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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
Be older than 18 years old
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
Pivotal Trial
No Placebo-Only Group

Summary

This trial aims to evaluate the safety of taking nintedanib by mouth in patients with a lung disease linked to Systemic Sclerosis. Nintedanib helps reduce lung damage by slowing down the formation of scar tissue. The focus is on patients who have this specific lung condition because it can be difficult to treat with standard therapies.

Eligible Conditions
  • Interstitial Lung Disease

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

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

Side effects data

From 2021 Phase 3 trial • 752 Patients • NCT01619085
70%
Diarrhoea
23%
Cough
21%
Nasopharyngitis
21%
Idiopathic pulmonary fibrosis
20%
Nausea
20%
Bronchitis
20%
Viral upper respiratory tract infection
17%
Weight decreased
16%
Dyspnoea
15%
Upper respiratory tract infection
14%
Decreased appetite
13%
Pneumonia
12%
Vomiting
9%
Fatigue
9%
Abdominal pain
8%
Constipation
8%
Back pain
7%
Pulmonary hypertension
7%
Abdominal pain upper
7%
Oedema peripheral
7%
Arthralgia
7%
Hypertension
7%
Dizziness
6%
Headache
6%
Pyrexia
6%
Respiratory tract infection
5%
Asthenia
5%
Lower respiratory tract infection
5%
Respiratory failure
5%
Chest pain
5%
Rhinitis
5%
Productive cough
5%
Insomnia
5%
Lung infection
5%
Influenza
4%
Anxiety
4%
Cataract
3%
Myalgia
2%
Hypoxia
2%
Pneumothorax
2%
Pulmonary embolism
2%
Pulmonary fibrosis
2%
Acute respiratory failure
2%
Cardiac failure
2%
Lung neoplasm malignant
1%
Atrial fibrillation
1%
Haemoptysis
1%
Cardiac arrest
1%
Cardiac failure congestive
1%
Cor pulmonale
1%
Coronary artery disease
1%
Coronary artery stenosis
1%
Right ventricular failure
1%
Interstitial lung disease
1%
Inguinal hernia
1%
Sudden death
1%
Cholecystitis acute
1%
Pneumonia bacterial
1%
Sepsis
1%
Fall
1%
Rib fracture
1%
Dehydration
1%
Lung adenocarcinoma
1%
Prostate cancer
1%
Small cell lung cancer
1%
Squamous cell carcinoma of skin
1%
Syncope
1%
Pulmonary arterial hypertension
1%
Renal failure
1%
Benign prostatic hyperplasia
1%
Gastrointestinal haemorrhage
1%
Basal cell carcinoma
1%
Transient ischaemic attack
1%
Myocardial infarction
1%
Cholelithiasis
1%
Urinary tract infection
1%
Femur fracture
1%
Squamous cell carcinoma
1%
Acute kidney injury
1%
Pulmonary oedema
1%
Acute myocardial infarction
1%
Angina pectoris
1%
Myocardial ischaemia
1%
Haemorrhoids
1%
Pancreatitis
1%
Multiple organ dysfunction syndrome
1%
Hepatic enzyme increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Total (1199.32/.34)
Nintedanib 150 Bid (1199.35/.187)
Total (1199.32/.34/.35/.187)
Placebo (1199.32/.34)
Placebo (1199.187)
Nintedanib 100 Bid (1199.35)
Total (1199.35/.187)
Nintedanib 150 Bid (1199.32/.34)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~3950

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,548 Previous Clinical Trials
14,400,857 Total Patients Enrolled
~56 spots leftby Nov 2025
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