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Could blocking TL1A stop skin scarring in scleroderma? early lab study hints at possibility

NCT ID NCT07642297

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test if blocking a protein called TL1A can reverse skin scarring in systemic sclerosis, a rare autoimmune disease. Researchers will take blood and skin samples from 10 patients with early diffuse scleroderma and 10 healthy people. They will treat the samples in the lab to see if blocking TL1A reduces immune activity, blood vessel damage, and fibrosis. This is a very early, proof-of-concept study — no treatment is given to participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TL1A neutralizing antibody and DR3 silencing (in lab, not given to participants)
What this could lead to
If successful, this could point toward a new treatment target for systemic sclerosis and other fibrotic diseases.
What could go wrong
This is a very early, small lab study using cells and skin samples, not a treatment trial. Results may not translate to real patients.

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

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Ten patients with early diffuse cutaneous Systemic Sclerosis (dcSSc) fulfilling the 2013 ACR/EULAR classification criteria and the LeRoy subset definition, with disease onset ≤5 years from the first non-Raynaud symptom, consecutively recruited from the Scleroderma Unit of Fondazione Policlinico Universitario Campus Bio-Medico, Rome. Ten age- and sex-matched healthy controls without SSc diagnosis, donating peripheral blood and residual skin tissue from elective surgical procedures or voluntary donation.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: 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 Exclusion Criteria: * 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 * Severe active infection or major surgery within 8 weeks before enrollment * Non-serious skin infections within 8 weeks before enrollment * 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

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Conditions

The condition(s) this trial relates to.

diffuse cutaneous systemic sclerosis diffuse scleroderma Fibrosis systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse cutaneous systemic sclerosis Skin fibrosis Systemic sclerosis (SSC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Immunorheumatology Unit, Fondazione Policlinico Universitario Campus Bio-Medico

    Rome, Italy, 00128, Italy

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Other studies related to the condition(s) this trial covers.