ANCA Associated VasculitisVASC-FASNCT03698071
Soluble CD95 Ligand Role in the Pathophysiology of Antineutrophil Cytoplasmic Antibody (ANCA) Associated Vasculitis
A study testing blood sample and urine sample in people with ANCA Associated Vasculitis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The study aims at defining the role of soluble CD95 Ligand in the physiopathology of a rare group of inflammatory diseases: ANCA associated vasculitis. Soluble CD95 Ligand might have a prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ANCA Associated Vasculitis
- What is being tested?
- blood sample and urine sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2018to 18 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ANCA associated vasculitis according to the Chapel-Hill Consensus Conference - 2012 modified version
- Age ≥ 18 years
- being affiliated to health insurance
- willing to participate and to sign informed consent.
Who cannot join
- Pregnant or breastfeeding women,
- patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Bordeaux - Service d'Immunologie et Immunogénétique
Bordeaux
About this study
Official title: Soluble CD95 Ligand Role in the Pathophysiology of ANCA Associated Vasculitis
The study aims at defining the role of soluble CD95 Ligand in the physiopathology of a rare group of inflammatory diseases: ANCA associated vasculitis. Soluble CD95 Ligand might have a prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies.
Read the detailed description
ANCA associated vasculitis are a rare group of diseases and potentially life-threatening inflammatory conditions. There is an urgent need to describe prognostic factors and to discover new therapeutic pathways. Soluble CD95-L is a cleaved part of CD95-L which binds the CD95 Death receptor. s-CD95-L has pro-inflammatory properties for Th17 lymphocytes and Neutrophils, two cells implicated in ANCA associated vasculitis. It also plays a role in systemic lupus erythematosus (which present with the same type of renal glomerulonephritis as ANCA-associated vasculitis). Finally, it has already be found elevated in this group of diseases. The investigators hypothesized that s-CD95-L levels might be a prognostic factor in ANCA associated vasculitis and the study of the molecular mechanisms involved could provide new therapeutic targets.
The study will recruit 50 patients with ANCA associated vasculitis followed in Bordeaux University Hospital. Among classical disease activity information, blood and urine samples will be collected at each visit to study s-CD95-L. Fundamental research will be realized on patients' sample to study molecular mechanisms involved.
Clinical and biological disease activity, treatment and outcomes will be studied in correlation with s-CD95-L to describe their potential prognostic role. Patients will be followed at regular intervals, as their usual follow-up would request. No extra visit will be needed and blood samples will be drawn at the same time as those drawn for clinical purposes.
- Conditions
- ANCA Associated Vasculitis
- Being tested
- blood sample, urine sample
- Keywords
- ANCA associated vasculitis, Granulomatosis with polyangiitis, microscopic polyangiitis, eosinophilic granulomatosis with polyangiitis, soluble-CD95-Ligand
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Churg-Strauss Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
urine sampleBiological
6 ml
| Study group | Role | What they receive |
|---|---|---|
| ANCA associated vasculitis | Experimental | Not described Receives: Biological: blood sample; Biological: urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of quantitative levels of s-CD95-L in ANCA associated vasculitis between baseline and Month 12
Measured: At baseline (Day 0) and 12 months from baseline
Secondary outcomes (4)
Change of disease activity scores for ANCA associated vasculitis between baseline and Month 12
Birmingham Vasculitis Activity Score - Version 3 (BVAS 3.0) The Birmingham Vasculitis Activity Score (BVAS) is a method for assessing the activity of vasculitis. Note that scoring ranges are higher when any of the features are new or worse. Creatinine levels can be scored at patient's first assessment only. The maximum score is 63 points for present symptoms and 32 points for new symptoms or symptoms which had worsened within the previous weeks.
Measured: At baseline (Day 0) and 12 months from baseline
Change of disease activity scores for ANCA associated vasculitis between baseline and Month 12
Vasculitis Damage Index (VDI)
Measured: At baseline (Day 0) and 12 months from baseline
Change of quantification of s-CD95-L in the blood and urine samples of ANCA associated vasculitis between baseline and Month 12
Measured: At baseline (Day 0) and 12 months from baseline
Change of quantification of ANCA in the blood samples of ANCA associated vasculitis between baseline and Month 12
Measured: At baseline (Day 0) and 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start14 Dec 2018
- Primary completion18 Sep 2024
- Study completion18 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ANCA Associated VasculitisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Patrick BLANCO, Prof, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698071
- Sponsor's protocol ID
- CHUBX 2018/22
- Acronym
- VASC-FAS
- Status last verified
- May 2025
- First submitted
- 4 Oct 2018
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boizard-Moracchini A, Msalbi D, Huot-Marchand S, Haymour L, Lebrault E, Tchen J, Jekel T, Galli G, Brilland B, Merillon N, Josensi C, Lozano C, Mazars J, Douard M, Danger Y, Verite F, Barnetche T, Lazaro E, Duffau P, Pfirmann P, Magerus-Chatinet A, Jean M, Augusto JF, Armengaud J, Richez C, Vacher P, Legembre P, Blanco P. Soluble CD95L triggers Caspase-10-driven reactive oxygen species production in neutrophils and aggravates anti-neutrophil cytoplasmic antibody-vasculitis. Nat Commun. 2026 Jun 20;17(1):7759. doi: 10.1038/s41467-026-74452-8.
PubMed 42321206
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble CD95 Ligand Role in the Pathophysiology of ANCA Associated Vasculitis
- ClinicalTrials.gov ID
- NCT03698071
- Acronym / sponsor ID
- VASC-FAS / CHUBX 2018/22
- Conditions
- ANCA Associated Vasculitis
- Keywords
- ANCA associated vasculitis, Granulomatosis with polyangiitis, microscopic polyangiitis, eosinophilic granulomatosis with polyangiitis, soluble-CD95-Ligand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 5 Oct 2018 (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.
The study aims at defining the role of soluble CD95 Ligand in the physiopathology of a rare group of inflammatory diseases: ANCA associated vasculitis. Soluble CD95 Ligand might have a prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies.
Detailed description
ANCA associated vasculitis are a rare group of diseases and potentially life-threatening inflammatory conditions. There is an urgent need to describe prognostic factors and to discover new therapeutic pathways. Soluble CD95-L is a cleaved part of CD95-L which binds the CD95 Death receptor. s-CD95-L has pro-inflammatory properties for Th17 lymphocytes and Neutrophils, two cells implicated in ANCA associated vasculitis. It also plays a role in systemic lupus erythematosus (which present with the same type of renal glomerulonephritis as ANCA-associated vasculitis). Finally, it has already be found elevated in this group of diseases. The investigators hypothesized that s-CD95-L levels might be a prognostic factor in ANCA associated vasculitis and the study of the molecular mechanisms involved could provide new therapeutic targets.
The study will recruit 50 patients with ANCA associated vasculitis followed in Bordeaux University Hospital. Among classical disease activity information, blood and urine samples will be collected at each visit to study s-CD95-L. Fundamental research will be realized on patients' sample to study molecular mechanisms involved.
Clinical and biological disease activity, treatment and outcomes will be studied in correlation with s-CD95-L to describe their potential prognostic role. Patients will be followed at regular intervals, as their usual follow-up would request. No extra visit will be needed and blood samples will be drawn at the same time as those drawn for clinical purposes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANCA associated vasculitis | Experimental | Biological: blood sample, Biological: urine sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of ANCA associated vasculitis according to the Chapel-Hill Consensus Conference - 2012 modified version
- Age ≥ 18 years
- being affiliated to health insurance
- willing to participate and to sign informed consent.
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding women,
- patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
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 |
|---|---|---|
| blood sample30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation | Biological | ANCA associated vasculitis |
| urine sample6 ml | Biological | ANCA associated vasculitis |
Primary outcome
Change of quantitative levels of s-CD95-L in ANCA associated vasculitis between baseline and Month 12
Time frame: At baseline (Day 0) and 12 months from baseline
4 secondary outcomes
Change of disease activity scores for ANCA associated vasculitis between baseline and Month 12
Time frame: At baseline (Day 0) and 12 months from baseline
Change of disease activity scores for ANCA associated vasculitis between baseline and Month 12
Time frame: At baseline (Day 0) and 12 months from baseline
Change of quantification of s-CD95-L in the blood and urine samples of ANCA associated vasculitis between baseline and Month 12
Time frame: At baseline (Day 0) and 12 months from baseline
Change of quantification of ANCA in the blood samples of ANCA associated vasculitis between baseline and Month 12
Time frame: At baseline (Day 0) and 12 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Results publication: PubMed 42321206Boizard-Moracchini A, Msalbi D, Huot-Marchand S, Haymour L, Lebrault E, Tchen J, Jekel T, Galli G, Brilland B, Merillon N, Josensi C, Lozano C, Mazars J, Douard M, Danger Y, Verite F, Barnetche T, Lazaro E, Duffau P, Pfirmann P, Magerus-Chatinet A, Jean M, Augusto JF, Armengaud J, Richez C, Vacher P, Legembre P, Blanco P. Soluble CD95L triggers Caspase-10-driven reactive oxygen species production in neutrophils and aggravates anti-neutrophil cytoplasmic antibody-vasculitis. Nat Commun. 2026 Jun 20;17(1):7759. doi: 10.1038/s41467-026-74452-8.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Patrick BLANCO, Prof principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample and urine sample in people with ANCA Associated Vasculitis, run by University Hospital, Bordeaux at 1 site 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of quantitative levels of s-CD95-L in ANCA associated vasculitis between baseline and Month 12 (time frame: At baseline (Day 0) and 12 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03698071, which also lists 1 linked publication.
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 17 Aug 2026.