AIRE DeficiencyNAD-AIRENCT06941584
Analysis of the Role of AIRE in Autoimmune Neurological Diseases Associated With Autoantibodies
An observational study of AIRE Deficiency, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Studying genetic predisposition in autoimmune neurological diseases could help improve diagnostic accuracy and offer new treatment possibilities Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AIRE Deficiency
- What is being tested?
- Test for AQP4, AChR, LGI1, and CASPR2 autoantibodies using cell-based assay, AIRE single gene sequencing and Molecular typing of HLA class I and II alleles
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 6 Nov 2024to 6 Jan 2027
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The first cohort includes adults (aged over 18 years) diagnosed with autoimmune neurological diseases, such as NMOSD, myasthenia gravis, and autoimmune encephalitis, as well as patients with at least one of the following autoimmune comorbidities: systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis or type 1 diabetes mellitus. The second cohort consists of adults (aged over 18 years) with dominant pathogenic mutations in the AIRE gene, as well as patients with homozygous mutations in the same gene.
Who may be able to join
- For the first cohort, the inclusion criteria were:
- Patients diagnosed with NMOSD associated with AQP4 autoantibodies who meet the 2015 diagnostic criteria and have at least one of the listed autoimmune comorbidities.
- Patients diagnosed with myasthenia gravis associated with AChR autoantibodies who also have another autoimmune comorbidity from the list.
- Patients diagnosed with autoimmune encephalitis who are positive for LGI1 and CASPR2 autoantibodies and have at least one additional autoimmune comorbidity.
- The second cohort included adults with dominant pathogenic AIRE mutations or homozygous AIRE mutations.
Who cannot join
- The presence of untreated thymoma or a history of thymoma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli, IRCSS Roma
Roma, 00136
Raffaele Iorio, MD, 3347185128, raffaele.iorio@policlinicogemelli.it
Martina Marini, MD, 3928425936, martinamarini95@gmail.com
About this study
Studying genetic predisposition in autoimmune neurological diseases could help improve diagnostic accuracy and offer new treatment possibilities
Read the detailed description
Autoimmune diseases involving the nervous system include conditions affecting both the central nervous system (CNS)-such as neuromyelitis optica spectrum disorder (NMOSD) and autoimmune encephalitis-and the peripheral nervous system, as exemplified by myasthenia gravis (MG), which targets the neuromuscular junction. Although these disorders present with distinct clinical features, they share a common immunopathogenic hallmark: the presence of pathogenic autoantibodies directed against neural or neuromuscular antigens.
While the mechanisms underlying the production of these autoantibodies remain only partially understood, increasing evidence points to defects in immune tolerance as key contributors to disease onset. In MG, in particular, the thymus is directly implicated in the disease process, with thymic follicular hyperplasia observed in early-onset forms and thymoma present in a significant subset of patients. Notably, reduced expression of the autoimmune regulator gene (AIRE) has been demonstrated in thymomas associated with MG, suggesting a failure of central immune tolerance in the pathogenesis of this condition.
Additionally, other autoimmune diseases of the CNS, such as neuromyelitis optica (NMOSD) and autoimmune encephalitis, have been associated with the contribution of peripheral tolerance in promoting the onset and maintenance of autoimmunity.
However, several studies suggest that the thymic escape of autoreactive T cells is an important pathophysiological mechanism in CNS autoimmune diseases mediated by autoantibodies. In animal models, thymic negative selection is a critical factor in determining susceptibility and severity of CNS inflammation. There is also indirect clinical data suggesting that thymic function is important in human CNS autoimmune diseases. In particular, the association between thymoma and paraneoplastic encephalitis-such as in the case of encephalitis associated with voltage-gated potassium channel (VGKC) complex antibodies (CASPR2 and LGI1)-highlights the involvement of thymic tolerance in these diseases.
Thymic central tolerance is orchestrated by thymic epithelial cells (TECs), the most abundant stromal cells, located in the cortical (cTEC) and medullary (mTEC) regions.
As known, HLA plays a crucial role in the selection of T-cells within the thymus. In the initial phase, only those T-cells whose TCRs bind to HLA molecules expressed by epithelial cells in the thymic cortex are positively selected, while the others undergo apoptosis. Immature thymocytes co-express both CD4 and CD8, but if their TCR preferentially recognizes class I HLA, they downregulate CD4 and upregulate CD8; conversely, if they recognize class II HLA, the opposite occurs.
