A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
Recruiting
Phase 3
Interventional Study
Interstitial Lung Diseases
Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 400 (estimated)
- Sponsor
- Boehringer Ingelheim · Industry
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About This Trial
Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with syste…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participant has systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD), defined as
* Diagnosis by a rheumatologist (or equally qualified medical physician) with at least 1 of the following SARDs: Rheumatoid arthritis (RA), systemic sclerosis…
Contacts