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NCT Number: NCT06387654

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Skin damage of documented or probable autoimmune, 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, checkpoint inhibitors, gene therapy, cell therapy, etc.).

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

Exclusion criteria

  • Patients under protective supervision (guardianship, curators)
  • Patients under 6 years old
  • Pregnant or breastfeeding woman

Treatment and study plan

Blood sampling

Biological

Blood will be taken in larger quantity

Remainders of samples taken as part of the treatment

Biological

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

Primary outcomes

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

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

    Blood sampling

Secondary outcomes

  1. Identification of new autoantibodies

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

    Western blot or immunoprecipitation method

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

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

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

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

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

    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

  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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chloé BOST, MD, PhD

CONTACT

[email protected]

5 61 77 61 44 ext. 0033

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Constitution of a Collection of Biological Samples With the Aim of Carrying Out Clinico-biological and Physiopathological Investigations of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases

Acronym: TekAPo

Important dates

Study start
2024
Primary completion
2029
Study completion
2034
First posted
Apr 29, 2024
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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