Lung Diseases, Interstitial
Conditions
Brief 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).
Interventions
DRUGNintedanib
Bid
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Events | From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days. | Number of participants with adverse events over the course of the extension trial, AEs defined as any untoward medical occurrence in a patient administered with the investigational product and which does not necessarily have to have a causal relationship with this treatment. |
Countries
Argentina, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Poland, Russia, South Korea, Spain, United Kingdom, United States
Participant flow
Recruitment details
A phase III, open label, extension trial. The study aimed to evaluate the long-term tolerability and safety of oral nintedanib treatment in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have completed (and did not prematurely discontinue trial medication in) the phase III parent trial, 1199.247 (INBUILD®) NCT02999178.
Pre-assignment details
Only patients with PF-ILD who completed the parent trial (INBUILD®) on treatment (i.e., did not discontinue treatment early) were eligible and were included in this trial if they fulfilled all the inclusion criteria and did not present any of the exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Nintedanib Patients taking 150 milligram (mg) bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib 150 mg bid in this extension trial. Patients taking 100 mg bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib in this extension trial either at 100 mg bid or at an increased dose of 150 mg bid at the discretion of the investigator orally as soft gelatine capsule, twice daily (bid), together with a glass of water (\
250 mL), in a dose interval of 12 hours. With an optional dose reduction to 100 mg bid temporarily or permanently to manage adverse events (AEs). The treatment had a duration of 96 weeks or until nintedanib was made available to the patients outside of the clinical trial. Treatment was stopped if any reason for withdrawal was met. | 434 |
| Total | 434 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 146 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Not treated | 1 |
| Overall Study | Other than listed | 23 |
| Overall Study | Protocol deviation | 1 |
| Overall Study | Withdrawal by Subject | 37 |
Baseline characteristics
| Characteristic | Nintedanib |
|---|---|
| Age, Continuous | 65.9 Years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 65 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 328 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 41 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 108 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 41 Participants |
| Race (NIH/OMB) White | 279 Participants |
| Sex: Female, Male Female | 211 Participants |
| Sex: Female, Male Male | 223 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 83 / 434 |
| other Total, other adverse events | 371 / 434 |
| serious Total, serious adverse events | 234 / 434 |
Outcome results
Primary
Number of Participants With Any Adverse Events
Number of participants with adverse events over the course of the extension trial, AEs defined as any untoward medical occurrence in a patient administered with the investigational product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Population: Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nintedanib | Number of Participants With Any Adverse Events | 417 Participants |