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RecruitingNCT06387654TekAPoUpdated Mar 17, 2026

Clinico-biological Collection of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases

An observational study in Autoimmune Bullous Dermatosis, Dysimmune Dermatological Diseases and Auto-inflammatory Dermatological Diseases, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 6 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-03-17.

Sponsored by University Hospital, Toulouse · Observational

From the registry’s dates

  • Started May 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
6 Years to 99 Years
Sex
All
01

Study summary

The aim of this project is to start a biological and clinical collection of patients presenting autoimmune, dysimmune or auto-inflammatory dermatological diseases. This collection will provide appropriate biological samples to identify new biomarkers and to be accessible to the medical, scientific and industrial communities for the identification of new therapeutic strategies.

Read the detailed description

Autoimmune diseases include around a hundred different clinical entities which are for the most part rare pathologies but which, in combination, concern 5-8% of the adult population with a strong female predominance (FAI²R: the disease chain rare autoimmune and auto-inflammatory drugs, fai2r.org). The common denominator of all these diseases is based on the breakdown of self-tolerance which is the origin of self-reactivity and whose physiopathological mechanisms are still not fully understood, which generates numerous cross-sectional or fundamental studies. In addition to this complexity, there are significant inter-individual variabilities which lead to the definition of subgroups of patients on the basis of the clinical-biological profile and / or the response to treatments. Consequently, and in view of the need to establish the diagnosis early and then to propose the best treatment in the perspective of an individualized medicine, the clinical, biological and genetic characteristics of these subgroups of patients must be explored in order to improve diagnostic and therapeutic capacities.

02

Conditions studied

  • Autoimmune Bullous Dermatosis
  • Dysimmune Dermatological Diseases
  • Auto-inflammatory Dermatological Diseases
  • Skin Diseases

Keywords

  • auto-inflammatory dermatological diseases
  • Cutaneous lupus
  • scleroderma
  • dermatomyositis
  • psoriasis
  • eczema
  • new therapies
03

In context

Skin Diseases

496 studies on the registry are indexed under Skin Diseases; 77 are open to participants now.

This study's planned enrollment of 800 is above the median of 165 across 101 observational studies indexed under Skin Diseases.

Browse Skin Diseases studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with autoimmune, dysimmune or auto-inflammatory dermatological disease

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Skin damage of documented or probable , dysimmune or autoinflammatory origin.

The patients included may be adults or children, and will be:

  • Patients with autoimmune bullous dermatoses (pemphigus, pemphigoid and others),
  • Patients with systemic autoimmune diseases associated with skin damage (lupus, scleroderma, dermatomyositis for example),
  • Patients with cutaneous lupus
  • Patients with dysimmune skin diseases (psoriasis, eczema)
  • Patients with immuno-induced dermatological disorders or drug dermatitis
  • Patients receiving, or likely to receive, new, innovative therapies (new molecule on the market, , gene therapy, cell therapy, etc.).

Patients with dermatological damage whose autoimmune, dysimmune or auto-inflammatory origin is suspected

Exclusion criteria

Exclusion Criteria:

  • Patients under protective supervision (guardianship, curators)
  • Patients under 6 years old
  • Pregnant or breastfeeding woman
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients suffering from autoimmune, dysimmune or auto-inflammatory dermatological disease

    Biological samples will be collected in the normal diagnosis and follow-up process

    Biological: Blood sampling · Biological: Remainders of samples taken as part of the treatment

Interventions

  • BiologicalBlood sampling

    Blood will be taken in larger quantity

  • BiologicalRemainders of samples taken as part of the treatment

    blood, CSF, saliva, stools, urine, other biological fluids and tissue biopsies, hair follicles

06

What researchers measure

Primary outcomes

  1. Building a collection of biological samples and clinical-biological data from patients with autoimmune, dysimmune or auto-inflammatory dermatological disease

    Blood sampling

    Time frame: Day 0 and through study completion, an average of 1 year

Secondary outcomes

  1. Identification of new autoantibodies

    Western blot or immunoprecipitation method

    Time frame: Day 0 and through study completion, an average of 1 year

  2. Identification of biomarkers regarding the severity (such as cytokines, survival factors) in order to help the therapeutic decisions

    Proteomic analysis of sera and plasma samples at diagnosis and during follow up

    Time frame: Day 0 and through study completion, an average of 1 year

  3. Exploration of the pathophysiological mechanisms of rare autoimmune dermatological pathologies

    Knock-out or knock-in animal models for one specific protein will be used to determine in vivo if the pathophysiological mechanisms of Dermatological Diseases can be induced by the abnormal expression of this protein. Analysis of the phenotypic profiling of blood immune cells by multicolor fluorescence-activated cell sorter (FACS) analysis and of the transcriptomic profiling of blood immune cells by RNA sequencing

    Time frame: Day 0 and through study completion, an average of 1 year

  4. Comparison of blood cells populations determinants with flow cytometry, before and after cell therapy and in patients responder or not responder to cell therapy

    Exploring blood cell populations before and after cell therapy with flow cytometry

    Time frame: Day 0 and through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • University Hospital
    Toulouse, 31059, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06387654
Responsible party
Sponsor
First posted
Apr 29, 2024
Start date
May 6, 2024
Primary completion
Apr 2029 (estimated)
Completion
Apr 2034 (estimated)
Last update
Mar 17, 2026

Study contacts

Chloé BOST, MD, PhD
Contact
bost.c@chu-toulouse.fr
5 61 77 61 44 ext. 0033
Chloé BOST, MD, PhD
principal investigator · University Hospital, Toulouse

Oversight

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

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