24 completed, 2 recruiting, 1 active not recruiting. 20 Phase 1, 4 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 20 | Completed 20 |
| Phase 3 | 4 | Completed 2, Active not recruiting 1, Recruiting 1 |
| Phase 2 | 3 | Completed 2, Recruiting 1 |
Follow BI 1015550: new trials by email Literature Review of BI 1015550 trials Research Report on BI 1015550
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood BI 1015550, Pirfenidone - Idiopathic Pulmonary Fibrosis | Phase 2 | Completed | Boehringer Ingelheim | 20 | 2026-03-05 | 2026-08-21 |
| A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis Nerandomilast, Placebo - Familial Pulmonary Fibrosis, Interstitial Lung Abnormalities | Phase 3 | Recruiting | Boehringer Ingelheim | 80 | 2026-02-10 | 2026-09-30 |
| A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food Nerandomilast 18 mg - adult formulation, Nerandomilast 1 mg - paediatric formulation - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 15 | 2024-10-15 | 2026-01-08 |
| A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast Nerandomilast - Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis | Phase 3 | Active not recruiting | Boehringer Ingelheim | 1666 | 2024-09-26 | 2026-10-14 |
| A Study in Healthy People to Compare How 2 Different Low Dose Formulations of BI 1015550 Are Taken up in the Body BI 1015550 - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 64 | 2024-06-06 | 2025-12-01 |
| A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body Nerandomilast - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 64 | 2024-06-04 | 2025-12-01 |
| A Study in Healthy People to Test How BI 1015550 is Taken up in the Body When Given With or Without Food BI 1015550 - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 18 | 2024-05-28 | 2025-12-01 |
| Platform Clinical Study for Conquering Scleroderma Amlitelimab, BI 1015550 (Nerandomilast), Placebo - Interstitial Lung Disease Due to Systemic Disease, Scleroderma | Phase 2 | Recruiting | Scleroderma Research Foundation, Inc. | 400 | 2024-04-15 | 2026-08-18 |
| A Study in Healthy People to Test Whether Different Doses of BI 1015550 Have Potential to Induce Heart Rhythm Abnormalities BI 1015550, Moxifloxacin, Placebo - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 46 | 2024-03-06 | 2025-11-28 |
| A Study to Test How Different Doses of Nerandomilast (BI 1015550) Are Taken up in the Body of Healthy Japanese Men Nerandomilast - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 12 | 2023-12-20 | 2025-12-01 |
| A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood BI 1015550, Nintedanib, Pirfenidone - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 14 | 2023-11-08 | 2025-12-02 |
| A Study in Healthy Men to Test How BI 1015550 is Taken up and Handled by the Body BI 1015550, BI 1015550 mixed with [C-14]-BI 1015550 - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 8 | 2023-02-14 | 2025-11-28 |
| A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Kidney Problems BI 1015550 - Renal Insufficiency, Healthy | Phase 1 | Completed | Boehringer Ingelheim | 26 | 2023-02-09 | 2025-11-28 |
| A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Liver Problems BI 1015550 - Hepatic Insufficiency | Phase 1 | Completed | Boehringer Ingelheim | 28 | 2023-02-07 | 2025-11-28 |
| A Study in Healthy Chinese People to Test How Different Doses of BI 1015550 Are Taken up in the Body BI 1015550 - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 24 | 2023-01-13 | 2025-11-28 |
| A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) BI 1015550, Placebo - Lung Diseases, Interstitial | Phase 3 | Completed | Boehringer Ingelheim | 1178 | 2022-11-16 | 2026-01-09 |
| A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Midazolam in the Blood BI 1015550, midazolam - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 15 | 2022-10-11 | 2025-12-01 |
| A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) BI 1015550, Placebo - Idiopathic Pulmonary Fibrosis | Phase 3 | Completed | Boehringer Ingelheim | 1177 | 2022-10-06 | 2025-10-20 |
| A Study in Healthy Men to Find Out How BI 1015550 is Taken up and Handled by the Body BI 1015550 (C-14) - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 6 | 2021-03-25 | 2025-11-28 |
| A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) BI 1015550, Placebo - Idiopathic Pulmonary Fibrosis | Phase 2 | Completed | Boehringer Ingelheim | 147 | 2020-07-28 | 2022-11-01 |
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Idiopathic Pulmonary Fibrosis (5) · Lung Diseases, Interstitial (3) · Hepatic Insufficiency (1) · Renal Insufficiency (1) · Scleroderma, Diffuse (1) · Scleroderma, Systemic (1)
Boehringer Ingelheim (26) · Scleroderma Research Foundation, Inc. (1)
Germany (19) · Netherlands (8) · Japan (7) · United Kingdom (7) · United States (7) · Italy (6) · Spain (6) · Argentina (5) · Australia (5) · Canada (5) · China (5) · Denmark (5) · Finland (5) · South Korea (5) · Austria (4)
Kevin O'Shea (1)
PMID 41345848, PMID 42563128, PMID 35569036, PMID 37597969, PMID 37709661, PMID 39544897, PMID 40387033, PMID 40388329
2023 (5), 2017 (4), 2019 (1), 2025 (1)