AzTrials
AzTrials

Systemic Lupus ErythematousPhase 1/2CLOPUSNCT02320357

Pilot Study Related to the Effect of Clopidogrel on Plasmatic Soluble CD40 Ligand During Systemic Lupus Erythematous

A Phase 1/2 study testing Treatment by clopidogrel in people with Systemic Lupus Erythematous, run by University Hospital, Bordeaux at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

CD40 Ligand (CD40L) has been identified as a key feature in systemic lupus erythematosus (SLE) pathogenesis, a systemic autoimmune disease characterized by a multiorgan involvement. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Lupus Erythematous
What is being tested?
Treatment by clopidogrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
3 sitesFrance
Study dates
19 Aug 2015to 11 Sep 2017
Phase
Phase 1/2
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 SLE according to revised criteria of American College of Rheumatology
  • Being affiliated to health insurance
  • Having signed an informed consent (later than the day of inclusion and before any examination required by research)

Who cannot join

  • > 20mg/day of prednisone equivalent for > 7 days 30 days before the pre-inclusion.
  • Diseases flare 3 months before the inclusion. A disease flare is defined by an increase of SLEDAI score >3 and or a change of the immunosuppressive treatment and or an increase of steroids dose.
  • Is treated or has received 3 months before the pre-inclusion steroids pulses or intravenous immunoglobulins.
  • Renal involvement that could required a kidney biopsy.
  • Required surgery in the next 12 weeks.
  • Has been treated by cyclophosphamide 3 months before the pre-inclusion.
Show all 18Show fewer
  • Has been treated by biotherapy 6 months before the pre-inclusion.
  • Contraindication to clopidogrel (annex 1).
  • History of cancer except healed basal cell carcinoma.
  • History of severe hemorrhage
  • Disease exposing to hemorrhage
  • Associated antiphospholipid syndrome
  • Pregnant or breastfeeding women
  • No contraception for women of childbearing age
  • Severe hypertension
  • Ongoing statin, non-steroidal anti-inflammatory, antiplatelet and anticoagulant drugs.
  • Being under guardianship
  • Patient participating at an other biomedical research with an exclusion period at the screening visit.

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Service de Médecine Interne et maladies Infectieuses - Hôpital Saint-André

    Bordeaux, Bordeaux, 33075

  • Service de Médecine Interne

    Limoges, 87000

  • Service de Médecine Interne et Immunopathologie

    Toulouse, 31 000

Other trials in France

About this study

CD40 Ligand (CD40L) has been identified as a key feature in systemic lupus erythematosus (SLE) pathogenesis, a systemic autoimmune disease characterized by a multiorgan involvement. As platelets are a major source of soluble CD40L (sCD40L), we propose to study the effect of clopidogrel, a platelet inhibitor, on plasmatic sCD40L levels in SLE patients.

Read the detailed description

Type I interferon (IFN) and CD40L have been identified as important in SLE pathogenesis (1). CD40L is now considered as a biomarker of lupus activity (4). Because platelets represent a major reservoir of CD40L, we previously studied the role of platelet derived CD40L in SLE pathogenesis (5). We showed that platelets from SLE patients were activated in vivo by circulating immune complexes composed of autoantibodies bound to self antigens through a Fc-gamma Receptor IIa (CD32)-dependent mechanism. Further, platelet activation correlated with severity of the disease and activated platelets formed aggregates with antigen-presenting cells including monocytes and plasmacytoid dendritic cells. In addition, activated platelets enhanced IFN-α secretion by immune complexes-stimulated plasmacytoid dendritic cells in vitro through a CD154-CD40 interaction. In lupus prone mice, depletion of platelets or administration of the clopidogrel improved all measures of disease activity and overall survival. In this pilot study the treatment of the research is clopidogrel given at the dose of 75mg once a day. For the features of the treatment, its contraindications, its disruption in case of side effects cf to annex 1. Clopidogrel associated with the usual treatment of patients will be given for 12 weeks, the follow up of patients will be 16 weeks, all side effects occurring during this period will be recorded.

Being tested
Treatment by clopidogrel
Keywords
Platelet activation, CD40 ligand, CD154, Interferon alpha, clopidogrel
Medical subject headings
Hyper-IgM Immunodeficiency Syndrome

What participants receive

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

  • Treatment by clopidogrelDrug

    Peripheral blood will be obtained during the study

Study groups in NCT02320357
Study groupRoleWhat they receive
ClopidogrelExperimentalNot described
Receives: Drug: Treatment by clopidogrel

What is being measured

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

  1. Measurements of plasmatic sCD40L levels

    Measured: 12 weeks afther the inclusion (D0)

Secondary outcomes (7)

  1. Measurements of plasmatic sCD40L levels

    Measured: At 1 month before the inclusion (M-1) and at 24 hours, 7 days, 4, 8 and 16 weeks after the inclusion (D0)

  2. Measurements of IFN inducible genes by RT-PCR in circulating monocytes

    Measured: At the inclusion (D0) and 12 weeks after the inclusion (D0)

  3. Measurements of platelet activation markers by flow cytometry

    Measured: 12 weeks afther the inclusion (D0)

  4. Measurements of platelet/circulating mononuclear cells aggregates by flow cytometry

    Measured: At 7 days and 12 weeks after the inclusion (D0)

  5. Measurements of T lymphocytes activation by flow cytometry

    Measured: At 7 days and 12 weeks after the inclusion (D0)

  6. Rate of haemorrhagic side effects during the follow up

    Measured: At 24 hours, 7 days, 4, 8, 12 and 16 weeks after the inclusion (D0)

  7. Measurements of inflammation markers, antiantibodies levels, complement fractions

    Measured: At 24 hours, 7 days, 4, 8, 12 and 16 weeks after the inclusion (D0)

Timeline

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

  1. First posted19 Dec 2014 (estimated)
  2. Study start19 Aug 2015
  3. Primary completion11 Sep 2017
  4. Study completion11 Sep 2017

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02320357
Sponsor's protocol ID
CHUBX 2013/27
Other IDs
2014-003733-25, 2014
Acronym
CLOPUS
Status last verified
Oct 2017
First submitted
16 Dec 2014
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No

Publications

  • Scherlinger M, Guillotin V, Truchetet ME, Contin-Bordes C, Sisirak V, Duffau P, Lazaro E, Richez C, Blanco P. Systemic lupus erythematosus and systemic sclerosis: All roads lead to platelets. Autoimmun Rev. 2018 Jun;17(6):625-635. doi: 10.1016/j.autrev.2018.01.012. Epub 2018 Apr 7.

    PubMed 29635077

  • Vial G, Gensous N, Savel H, Richez C, Lazaro E, Truchetet ME, Bonnet F, Pellegrin I, Thiebaut R, Blanco P, Duffau P. The impact of clopidogrel on plasma-soluble CD40 ligand levels in systemic lupus erythematosus patients: the CLOPUS phase I/II pilot study. Joint Bone Spine. 2021 Mar;88(2):105097. doi: 10.1016/j.jbspin.2020.105097. Epub 2020 Nov 2. No abstract available.

    PubMed 33152483

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Treatment by clopidogrel in people with Systemic Lupus Erythematous, run by University Hospital, Bordeaux 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 3 inclusion and 18 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 14 May 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

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

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?

Measurements of plasmatic sCD40L levels (time frame: 12 weeks afther the inclusion (D0)). 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 NCT02320357, which also lists 2 linked publications.

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 14 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in