CClinicalTrials.gg
RecruitingNCT07040774EU-IFNpUpdated Sep 10, 2026

Natural History of Type 1 Interferonopathies: Insights From a European Cohort

An observational study in Genetic Disease, Immune Dysfunction and Neurological Diseases or Conditions, sponsored by Imagine Institute. Recruiting at 32 sites in 11 countries. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Imagine Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
500
Sex
All
01

Study summary

Type I interferonopathies are rare autoinflammatory disorders caused by genetic defects and associated with significant morbidity and mortality. These diseases are refractory to conventional immunosuppressive therapies. They typically occur in childhood, although disease onset in adulthood has been observed. The clinical spectrum is wide and mainly involves the central nervous system. Joint involvement is also common, and more rarely, haematological features such as cytopenias or immunodeficiency may be observed.

Nearly all patients show consistent over-activation of the type I IFN pathway, as evidenced, the expression of IFN-stimulated genes, the so-called 'interferon signature'. To date, the natural history of interferonopathies remains unclear.

In this context, the establishment of a natural history of type I interferonopathy in patients is proposed to elucidate the pathophysiological mechanisms and identify biomarkers for diagnosis, prognosis, and disease activity, with the aim of better characterising the diversity of interferonopathies.

The main objective is to characterise the evolution of the pathology in paediatric and adult patients with type I interferonopathies.

The overall aim of this research is to propose therapeutic options tailored to patient phenotypes and to better define patient sub-groups in order to optimise the preparation of future clinical trials.

02

Conditions studied

  • Genetic Disease
  • Immune Dysfunction
  • Neurological Diseases or Conditions
  • Autoimmune Diseases

Keywords

  • Immune dysfuntion
  • Neurological disease
  • Autoimmune diseases
  • Genetics diseases
  • Interferon
  • Aicardi-Goutieres Syndrom
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with genetically confirmed type I interferonopathy in Europe. 500 patients estimated.

Inclusion criteria

  • Genetically confirmed patient with type I interferonopathy
  • Patient affiliated to a social security scheme or beneficiary of such a scheme.

Exclusion criteria

Exclusion Criteria:

- Opposition of the patient and/or parental authority if the patient is a minor, to participation in the study.

04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients

    Patients with genetically confirmed type I interferonopathy

05

What researchers measure

Primary outcomes

  1. Characterizing disease progression in pediatric and adult patients with type I interferonopathies

    Composite description of phenotypes of patients with type I interferonopathies according to genotype (clinical, biological) over time.

    Time frame: 2025-2045

Secondary outcomes

  1. Identifing and characterising genotype-specific immunological factors

    Description of specific immunological factors according to genotype

    Time frame: 2025-2045

  2. Research of biomarkers for diagnosis, prognosis and monitoring of disease activity

    Biomarkers identified for diagnosis, prognosis and monitoring of disease activity

