Systemic SclerosisSCLEROKINENCT03537105
Analysis of Cytokine Expression Pattern in Systemic Sclerosis
A study testing Skin biopsies in people with Systemic Sclerosis, run by Poitiers University Hospital at 1 site in France.
Trial summary
By contrast to other proinflammatory cytokines which are found up-regulated in the skin of patients with psoriasis, atopic dermatitis or systemic sclerosis, IL-34 is the only cytokine that undergoes down-regulation. This finding is interesting regarding the description of IL-34 as an immunosuppressive cytokine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Skin biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2018to 4 Sep 2019
- 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
- Age ≥ 18 year-old
- Diagnosis of systemic sclerosis according to ACR/EURAL 2013 criteria.
- Skin sclerosis reaching an area over finger bases of hands and feet
- Free subject, without neither guardianship, wardship nor subordination
- Patient with Social Security
- Informed and signed consent by the patient after clear and loyal information on the study
Who cannot join
- Age < 18 year-old
- Patients that do not fit the ACR/EURAL 2013 criteria
- Patients under immunosuppressive treatment
- Sclerosis limited to fingers of hands and feets.
- Patient without Social Security
- Pregnant and nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Cytokine Expression Pattern in Systemic Sclerosis: Study of the Role of Interleukine-34
By contrast to other proinflammatory cytokines which are found up-regulated in the skin of patients with psoriasis, atopic dermatitis or systemic sclerosis, IL-34 is the only cytokine that undergoes down-regulation. This finding is interesting regarding the description of IL-34 as an immunosuppressive cytokine. In this study, the expression and the role of interleukin-34 (IL-34) will be investigated in the physiopathology of systemic sclerosis.
Read the detailed description
The mechanisms involved in the physiopathology of systemic sclerosis (SSc) are not fully understood, particularly the pattern of cytokine expression in the skin of SSc patients. These cytokines are known to play a central role in the regulation of numerous inflammatory diseases and, among them, IL-34 is the only cytokine which has been found to be down-regulated in other skin inflammatory disorders such psoriasis or atopic dermatitis. IL-34 has been described as an immunosuppressive cytokine, and our preliminary results show that IL-34 is active on fibroblasts, a key cell that undergoes dysfunction in SSc. Thus, we are willing to explore its expression profile in the skin of SSc patients and its potential role in the physiopathology of the disease. For this study, we will analyze IL-34 mRNA levels in the skin and the plasma of SSc patients by comparison to healthy patients. Thirty patients will be included in the Internal Medicine Unit of the CHU de Poitiers during a single visit, in the frame of their medical follow-up, to collect two skin biopsies and 5 ml of blood after obtaining their informed consent. The expression of IL-34 will also be investigated at the protein level by immunostaining on skin sections and by ELISA (skin protein lysates and plasma). Moreover, the expression of other proinflammatory cytokines will be investigated both at the mRNA and protein levels.
- Conditions
- Systemic Sclerosis
- Being tested
- Skin biopsies
- Keywords
- cytokine, skin inflammation
- Medical subject headings
- Scleroderma, Systemic, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsiesProcedure or surgery
Also called Serum collection
Two skin biopsies (4mm punch) are performed under local anesthesia at the site of cutaneous inflammation/fibrosis.
| Study group | Role | What they receive |
|---|---|---|
| Sclerodermic patients | Experimental | Sclerodermic patients presenting cutaneous fibrosis Receives: Procedure: Skin biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin IL-34 mRNA expression levels
Skin IL-34 mRNA expression levels (expressed in % of relative expression of GAPDH) in systemic sclerosis patients by comparison with healthy subjects. Skin biopsies are collected at D0 for SSc patients (inclusion day)
Measured: 1 day
Secondary outcomes (3)
Immunostainings against IL-34 and other cytokines on skin sections
Immunostainings against IL-34 and other cytokines on skin sections from systemic sclerosis patients versus healthy skins
Measured: 1 day
Protein expression levels of IL-34 and other cytokines by ELISA
Protein expression levels of IL-34 and other cytokines by ELISA (quantitative study) in plasma and lysates of skin biopsies from systemic sclerosis patients versus
Measured: 1 day
Skin IL-34 mRNA expression levels of other cytokines
Skin IL-34 mRNA expression levels of other cytokines in patients with systemic sclerosis compared to healthy patients.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start12 Jul 2018
- Primary completion4 Sep 2019
- Study completion4 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Sclerodermic patients
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Poitiers
- Responsible party
- Sponsor
- Investigators
- Jean-François Jégou, PhD, Study director, University of Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537105
- Sponsor's protocol ID
- SCLEROKINE
- Acronym
- SCLEROKINE
- Status last verified
- Apr 2020
- First submitted
- 15 May 2018
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Cytokine Expression Pattern in Systemic Sclerosis: Study of the Role of Interleukine-34
- ClinicalTrials.gov ID
- NCT03537105
- Acronym / sponsor ID
- SCLEROKINE / SCLEROKINE
- Conditions
- Systemic Sclerosis
- Keywords
- cytokine, skin inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- University of Poitiers
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 4 Sep 2019 (actual)
- Study completion
- 4 Sep 2019 (actual)
- First posted
- 25 May 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.
