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Lung disease drug tested in rare muscle condition – trial cut short

NCT ID NCT05335278

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested the drug nintedanib (Ofev) in 11 people with myositis-related interstitial lung disease, a condition where lung scarring occurs alongside muscle inflammation. The goal was to see if the drug is safe and tolerable when added to standard immune-suppressing treatments. The trial was terminated early, so results are limited.

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 could show that adding nintedanib to standard care is safe and tolerable for people with myositis-related lung disease, potentially slowing disease progression.
What could go wrong
The trial was terminated early with only 11 participants, so results are very limited. It was a small, early-stage safety study, not designed to prove effectiveness.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

11 people

The number who actually took part.

Started

Jun 2021

Finished

Apr 2025

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.

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: * 1\. 18 years and older 2. Diagnosis of autoimmune myopathy (dermatomyositis, polymyositis, overlap myositis or anti-synthetase syndrome) as diagnosed by a rheumatologist. 3\. Interstitial lung disease confirmed by high resolution CT scan (Extent of disease 10% or more on CT done within 12 months of enrolment) with evidence of fibrosis, defined as reticular abnormality with traction bronchiectasis with or without honeycombing. 4\. Evidence of progressive disease within 24 months of screening visit: 1. Clinically significant decline in Forced Vital Capacity (FVC) % pred based on a relative decline of \>=10% 2. Marginal decline in FVC % pred based on a relative decline of .\>=5-\<10% combined with worsening of respiratory symptoms 3. Marginal decline in FVC % pred based on a relative decline of \>=5-\<10% combined with increasing extent of fibrotic changes on chest imaging 4. Worsening of respiratory symptoms such as cough or shortness of breath as well as increasing extent of fibrotic changes on chest imaging as per radiologist or pulmonologist who read the scan 5. Current and ongoing treatment with immunosuppressive medications, on a stable medication regimen and dosage for at least 6 weeks (considered standard of care medical therapy) Concomitant medications allowed are: <!-- --> 1. mycophenolate, 2. azathioprine, 3. tacrolimus, 4. cyclosporine, 5. rituximab (injection within the last year), 6. prednisone low dose =\<20 mg daily, 7. Intravenous immunoglobulins Exclusion Criteria: 1. Contraindication to treatment with nintedanib (based on Canadian labeling) 2. The female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding. 3. The male patient plans to father a child during the course of the study 4. Hypersensitivity to nintedanib, peanut or soy 5. Elevated liver enzymes greater than 1.5 times the upper limit of normal 6. Creatinine clearance \<30 mL/min 7. Patient with risks factors of aneurysm or artery dissection, such as known history of aneurysm or uncontrolled hypertension

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Research Institute McGill University Health Center

    Montreal, Quebec, H4A3J1, Canada

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