Can skin biopsies unlock new treatments for scleroderma?
NCT ID NCT06894654
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This study aims to understand the cellular and molecular mechanisms behind systemic sclerosis (SSc), a rare autoimmune disease that causes skin and organ fibrosis. Researchers will collect skin punch biopsies and blood samples from 500 participants, including those with SSc and healthy volunteers, to analyze gene expression and genetic variations. The goal is to identify novel therapeutic targets for SSc and related connective tissue diseases.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Skin punch biopsy and blood sampling for molecular and genetic analysis
- What this could lead to
- If successful, this could reveal new drug targets for systemic sclerosis and related autoimmune diseases, potentially leading to more effective, personalized treatments.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly test a therapy. Findings may not translate into immediate clinical benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants with either early systemic sclerosis (SSc) or late systemic sclerosis (SSc)
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: SSc participant cohort: 1. Age of 18 years inclusive, or older at the time of signing the informed consent 2. Documented diagnosis of systemic scleroderma (SSc) (early or late diagnosis) Healthy cohort: 1. Approximate age/sex matching (majority of healthy participants to be recruited after cohort 1 and 2) 2. Absence of Raynaud's Phenomenon 3. Absence of lung disease 4. Not on immunosuppressive treatment Exclusion Criteria: SSc participant cohort: 1. Participants unable to provide informed consent. 2. Participants with suspected/established underlying malignancy. 3. Participants with suspected/established skin cancer. 4. Participants with suspected/established bloodborne disease. 5. Current enrolment or past participation in a study involving an investigational drug within 3 months or 5 half-lives of the investigational drug treatment (whichever is longer) before the day of sample collection. 6. Participants treated with cellular therapies, e.g., HSCT, Car-T cells, T cell engagers. 7. Participants treated with B-cell depletion therapies within 6 months. 8. Concurrent diagnosis of any other connective tissue disease (CTD) in overlap. 9. Diagnosis of other non-SSc dermatological conditions. 10. Systemic sclerosis-like illness, including but not limited to localised scleroderma (morphoea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro mucinous conditions (scleredema, scleromyxedema), scleroderma-like conditions that are associated with environmental chemical and drug exposure (e.g., toxic rapeseed oil, vinyl chloride, bleomycin, gadolinium-based contrast agents \[nephrogenic systemic fibrosis\], or due to metabolic disease). 11. History or presence of significant non-sclereoderma related cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurological disorders, or treatments for those, capable of significantly interfering with the results and interpretation of data. 12. Smoking history (5 years smoke free acceptable)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chapel Allerton Hospital
NOT_YET_RECRUITINGLeeds, LS7 4SA, United Kingdom
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Royal Free Hospital
RECRUITINGLondon, NW3 2QG, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can inhaled cell vesicles soothe damaged lungs in autoimmune disease?
- Can a single cell therapy calm multiple autoimmune diseases?
- Could a skin patch ease stomach pain in scleroderma?
- Could a painless microneedle pad ease Raynaud's in scleroderma?
- Can a new pill ease the hardening skin of systemic sclerosis?
- A drug after transplant may stop scleroderma from coming back