NCT07642297Not yet recruiting
TL1A Inhibition in Systemic Sclerosis-Related Skin Fibrosis and Immunological Alterations: A Proof-of-Concept In Vitro Study (FIBROSTOP)
The Potential Pharmacological Role of the TNF-Like Ligand 1A (TL1A) Inhibition in Modulating Systemic Sclerosis (SSc)-Related Skin Fibrosis and Immunological Alterations: A Proof-of-Concept, In Vitro, Study
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
Systemic Sclerosis (SSc) is a rare autoimmune connective tissue disease characterized by microvascular injury, immune activation, and progressive fibrosis of the skin and internal organs. Diffuse cutaneous SSc (dcSSc), particularly in its early phase, is associated with aggressive fibrotic evolution and high morbidity. Despite advances in immunomodulatory therapy, no treatment has proven capable of consistently halting or reversing fibrosis, highlighting the need for new mechanistic targets. TL1A (TNF-like ligand 1A) is a cytokine of the TNF superfamily expressed by endothelial and immune cells, which interacts with death receptor 3 (DR3) to regulate immune activation, endothelial dysfunction, and tissue remodeling. Elevated TL1A levels have been observed in SSc patients and correlate with disease activity. TL1A has also been shown to promote lung fibrosis in preclinical models. The FIBROSTOP study is a proof-of-concept, in vitro, interventional study on biological samples aimed at elucidating the immunological and fibrotic mechanisms regulated by TL1A, and at assessing whether TL1A inhibition can reverse pathogenic processes in SSc. Ten (n=10) patients with early diffuse cutaneous SSc and ten (n=10) age- and sex-matched healthy controls will be enrolled at a single center (Fondazione Policlinico Universitario Campus Bio-Medico, Rome). Each participant will undergo a single visit (T0) involving peripheral blood sampling and skin biopsy. No follow-up visits are planned. The study pursues three co-primary objectives: (1) evaluating the role of TL1A and its inhibition in modulating T lymphocyte activity; (2) assessing the effects of TL1A and its inhibition on endothelial cell activation and function; (3) investigating the impact of TL1A and its inhibition on fibrotic remodeling in ex vivo SSc skin cultures using single-cell RNA sequencing. The findings may inform future targeted antifibrotic interventions in SSc and other fibrotic diseases.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 4 Jun 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT07642297
What you commit to
- Study type: Observational
- Planned participants: 20
- From 1 Sept 2026 to the primary completion date, 1 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe active infection or major surgery within 8 weeks before enrollment
- Non-serious skin infections within 8 weeks before enrollment
Other illness
- Coexisting active or treated skin diseases (e.g., atopic dermatitis), except for SSc
- Diagnosis of other systemic autoimmune rheumatic diseases, including overlap syndromes (e.g., SSc + dermatomyositis)
- History or current signs/symptoms of severe or uncontrolled non-rheumatic diseases
- Active malignancy or history of malignancy within the previous 5 years (except adequately treated non-melanoma skin cancer or in situ cervical carcinoma)
- Chronic or recurrent infections, including viral hepatitis B/C, HIV, or untreated tuberculosis
Other
- Limited cutaneous SSc or SSc sine scleroderma
- SSc patients unable to undergo therapeutic stabilization due to severe organ complications
- Pregnancy or lactation
- Inability to provide informed consent
Who the study is looking for
- For both SSc and healthy control populations:
- Signed written informed consent
- Age ≥18 years at the time of consent
- For SSc population only:
- Diagnosis of SSc according to ACR/EULAR 2013 classification criteria
- Diffuse cutaneous SSc subtype (LeRoy et al., 1988)
- Disease onset (defined as the first non-Raynaud symptom) within 5 years prior to recruitment
- No new initiation of immunosuppressive therapy (including methotrexate, mycophenolate mofetil, cyclophosphamide, rituximab, tocilizumab, or prednisone \>20 mg/day) within the 2 months preceding recruitment
- Ongoing immunosuppressive therapy must be at a stable dose for at least 1 month prior to enrollment
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Immunorheumatology Unit, Fondazione Policlinico Universitario Campus Bio-Medico Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.