The T-cells then migrate to the thymic medulla, where a broad array of self-peptides bound to HLA I and II are presented. At this stage, thymocytes that form high-affinity interactions with these self-peptides are eliminated, a process that helps suppress autoimmunity and foster self-tolerance. Several mechanisms have been proposed that link HLA to disease, often involving the failure of thymic negative selection due to disturbances in the TCR-peptide-HLA interaction.
The ectopic expression of thousands of genes, including tissue-specific antigens (TRA) by mTECs, is crucial for eliminating T cells that bind to these antigens. The recognition of autoantigens in the thymus is facilitated by multigenic transcription factors, such as AIRE (autoimmune regulator), expressed in the thymic medulla. AIRE plays a crucial role in inducing the expression of peripheral antigens in the thymus, enabling the elimination of autoreactive T cells through negative selection.
The congenital loss of AIRE function leads to autoimmune polyglandular syndrome type 1 (APS1). This condition is characterized by a combination of Addison's disease, hypoparathyroidism, chronic mucocutaneous candidiasis, and several other autoimmune diseases caused by the presentation of a limited repertoire of autoantigens by mTECs, compromising the removal of autoreactive T cells. The manifestations of APS1 underscore the crucial role of AIRE in the presentation of autoantigens in the thymus and in building thymic tolerance.
Despite the central role of the AIRE gene in mediating thymic tolerance, its contribution to the pathogenesis of autoimmune neurological diseases remains largely unexplored. While previous research has focused on peripheral tolerance mechanisms, few studies have investigated how AIRE dysfunction might affect the presentation of key neural autoantigens-such as AQP4, AChR, LGI1, and CASPR2-within medullary thymic epithelial cells (mTECs).
Notably, no systematic screening for pathogenic antibodies has been conducted in patients with AIRE mutations, and the role of AIRE gene variants in patients with NMOSD, myasthenia gravis, or autoimmune encephalitis remains undefined.
Another important factor contributing to susceptibility to autoimmune diseases is HLA typing. Several studies have demonstrated that specific HLA haplotypes are associated with an increased risk of developing autoimmune neurological diseases. In particular, NMOSD has been associated with the HLA-DRB1*03:01 haplotype, which seems to be a significant risk factor in anti-AQP4 positive patients (Zéphir et al., 2009). Similarly, myasthenia gravis is strongly correlated with HLA-DR3, especially in patients with early-onset disease (Berrih-Aknin, 2017). Moreover, autoimmune encephalitis associated with autoantibodies against LGI1 and CASPR2 shows a significant association with HLA-DRB1*07:01, suggesting a crucial role for HLA in antigen presentation and the development of neurological autoimmunity (Kim et al., 2017; van Sonderen et al., 2017).
The aim of this study is to explore the role of the AIRE gene in the pathogenesis of autoimmune neurological diseases and investigate how specific HLA haplotypes may predispose individuals to develop these conditions.
Our hypothesis is that alterations in AIRE expression and dysfunctions in central tolerance may contribute to the development of neurological autoimmunity, especially in individuals with certain high-risk HLA haplotypes.
- Conditions
- AIRE Deficiency
- Being tested
- Test for AQP4, AChR, LGI1, and CASPR2 autoantibodies using cell-based assay, AIRE single gene sequencing, Molecular typing of HLA class I and II alleles
- Keywords
- AIRE gene mutation, Myasthenia gravis, Neuromyelitis Optica Spectrum Disorder, Acquired neuromyotonia, Autoimmune encephalitis, Thymic central tolerance, HLA haplotype
- Medical subject headings
- Polyendocrinopathies, Autoimmune, Myasthenia Gravis, Neuromyelitis Optica, Isaacs Syndrome, Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test for AQP4, AChR, LGI1, and CASPR2 autoantibodies using cell-based assayDiagnostic test
To evaluate the prevalence of specific autoantibodies (AQP4, AChR, LGI1, and CASPR2) in the population of patients carrying AIRE mutations (second cohort)
AIRE single gene sequencingGenetic
To assess the prevalence of AIRE gene mutations in patients with NMOSD associated with AQP4 autoantibodies, myasthenia gravis (MG) associated with AChR autoantibodies, acquired neuromyotonia, and autoimmune encephalitis associated with CASPR2 and LGI1 autoantibodies (first cohort)
Molecular typing of HLA class I and II allelesGenetic
To assess the HLA haplotypes of class I and II by comparing patients with and without AIRE mutations, as well as those with and without autoimmune neurological diseases
| Study group | Role | What they receive |
|---|---|---|
| First cohort - Patients with diagnosis of a neurological autoimmune disease | For the first cohort, the inclusion criteria were:
* Patients diagnosed with NMOSD associated with AQP4 autoantibodies who meet the 2015 diagnostic criteria and have at least one of the listed autoimmune comorbidities.
