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Tyrosine Kinase Inhibitor
A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
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
- COVID-19 Pneumonia
- Interstitial Lung Disease
Timeline
Screening ~ 3 weeks3 visits
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.
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.
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 • NCT0161908569%
Diarrhoea
22%
Cough
20%
Idiopathic pulmonary fibrosis
20%
Nasopharyngitis
19%
Bronchitis
19%
Nausea
16%
Weight decreased
16%
Dyspnoea
15%
Upper respiratory tract infection
14%
Decreased appetite
13%
Pneumonia
12%
Vomiting
9%
Fatigue
8%
Abdominal pain
8%
Constipation
8%
Back pain
7%
Hypertension
7%
Oedema peripheral
7%
Arthralgia
6%
Pulmonary hypertension
6%
Abdominal pain upper
6%
Pyrexia
6%
Respiratory tract infection
6%
Headache
6%
Dizziness
5%
Chest pain
5%
Respiratory failure
5%
Asthenia
5%
Lower respiratory tract infection
5%
Rhinitis
5%
Insomnia
5%
Productive cough
5%
Influenza
4%
Cataract
3%
Myalgia
3%
Anxiety
2%
Pulmonary fibrosis
2%
Hypoxia
2%
Pneumothorax
2%
Pulmonary embolism
2%
Acute respiratory failure
2%
Lung neoplasm malignant
2%
Cardiac failure
1%
Hepatic enzyme increased
1%
Haemoptysis
1%
Cor pulmonale
1%
Coronary artery disease
1%
Right ventricular failure
1%
Haemorrhoids
1%
Inguinal hernia
1%
Pancreatitis
1%
Multiple organ dysfunction syndrome
1%
Sudden death
1%
Cholelithiasis
1%
Sepsis
1%
Urinary tract infection
1%
Fall
1%
Femur fracture
1%
Basal cell carcinoma
1%
Lung adenocarcinoma
1%
Prostate cancer
1%
Small cell lung cancer
1%
Squamous cell carcinoma
1%
Squamous cell carcinoma of skin
1%
Pulmonary arterial hypertension
1%
Acute myocardial infarction
1%
Angina pectoris
1%
Gastrointestinal haemorrhage
1%
Rib fracture
1%
Syncope
1%
Atrial fibrillation
1%
Cardiac arrest
1%
Myocardial ischaemia
1%
Cholecystitis acute
1%
Pneumonia bacterial
1%
Dehydration
1%
Transient ischaemic attack
1%
Acute kidney injury
1%
Benign prostatic hyperplasia
1%
Interstitial lung disease
1%
Pulmonary oedema
1%
Cardiac failure congestive
1%
Myocardial infarction
1%
Coronary artery stenosis
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Total (1199.32/.34/.35/.187)
Nintedanib 150 Bid (1199.35/.187)
Placebo (1199.187)
Total (1199.35/.187)
Total (1199.32/.34)
Placebo (1199.32/.34)
Nintedanib 100 Bid (1199.35)
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
2,551 Previous Clinical Trials
15,857,581 Total Patients Enrolled