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A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)
Phase 3 trial testing Nintedanib (Ofev®) in Lung Diseases, Interstitial in 54 participants. Completed in 13 August 2025.
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 6 April 2022 |
| Primary completion | 13 August 2025 |
| Estimated completion | 13 August 2025 |
| Sites | 28 locations across France, Italy, Finland, Greece, Belgium, United Kingdom, Germany, Poland |
Boehringer Ingelheim — full company profile →
Adults 6 to 17, any sex, with Lung Diseases, Interstitial. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of patients with treatment-emergent adverse events (AEs) over the whole trial.
| Group | Value | 95% CI |
|---|---|---|
| Nintedanib | 53 |
Time frame: From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Nintedanib |
|---|---|---|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | — |
| Respiratory tract infection | Infections and infestations | — |
| Headache | Nervous system disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Sickle cell anaemia with crisis | Blood and lymphatic system disorders | — |
| Atrial thrombosis | Cardiac disorders | — |
| Right ventricular failure | Cardiac disorders | — |
| Sickle cell anaemia | Congenital, familial and genetic disorders | — |
| Optic atrophy | Eye disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Gastric fistula | Gastrointestinal disorders | — |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Oesophageal hypomotility | Gastrointestinal disorders | — |
| Tooth development disorder | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Drug-induced liver injury | Hepatobiliary disorders | — |
| Gallbladder rupture | Hepatobiliary disorders | — |
| Hepatitis | Hepatobiliary disorders | — |
| Transplant rejection | Immune system disorders | — |
| Infection | Infections and infestations | — |
| Pelvic abscess | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Pneumonia bacterial | Infections and infestations | — |
| Reaction | System | Nintedanib |
|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Dental caries | Gastrointestinal disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Headache | Nervous system disorders | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Nasopharyngitis | Infections and infestations | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Respiratory tract infection | Infections and infestations | — |
| Weight decreased | Investigations | — |
| Pyrexia | General disorders | — |
| Bronchitis | Infections and infestations | — |
| COVID-19 | Infections and infestations | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — |
| Influenza | Infections and infestations | — |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — |
| Hepatic enzyme increased | Investigations | — |
| Constipation | Gastrointestinal disorders | — |
| Gastroenteritis | Infections and infestations | — |
| Gastroenteritis viral | Infections and infestations | — |
| Viral infection | Infections and infestations | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Dizziness | Nervous system disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Leukopenia | Blood and lymphatic system disorders | — |
| Abdominal pain upper | Gastrointestinal disorders | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — |
| Chest pain | General disorders | — |
| Fatigue | General disorders | — |
| Cholelithiasis | Hepatobiliary disorders | — |
| Pneumonia | Infections and infestations | — |
| Rhinitis | Infections and infestations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Anxiety | Psychiatric disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Interstitial lung disease, Respiratory tract infection, Headache, Dyspnoea, Pneumothorax, Respiratory failure, Sickle cell anaemia with crisis, Atrial thrombosis.
Data from ClinicalTrials.gov NCT05285982 adverse events section.
This study is open to children and adolescents with interstitial lung disease (ILD) that causes lung fibrosis. This is a study for people who took part in a previous study called InPedILD (study 1199-0337) and for people who are between 6 and 17 years old (in France, between 12 and 17 years old) and have fibrosing ILD. This study tests a medicine called nintedanib. Nintedanib is already used to treat different types of lung fibrosis in adults. The purpose of the study is to find out how well long-term treatment with nintedanib is tolerated in children and adolescents. All participants take nintedanib capsules twice a day. Participants coming from the previous study are in this study for at least 3 years or until nintedanib or other treatment options become available outside of this study. New participants are in the study until the overall end of study meaning for at least 1.5 years. Participants visit the study site about 15 times for a study participation of 3 years. Afterwards, they visit the study site every 3 months. The doctors collect information on any health problems of the participants.
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05285982.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing