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Tyrosine Kinase Inhibitor

Nintedanib for Interstitial Lung Disease

Phase 3
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Further inclusion criteria apply
Patients who completed the parent trial 1199.214/1199-0340 per protocol and did not permanently discontinue study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to approximate 60 months.
Awards & highlights

Study Summary

This trial will study the long-term safety of a drug called nintedanib in patients with a lung disease called SSc-ILD.

Eligible Conditions
  • Interstitial Lung Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to approximate 60 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and first trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to approximate 60 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients With Any Adverse Event (AE) Over the Course of the Trial

Side effects data

From 2017 Phase 4 trial • 105 Patients • NCT02579603
31%
Diarrhoea
16%
Dyspnoea
12%
Vomiting
12%
Nausea
12%
Fatigue
10%
Decreased appetite
8%
Abdominal pain upper
6%
Asthenia
6%
Dizziness
6%
Weight decreased
6%
Abdominal pain
6%
Contusion
6%
Cough
4%
Bronchitis
4%
Nasopharyngitis
2%
Gastrooesophageal reflux disease
2%
Atrial flutter
2%
Transient ischaemic attack
2%
Phlebitis
2%
Constipation
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Pyrexia
2%
Acute respiratory failure
2%
Pancreatitis acute
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nintedanib
Nintedanib + Pirfenidone

Trial Design

1Treatment groups
Experimental Treatment
Group I: NintedanibExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nintedanib
2015
Completed Phase 4
~3680

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,505 Previous Clinical Trials
11,339,848 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations are conducting this research project?

"There are 41 sites participating in this trial, including Thomas Jefferson University in Philadelphia, University of Cincinnati in Cincinnati, Virginia Mason Medical Center in Seattle, and many others."

Answered by AI

Does Nintedanib have the green light from the FDA?

"Nintedanib has received a 3 for safety. This is due to the fact that it is in Phase 3 trials, meaning there is both efficacy and safety data supporting its use."

Answered by AI

Are new patients being accepted into this trial at this time?

"Unfortunately, this particular study has ceased recruiting new patients. The trial was initially posted on November 27th, 2017 and last updated on November 14th, 2020. If you are seeking other studies to participate in, there are 304 trials for pneumonia, interstitial and 22 Nintedanib trials that are currently looking for participants."

Answered by AI

Is this research the first to study this medication?

"There are 22 active clinical trials for nintedanib across 53 cities and 30 countries. The first study occurred in 2012 and was sponsored by Boehringer Ingelheim. It involved 140 participants and completed its Phase 1 & 2 drug approval stage. Since 2012, 91 studies have been completed."

Answered by AI

Can you tell me if Nintedanib has been studied before in other trials?

"At the moment, 22 studies are underway for nintedanib. 5 of those trials are in their third and final phase. Although a majority of the clinical trials for nintedanib originate from Chicago, Illinois, there are actually 281 locations running these sorts of tests."

Answered by AI

What are the usual treatments that Nintedanib is prescribed for?

"Nintedanib is a possible treatment for adenocarcinoma, metastatic non-small cell lung cancer (nsclc) caused by adenocarcinoma, and other related pharmacotherapy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
2017. "A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03313180.
~61 spots leftby Apr 2025
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