Recruiting
Phase 3

BI 1291583

Sponsor:

Boehringer Ingelheim

Code:

NCT06872892

Conditions

Bronchiectasis

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

BI 1291583

Placebo matching BI 1291583

Study Details

Brief summary:

This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations).

The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months.

Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

Bronchiectasis

Study ID

NCT06872892

Start date

Jun 9, 2025

Status verified date

Sep, 2026

Completion date

Dec 20, 2027

Anticipated

Primary completion date

Jun 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1 % per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the participant information.
  • Signed and dated written informed consent and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation.
  • Age of participants when signing the informed consent/assent ≥12 years.

\-- Adolescents need to weigh at least 35 kg at Visit 1.
  • Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan where bronchiectasis has been documented by a radiologist.

Participants whose past CT scan image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than five years.

  • Adult participants should be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period.
  • History of documented pulmonary exacerbations (assessed and recorded by the investigator) requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either:

  • at least 2 exacerbations, or
  • at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of >40 at screening Visit 1 (adults only)
  • at least 1 exacerbation and high symptom burden according to the investigator's judgement (adolescents only) For participants on oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy (CFTR-MT), at least one exacerbation must have occurred since initiation of antibiotics or CFTR-MT.

Exclusion criteria:

  • Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.
  • Allergic bronchopulmonary aspergillosis being treated or requiring treatment.
  • Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment
  • Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the participant at risk by participating in the trial.
  • Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the investigator prior to Visit 2.
  • Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study.
  • Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period.
  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated in situ non-melanoma skin cancers or in situ carcinoma of uterine cervix.
  • Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment).
  • estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (adults) or Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) <30 mL/min at Visit 1.
  • Previous treatment with a dipeptidyl peptidase-1 (DPP1) (Cathepsin C (CatC)) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed.) Further exclusion criteria apply.

Study Design

Enrollment

1755 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment arm

placebo comparator: Placebo arm

Interventions

BI 1291583

BI 1291583

Placebo matching BI 1291583

Placebo matching BI 1291583

Primary outcome measure

  • Annualised rate of adjudicated pulmonary exacerbations (number of events per person year) up to Week 76 [ Time Frame: up to 76 weeks ]

Central Contacts and Locations

Central contacts

Boehringer Ingelheim

1-800-243-0127clintriage.rdg@boehringer-ingelheim.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Emory University

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03766

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Rutgers Robert Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

New York Medical College - Hawthorne

Recruiting

Hawthorne, New York, United States, 10532

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Akron Children's Hospital

Recruiting

Akron, Ohio, United States, 44308

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Oregon Health and Sciences University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

St. Paul's Hospital (Vancouver)

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

Cardio 1 Medical Clinic

Recruiting

Winnipeg, Manitoba, Canada, R3L 1Z5

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

QEII Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

BLC Clinical Research

Recruiting

Burlington, Ontario, Canada, L7N 3V2

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

Centre Hospitalier de l'Universite de Montreal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

Diex Recherche (Sherbrooke Est)

Recruiting

Sherbrooke, Quebec, Canada, J1E 0N8

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

Diex Recherche (Trois-Rivieres)

Recruiting

Trois-Rivières, Quebec, Canada, G9A 4P3

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

Royal University Hospital (Saskatoon)

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

Recruiting

Québec, Canada, G1V 4G5

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-09-03.