* Patients diagnosed with myasthenia gravis associated with AChR autoantibodies who also have another autoimmune comorbidity from the list.
* Patients diagnosed with autoimmune encephalitis who are positive for LGI1 and CASPR2 autoantibodies and have at least one additional autoimmune comorbidity.
The only exclusion criterion was the presence of untreated thymoma or a history of thymoma. Receives: Genetic: AIRE single gene sequencing; Genetic: Molecular typing of HLA class I and II alleles | |
| Second cohort - Patients with AIRE mutations | The second cohort included adults with dominant pathogenic AIRE mutations or homozygous AIRE mutations. Receives: Diagnostic Test: Test for AQP4, AChR, LGI1, and CASPR2 autoantibodies using cell-based assay; Genetic: Molecular typing of HLA class I and II alleles |
What is being measured
The primary outcome is the main question the study is designed to answer.
The role of AIRE in neurological autoimmune diseases
To assess the prevalence of AIRE gene mutations in patients with NMOSD associated with AQP4 autoantibodies, myasthenia gravis (MG) associated with AChR autoantibodies, acquired neuromyotonia, and autoimmune encephalitis associated with CASPR2 and LGI1 autoantibodies
Measured: 36 months
Secondary outcomes (2)
The prevalence of specific autoantibodies (AQP4, AChR, LGI1, CASPR2) in patients carrying AIRE mutations
To evaluate the prevalence of specific autoantibodies (AQP4, AChR, LGI1, and CASPR2) in the population of patients carrying AIRE mutations
Measured: 36 months
The synergy between AIRE gene mutations and HLA haplotype in patients with autoimmune neurological diseases
assess the HLA haplotypes of class I and II by comparing patients with and without AIRE mutations, as well as those with and without autoimmune neurological diseases
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start6 Nov 2024
- Primary completion6 Jan 2027 (estimated)
- Study completion6 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIRE DeficiencyStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Raffaele Iorio, MD, Principal investigator, Dipartimento di Neurologia - Policlinico Fondazione Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941584
- Sponsor's protocol ID
- 6449
- Acronym
- NAD-AIRE
- Status last verified
- Mar 2025
- First submitted
- 16 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Role of AIRE in Autoimmune Neurological Diseases Associated With Autoantibodies
- ClinicalTrials.gov ID
- NCT06941584
- Acronym / sponsor ID
- NAD-AIRE / 6449
- Conditions
- AIRE Deficiency
- Keywords
- AIRE gene mutation, Myasthenia gravis, Neuromyelitis Optica Spectrum Disorder, Acquired neuromyotonia, Autoimmune encephalitis, Thymic central tolerance, HLA haplotype
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 6 Jan 2027 (estimated)
- Study completion
- 6 Jan 2027 (estimated)
- First posted
- 24 Apr 2025 (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.
Studying genetic predisposition in autoimmune neurological diseases could help improve diagnostic accuracy and offer new treatment possibilities
Detailed description
Autoimmune diseases involving the nervous system include conditions affecting both the central nervous system (CNS)-such as neuromyelitis optica spectrum disorder (NMOSD) and autoimmune encephalitis-and the peripheral nervous system, as exemplified by myasthenia gravis (MG), which targets the neuromuscular junction. Although these disorders present with distinct clinical features, they share a common immunopathogenic hallmark: the presence of pathogenic autoantibodies directed against neural or neuromuscular antigens.
While the mechanisms underlying the production of these autoantibodies remain only partially understood, increasing evidence points to defects in immune tolerance as key contributors to disease onset. In MG, in particular, the thymus is directly implicated in the disease process, with thymic follicular hyperplasia observed in early-onset forms and thymoma present in a significant subset of patients. Notably, reduced expression of the autoimmune regulator gene (AIRE) has been demonstrated in thymomas associated with MG, suggesting a failure of central immune tolerance in the pathogenesis of this condition.
