Deciphering IL-17-dependant Inflammatory Response in Bullous Pemphigoid

NCT06479018 | Recruiting

• 1 other identifier: PO21096
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Bullous Pemphigoid

Keywords

Bullous pemphigoid; IL-17 family; inflammatory response

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (7)

• Measurement of IL-17B concentrations in sera

  Day 1

• Measurement of IL-17B concentrations in sera

  Day 30

• Measurement of IL-17B concentrations in sera

  Day 60

• Measurement of IL-17B concentrations in sera

  Day 90

• Measurement of IL-17B concentrations in sera

  Day 150

Study Arms (2)

Patients with Bullous Pemphigoid

EXPERIMENTAL

Biological: Blood sampling; Biological: Liquid bubble sampling; Procedure: Cutaneous biopsy

Control subjects

EXPERIMENTAL

Biological: Blood sampling

Interventions

Blood sampling BIOLOGICAL

Venous blood sampling will be carried out for each patient included in the study.

Control subjects; Patients with Bullous Pemphigoid

Liquid bubble sampling BIOLOGICAL

Liquid bubble sampling will be carried out for each patients with Bullous Pemphigoid included in the study.

Patients with Bullous Pemphigoid

Cutaneous biopsy PROCEDURE

At least the first cutaneous biopsy will be carried out for each patients with Bullous Pemphigoid included in the study.

Patients with Bullous Pemphigoid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patient with a pemphigoid gestationis
• patient with a relapse of Bullous Pemphigoid
• anemic patient (hemoglobin \< 10 g/dL)

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

MeSH Terms

Conditions

Pemphigoid, Bullous

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Manuelle VIGUIER, Pr.

CONTACT

03.10.73.66.76; mviguier@chu-reims.fr

Sébastien LE JAN, Dr.

CONTACT

03.26.91.35.24; sebastien.le-jan@univ-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 27, 2024
• Study Start: February 10, 2022
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2026
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

FR (1)