pemphigoid
Cutaneous biopsy
At least the first cutaneous biopsy will be carried out for each patients with Bullous Pemphigoid included in the study.
Arms:
Patients with Bullous Pemphigoid
Size
140
Primary endpoint
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Day 1
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Day 30
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Day 60
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Day 90
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Day 150
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Day 270
Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood
Day 365
Identification of IL-17RB-expressing cells at the lesional site
Day 1
Identification of IL-17RB-expressing cells at the lesional site
Day 60
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}
Updated at
2024-06-27

1 organization

2 products

1 indication