Studying Interferon Overactivity in Lupus, Systemic Sclerosis and Related Immune Diseases
Studies blood immune responses in people with autoimmune diseases or interferonopathies.
Key facts
- Who runs it
- Hospices Civils de Lyon
- Where
- Bron, Lyon, and Oullins, FranceSee the 3 sites
- Trial code
- Registry title
- Investigation of Type I Interferon Excess in Patients With Systemic Autoimmune Diseases and Genetic Type I Interferonopathies
- Status
- Not yet recruiting
- People taking part
- 120 people, planned
- Starts
- 1 Dec 2026
- Expected to end
- 1 Jan 2033
- Type of study
- Interventional, 2 groups
- Treatments tested
- biological samples
- Record updated
- 24 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with certain autoimmune diseases or genetic interferon diseases, and also healthy volunteers. Blood samples are used to study the type I interferon response.
- Age
- Over 6 years and under 60 years.
- Sex
- All sexes can join.
- Disease stage
- Confirmed systemic lupus erythematosus, myositis, systemic sclerosis, mixed or undifferentiated connective tissue disease, or genetically confirmed monogenic lupus or interferonopathy.
Main reasons for not taking part
- Infection within 2 weeks before sampling
- Vaccination within 1 month before sampling
- Taking part in an interventional drug study (patients)
- Pregnant, giving birth or breastfeeding women
- Healthy volunteers: any long-term chronic disease or primary immunodeficiency
The registry criteria, word for word
Show all 30 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Participant with a long-term chronic disease (ALD) or any chronic medical condition
- History of neoplasia (< 5 years) or ongoing neoplastic disease
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 60 years old?
Where in France
- Hôpital Femme Mère EnfantBron, FranceContact: Alexandre BELOT, MD, Ph DNo longer taking part
- Hopital Edouard HerriotLyon, FranceContact: Thomas BARBA, MDNo longer taking part
- Centre Hospitalier Lyon SudOullins, FranceContact: Maël RICHARD, MDNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- PatientsOther group
Patients with systemic lupus erythematosus, systemic sclerosis, myositis, and mixed or undifferentiated connective tissue diseases, and genetic type 1 interferonopathies
Treatment: biological samples
- controlOther group
Healthy volunteer
Treatment: biological samples
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Type I Interferon Excess in Autoimmune Diseases and Genetic Type I Interferonopathies
- Plain-language title
- Studying Interferon Overactivity in Lupus, Systemic Sclerosis and Related Immune DiseasesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07837986, who can take part
- Record updated
- 24 September 2026