Additionally, other autoimmune diseases of the CNS, such as neuromyelitis optica (NMOSD) and autoimmune encephalitis, have been associated with the contribution of peripheral tolerance in promoting the onset and maintenance of autoimmunity.
However, several studies suggest that the thymic escape of autoreactive T cells is an important pathophysiological mechanism in CNS autoimmune diseases mediated by autoantibodies. In animal models, thymic negative selection is a critical factor in determining susceptibility and severity of CNS inflammation. There is also indirect clinical data suggesting that thymic function is important in human CNS autoimmune diseases. In particular, the association between thymoma and paraneoplastic encephalitis-such as in the case of encephalitis associated with voltage-gated potassium channel (VGKC) complex antibodies (CASPR2 and LGI1)-highlights the involvement of thymic tolerance in these diseases.
Thymic central tolerance is orchestrated by thymic epithelial cells (TECs), the most abundant stromal cells, located in the cortical (cTEC) and medullary (mTEC) regions.
As known, HLA plays a crucial role in the selection of T-cells within the thymus. In the initial phase, only those T-cells whose TCRs bind to HLA molecules expressed by epithelial cells in the thymic cortex are positively selected, while the others undergo apoptosis. Immature thymocytes co-express both CD4 and CD8, but if their TCR preferentially recognizes class I HLA, they downregulate CD4 and upregulate CD8; conversely, if they recognize class II HLA, the opposite occurs.
The T-cells then migrate to the thymic medulla, where a broad array of self-peptides bound to HLA I and II are presented. At this stage, thymocytes that form high-affinity interactions with these self-peptides are eliminated, a process that helps suppress autoimmunity and foster self-tolerance. Several mechanisms have been proposed that link HLA to disease, often involving the failure of thymic negative selection due to disturbances in the TCR-peptide-HLA interaction.
The ectopic expression of thousands of genes, including tissue-specific antigens (TRA) by mTECs, is crucial for eliminating T cells that bind to these antigens. The recognition of autoantigens in the thymus is facilitated by multigenic transcription factors, such as AIRE (autoimmune regulator), expressed in the thymic medulla. AIRE plays a crucial role in inducing the expression of peripheral antigens in the thymus, enabling the elimination of autoreactive T cells through negative selection.
The congenital loss of AIRE function leads to autoimmune polyglandular syndrome type 1 (APS1). This condition is characterized by a combination of Addison's disease, hypoparathyroidism, chronic mucocutaneous candidiasis, and several other autoimmune diseases caused by the presentation of a limited repertoire of autoantigens by mTECs, compromising the removal of autoreactive T cells. The manifestations of APS1 underscore the crucial role of AIRE in the presentation of autoantigens in the thymus and in building thymic tolerance.
Despite the central role of the AIRE gene in mediating thymic tolerance, its contribution to the pathogenesis of autoimmune neurological diseases remains largely unexplored. While previous research has focused on peripheral tolerance mechanisms, few studies have investigated how AIRE dysfunction might affect the presentation of key neural autoantigens-such as AQP4, AChR, LGI1, and CASPR2-within medullary thymic epithelial cells (mTECs).
Notably, no systematic screening for pathogenic antibodies has been conducted in patients with AIRE mutations, and the role of AIRE gene variants in patients with NMOSD, myasthenia gravis, or autoimmune encephalitis remains undefined.
Another important factor contributing to susceptibility to autoimmune diseases is HLA typing. Several studies have demonstrated that specific HLA haplotypes are associated with an increased risk of developing autoimmune neurological diseases. In particular, NMOSD has been associated with the HLA-DRB1*03:01 haplotype, which seems to be a significant risk factor in anti-AQP4 positive patients (Zéphir et al., 2009). Similarly, myasthenia gravis is strongly correlated with HLA-DR3, especially in patients with early-onset disease (Berrih-Aknin, 2017). Moreover, autoimmune encephalitis associated with autoantibodies against LGI1 and CASPR2 shows a significant association with HLA-DRB1*07:01, suggesting a crucial role for HLA in antigen presentation and the development of neurological autoimmunity (Kim et al., 2017; van Sonderen et al., 2017).
The aim of this study is to explore the role of the AIRE gene in the pathogenesis of autoimmune neurological diseases and investigate how specific HLA haplotypes may predispose individuals to develop these conditions.
