NCT07837986Not yet recruiting
Investigation of Type I Interferon Excess in Patients With Systemic Autoimmune Diseases and Genetic Type I Interferonopathies
Type I Interferon Excess in Autoimmune Diseases and Genetic Type I Interferonopathies
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
Systemic autoimmune diseases associated with type I interferon (IFN-I) dysregulation, such as systemic lupus erythematosus, systemic sclerosis, myositis, and mixed or undifferentiated connective tissue diseases, and genetic type 1 interferonopathies are characterized by chronic and excession IFN-I signaling and production contributing to disease pathogenesis. Aberrant IFN-I production can be triggered through the activation of multiple signaling pathways, particularly those involving intracellular and extracellular RNA and DNA sensing receptors. We hypothesize that excessive IFN-I production results from an increased tonic activation state of nucleic acid sensors and/or an enhanced responsiveness of these sensors to endogenous nucleic acids, thereby sustaining pathological IFN-I signaling and chronic inflammation. The aim of this study is to characterize the type I interferon (IFN-I) response, defined by both the IFN-I gene signature and plasma IFN-α levels, following stimulation with a panel of ligands specific for DNA- and RNA-sensing pathways.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 10 Sept 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 1 Jan 2033
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT07837986
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Dec 2026 to the primary completion date, 1 Jan 2033
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- documented infection or symptoms consistent with a bacterial or viral infection within 2 weeks prior to sampling
- Subjects currently participating in an interventional drug study
- Vaccination within 1 month prior to sampling
- Individuals receiving psychiatric care
- Documented infection or symptoms consistent with a bacterial or viral infection occurring within 2 weeks prior to sample collection.
- Vaccination within 1 month prior to sample collection.
- Individuals receiving psychiatric care.
Other illness
- Participant with a long-term chronic disease (ALD) or any chronic medical condition.
Age
- History of neoplasia (\< 5 years) or ongoing neoplastic disease.
Other
- Patient
- Pregnant, parturient, or breastfeeding women
- Individuals deprived of liberty by judicial or administrative decision
- Individuals admitted to a healthcare or social care institution for reasons other than participation in the research
- Adults subject to a legal protection measure
- Individuals not affiliated with a social security scheme or not covered by an equivalent health insurance system
- Healthy Volunteer Participants
- Participant with a primary immunodeficiency.
- Pregnant, parturient, or breastfeeding women.
- Individuals deprived of liberty by a judicial or administrative decision.
- Individuals admitted to a health or social care institution for purposes other than participation in research.
- Adults subject to a legal protection measure (guardianship or curatorship).
- Individuals not affiliated with a social security system or not benefiting from an equivalent health insurance scheme.
Who the study is looking for
- Patient
- Patient followed at the Hospices Civils de Lyon (HCL) for their disease.
- Patient aged over 6 years and under 60 years.
- Body weight ≥ 25 kg.
- Patient with a confirmed diagnosis of
- Systemic lupus erythematosus
- Myositis, histologically confirmed or not
- Systemic sclerosis,
- Mixed connective tissue disease, according to the Sharp or Kasukawa criteria Undifferentiated connective tissue disease, according to the criteria proposed by Mosca et al.
- Genetically confirmed monogenic lupus or monogenic interferonopathy.
- Patient, parents, or legal guardians informed about the study and having signed the informed consent form.
- Healthy Volunteer Participants
- Subjects aged over 6 years and under 60 years.
- Body weight greater than or equal to 25 kg.
- Participants, parents, or legal guardians who have been informed about the study and have provided written informed consent.
Age in the registry: 6 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Femme Mère Enfant Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| Hopital Edouard Herriot Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Centre Hospitalier Lyon Sud Coordinator of this site? Confirm its status | Oullins | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.