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SclerodermaPhase 2/3PSSITNCT05098704

Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk

A Phase 2/3 study testing clopidogrel treatment in people with Scleroderma and Systemic Sclerosis, run by University Hospital, Bordeaux at 11 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Systemic sclerosis (SSc) is a severe autoimmune disease associating dysimmunity, vasculopathy and fibrosis. No curative treatment is available. Pre-clinical abnormalities can be found such as specific autoantibodies. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Scleroderma, Systemic Sclerosis
What is being tested?
clopidogrel treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
11 sitesFrance
Study dates
22 Jun 2022to Jun 2032
Phase
Phase 2/3
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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient over 18 years old, and less than 85 years old.
  • Patient with positive AAN (AAN ≥ 1/160) with the following specificity: anti-Scl70 or anti-centromere or anti-RNApolIII, or any other auto-antibodies related to systemic sclerosis
  • Patient with RP reported by the subject and confirmed by the physician.
  • Patient affiliated to a health insurance system.
  • Patient who accepts to participate to the study and signs an inform consent form.

Who cannot join

  • Patient with an SSc diagnosis according to ACR/EULAR 2013 criteria.
  • Patient with skin fibrosis at screening.
  • Patient with antiplatelet treatment at screening.
  • Patient with contraindications to clopidogrel.
  • Patient treated by immunosuppressive agent at screening.
  • Patient treated by anticoagulants at screening
Show all 9Show fewer
  • Pregnant or breastfeeding women.
  • Women of childbearing age refusing effective contraception method during the study treatment (24 months).
  • Incompetent adults (i.e. Individuals under the protection of a conservator)

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Marie-Elise TRUCHETET, Prof contact

05.56.79.55.56 ext. +33

marie-elise.truchetet@chu-bordeaux.fr

Thomas BARNETCHE, PhD contact

thomas.barnetche@chu-bordeaux.fr

11 sites in 1 country

France11 sites, 11 recruiting

  • CH de la Cote Basque - service de rhumatologie

    Bayonne

    Léa BLAISE, MD, llopez@ch-cotebasque.fr

    Léa LOPEZ, MD

    Recruiting

  • CHU de Bordeaux - service de Médecine Interne et Maladies Infectieuses

    Bordeaux

    Fabrice BONNET, Prof, fabrice.bonnet@chu-bordeaux.fr

    Fabrice BONNET, Prof

    Not yet recruiting

  • CHU de Bordeaux - service de rhumatologie

    Bordeaux

    Marie-Elise TRUCHETET, Prof, marie-elise.truchetet@chu-bordeaux.fr

    Thomas BARNETCHE, PhD, thomas.barnetche@chu-bordeaux.fr

    Recruiting

  • CHU de Brest - service de rhumatologie

    Brest

    Alain SARAUX, Prof, alain.saraux@chu-brest.fr

    Alain SARAUX, Prof

    Recruiting

  • CHU de Grenoble Alpes - service de médecine vasculaire

    Grenoble

    Sophie BLAISE, MD, sblaise@chu-grenoble.fr

    Sophie BLAISE, MD

    Recruiting

  • CH de Libourne - service de rhumatologie

    Libourne

    Jean-Philippe VERNHES, MD, philippe.vernhes@ch-libourne.fr

    Jean-Philippe VERNHES, MD

    Recruiting

  • CH de Mont-de-Marsan - service de rhumatologie

    Mont-de-Marsan

    Marion MIRABEL, MD, marion.mirabel@ch-mdm.fr

    Marion MIRABEL, MD

    Recruiting

  • AP-HP - Hôpital Cochin - service de médecine interne

    Paris

    Benjamin CHAIGNE, MD, benjamin.chaigne@aphp.fr

    Benjamin CHAIGNE, MD

    Recruiting

  • CH de Pau - service de médecine interne

    Pau

    Xavier DELBREL, MD, xavier.delbrel@ch-pau.fr

    Xavier DELBREL, MD

    Recruiting

  • Service de Médecine Interne et Immunologie Clinique

    Rennes

    Alain LESCOAT, Prof, alain.lescoat@chu-rennes.fr

    Alain LESCOAT, Prof

    Not yet recruiting

  • CHU de Toulouse - service de médecine interne

    Toulouse

    Grégory PUGNET, MD, pugnet.g@chu-toulouse.fr

    Grégory PUGNET, MD

    Not yet recruiting

Other trials in France

About this study

Official title: Phase II/III Double-blind Randomized Placebo-controlled Trial Assessing the Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk in Subjects With Specific Dysimmunity and Raynaud Phenomenon

Systemic sclerosis (SSc) is a severe autoimmune disease associating dysimmunity, vasculopathy and fibrosis. No curative treatment is available. Pre-clinical abnormalities can be found such as specific autoantibodies. The association of Raynaud phenomenon and SSc-specific anti-nuclear antibodies is the hallmark of pre-scleroderma subjects, among who around 47% declare a complete disease after five years. The aim of this study is to assess in this particular population the preventive effect of an anti-platelet treatment.

