A Phase 3 interventional study of Nintedanib in Lung Diseases, Interstitial, sponsored by Boehringer Ingelheim. Completed at 159 sites in 30 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
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Among 11 studies testing nintedanib in Lung Diseases, Interstitial — 1 open to participants now, 1 under way, 1 of them phase 3. nintedanib · Lung Diseases, Interstitial.
Among the 11 studies testing nintedanib in Lung Diseases, Interstitial, this one is the 2nd largest by enrollment, is one of 2 that started in 2017, is one of 8 in phase 3, and was the 2nd registered.
681 studies on the registry are indexed under Lung Diseases, Interstitial; 245 are open to participants now.
Browse Lung Diseases, Interstitial studies →1 of the 11 studies testing nintedanib in Lung Diseases, Interstitial is open now, in 1 country. Recruiting first, the newest first:
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · Sites in Poland
Ages 18–74
By country, each count listing its studies:
nintedanib: first FDA approval 2014 (OFEV), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
Of the 172 Lung Diseases, Interstitial studies recruiting now, 108 (63%) set no upper age limit and 25 (15%) stop at 75 or younger; 13 take children under 18; 21 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 2 started in 2017.
This study's enrollment of 444 is above the median of 60 across 385 interventional studies indexed under Lung Diseases, Interstitial.
Median enrollment 81 across the 11 interventional studies. Of the 9 that completed or were terminated, 8 (89%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 11 have an industry lead sponsor. The 6 most frequent:
Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 61 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 123 (73%) have results posted.
24 studies in Lung Diseases, Interstitial by Boehringer Ingelheim: 4 open now, 6 under way, 4 of them phase 3. Of 16 finished, 11 (69%) have results posted.
Among the 24 studies in Lung Diseases, Interstitial by Boehringer Ingelheim, this one is the 4th largest by enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2017, is one of 11 in phase 3, and was the 2nd registered.
Boehringer Ingelheim’s Lung Diseases, Interstitial studies by the year they started, since 2017.
None of the studies under way reaches primary completion within a year.
Among the 11 studies testing nintedanib in Lung Diseases, Interstitial, from their registry updates:
Among Boehringer Ingelheim’s 24 in Lung Diseases, Interstitial:
This tab as a report to print or save as PDF → With an account.
The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Bleeding risk, any of the following
Patients who require
Any of the following after last treatment of 1199.214/1199-0340:
New major thrombo-embolic events developed after completion of the parent trial 1199.214/1199-0340:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Nintedanib
Administered twice daily
Also known as: OVEF
Number of Patients With Any Adverse Event (AE) Over the Course of the Trial
Number of patients with any adverse event (AE) over the course of the trial.
Time frame: First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to approximate 60 months.
This was a prospective, open-label extension trial to assess long-term safety and tolerability of nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) who had completed treatment (including the follow-up visit or end of treatment/study visit, respectively) of the randomised, double-blind, placebo-controlled parent trial 1199.214 or trial 1199-0340.
| Milestone | Nintedanib |
|---|---|
| Started | 444 |
| Completed | 265 |
| Not completed | 179 |
| Withdrew: Adverse event | 120 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Withdrawal by subject | 39 |
| Withdrew: Other than listed above | 15 |
| Withdrew: Covid-19 related | 2 |
Number of patients with any adverse event (AE) over the course of the trial.
| Participants | Nintedanib |
|---|---|
| Number of Patients With Any Adverse Event (AE) Over the Course of the Trial | 441 |
Collected over First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nintedanib | 23/444 (5.2%) | 198/444 (44.6%) | 425/444 (95.7%) |
| Event | Nintedanib |
|---|---|
| PneumoniaInfections and infestations | 26/444 |
| Pulmonary hypertensionRespiratory, thoracic and mediastinal disorders | 17/444 |
| Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders | 13/444 |
| COVID-19Infections and infestations | 9/444 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 9/444 |
| Pulmonary arterial hypertensionRespiratory, thoracic and mediastinal disorders | 9/444 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 8/444 |
| Skin ulcerSkin and subcutaneous tissue disorders | 8/444 |
| Cardiac failureCardiac disorders | 7/444 |
| Pulmonary fibrosisRespiratory, thoracic and mediastinal disorders | 7/444 |
| Event | Nintedanib |
|---|---|
| DiarrhoeaGastrointestinal disorders | 338/444 |
| NauseaGastrointestinal disorders | 122/444 |
| Skin ulcerSkin and subcutaneous tissue disorders | 110/444 |
| VomitingGastrointestinal disorders | 100/444 |
| CoughRespiratory, thoracic and mediastinal disorders | 83/444 |
| NasopharyngitisInfections and infestations | 82/444 |
| Upper respiratory tract infectionInfections and infestations | 76/444 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 75/444 |
| COVID-19Infections and infestations | 68/444 |
| Weight decreasedInvestigations | 63/444 |
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication
| Age, Continuous(years) | Nintedanib |
|---|---|
| Mean | 55.0 ± 11.9 |
| Sex: Female, Male(Participants) | Nintedanib |
|---|---|
| Female | 335 |
| Male | 109 |
| Ethnicity (NIH/OMB)(Participants) | Nintedanib |
|---|---|
| Hispanic or Latino | 38 |
| Not Hispanic or Latino | 406 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Nintedanib |
|---|---|
| American Indian or Alaska Native | 4 |
| Asian | 110 |
| Native Hawaiian or Other Pacific Islander | 2 |
| Black or African American | 18 |
| White | 308 |
| More than one race | 2 |
| Unknown or Not Reported | 0 |
Showing the first 100 of 159 sites across 30 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Data sharing details ↗ · www.mystudywindow.com
Ran from Nov 2017 to primary completion in Jan 2023, 61 months.
Results were first posted in Feb 2024, 1 year after primary completion.
Of 36 phase 3 interventional studies under Lung Diseases, Interstitial, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 61. This study's 61 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nintedanib