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New study tracks how well nintedanib works over time for scleroderma lung disease

NCT ID NCT07080125

Disease control Sponsor: Boehringer Ingelheim 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 2,000 people with systemic sclerosis (scleroderma) who have lung disease and are taking the drug nintedanib (Ofev®). Researchers want to see how the drug affects lung function, quality of life, and survival over the long term. The study is observational, meaning it just watches what happens in real-world care, without giving anyone a new treatment.

What this could mean

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

Active substance
Nintedanib (Ofev®)
What this could lead to
If successful, this study could confirm that nintedanib helps slow lung decline and improve survival in people with systemic sclerosis-associated lung disease.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It also only includes patients already enrolled in a registry, which may limit how well findings apply to everyone.

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 2,000 people

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

Started

Jun 2025

Expected to finish

Dec 2033

An estimate. End dates often move.

Lead sponsor

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

The study cohort will constitute patients with Systemic Sclerosis (SSc) and Interstitial Lung Disease (ILD) (based on radiological evidence) enrolled in the European Scleroderma Trials and Research (EUSTAR) registry.

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: * Enrolled in the EUSTAR registry * Provided consent at their site to have their data included in the EUSTAR registry for a broad range of research studies, and agree to visit the site every 12 months * Have a diagnosis of ILD defined by radiological findings on High Resolution Computed Tomography (HRCT) and/or X-ray that is documented in the electronic Case Report Form (eCRF) by the treating physician Exclusion Criteria: * Women with Systemic Sclerosis Interstitial Lung Disease (SSc-ILD) who are pregnant, or breastfeeding will be excluded since Ofev® is contraindicated for women who are pregnant due to safety concerns * SSc-ILD patients aged \<18 years: only adults will be included in the study since Ofev® is approved for treatment of SSc-ILD in adults * Patients with a previous Hematopoietic Stem Cell Transplantation (HSCT)

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Conditions

The condition(s) this trial relates to.

interstitial lung disease pulmonary systemic sclerosis

As listed by the trial registrant

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

Interstitial lung diseases Systemic sclerosis associated interstitial lung disease

Contacts and locations

Locations

  • EUSTAR Registry

    Basel, 4051, Switzerland

More trials for these conditions

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