Tolerability and Safety of Nintedanib in Myositis Associated Interstitial Lung Disease

NCT ID: NCT05335278

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2025-04-30

Brief 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nintedanib treatment

Single arm treatment with nintedanib

Group Type: EXPERIMENTAL

Nintedanib 150 milligrams [Ofev]

Intervention Type: DRUG

All patients will be given nintedanib 150 milligrams orally twice daily

Interventions

Nintedanib 150 milligrams [Ofev]

All patients will be given nintedanib 150 milligrams orally twice daily

Intervention Type: DRUG

Eligibility Criteria

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:

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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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Deborah Assayag

Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah Assayag, MD

Role: PRINCIPAL_INVESTIGATOR

Research Institute - McGill University Health Center

Locations

Research Institute McGill University Health Center

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2020-5543

Identifier Type: -

Identifier Source: org_study_id