Trial · NCT05285982

A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)

NCT05285982, Phase 3, Completed, Boehringer Ingelheim; results first posted 2026-03-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON). Trials, record NCT05285982. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05285982

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)
NCT number: NCT05285982
Status: Completed
Phases: Phase 3
Enrollment: 54 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Lung Diseases, Interstitial
Interventions: Nintedanib (Ofev®)
First posted: 2022-03-18
Last updated: 2026-03-04
Other registries' IDs: eudract:2020-005554-23
Results first posted: 2026-03-04
Limitations and caveats: Some limitations due to the nature of the extension trial should be considered when interpreting the data (i.e. bias in the selection of the population and no comparative arm). All endpoints were considered exploratory only.

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Patients With Treatment-emergent Adverse Events (AEs) Over the Whole Trial	From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.	Number of patients with treatment-emergent adverse events (AEs) over the whole trial.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Patients With Treatment-emergent Adverse Events (AEs) Over the Whole Trial	From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.	Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group1

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Patients With Treatment-emergent Adverse Events (AEs) Over the Whole Trial	Nintedanib		53		Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Nintedanib	54
Overall Study	COMPLETED	Nintedanib	30
Overall Study	NOT COMPLETED	Nintedanib	24

Source ClinicalTrials.gov

Adverse events76

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Leukopenia	Blood and lymphatic system disorders	Nintedanib	3	54
other	Abdominal pain	Gastrointestinal disorders	Nintedanib	10	54
other	Abdominal pain upper	Gastrointestinal disorders	Nintedanib	3	54
other	Constipation	Gastrointestinal disorders	Nintedanib	4	54
other	Dental caries	Gastrointestinal disorders	Nintedanib	16	54
other	Diarrhoea	Gastrointestinal disorders	Nintedanib	26	54
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Nintedanib	3	54
other	Nausea	Gastrointestinal disorders	Nintedanib	17	54
other	Vomiting	Gastrointestinal disorders	Nintedanib	21	54
other	Chest pain	General disorders	Nintedanib	3	54

1 to 10 of 76Source ClinicalTrials.gov

See all 76 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nintedanib	3	54
Total, other adverse events	Nintedanib	53	54
Total, serious adverse events	Nintedanib	24	54

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05285982

GET https://conductscience.org/api/trials/v1/NCT05285982/events?page=2

API reference For AI assistants