40 and older, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of Adverse Events (AEs)Primary· From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days.
This is the measure for percentage of patients with adverse events (AEs) observed during the trial. The incidence of adverse events (% of patients) over the course of the trial, including the incidence of serious AEs, AEs leading to discontinuation, and fatal AEs are presented.
Any AEs
Group
Value
95% CI
Total (1199.32/.34)
98.5
AEs leading to discontinuation of trial drug
Group
Value
95% CI
Total (1199.32/.34)
42.6
Serious AEs
Group
Value
95% CI
Total (1199.32/.34)
68.9
Fatal AEs
Group
Value
95% CI
Total (1199.32/.34)
23.8
Adverse events — posted to ClinicalTrials.gov
Time frame: From first drug administration in this study until 28 days after the last drug, up to 7.5 years..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Total (1199.32/.34)
Serious: 509/734 (69%)
Deaths: 182/734
Placebo (1199.32/.34)
Serious: 208/304 (68%)
Deaths: 78/304
Nintedanib 150 Bid (1199.32/.34)
Serious: 301/430 (70%)
Deaths: 104/430
Placebo (1199.187)
Serious: 0/7 (0%)
Deaths: 0/7
Nintedanib 100 Bid (1199.35)
Serious: 0/2 (0%)
Deaths: 0/2
Nintedanib 150 Bid (1199.35/.187)
Serious: 1/8 (13%)
Deaths: 0/8
Total (1199.35/.187)
Serious: 1/17 (6%)
Deaths: 0/17
Total (1199.32/.34/.35/.187)
Serious: 510/751 (68%)
Deaths: 182/751
Serious adverse events (364 terms)
Reaction
System
Total (1199.32/.34)
Placebo (1199.32/.34)
Nintedanib 150 Bid (1199.3…
Placebo (1199.187)
Nintedanib 100 Bid (1199.35)
Nintedanib 150 Bid (1199.3…
Total (1199.35/.187)
Total (1199.32/.34/.35/.187)
Idiopathic pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
—
—
—
—
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
Pneumothorax
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
Respiratory tract infection
Infections and infestations
—
—
—
—
—
—
—
—
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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 Idiopathic Pulmonary Fibrosis
Currently open trials in the same condition.
NCT05988463 — Dose-Escalation Study of Artesunate Patients With IPF
· Phase 1
· recruiting
NCT06241560 — A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in
· Phase 2
· recruiting
NCT07407543 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Cauc
· Phase 1
· recruiting
NCT07036523 — A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
· Phase 2
· recruiting
NCT07225296 — A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics o
· Phase 1
· 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
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: 25 March 2022
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/NCT01619085.