BI 1323495 / Boehringer Ingelheim - LARVOL DELTA

A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation (clinicaltrials.gov) - P1 | N=7 | Terminated | Sponsor: Boehringer Ingelheim | Completed ➔ Terminated; Company decision

Biomarker • Trial termination • Bronchiectasis • Genetic Disorders • Immunology • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases

A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: Boehringer Ingelheim | Terminated ➔ Completed

Trial completion • Bronchiectasis • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases • ELANE

A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation (clinicaltrials.gov) - P1 | N=7 | Terminated | Sponsor: Boehringer Ingelheim | N=36 ➔ 7 | Trial completion date: Jun 2022 ➔ Dec 2021 | Suspended ➔ Terminated | Trial primary completion date: Jun 2022 ➔ Dec 2021; recruitment in 2021 was not according to plan

Biomarker • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Bronchiectasis • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases • ELANE

A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation (clinicaltrials.gov) - P1; N=36; Suspended; Sponsor: Boehringer Ingelheim; Recruiting ➔ Suspended

Biomarker • Clinical • Trial suspension • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases • ELANE

A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Mar 2022 ➔ Jun 2022; Trial primary completion date: Mar 2022 ➔ Jun 2022

Biomarker • Clinical • Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases • ELANE

A Study in Healthy Japanese Men to Test How Different Doses of BI 1323495 Are Tolerated and How Itraconazole Influences the Amount of BI 1323495 in the Blood (clinicaltrials.gov) - P1; N=74; Completed; Sponsor: Boehringer Ingelheim; Active, not recruiting ➔ Completed

Trial completion

A Study in Healthy Japanese Men to Test How Different Doses of BI 1323495 Are Tolerated and How Itraconazole Influences the Amount of BI 1323495 in the Blood (clinicaltrials.gov) - P1; N=74; Active, not recruiting; Sponsor: Boehringer Ingelheim; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A Study in Healthy Japanese Men to Test How Different Doses of BI 1323495 Are Tolerated and How Itraconazole Influences the Amount of BI 1323495 in the Blood (clinicaltrials.gov) - P1; N=74; Recruiting; Sponsor: Boehringer Ingelheim; N=50 ➔ 74

Clinical • Enrollment change

A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Boehringer Ingelheim

Biomarker • Clinical • New P1 trial • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Respiratory Diseases • ELANE

A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Boehringer Ingelheim; Not yet recruiting ➔ Recruiting

Enrollment open • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Respiratory Diseases • ELANE

A Study in Healthy Men and Women to Test How Well Different Doses of BI 1323495 Are Tolerated (clinicaltrials.gov) - P1; N=87; Completed; Sponsor: Boehringer Ingelheim; Recruiting ➔ Completed

Clinical • Trial completion

A Study in Healthy Japanese Men to Test How Different Doses of BI 1323495 Are Tolerated and How Itraconazole Influences the Amount of BI 1323495 in the Blood (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Mar 2021 ➔ Jul 2021; Trial primary completion date: Mar 2021 ➔ Jul 2021

Clinical • Trial completion date • Trial primary completion date

A Study in Healthy Japanese Men to Test How Different Doses of BI 1323495 Are Tolerated and How Itraconazole Influences the Amount of BI 1323495 in the Blood (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Boehringer Ingelheim; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study in Healthy Japanese Men to Test How Different Doses of BI 1323495 Are Tolerated and How Itraconazole Influences the Amount of BI 1323495 in the Blood (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Boehringer Ingelheim

Clinical • New P1 trial

[VIRTUAL] NEUTROPHIL ELASTASE INHIBITOR BI 1323495 PREVENTS NEUTROPHIL ELASTASE-INDUCED BREAKDOWN OF EPITHELIAL BARRIER INTEGRITY AND REDUCTION IN CILIA BEAT FREQUENCY IN CF HBECS AND ABERRANT NEUTROPHIL-MEDIATED KILLING OF PSEUDOMONAS (NACFC 2020) - "The NE inhibitor BI 1323495 restores epithelial barrier integrity and CBF in NE-exposed CF HBECs and may protect against NE-induced suppression of neutrophil PA killing."

Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Respiratory Diseases • ELANE • Mucin 5

A Study in Healthy Men to Test the Influence of BI 1323495 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood (clinicaltrials.gov) - P1; N=28; Completed; Sponsor: Boehringer Ingelheim; Active, not recruiting ➔ Completed

Clinical • Trial completion

[VIRTUAL] In vitro and in vivo characterisation of the novel neutrophil elastase inhibitor BI 1323495 (ERS 2020) - "BI 1323495 is a very potent and highly selective inhibitor of human NE with in vivo efficacy."

Preclinical • Acute Lung Injury • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases • ELANE

[VIRTUAL] Safety, pharmacokinetics and pharmacodynamics of BI 1323495 in healthy males (ERS 2020) - P1 | "BI 1323495 was well tolerated in doses up to 600mg, with dose linearity up to 300mg. Exposure was higher in fed than fasted state."

Clinical • PK/PD data • Chronic Obstructive Pulmonary Disease • Immunology • Pain • ELANE

A Study in Healthy Men to Test the Influence of BI 1323495 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood (clinicaltrials.gov) - P1; N=28; Recruiting; Sponsor: Boehringer Ingelheim; Suspended ➔ Recruiting; N=14 ➔ 28

Clinical • Enrollment change • Enrollment open

Neutrophil elastase inhibitor BI 1323495 restores epithelial barrier integrity and ciliary beat frequency in cystic fibrosis bronchial epithelial cells and protects neutrophil-mediated Pseudomonas killing (ECFS 2020) - "The NE inhibitor BI 1323495 restores epithelial barrier integrity and CBF in NE-exposed CF HBECs and may protect against NE- induced suppression of neutrophil Pa killing."

Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Respiratory Diseases • ELANE • Mucin 5

A Study in Healthy Men and Women to Test How Well Different Doses of BI 1323495 Are Tolerated (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: Boehringer Ingelheim; Suspended ➔ Recruiting

Clinical • Enrollment open

A Study in Healthy Men to Test the Influence of BI 1323495 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood (clinicaltrials.gov) - P1; N=14; Suspended; Sponsor: Boehringer Ingelheim; Trial completion date: Apr 2020 ➔ Aug 2020; Active, not recruiting ➔ Suspended; Trial primary completion date: Apr 2020 ➔ Aug 2020

Clinical • Trial completion date • Trial primary completion date • Trial suspension

A Study in Healthy Men and Women to Test How Well Different Doses of BI 1323495 Are Tolerated (clinicaltrials.gov) - P1; N=60; Suspended; Sponsor: Boehringer Ingelheim; Recruiting ➔ Suspended

Clinical • Trial suspension

A Study in Healthy Men to Test the Influence of BI 1323495 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood (clinicaltrials.gov) - P1; N=14; Active, not recruiting; Sponsor: Boehringer Ingelheim; N=28 ➔ 14

Clinical • Enrollment change

A Study in Healthy Men to Test the Influence of BI 1323495 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood (clinicaltrials.gov) - P1; N=28; Active, not recruiting; Sponsor: Boehringer Ingelheim; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed