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New combo therapy aims to halt lung scarring in scleroderma

NCT ID NCT07491523

Disease control Sponsor: University of Patras Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is for people with scleroderma who also have lung scarring (interstitial lung disease). It compares two treatments: a double immunosuppression regimen (rituximab plus mycophenolate mofetil) versus the same double therapy plus an anti-fibrotic drug (nintedanib or pirfenidone). The goal is to see if adding the anti-fibrotic better preserves lung function over one year. About 35 participants will be followed with regular breathing tests.

What this could mean

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

Active substance
Rituximab, mycophenolate mofetil, and either nintedanib or pirfenidone
What this could lead to
If it works, this could point toward a better treatment combination to slow lung damage in people with scleroderma-related lung disease.
What could go wrong
This is a small, early-phase study with only 35 participants, so results may not apply to everyone. Adding an anti-fibrotic drug may also increase side effects like stomach issues or fatigue.

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 35 people

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

Started

Jun 2025

Expected to finish

Mar 2027

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

Patients with ssc-ild

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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:ild-ssc with double immunosuppression \- Exclusion Criteria: * ssc without ild

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Conditions

The condition(s) this trial relates to.

pulmonary systemic sclerosis systemic sclerosis

As listed by the trial registrant

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

SSC-systemic sclerosis

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

  • University of patras

    RECRUITING

    Pátrai, Greece

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