Phase 3
N=435
A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Lung Diseases, Interstitial
Bottom Line
View on ClinicalTrials.gov: NCT03820726 ↗Enrolled (actual)
435
Serious AEs
53.9%
Results posted
Sep 2023
Primary outcome: Primary: Number of Participants With Any Adverse Events — 417 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nintedanib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Adverse Events |
417 | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03820726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.