RCT of Nintedanib in Fibrotic Sarcoidosis

Sarcoidosis is generally managed with outdoor immune modulatory drugs, most commonly oral steroids and at times drugs like methotrexate or azathioprine as a steroid sparing agent. Around 15-20% of sarcoidosis patient develop fibrosis of the lung parenchyma. The effect of antifibrotics in such patients needs more studies. Nintedanib has been used with good results in patients with fibrosing interstitial lung disease like IPF, SSC- ILD, and other progressive fibrosing ILD. By using nintedanib in fibrotic sarcoidosis it may be possible to limit the functional disability in these patients by slowing the rate of fibrosis and loss of lung function. The use of nintedanib if results in decrease in fibrosis and consequent decline in loss of lung function then it may be a safe and viable option for such patients. The hypothesis of this study is that in patients with fibrotic sarcoidosis on standard of care anti-inflammatory therapy, nintedanib may help in reducing the rate of decline in lung function and progressive fibrosis. The aim is to evaluate the efficacy and safety of nintedanib in subjects with fibrotic sarcoidosis

NCT Number	NCT06479603
Lead Sponsor	Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions	Sarcoidosis, Pulmonary
Enrollment	120 participants
Start Date	2024-06-30
Primary Completion	2025-12-31 (estimated)
Study Completion	2026-01-31 (estimated)
Updated on ClinicalTrials.gov	2024-10-23