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Tyrosine Kinase Inhibitor
A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD) (InPedILD® Trial)
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 younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up mmrm included measurements pre-administration at -4 weeks and at 0, 2, 6, 12, 24, 26, 36, and 52 weeks after first drug administration. mmrm values at week 24 are reported in the table below
Awards & highlights
Pivotal Trial
Summary
This trial is testing a drug called nintedanib to see if it's safe and effective for kids with fibrosing Interstitial Lung Disease.
Eligible Conditions
- Interstitial Lung Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ mmrm included measurements pre-administration at -4 weeks and at 0, 12, 24, 36, 52, 64, 76, and 88 weeks after first drug administration. mmrm values at week 24 are reported in the table below.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~mmrm included measurements pre-administration at -4 weeks and at 0, 12, 24, 36, 52, 64, 76, and 88 weeks after first drug administration. mmrm values at week 24 are reported in the table below.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Area Under the Plasma Concentration-time Curve at Steady State (AUCτ,ss) Based on Sampling at Steady State (at Week 2 and Week 26)
Number of Participants With Treatment-emergent Adverse Events During the Double-blind Period
Secondary study objectives
Absolute Change From Baseline in 6 Minutes (Min) Walk Distance at Week 24
Absolute Change From Baseline in 6 Minutes (Min) Walk Distance at Week 52
Absolute Change From Baseline in Forced Vital Capacity (FVC) % Predicted at Week 24
+29 moreSide effects data
From 2021 Phase 3 trial • 752 Patients • NCT0161908570%
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
Placebo (1199.187)
Total (1199.32/.34)
Nintedanib 150 Bid (1199.35/.187)
Total (1199.35/.187)
Total (1199.32/.34/.35/.187)
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.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Double-blind period (DBP) + open-label Nintedanib period (OLNP): Randomised NintedanibExperimental Treatment1 Intervention
This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose.
Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed.
In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms.
DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.
Group II: DBP+OLNP: Randomised placeboPlacebo Group1 Intervention
Placebo randomised participants were treated orally with a Nintedanib matching placebo soft capsule twice daily in the double-blind period (DBP).
Participants who continued with the open-label Nintedanib period (OLNP) after the DBP switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily.
Medication dosage was per administration 50 milligram (mg) \[2 25 mg capsules (cap)\],75 mg \[3 25 mg cap\], 100 mg \[1 100 mg or 4 25 mg cap\] or 150 mg \[1 150 mg or 6 25 mg cap\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed.
The dose interval was approximately 12 hours between one and the next dose.
Here participants received placebo first (DBP) and then Nintedanib (OLNP). DBP: Planned was from first to last randomised blinded drug intake. OLNP: Planned was from first to last open-label Nintedanib intake.
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
2,552 Previous Clinical Trials
15,858,071 Total Patients Enrolled