Interstitial Lung DiseaseNCT05335278
Tolerability and Safety of Nintedanib in Myositis Associated Interstitial Lung Disease
A study testing Nintedanib 150 milligrams [Ofev] in people with Interstitial Lung Disease and Myopathy, Inflammatory, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
There is likely a role for using anti-fibrotic medications in patients with myositis-associated interstitial lung disease (MA-ILD) to slow down disease progression, especially in patients who have fibrotic and progressive disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Myopathy, Inflammatory
- What is being tested?
- Nintedanib 150 milligrams [Ofev]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Clinically significant decline in Forced Vital Capacity (FVC) % pred based on a relative decline of >=10%
- Marginal decline in FVC % pred based on a relative decline of .>=5-<10% combined with worsening of respiratory symptoms
- Marginal decline in FVC % pred based on a relative decline of >=5-<10% combined with increasing extent of fibrotic changes on chest imaging
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- 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:
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- mycophenolate,
- azathioprine,
- tacrolimus,
- cyclosporine,
- rituximab (injection within the last year),
- prednisone low dose =<20 mg daily,
- Intravenous immunoglobulins
Who cannot join
- Contraindication to treatment with nintedanib (based on Canadian labeling)
- The female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.
- The male patient plans to father a child during the course of the study
- Hypersensitivity to nintedanib, peanut or soy
- Elevated liver enzymes greater than 1.5 times the upper limit of normal
- Creatinine clearance <30 mL/min
- Patient with risks factors of aneurysm or artery dissection, such as known history of aneurysm or uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
Canada1 site
Research Institute McGill University Health Center
Montreal, Quebec, H4A3J1
About this study
There is likely a role for using anti-fibrotic medications in patients with myositis-associated interstitial lung disease (MA-ILD) to slow down disease progression, especially in patients who have fibrotic and progressive disease. These patients however are currently being excluded from clinical trials of anti-fibrotic agents in progressive ILD because of the concomitant use of immunosuppression. The benefit of anti-fibrotic agents is being assessed in other rheumatic diseases and should be assessed in MA-ILD as well. They are a unique group of patients with a heterogeneous disease, and are much more frequently on concomitant immune-modulating therapy. As such, they should be studied on their own in separate clinical trials, and the use of nintedanib should be studied as an addition to standard of care immunosuppression.
The objective of this study is to assess safety and tolerability of nintedanib in patients with MA-ILD.
- Conditions
- Interstitial Lung Disease, Myopathy, Inflammatory
- Being tested
- Nintedanib 150 milligrams [Ofev]
- Medical subject headings
- Lung Diseases, Interstitial, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintedanib 150 milligrams [Ofev]Drug
All patients will be given nintedanib 150 milligrams orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Nintedanib treatment | Experimental | Single arm treatment with nintedanib Receives: Drug: Nintedanib 150 milligrams [Ofev] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability - completed doses
Percentage of subjects who complete 24 weeks on nintedanib. Subjects will be considered to have completed the 24 weeks of the study if they took 90% of the study drug doses.
Measured: 24 weeks
Safety and adverse events
numbers of patients with adverse events during course of the study
Measured: 24 weeks
Secondary outcomes (3)
Change in forced vital capacity
Measured: 24 weeks
Change in diffusion capacity of the lung for carbon monoxide
Measured: 24 weeks
Change in 6 minute walking distance
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Jun 2021
- Primary completion31 Dec 2024
- Study completion30 Apr 2025
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, open label study
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Assayag, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Deborah Assayag, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335278
- Sponsor's protocol ID
- 2020-5543
- Status last verified
- May 2025
- First submitted
- 13 Apr 2022
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Assayag D, Brilland B, Hudson M, Azuelos I, Langlais D, Hirsch A. Tolerability and Safety of Nintedanib and Immunosuppression in Autoimmune Inflammatory Myopathy-Associated Progressive Pulmonary Fibrosis. CHEST Pulm. 2025 Nov 27;4(1):100230. doi: 10.1016/j.chpulm.2025.100230. eCollection 2026 Mar.
PubMed 42548349
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Safety of Nintedanib in Myositis Associated Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT05335278
- Acronym / sponsor ID
- 2020-5543
- Conditions
- Interstitial Lung Disease, Myopathy, Inflammatory
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is likely a role for using anti-fibrotic medications in patients with myositis-associated interstitial lung disease (MA-ILD) to slow down disease progression, especially in patients who have fibrotic and progressive disease. These patients however are currently being excluded from clinical trials of anti-fibrotic agents in progressive ILD because of the concomitant use of immunosuppression. The benefit of anti-fibrotic agents is being assessed in other rheumatic diseases and should be assessed in MA-ILD as well. They are a unique group of patients with a heterogeneous disease, and are much more frequently on concomitant immune-modulating therapy. As such, they should be studied on their own in separate clinical trials, and the use of nintedanib should be studied as an addition to standard of care immunosuppression.
The objective of this study is to assess safety and tolerability of nintedanib in patients with MA-ILD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, open label study
| Arm | Type | Receives |
|---|---|---|
| Nintedanib treatment | Experimental | Drug: Nintedanib 150 milligrams [Ofev]Single arm treatment with nintedanib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
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Key exclusion criteria (7 listed)
- Contraindication to treatment with nintedanib (based on Canadian labeling)
- The female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.
- The male patient plans to father a child during the course of the study
- Hypersensitivity to nintedanib, peanut or soy
- Elevated liver enzymes greater than 1.5 times the upper limit of normal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nintedanib 150 milligrams [Ofev]All patients will be given nintedanib 150 milligrams orally twice daily | Drug | Nintedanib treatment |
Primary outcome
Tolerability - completed doses
Time frame: 24 weeks
Percentage of subjects who complete 24 weeks on nintedanib. Subjects will be considered to have completed the 24 weeks of the study if they took 90% of the study drug doses.
Safety and adverse events
Time frame: 24 weeks
numbers of patients with adverse events during course of the study
3 secondary outcomes
Change in forced vital capacity
Time frame: 24 weeks
Change in diffusion capacity of the lung for carbon monoxide
Time frame: 24 weeks
Change in 6 minute walking distance
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Derived from this study: PubMed 42548349Assayag D, Brilland B, Hudson M, Azuelos I, Langlais D, Hirsch A. Tolerability and Safety of Nintedanib and Immunosuppression in Autoimmune Inflammatory Myopathy-Associated Progressive Pulmonary Fibrosis. CHEST Pulm. 2025 Nov 27;4(1):100230. doi: 10.1016/j.chpulm.2025.100230. eCollection 2026 Mar.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Assayag, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nintedanib 150 milligrams [Ofev] in people with Interstitial Lung Disease and Myopathy, Inflammatory, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability - completed doses (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05335278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.