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RecruitingNCT06377462Updated May 15, 2026

Multicenter, Interdisciplinary National VEXAS Registry With Accompanying Biomaterial Collection

An observational study in VEXAS Syndrome, sponsored by Technische Universität Dresden. Recruiting at 17 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Technische Universität Dresden · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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 the detailed description

see brief summary

02

Conditions studied

  • VEXAS Syndrome

Keywords

  • VEXAS
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  • Planned recruitment: 20-30 patients/year
  • Number of planned study centres: 15-20

Inclusion criteria

  • Patients with established or suspected (clinical and hematological criteria) VEXAS Syndrome
  • Age ≥18 years
  • Signed informed consent form

Exclusion criteria

Exclusion Criteria:

  • patients who are not in a position to understand the nature and scope of participation in this register
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. Collection of epidemiological data on VEXAS

    incidence, age and sex distribution in adults in Germany

    Time frame: enrollment

  2. 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

    Time frame: 5 years

  3. Documentation of the treatment approaches and therapy sequences

    Documentation of the treatment approaches and therapy sequences

    Time frame: 5 years

  4. Analysis of clinical-relevant clinical endpoints

    complete remission (CR), hematological and clinical remission, molecular remissions, treatment-free remission (TFR)

    Time frame: 5 years

Secondary outcomes

  1. Describe disease cluster

    * Phenotype cluster? * Genotype-phenotype associations? * Identification of biomarker?

    Time frame: 5 years

  2. 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

    Time frame: 5 years

  3. Correlation clinical endpoints with treatment approaches

    Correlation clinical endpoints with treatment approaches

    Time frame: 5 years

  4. Quality of life data (QoL), fatigue questionnaire (Facit-F)

    Quality of life data (QoL), fatigue questionnaire (Facit-F)

    Time frame: 5 years

  5. Accompanying translational research

    * Metabolic signature * Inflammatory signature * Microbiome * Identify disease trigger /risc factors for disease onset

    Time frame: 5 years

  6. Collection of Biospecimens

    Collection of Biospecimens

    Time frame: 5 years

06

Study locations

17 of 17 sites recruiting
  • Universitätsklinikum Aachen
    Aachen, Germany
    Recruiting
  • Klinikum Chemnitz gGmbH
    Chemnitz, Germany
    Recruiting
  • Universitätsklinikum Carl Gustav Carus
    Dresden, 01307, Germany
    • Katja Sockel, Dr. med. · Contact
    Recruiting
  • Universitätsklinikum Düsseldorf
    Düsseldorf, Germany
    Recruiting
  • Evang. Kliniken Essen-Mitte
    Essen, Germany
    Recruiting
  • Universitätsmedizin Göttingen
    Göttingen, Germany
    Recruiting
  • Universitätsklinikum Hamburg-Eppendorf
    Hamburg, Germany
    Recruiting
  • Universitätsklinikum Jena
    Jena, Germany
    Recruiting
  • Universitätsklinikum Leipzig AöR
    Leipzig, Germany
    Recruiting
  • Universitätsmedizin Mannheim
    Mannheim, Germany
    Recruiting
  • Klinikum rechts der Isar TUM
    München, Germany
    Recruiting
  • Klinikum Nürnberg, Campus Nord
    Nuremberg, Germany
    Recruiting
  • Klinikum Osnabrück GmbH
    Osnabrück, Germany
    Recruiting
  • Helios Kliniken Schwerin GmbH
    Schwerin, Germany
    Recruiting
  • Robert Bosch Gesellschaft für Medizinische Forschung mb
    Stuttgart, Germany
    Recruiting
  • Krankenhaus der Barmherzigen Brüder
    Trier, Germany
    Recruiting
  • Universitätsklinikum Tübingen
    Tübingen, Germany
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06377462
Lead sponsor
Technische Universität Dresden
Collaborators
Bristol-Myers Squibb, University Hospital Munich
Responsible party
Sponsor
First posted
Apr 22, 2024
Start date
Mar 13, 2024
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
May 15, 2026

Study contacts

Katja Sockel, Dr. med.
Contact
katja.sockel@ukdd.de
+493514585627
Katharina Goetze, Prof.
Contact
katharina.goetze@tum.de
+498941404618
Katja Sockel, Dr. med.
study chair · TU Dresden

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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