Systememic Lupus ErythematosusSAFRANNCT07837986
Investigation of Type I Interferon Excess in Patients With Systemic Autoimmune Diseases and Genetic Type I Interferonopathies
A study testing biological samples in people with Systememic Lupus Erythematosus and Systemic Sclerosis (SSc), run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Systememic Lupus Erythematosus, Systemic Sclerosis (SSc), Inflammatory Myopathies
- What is being tested?
- biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Dec 2026to 1 Jan 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- 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 join
- Patient
- 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
- Pregnant, parturient, or breastfeeding women
- Individuals deprived of liberty by judicial or administrative decision
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- Individuals receiving psychiatric care
- 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
- Documented infection or symptoms consistent with a bacterial or viral infection occurring within 2 weeks prior to sample collection.
- Participant with a long-term chronic disease (ALD) or any chronic medical condition.
- Participant with a primary immunodeficiency.
- Vaccination within 1 month prior to sample collection.
- History of neoplasia (< 5 years) or ongoing neoplastic disease.
- Pregnant, parturient, or breastfeeding women.
- Individuals deprived of liberty by a judicial or administrative decision.
- Individuals receiving psychiatric care.
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Hôpital Femme-Mère-Enfant
Bron, 69500
Alexandre BELOT, MD, Ph D, +33427856126, alexandre.belot@chu-lyon.fr
Alexandre BELOT, MD, Ph D
Hôpital Edouard Herriot
Lyon, 69003
Thomas BARBA, MD, +33472119583, thomas.barba@chu-lyon.fr
Thomas BARBA, MD
Centre Hospitalier Lyon-Sud
Oullins, 69495
Maël RICHARD, MD, +33478843973, mael.richard@chu-lyon.fr
Mael RICHARD, MD
About this study
Official title: Type I Interferon Excess in Autoimmune Diseases and Genetic Type I Interferonopathies
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.
Read the detailed description
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.
- Conditions
- Systememic Lupus Erythematosus, Systemic Sclerosis (SSc), Inflammatory Myopathies, Connective Tissue Diseases, Type 1 Interferonopathies
- Being tested
- biological samples
- Keywords
- Interferon, IFN signature, interferon-alpha
- Medical subject headings
- Scleroderma, Systemic, Myositis, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological samplesBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Patients with systemic lupus erythematosus, systemic sclerosis, myositis, and mixed or undifferentiated connective tissue diseases, and genetic type 1 interferonopathies Receives: Biological: biological samples |
| control | Other | Healthy volunteer Receives: Biological: biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 and Month 12 (if applicable)
Secondary outcomes (2)
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.
Measured: 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
Measured: Day 1 and Month 12 (if applicable)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jan 2033 (estimated)
- Study completion1 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systememic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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 in patients with systemic lupus erythematosus, systemic sclerosis, myositis, and mixed or undifferentiated connective tissue diseases, and genetic type 1 interferonopathies compared and in healthy volunteers.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837986
- Sponsor's protocol ID
- 69HCL25_0143
- Acronym
- SAFRAN
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type I Interferon Excess in Autoimmune Diseases and Genetic Type I Interferonopathies
- ClinicalTrials.gov ID
- NCT07837986
- Acronym / sponsor ID
- SAFRAN / 69HCL25_0143
- Conditions
- Systememic Lupus Erythematosus, Systemic Sclerosis (SSc), Inflammatory Myopathies, Connective Tissue Diseases, Type 1 Interferonopathies
- Keywords
- Interferon, IFN signature, interferon-alpha
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jan 2033 (estimated)
- Study completion
- 1 Jan 2033 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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 in patients with systemic lupus erythematosus, systemic sclerosis, myositis, and mixed or undifferentiated connective tissue diseases, and genetic type 1 interferonopathies compared and in healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Biological: biological samplesPatients with systemic lupus erythematosus, systemic sclerosis, myositis, and mixed or undifferentiated connective tissue diseases, and genetic type 1 interferonopathies |
| control | Other | Biological: biological samplesHealthy volunteer |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (22 listed)
- Patient
- 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
- Pregnant, parturient, or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological samplesHealthy 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). | Biological | Patients, control |
Primary outcome
IFN-I signature score
Time frame: Day 1 and Month 12 (if applicable)
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.
2 secondary outcomes
Clinical phenotype
Time frame: Day 1 and Month 12 (if applicable)
plasma IFN-α concentration
Time frame: Day 1 and Month 12 (if applicable)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biological samples in people with Systememic Lupus Erythematosus and Systemic Sclerosis (SSc), run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre BELOT, MD, PhD (+3342786126, Alexandre.belot@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IFN-I signature score (time frame: Day 1 and Month 12 (if applicable)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.