RCT of Nintedanib in Fibrotic Sarcoidosis

PHASE4RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

June 30, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

January 31, 2026

Conditions
Sarcoidosis, Pulmonary
Interventions
DRUG

Nintedanib

The subjects will receive oral nintedanib. It will be prescribed to be taken after meals with 12 hrs gap between doses. The drug will be started at a dose of 100 mg twice daily. After 2 weeks, the dose will be titrated up to 150 mg twice daily, which will be continued till the end of 52 weeks. The standard-of-care immunosuppressive treatment will be continued along with the study drug (nintedanib). In case of intolerance to the 300 mg/day dose of nintedanib, the dose will be reduced to 100 mg twice daily. In case of severe adverse effects, the drug will be stopped and reintroduced after a period of up to 1-4 weeks. A dose of 100 mg twice daily will be started and continued. One attempt to titrate the dose up to 150 mg twice daily will be permitted.

DRUG

Standard of care

The subjects will receive the standard-of-care immunosuppressive treatment alone that may include glucocorticoids and other steroid-sparing agents that the subject would already be receiving.

Trial Locations (1)

Unknown

RECRUITING

Postgraduate Institute of Medical Education and Research, Chandigarh

All Listed Sponsors
lead

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER