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Deciphering IL-17-dependant Inflammatory Response in Bullous Pemphigoid

ConditionBullous Pemphigoid
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCHU de Reims

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood sampling

    Biological/Vaccine

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

  • Liquid bubble sampling

    Biological/Vaccine

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

  • Cutaneous biopsy

    Procedure/Surgery

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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Patients with Bullous PemphigoidExperimental treatment 3 interventions
Group B: Control subjectsExperimental treatment 1 intervention

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CHU de Reims

Lead sponsor

Source ClinicalTrials.gov
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