Actively Recruiting
A Double Blind, Randomised, Placebo-controlled Trial Evaluating Nerandomilast in Patients With Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases Over At Least 26 Weeks
Led by Boehringer Ingelheim · Updated on 2026-05-29
400
Participants Needed
158
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial studies adults 18 years and older with lung fibrosis caused by systemic autoimmune rheumatic diseases SARD-ILD. It focuses on people whose lung function has not improved after standard immunosuppressant treatment. The study aims to learn how the medicine nerandomilast affects lung health in these patients by comparing it to a placebo, with the trial sponsored by Boehringer Ingelheim. Participants are randomly assigned to one of two groups one takes nerandomilast tablets and the other takes placebo tablets that look identical but contain no medicine. They take the tablets twice daily for at least 26 weeks and up to one year while continuing their usual immunosuppressive therapy. The trial is double-blind and placebo-controlled to fairly evaluate the effects of nerandomilast. Each participant stays in the study for about 7.5 to 13 months, depending on when they start. During this time, they visit the study site 9 to 10 times for lung function tests and chest imaging at select visits. They also complete questionnaires about symptoms and quality of life. The researchers monitor health regularly and record any side effects. The main outcome is the change in lung disease extent measured by CT scans after 26 weeks.
CONDITIONS
Brief Title
A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of systemic autoimmune rheumatic diseases associated interstitial lung disease (SARD-ILD) by a qualified physician
- Presence of fibrotic interstitial lung disease on high-resolution CT with disease extent over 10%
- No improvement in lung function (FVC % predicted) greater than 5% in the past 15 months
- No clinically significant improvement in lung disease based on clinician judgement
- FVC at least 45% of predicted normal at screening
- DLCO at least 25% of predicted normal corrected for hemoglobin
- Stable immunosuppressant treatment for at least 6 months (3 months for idiopathic inflammatory myopathy-ILD)
- Stable prednisone dose for at least 4 weeks if used
- Completed rituximab cycle over 6 months before screening if used
- Stable nintedanib dose for at least 12 weeks if used
- No planned change in background immunosuppressant or immunomodulator treatment
You will not qualify if you...
- Organising pneumonia as the main pattern on CT
- Prebronchodilator FEV1/FVC ratio less than 0.7 at screening
- Acute ILD exacerbation within 3 months before screening
- Active or uncontrolled vasculitis within 8 weeks before screening
- Any suicidal behavior in the past 2 years
- Suicidal ideation of type 4 or 5 on C-SSRS within past 3 months or at screening
- Use of cyclophosphamide within 6 months before screening
- Use of pirfenidone within 8 weeks before screening
Research Team
B
Boehringer Ingelheim
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