NCT04325217 is a clinical trial of Nintedanib in Lung Diseases, Interstitial, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT04325217?

NCT04325217 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT04325217?

Interventions in NCT04325217: Nintedanib.

What condition does NCT04325217 study?

NCT04325217 studies Lung Diseases, Interstitial.

Is NCT04325217 still recruiting?

NCT04325217 is currently active, enrolled. Last updated 17 March 2026.

Last reviewed 2026-03-17 · How we verify

NCT04325217

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan

Active, enrolled Last updated 17 March 2026

What this trial tests

trial testing Nintedanib in Lung Diseases, Interstitial in 586 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 May 2020

Primary endpoint
30 June 2026

30 June 2026

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	586
Start date	27 May 2020
Primary completion	30 June 2026
Estimated completion	30 June 2026
Sites	1 location across Japan

Drugs / interventions tested

Nintedanib (NINTEDANIB) — full drug profile →

Conditions studied

Lung Diseases, Interstitial — all drugs for Lung Diseases, Interstitial →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Eligibility, any sex, with Lung Diseases, Interstitial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective is to confirm the incidence of adverse drug reactions (focus on gastrointestinal symptoms including diarrhoea and nausea) to Ofev Capsules seen in clinical trials with real world data generated in patients with SSc-ILD.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Patient characteristics and pharmacologic treatment patterns in antifibrotic-treated patients with fibrosing interstitial lung diseases: real-world results from a claims database.
Kondoh Y, Ito T, Kimura H, Bao H, et al · · 2025 · cited 1× · PMID 40405141 · DOI 10.1186/s12890-025-03713-x

Verify or expand the search:

Other trials of Nintedanib

Trials testing the same drug.

NCT07335562 — A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versu · Phase 3 · recruiting
NCT07162961 — Nintedanib for Improving Reproductive Outcomes in Adenomyosis · Phase 3 · not yet recruiting
NCT06297096 — Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease · Phase 3 · recruiting
NCT07015398 — A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in · Phase 1 · completed
NCT06643091 — Nintedanib Treatment in Unicentric Castleman Disease · Phase 2 · not yet recruiting

Other recruiting trials for Lung Diseases, Interstitial

Currently open trials in the same condition.

NCT05819385 — Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) Epidemiology Non-interventional Study (NIS) · recruiting
NCT06325696 — H01 in Adults With Interstitial Lung Disease (The SOLIS Study) · Phase 2 · recruiting
NCT06572384 — A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tiss · Phase 3 · recruiting
NCT05867914 — Early Feasibility Study Evaluating the 3P-100 Device in Subjects With PH-ILD · NA · active not recruiting
NCT06440746 — Efficacy and Safety of Olokizumab in Patients With Progressive Fibrosing Interstitial Lung Diseases · Phase 2, PHASE3 · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04325217 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 17 March 2026

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/NCT04325217.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing