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

Completed · Phase 3

Conditions studied: Lung Diseases, Interstitial

In brief

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).

Key facts

Study ID

NCT03820726

Run by

Boehringer Ingelheim

People needed

435

Starts

2019-04-16

Expected to finish

2022-08-30

Last updated by the study team

2023-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of California Los Angeles — Los Angeles, California, United States
• University of California Davis — Sacramento, California, United States
• National Jewish Health — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Pulmonary and Sleep of Tampa Bay — Brandon, Florida, United States
• University of Florida College of Medicine — Jacksonville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Pulmonary and Critical Care Associates of Baltimore — Towson, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Mayo Clinic, Rochester — Rochester, Minnesota, United States
• The Lung Research Center, LLC — Chesterfield, Missouri, United States
• Creighton University — Omaha, Nebraska, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Columbia University Medical Center-New York Presbyterian Hospital — New York, New York, United States
• NewYork-Presbyterian/Weill Cornell Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Oregon Clinic — Portland, Oregon, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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