An interventional study of biological samples in Systememic Lupus Erythematosus, Systemic Sclerosis (SSc) and Inflammatory Myopathies, sponsored by Hospices Civils de Lyon. Not yet recruiting at 3 sites in France. Open to participants aged 6 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science
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.
The investigators hypothesize that chronic overproduction of type I interferons (IFN-I) is driven by increased basal activation of nucleic acid-sensing pathways and/or heightened cellular responsiveness to endogenous nucleic acids, leading to sustained IFN-I signaling and persistent inflammation. The objective of the study is to characterize the IFN-I response by assessing both the interferon gene signature and plasma IFN-α levels following stimulation of PBMCs with a panel of DNA- and RNA-sensing pathway-specific ligands.
The SAFRAN study protocol comprises two study visits for patients: a mandatory Visit 1 (V1) and an optional Visit 2 (V2), the performance of which depends on the results obtained at V1. Healthy control participants will undergo Visit 1 (V1) only.
During Visit 1 (V1), the investigator will perform a clinical assessment as part of routine disease management. Disease activity will be evaluated using validated clinical scoring systems. For patients with systemic lupus erythematosus (SLE), disease activity will be assessed using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). For patients with systemic sclerosis, skin involvement will be evaluated using the modified Rodnan Skin Score (mRSS). In addition, disease activity will be assessed in all patients using the Physician Global Assessment (PGA) scale.
During Visit 2 (V2), patients in whom an abnormality in interferon signaling is identified through the in vitro assays will undergo additional blood sampling during a routine follow-up visit conducted as part of standard clinical care. An additional blood volume of 12 mL will be collected to further characterize the abnormality detected in the previous sample (V1), within 12 months of the initial assessment.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 120 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Patient
Patient with a confirmed diagnosis of
Healthy Volunteer Participants
Exclusion Criteria:
Patient
Healthy Volunteer Participants
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with systemic lupus erythematosus, systemic sclerosis, myositis, and mixed or undifferentiated connective tissue diseases, and genetic type 1 interferonopathies
Biological: biological samples
Healthy volunteer
Biological: biological samples
Healthy volunteers will undergo a blood draw of a total volume of 20 mL for the following analyses: ex vivo analysis of the interferon signaling pathway (12 mL) and biological sample collection, if the patient/holder of parental authority provides consent (8 mL).
IFN-I signature score
The interferon signature assessed by transcriptomic analysis and IFN-α concentrations measured using the Simoa assay will be compared across the different disease groups and with healthy volunteers.
Time frame: Day 1 and Month 12 (if applicable)
Clinical phenotype
Correlation between the extent of specific organ involvement and the activation of nucleic acid-sensing pathways, assessed by the levels of IFN-α production.
Time frame: Day 1 and Month 12 (if applicable)
plasma IFN-α concentration
In vitro change in the IFN signature and IFN-α production in patients' PBMCs after exposure to selective inhibitors of overactivated IFN-I signaling pathways
Time frame: Day 1 and Month 12 (if applicable)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jan 2033, 73 months later.
Of 94 non-industry interventional studies with no phase under Scleroderma, Systemic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 73 months is above that.
Counting every sponsor, half of 100 studies reached it within 23 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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