Status:
RECRUITING
DERMATOMICS: Identifying Regulators of Skin Homeostasis
Lead Sponsor:
Relation Therapeutics
Conditions:
Systemic Sclerosis (SSc)
Eligibility:
All Genders
18+ years
Brief Summary
Diseases of the skin associated with chronic immune driven conditions, including scleroderma, lupus, dermatomyositis, psoriasis, and atopic dermatitis, significantly impact skin integrity, function, a...
Eligibility Criteria
Inclusion
- SSc participant cohort:
- Age of 18 years inclusive, or older at the time of signing the informed consent
- Documented diagnosis of systemic scleroderma (SSc) (early or late diagnosis)
- Healthy cohort:
- Approximate age/sex matching (majority of healthy participants to be recruited after cohort 1 and 2)
- Absence of Raynaud's Phenomenon
- Absence of lung disease
- Not on immunosuppressive treatment
Exclusion
- SSc participant cohort:
- Participants unable to provide informed consent.
- Participants with suspected/established underlying malignancy.
- Participants with suspected/established skin cancer.
- Participants with suspected/established bloodborne disease.
- 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.
- Participants treated with cellular therapies, e.g., HSCT, Car-T cells, T cell engagers.
- Participants treated with B-cell depletion therapies within 6 months.
- Concurrent diagnosis of any other connective tissue disease (CTD) in overlap.
- Diagnosis of other non-SSc dermatological conditions.
- 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).
- 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.
- Smoking history (5 years smoke free acceptable)
Key Trial Info
Start Date :
December 10 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2030
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06894654
Start Date
December 10 2024
End Date
November 1 2030
Last Update
July 28 2025
Active Locations (2)
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1
Chapel Allerton Hospital
Leeds, United Kingdom, LS7 4SA
2
Royal Free Hospital
London, United Kingdom, NW3 2QG