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RecruitingNCT06479018BP-IL17RBUpdated Jun 27, 2024

Deciphering IL-17-dependant Inflammatory Response in Bullous Pemphigoid

An interventional study of Blood sampling and Liquid bubble sampling in Bullous Pemphigoid, sponsored by CHU de Reims. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-27.

Sponsored by CHU de Reims · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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:

  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.
02

Conditions studied

  • Bullous Pemphigoid

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Keywords

  • Bullous pemphigoid
  • IL-17 family
  • inflammatory response
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Patients with Bullous Pemphigoid

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

  • Experimental
    Control subjects

    Biological: Blood sampling

Interventions

  • BiologicalBlood sampling

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

  • BiologicalLiquid bubble sampling

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

  • ProcedureCutaneous biopsy

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

05

What researchers measure

Primary outcomes

  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

    Time frame: Day 1

  2. 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

    Time frame: Day 30

  3. 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

    Time frame: Day 60

  4. 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

    Time frame: Day 90

  5. 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

    Time frame: Day 150

  6. 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

    Time frame: Day 270

  7. 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

    Time frame: Day 365

  8. 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

    Time frame: Day 1

  9. 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

    Time frame: Day 60

Secondary outcomes

  1. Measurement of IL-17B concentrations in sera

    Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique

    Time frame: Day 1

  2. Measurement of IL-17B concentrations in sera

    Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique

    Time frame: Day 30

  3. Measurement of IL-17B concentrations in sera

    Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique

    Time frame: Day 60

  4. Measurement of IL-17B concentrations in sera

    Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique

    Time frame: Day 90

  5. Measurement of IL-17B concentrations in sera

    Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique

    Time frame: Day 150

  6. Measurement of IL-17B concentrations in sera

    Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique

    Time frame: Day 270

  7. Measurement of IL-17B concentrations in sera

    Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique

    Time frame: Day 365

06

Study locations

1 of 1 sites recruiting
  • Chu Reims
    Reims, 51092, France
    Recruiting
07

Registry details

Key details

Study ID
NCT06479018
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
Jun 27, 2024
Start date
Feb 10, 2022
Primary completion
Jan 10, 2025 (estimated)
Completion
Jan 10, 2026 (estimated)
Last update
Jun 27, 2024

Study contacts

Manuelle VIGUIER, Pr.
Contact
mviguier@chu-reims.fr
03.10.73.66.76
Sébastien LE JAN, Dr.
Contact
sebastien.le-jan@univ-reims.fr
03.26.91.35.24

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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