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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06387654
- Acronym / sponsor ID
- TekAPo / RC31/23/0361
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2034 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suffering from autoimmune, dysimmune or auto-inflammatory dermatological disease | – | Biological: Blood sampling, Biological: Remainders of samples taken as part of the treatmentBiological samples will be collected in the normal diagnosis and follow-up process |
Who may qualify
- Ages
- 6 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with autoimmune, dysimmune or auto-inflammatory dermatological disease
Key inclusion criteria (9 listed)
- Skin damage of documented or probable autoimmune, dysimmune or autoinflammatory origin.
- 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)
Key exclusion criteria (3 listed)
- Patients under protective supervision (guardianship, curators)
- Patients under 6 years old
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood will be taken in larger quantity | Biological | Patients suffering from autoimmune, dysimmune or auto-inflammatory dermatological disease |
| Remainders of samples taken as part of the treatmentblood, CSF, saliva, stools, urine, other biological fluids and tissue biopsies, hair follicles | Biological | Patients suffering from autoimmune, dysimmune or auto-inflammatory dermatological disease |
Primary outcome
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
4 secondary outcomes
Identification of new autoantibodies
Time frame: 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
Time frame: Day 0 and through study completion, an average of 1 year
Exploration of the pathophysiological mechanisms of rare autoimmune dermatological pathologies
Time frame: 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
Time frame: Day 0 and through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chloé BOST, MD, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Bullous Dermatosis and Dysimmune Dermatological Diseases, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chloé BOST, MD, PhD (5 61 77 61 44 ext. 0033, bost.c@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.