A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Boehringer Ingelheim

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial aims to evaluate the safety of taking nintedanib by mouth in patients with a lung disease linked to Systemic Sclerosis. Nintedanib helps reduce lung damage by slowing down the formation of scar tissue. The focus is on patients who have this specific lung condition because it can be difficult to treat with standard therapies.

Eligibility Criteria

Treatment Details

1Treatment groups

Experimental Treatment

Group I: NintedanibExperimental Treatment1 Intervention

Patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) who took part in the parent trials 1199.214 (Nintedanib or Placebo) or 1199-0340 (Nintedanib). Patients continued in this trial and received Nintedanib 150 mg (milligram) twice daily (bid) unless they had reduced their dose to 100 mg bid trial medication (Nintedanib or Placebo) in the parent trial. Patients receiving 100 mg bid trial medication at the end of the parent trial could receive either Nintedanib 100 mg bid or 150 mg bid at the discretion of the investigator.