VEXAS SyndromeNCT06377462
Multicenter, Interdisciplinary National VEXAS Registry With Accompanying Biomaterial Collection
An observational study of VEXAS Syndrome, run by Technische Universität Dresden at 17 sites in Germany.
Trial summary
The aim is rapid collection of real-life data on the epidemiology, treatment and disease course in patients with VEXAS syndrome during routine clinical practice and collect biomaterials to evaluate genotype-phenotype associations, determine optimal treatment schedule, identify diagnostic features and biomarkers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VEXAS Syndrome
- How many people
- 500 participants
- Where
- 17 sitesGermany
- Study dates
- 13 Mar 2024to 31 Dec 2030
- How long will I take part?
- 5 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: * Planned recruitment: 20-30 patients/year * Number of planned study centres: 15-20
Who may be able to join
- Patients with established or suspected (clinical and hematological criteria) VEXAS Syndrome
- Age ≥18 years
- Signed informed consent form
Who cannot join
- patients who are not in a position to understand the nature and scope of participation in this register
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
Germany17 sites, 17 recruiting
- Recruiting
Universitätsklinikum Aachen
Aachen
- Recruiting
Klinikum Chemnitz gGmbH
Chemnitz
- Recruiting
Universitätsklinikum Carl Gustav Carus
Dresden, 01307
Katja Sockel, Dr. med.
- Recruiting
Universitätsklinikum Düsseldorf
Düsseldorf
- Recruiting
Evang. Kliniken Essen-Mitte
Essen
- Recruiting
Universitätsmedizin Göttingen
Göttingen
- Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg
- Recruiting
Universitätsklinikum Jena
Jena
- Recruiting
Universitätsklinikum Leipzig AöR
Leipzig
- Recruiting
Universitätsmedizin Mannheim
Mannheim
- Recruiting
Klinikum rechts der Isar TUM
München
- Recruiting
Klinikum Nürnberg, Campus Nord
Nuremberg
- Recruiting
Klinikum Osnabrück GmbH
Osnabrück
- Recruiting
Helios Kliniken Schwerin GmbH
Schwerin
- Recruiting
Robert Bosch Gesellschaft für Medizinische Forschung mb
Stuttgart
- Recruiting
Krankenhaus der Barmherzigen Brüder
Trier
- Recruiting
Universitätsklinikum Tübingen
Tübingen
About this study
The aim is rapid collection of real-life data on the epidemiology, treatment and disease course in patients with VEXAS syndrome during routine clinical practice and collect biomaterials to evaluate genotype-phenotype associations, determine optimal treatment schedule, identify diagnostic features and biomarkers
Read the detailed description
see brief summary
- Conditions
- VEXAS Syndrome
- Keywords
- VEXAS
- Medical subject headings
- VEXAS syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of epidemiological data on VEXAS
incidence, age and sex distribution in adults in Germany
Measured: enrollment
Collection and monitoring of initial disease manifestations
- spectrum and frequency of inflammatory manifestations
- Association with hematological (pre)malignancies (MDS, Myeloma, MGUS, CHIP)
- Monitor cardiovascular risk/thromboembolic events
Measured: 5 years
Documentation of the treatment approaches and therapy sequences
Documentation of the treatment approaches and therapy sequences
Measured: 5 years
Analysis of clinical-relevant clinical endpoints
complete remission (CR), hematological and clinical remission, molecular remissions, treatment-free remission (TFR)
Measured: 5 years
Secondary outcomes (6)
Describe disease cluster
- Phenotype cluster?
- Genotype-phenotype associations?
- Identification of biomarker?
Measured: 5 years
Laboratory diagnostics
- Establish Diagnostic FACS signature
- Establish biomarker for disease monitoring
- Molecular characterization of the key regulatory gene UBA1, but also accompanying molecular mutations
- Correlation with HLA polymorphisms
- Coagulation Diagnostics
Measured: 5 years
Correlation clinical endpoints with treatment approaches
Correlation clinical endpoints with treatment approaches
Measured: 5 years
Quality of life data (QoL), fatigue questionnaire (Facit-F)
Quality of life data (QoL), fatigue questionnaire (Facit-F)
Measured: 5 years
Accompanying translational research
- Metabolic signature
- Inflammatory signature
- Microbiome
- Identify disease trigger /risc factors for disease onset
Measured: 5 years
Collection of Biospecimens
Collection of Biospecimens
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start13 Mar 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VEXAS SyndromeStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, University Hospital Munich
- Responsible party
- Sponsor
- Investigators
- Katja Sockel, Dr. med., Study chair, TU Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377462
- Sponsor's protocol ID
- VEXAS-Registry
- Status last verified
- May 2026
- First submitted
- 17 Apr 2024
- Last updated
- 15 May 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Interdisciplinary National VEXAS Registry With Accompanying Biomaterial Collection
- ClinicalTrials.gov ID
- NCT06377462
- Acronym / sponsor ID
- VEXAS-Registry
- Conditions
- VEXAS Syndrome
- Keywords
- VEXAS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, University Hospital Munich
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 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 is rapid collection of real-life data on the epidemiology, treatment and disease course in patients with VEXAS syndrome during routine clinical practice and collect biomaterials to evaluate genotype-phenotype associations, determine optimal treatment schedule, identify diagnostic features and biomarkers
Detailed description
see brief summary
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Planned recruitment: 20-30 patients/year * Number of planned study centres: 15-20
Key inclusion criteria (3 listed)
- Patients with established or suspected (clinical and hematological criteria) VEXAS Syndrome
- Age ≥18 years
- Signed informed consent form
Key exclusion criteria (1 listed)
- patients who are not in a position to understand the nature and scope of participation in this register
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collection of epidemiological data on VEXAS
Time frame: enrollment
incidence, age and sex distribution in adults in Germany
Collection and monitoring of initial disease manifestations
Time frame: 5 years
* spectrum and frequency of inflammatory manifestations * Association with hematological (pre)malignancies (MDS, Myeloma, MGUS, CHIP) * Monitor cardiovascular risk/thromboembolic events
Documentation of the treatment approaches and therapy sequences
Time frame: 5 years
Documentation of the treatment approaches and therapy sequences
Analysis of clinical-relevant clinical endpoints
Time frame: 5 years
complete remission (CR), hematological and clinical remission, molecular remissions, treatment-free remission (TFR)
6 secondary outcomes
Describe disease cluster
Time frame: 5 years
Laboratory diagnostics
Time frame: 5 years
Correlation clinical endpoints with treatment approaches
Time frame: 5 years
Quality of life data (QoL), fatigue questionnaire (Facit-F)
Time frame: 5 years
Accompanying translational research
Time frame: 5 years
Collection of Biospecimens
Time frame: 5 years
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 15 May 2026.
- Website VEXAS RegistryLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for VEXAS Syndrome
RecruitingPhase 2
A Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS)
VEXAS, VEXAS Syndrome
RecruitingPhase 2
A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for Subjects With VEXAS (Vacuoles, E1 Enzyme, X-linked, Autoinflammatory, Somatic) Syndrome
Immunodeficiency, Hematopoietic Stem Cell Transplantation
Enrolling by invitationObservational study
Molecular and Clinical Analysis of Bone Marrow Failure: A Secondary Research Study
Bone Marrow Failure Disorders, VEXAS Syndrome
RecruitingPhase 2
A 52-Week Study Evaluating the Efficacy and Safety of Arumakimig (MAS825) in Participants With VEXAS Followed by Open-Label Extension (OLE) Period
VEXAS Syndrome
RecruitingPhase 2
Momelotinib in VEXAS Syndrome
VEXAS Syndome, Myelo Dysplastic Syndrome
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.
Katja Sockel, Dr. med. study chair
TU Dresden
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of VEXAS Syndrome, run by Technische Universität Dresden at 17 sites in Germany.
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 3 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 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany. 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 Katja Sockel, Dr. med. (+493514585627, katja.sockel@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of epidemiological data on VEXAS (time frame: enrollment). The study lists 4 primary outcomes in all. 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 15 May 2026.