    Time frame: 2025-2045

  3. Monitoring of treatment response according to phenotype and genotype

    Treatment response by phenotype and genotype

    Time frame: 2025-2045

06

Study locations

18 of 32 sites recruiting
  • Medical University Innsbruck
    Innsbruck, Austria
    Not yet recruiting
  • Antwerp University Hospital
    Antwerp, Belgium
    Not yet recruiting
  • Children's Hospital Zagreb
    Zagreb, Croatia
    • Alenka GAGRO, Dr · Contact
    • Alenka GAGRO, Dr · Principal investigator
    Not yet recruiting
  • Motol University Hospital
    Prague, Czechia
    • Markéta BLOOMFIELD, Dr · Contact · marketa.bloomfield@fnmotol.cz
    • Markéta BLOOMFIELD, Dr · Principal investigator
    • Dita CEBECAUROVA, Dr · Sub investigator
    Recruiting
  • CHU d'Angers
    Angers, 49000, France
    Recruiting
  • Hôpital de Mercy - CHR Metz Thionville
    Ars-Laquenexy, 57530, France
    Recruiting
  • CHU de Besançon
    Besançon, 25030, France
    Recruiting
  • CHU de Bordeaux
    Bordeaux, France
    Not yet recruiting
  • CHU Morvan
    Brest, 29200, France
    Recruiting
  • Hôpital Femme Mère Enfant - HCL
    Bron, 69500, France
    Recruiting
  • CHU de Dijon
    Dijon, 21231, France
    Not yet recruiting
  • Hôpitaux Nord Ouest Villefranche
    Gleizé, 69400, France
    • Vanessa REMY PICCOLO, Dr · Contact · vremypiccolo@hno.fr
    • Vanessa REMY PICCOLO, Dr · Principal investigator
    Recruiting
  • Hôpital Bicêtre
    Le Kremlin-Bicêtre, 94270, France
    Not yet recruiting
  • Hôpital Claude Huriez, CHU de Lille
    Lille, 59000, France
    Not yet recruiting
  • APHM Hôpitaux de Marseille
    Marseille, France
    Recruiting
  • CHU de Montpellier
    Montpellier, 34295, France
    Recruiting
  • CHRU Nancy
    Nancy, France
    Recruiting
  • CHU de Nantes
    Nantes, 44000, France
    Recruiting
  • CH Agen-Nérac
    Nérac, 47600, France
    Recruiting
  • Hôpital de l'Archet
    Nice, 06200, France
    Recruiting
  • Hôpital Armand Trousseau
    Paris, 75012, France
    • Isabelle MELKI, Dr · Contact · isabelle.melki@aphp.fr
    • Isabelle MELKI, Dr · Principal investigator
    • Nadia NATHAN, Dr · Sub investigator
    • Florence RENALDO, Dr · Sub investigator
    Not yet recruiting
  • Hôpital Bichat
    Paris, 75018, France
    Not yet recruiting
  • Hôpital Robert Debré
    Paris, 75019, France
    Not yet recruiting
  • Hôpital des Enfants - CHU de Toulouse
    Toulouse, 31300, France
    Recruiting
  • Hôpital Necker Enfants Malades
    Paris, Île-de-France Region 75015, France
    • Marie-Louise FREMOND, Pr · Contact · marie-louise.fremond@institutimagine.org
    • Marie-Louise FREMOND, Pr · Principal investigator
    • Anne WELFRINGER, Dr · Sub investigator
    • Bénédicte NEVEN, Pr · Sub investigator
    • Marie HULLY, Dr · Sub investigator
    • Alice HADCHOUEL, Pr · Sub investigator
    Recruiting
  • University of Tübingen
    Tübingen, Germany
    • Özlem SATIRER · Contact
    • Özlem SATIRER, Dr · Principal investigator
    Recruiting
  • Meyer Children's Hospital IRCCS
    Florence, Italy
    Recruiting
  • Hospital Universitari Vall d'Hebron
    Barcelona, Spain
    Not yet recruiting
  • Hospital Universitario Son Espases
    Palma de Mallorca, Spain
    Not yet recruiting
  • Karolinska University Hospital
    Stockholm, Sweden
    Not yet recruiting
  • Hacettepe İhsan Doğramacı Children's Hospital
    Ankara, Turkey (Türkiye)
    Recruiting
  • Leeds Teaching Hospitals NHS Trust
    Leeds, United Kingdom
    Not yet recruiting
07

Registry details

Key details

Study ID
NCT07040774
Lead sponsor
Imagine Institute
Responsible party
Sponsor
First posted
Jun 27, 2025
Start date
Oct 1, 2025
Primary completion
Oct 2045 (estimated)
Completion
Oct 2045 (estimated)
Last update
Sep 10, 2026

Study contacts

Marie-Louise FREMOND, Pr
Contact
marie-louise.fremond@institutimagine.org
01 44 49 48 24

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion