A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

• Status: Active, not recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

Summary

The main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Nintedanib

Criteria

Inclusion Criteria:

• Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.

• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

• Women of childbearing potential (WOCBP)1 must continue to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method, for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information

Exclusion Criteria:

• Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of the INBUILD® trial. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in INBUILD®, if the investigator's benefit-risk assessment remains favourable.

• Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial

• Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator's judgement.

• Previous enrolment in this trial. Further exclusion criteria apply.