Read the detailed description

In this study, platelet activation is targeted as it could play a key role in the pathogenesis of SSc. It has been shown in several publications that platelets are activated in SSc with a correlation between the level of activation and disease activity. Secondary to this activation, soluble and membrane effectors were increased, and induced vascular damages and fibrosis. The results obtained in the laboratory (CNRS UMR-5164) directly involved platelets in this mechanism by inducing the thymic stromal lymphopoietin (TSLP) production by endothelial cells and by showing the pro-fibrotic effect of TSLP. In vivo data in SSc murine model recently obtained, confirmed the preventive role on fibrosis of clopidogrel. The early control of this platelet activation could prevent the course of events leading to SSc.

The therapeutic strategy assessed in this study will be the oral administration of clopidogrel (75 mg per day) during two years to subjects presenting an association of specific dysimmunity and Raynaud phenomenon (RP). The administration of clopidogrel will be double-blinded versus placebo.

Subjects will be included and treated during a 2-year period and will be followed for a period of 36 months after treatment, i.e. a total of 60 months. The follow-up will be every six months mainly comprising clinical examination, patient reported outcomes and blood sampling.

Being tested
clopidogrel treatment, Placebo
Keywords
systemic sclerosis, clopidogrel, platelet, prevention, primary care
Medical subject headings
Scleroderma, Diffuse, Scleroderma, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clopidogrel treatmentDrug

    75 mg daily during 24 months

  • PlaceboDrug

    75 mg daily during 24 months

Study groups in NCT05098704
Study groupRoleWhat they receive
clopidogrelExperimentalNot described
Receives: Drug: clopidogrel treatment
placeboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of occurrence of SSc at 5 years according to American College of Rheumatology (ACR) / European League Against Rhumatism (EULAR) 2013 criteria in the two randomization groups

    Measured: 60 months after baseline (Day 0)

Secondary outcomes (11)

  1. Frequency of occurrence of cutaneous fibrosis (sclerodactyly or other affected area) clinically assessed by at least 2 independent investigators in the two randomization groups

    Measured: 60 months after baseline (Day 0)

  2. Mean of modified Rodnan skin score (which varies between 0 and 51, with higher values mean higher disease severity) in the two randomization groups.

    Measured: 60 months after baseline (Day 0)

  3. Mean of Cochin hand function scale (which varies between 0 and 90, with higher values mean higher disease severity) in the two randomization groups.

    Measured: 60 months after baseline (Day 0)

  4. Proportion of sex ratio at inclusion in the two randomization groups.

    Measured: At baseline (Day 0)

  5. Mean age at inclusion in the two randomization groups.

    Measured: At baseline (Day 0)

  6. Proportion of patients exposed to toxic products at inclusion in the two randomization groups.

    Measured: At baseline (Day 0)

  7. Proportion of patients exposed to toxic products at 5 years in the two randomization groups.

    Measured: 60 months after baseline (Day 0)

  8. Proportion of patients affected by a limited form of SSc at 5 years in the two randomization groups.

    Measured: 60 months after baseline (Day 0)

  9. Proportion of patients affected by a diffuse form of SSc at 5 years in the two randomization groups.

    Measured: 60 months after baseline (Day 0)

  10. Proportion of patients presenting a specific antibody positivity (anti-scl70, anti-centromere) in the two randomization groups at inclusion.

    Measured: At baseline (Day 0)

  11. Proportion of patients presenting megacapillaries by capillaroscopy at 5 years in the two randomization groups.

    Measured: 60 months after baseline (Day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2021
  2. Study start22 Jun 2022
  3. Primary completionJun 2032 (estimated)
  4. Study completionJun 2032 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
placebo-controlled trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05098704
Sponsor's protocol ID
CHUBX 2017/45
Other IDs
2024-511005-39-00
Acronym
PSSIT
Status last verified
Jul 2026
First submitted
4 Oct 2021
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing clopidogrel treatment in people with Scleroderma and Systemic Sclerosis, run by University Hospital, Bordeaux at 11 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Marie-Elise TRUCHETET, Prof (05.56.79.55.56 ext. +33, marie-elise.truchetet@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of occurrence of SSc at 5 years according to American College of Rheumatology (ACR) / European League Against Rhumatism (EULAR) 2013 criteria in the two randomization groups (time frame: 60 months after baseline (Day 0)). 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 NCT05098704.

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 7 Jul 2026.

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