By contrast to other proinflammatory cytokines which are found up-regulated in the skin of patients with psoriasis, atopic dermatitis or systemic sclerosis, IL-34 is the only cytokine that undergoes down-regulation. This finding is interesting regarding the description of IL-34 as an immunosuppressive cytokine. In this study, the expression and the role of interleukin-34 (IL-34) will be investigated in the physiopathology of systemic sclerosis.
Detailed description
The mechanisms involved in the physiopathology of systemic sclerosis (SSc) are not fully understood, particularly the pattern of cytokine expression in the skin of SSc patients. These cytokines are known to play a central role in the regulation of numerous inflammatory diseases and, among them, IL-34 is the only cytokine which has been found to be down-regulated in other skin inflammatory disorders such psoriasis or atopic dermatitis. IL-34 has been described as an immunosuppressive cytokine, and our preliminary results show that IL-34 is active on fibroblasts, a key cell that undergoes dysfunction in SSc. Thus, we are willing to explore its expression profile in the skin of SSc patients and its potential role in the physiopathology of the disease. For this study, we will analyze IL-34 mRNA levels in the skin and the plasma of SSc patients by comparison to healthy patients. Thirty patients will be included in the Internal Medicine Unit of the CHU de Poitiers during a single visit, in the frame of their medical follow-up, to collect two skin biopsies and 5 ml of blood after obtaining their informed consent. The expression of IL-34 will also be investigated at the protein level by immunostaining on skin sections and by ELISA (skin protein lysates and plasma). Moreover, the expression of other proinflammatory cytokines will be investigated both at the mRNA and protein levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sclerodermic patients
| Arm | Type | Receives |
|---|---|---|
| Sclerodermic patients | Experimental | Procedure: Skin biopsiesSclerodermic patients presenting cutaneous fibrosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 year-old
- Diagnosis of systemic sclerosis according to ACR/EURAL 2013 criteria.
- Skin sclerosis reaching an area over finger bases of hands and feet
- Free subject, without neither guardianship, wardship nor subordination
- Patient with Social Security
Key exclusion criteria (6 listed)
- Age < 18 year-old
- Patients that do not fit the ACR/EURAL 2013 criteria
- Patients under immunosuppressive treatment
- Sclerosis limited to fingers of hands and feets.
- Patient without Social Security
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 |
|---|---|---|
| Skin biopsiesAlso: Serum collectionTwo skin biopsies (4mm punch) are performed under local anesthesia at the site of cutaneous inflammation/fibrosis. | Procedure or surgery | Sclerodermic patients |
Primary outcome
Skin IL-34 mRNA expression levels
Time frame: 1 day
Skin IL-34 mRNA expression levels (expressed in % of relative expression of GAPDH) in systemic sclerosis patients by comparison with healthy subjects. Skin biopsies are collected at D0 for SSc patients (inclusion day)
3 secondary outcomes
Immunostainings against IL-34 and other cytokines on skin sections
Time frame: 1 day
Protein expression levels of IL-34 and other cytokines by ELISA
Time frame: 1 day
Skin IL-34 mRNA expression levels of other cytokines
Time frame: 1 day
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 21 Apr 2020.
- Individual participant dataSharing planned: Undecided
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A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
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Recruiting
Tissue Modeling in Systemic Sclerosis Using Induced Pluripotent Stem Cells (iPSCs)
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Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
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RecruitingPhase 1
A Study of ATG-201 in Adult Participants With Autoimmune Diseases
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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.
Jean-François Jégou, PhD study director
University of Poitiers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsies in people with Systemic Sclerosis, run by Poitiers University Hospital 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 6 inclusion and 6 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 21 Apr 2020. 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?
Skin IL-34 mRNA expression levels (time frame: 1 day). 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 21 Apr 2020; AzTrials last refreshed its copy on 31 Oct 2026.