Lung disease drug tested in rare muscle condition – trial cut short
NCT ID NCT05335278
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
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11 people
The number who actually took part.
- Started
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Jun 2021
- Finished
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Apr 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Research Institute McGill University Health Center
Montreal, Quebec, H4A3J1, Canada
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