Our hypothesis is that alterations in AIRE expression and dysfunctions in central tolerance may contribute to the development of neurological autoimmunity, especially in individuals with certain high-risk HLA haplotypes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First cohort - Patients with diagnosis of a neurological autoimmune disease | – | Genetic: AIRE single gene sequencing, Genetic: Molecular typing of HLA class I and II allelesFor the first cohort, the inclusion criteria were: * Patients diagnosed with NMOSD associated with AQP4 autoantibodies who meet the 2015 diagnostic criteria and have at least one of the listed autoimmune comorbidities. * Patients diagnosed with myasthenia gravis associated with AChR autoantibodies who also have another autoimmune comorbidity from the list. * Patients diagnosed with autoimmune encephalitis who are positive for LGI1 and CASPR2 autoantibodies and have at least one additional autoimmune comorbidity. The only exclusion criterion was the presence of untreated thymoma or a history of thymoma. |
| Second cohort - Patients with AIRE mutations | – | Diagnostic Test: Test for AQP4, AChR, LGI1, and CASPR2 autoantibodies using cell-based assay, Genetic: Molecular typing of HLA class I and II allelesThe second cohort included adults with dominant pathogenic AIRE mutations or homozygous AIRE mutations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The first cohort includes adults (aged over 18 years) diagnosed with autoimmune neurological diseases, such as NMOSD, myasthenia gravis, and autoimmune encephalitis, as well as patients with at least one of the following autoimmune comorbidities: systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis or type 1 diabetes mellitus. The second cohort consists of adults (aged over 18 years) with dominant pathogenic mutations in the AIRE gene, as well as patients with homozygous mutations in the same gene.
Key inclusion criteria (5 listed)
- Patients diagnosed with NMOSD associated with AQP4 autoantibodies who meet the 2015 diagnostic criteria and have at least one of the listed autoimmune comorbidities.
- Patients diagnosed with myasthenia gravis associated with AChR autoantibodies who also have another autoimmune comorbidity from the list.
- Patients diagnosed with autoimmune encephalitis who are positive for LGI1 and CASPR2 autoantibodies and have at least one additional autoimmune comorbidity.
- The second cohort included adults with dominant pathogenic AIRE mutations or homozygous AIRE mutations.
Key exclusion criteria (1 listed)
- The presence of untreated thymoma or a history of thymoma.
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 |
|---|---|---|
| Test for AQP4, AChR, LGI1, and CASPR2 autoantibodies using cell-based assayTo evaluate the prevalence of specific autoantibodies (AQP4, AChR, LGI1, and CASPR2) in the population of patients carrying AIRE mutations (second cohort) | Diagnostic test | Second cohort - Patients with AIRE mutations |
| AIRE single gene sequencingTo assess the prevalence of AIRE gene mutations in patients with NMOSD associated with AQP4 autoantibodies, myasthenia gravis (MG) associated with AChR autoantibodies, acquired neuromyotonia, and autoimmune encephalitis associated with CASPR2 and LGI1 autoantibodies (first cohort) | Genetic | First cohort - Patients with diagnosis of a neurological autoimmune disease |
| Molecular typing of HLA class I and II allelesTo assess the HLA haplotypes of class I and II by comparing patients with and without AIRE mutations, as well as those with and without autoimmune neurological diseases | Genetic | First cohort - Patients with diagnosis of a neurological autoimmune disease, Second cohort - Patients with AIRE mutations |
Primary outcome
The role of AIRE in neurological autoimmune diseases
Time frame: 36 months
To assess the prevalence of AIRE gene mutations in patients with NMOSD associated with AQP4 autoantibodies, myasthenia gravis (MG) associated with AChR autoantibodies, acquired neuromyotonia, and autoimmune encephalitis associated with CASPR2 and LGI1 autoantibodies
2 secondary outcomes
The prevalence of specific autoantibodies (AQP4, AChR, LGI1, CASPR2) in patients carrying AIRE mutations
Time frame: 36 months
The synergy between AIRE gene mutations and HLA haplotype in patients with autoimmune neurological diseases
Time frame: 36 months
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 24 Apr 2025.
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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.
Raffaele Iorio, MD principal investigator
Dipartimento di Neurologia - Policlinico Fondazione Agostino Gemelli
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 AIRE Deficiency, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 5 inclusion and 1 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 24 Apr 2025. 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 Italy. 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 Raffaele Iorio, MD (3347185128, raffaele.iorio@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The role of AIRE in neurological autoimmune diseases (time frame: 36 months). 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 24 Apr 2025.