Autoimmune Bullous DermatosisTekAPoNCT06387654
Clinico-biological Collection of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases
An observational study of Autoimmune Bullous Dermatosis and Dysimmune Dermatological Diseases, run by University Hospital, Toulouse at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 99 years
- Conditions the study is for
- Autoimmune Bullous Dermatosis, Dysimmune Dermatological Diseases, Auto-inflammatory Dermatological Diseases
- What is being tested?
- Blood sampling and Remainders of samples taken as part of the treatment
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2024to Apr 2034
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with autoimmune, dysimmune or auto-inflammatory dermatological disease
Who may be able to join
- 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)
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- 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
Who cannot join
- Patients under protective supervision (guardianship, curators)
- Patients under 6 years old
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital
Toulouse, 31059
Chloé BOST, MD, PhD, 5 61 77 61 44 ext. 0033, bost.c@chu-toulouse.fr
About this study
Official 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
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.
- Conditions
- Autoimmune Bullous Dermatosis, Dysimmune Dermatological Diseases, Auto-inflammatory Dermatological Diseases, Skin Diseases
- Being tested
- Blood sampling, Remainders of samples taken as part of the treatment
- Keywords
- auto-inflammatory dermatological diseases, Cutaneous lupus, scleroderma, dermatomyositis, psoriasis, eczema, new therapies
- Medical subject headings
- Skin Diseases, Scleroderma, Diffuse, Dermatomyositis, Psoriasis, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Blood will be taken in larger quantity
Remainders of samples taken as part of the treatmentBiological
blood, CSF, saliva, stools, urine, other biological fluids and tissue biopsies, hair follicles
| Study group | Role | What they receive |
|---|---|---|
| Patients suffering from autoimmune, dysimmune or auto-inflammatory dermatological disease | Biological samples will be collected in the normal diagnosis and follow-up process Receives: Biological: Blood sampling; Biological: Remainders of samples taken as part of the treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Building a collection of biological samples and clinical-biological data from patients with autoimmune, dysimmune or auto-inflammatory dermatological disease
Blood sampling
Measured: Day 0 and through study completion, an average of 1 year
Secondary outcomes (4)
Identification of new autoantibodies
Western blot or immunoprecipitation method
Measured: Day 0 and through study completion, an average of 1 year
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
Measured: Day 0 and through study completion, an average of 1 year
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
Measured: Day 0 and through study completion, an average of 1 year
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
Measured: Day 0 and through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start6 May 2024
- Primary completionApr 2029 (estimated)
- Study completionApr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Bullous DermatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloé BOST, MD, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387654
- Sponsor's protocol ID
- RC31/23/0361
- Acronym
- TekAPo
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No