Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06479018

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

Led by CHU de Reims · Updated on 2024-06-27

140

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Bullous pemphigoid (BP) is the most common autoimmune skin disease, mainly affecting older adults. It typically causes tense blisters on the trunk and limbs with severe itching, but can also appear as atypical forms without blisters or with mucosal damage. Current treatments mainly involve strong topical and systemic steroids, which are effective but not targeted, leading to many side effects, especially in elderly patients. About 30% of patients experience relapse within the first year after reducing or stopping steroid therapy. This research focuses on the role of IL-17 family inflammatory cytokines in BP, aiming to better understand their role in inflammation and relapse to advance precision medicine approaches. This study is a prospective, single-center investigation involving 90 patients with bullous pemphigoid. Researchers will analyze the cellular and molecular components of the IL-17B/IL-17RB axis at diagnosis and during treatment. The study aims to confirm IL-17B as a potential biomarker for treatment outcomes, examine how IL-17B and its receptor change during therapy, evaluate their involvement in disease relapse, and characterize inflammatory cell profiles in skin and blood over the first year of treatment. Participants will undergo blood sampling and skin biopsies at multiple time points, including days 1, 30, 60, 90, 150, 270, and 365. Researchers will identify IL-17RB-expressing and IL-17B-producing cells in blood and lesion sites and measure IL-17B concentrations in serum. The study includes detailed clinical evaluations, aiming to better understand BP's inflammatory mechanisms, treatment responses, and relapse patterns over one year.

CONDITIONS

Brief Title

Deciphering IL-17-dependant Inflammatory Response in Bullous Pemphigoid

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with bullous pemphigoid confirmed by clinical features, subepidermal blister on skin biopsy, and deposits of IgG and/or C3 along the epidermal basement membrane zone
  • Patient agrees to participate in the study
  • Patient is affiliated with the French Healthcare System
  • Patient is 18 years of age or older
Not Eligible

You will not qualify if you...

  • Patient unable to provide written informed consent
  • Patient with pemphigoid gestationis
  • Patient experiencing a relapse of bullous pemphigoid
  • Patient who received local superpotent corticosteroids within 14 days before inclusion
  • Patient who received systemic corticosteroids within 28 days before inclusion
  • Patient with anemia (hemoglobin below 10 g/dL)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Day 1

Participants undergo blood sampling, liquid bubble sampling, and a cutaneous biopsy to identify IL-17RB-expressing cells and IL-17B-producing cells at diagnosis.

1 visit (in-person)

Long-term Monitoring

Duration - 1 year

Participants have repeated blood samplings and liquid bubble samplings to study IL-17B and IL-17RB expression and concentrations over the first year of treatment.

Visits on Day 30, 60, 90, 150, 270, and 365 (in-person)

Diagnostic Evaluation

Duration - Day 60

Participants undergo a second cutaneous biopsy at Day 60 to assess IL-17RB-expressing cells at the lesional site during follow-up.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Chu Reims

Reims, France, 51092

Actively Recruiting

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Research Team

M

Manuelle VIGUIER, Pr.

S

Sébastien LE JAN, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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