NCT05865886

Brief Summary

This study is open to adults aged 18 years and older with cystic fibrosis bronchiectasis. The purpose of this study is to find out whether a medicine called BI 1291583 is tolerated by people with cystic fibrosis bronchiectasis. Participants are put randomly into 2 groups. One group takes BI 1291583 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1291583 tablets but do not contain any medicine. Participants in both groups take 1 tablet once a day for 12 weeks. Participants have twice the chance of being placed in the BI 1291583 group than in the placebo group. Participants are in the study for about 6 months. During this time, they visit the study site 7 times. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 1291583.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2024

Shorter than P25 for phase_2

Geographic Reach
6 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

April 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 18, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

May 10, 2023

Results QC Date

October 7, 2025

Last Update Submit

November 4, 2025

Conditions

Cystic FibrosisBronchiectasis

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Any Treatment Emergent Adverse Events

    Occurrence of any treatment emergent adverse events is expressed as percentages of participants with treatment emergent adverse events. Percentages are rounded to one decimal place.

    From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.

Secondary Outcomes (5)

  • Relative Change From Baseline in NE Activity, in Sputum, at Week 8 After First Drug Administration

    Before the first drug administration (baseline: mean value of screening and Week 0 prior to the first treatment intake) and Week 8 after first study drug administration.

  • Area Under the Curve of BI 1291583 in Plasma Over a Uniform Dosing Interval Tau=6h After the First Dose (AUC0-6)

    Before drug administration and 1 hour (h), 3.5h, 6h after administration of the first dose of BI 1291583 at Day 1.

  • Area Under the Curve of BI 1291583 in Plasma Over a Uniform Dosing Interval Tau=6h at Steady State (AUC0-6,ss)

    Before drug administration at Day 85 and 1 hour (h), 3.5h, 6h after administration of BI 1291583 at Day 85.

  • Maximum Measured Concentration of BI 1291583 in Plasma After the First Dose

    Before drug administration and 1 hour (h), 3.5h, 6h, and 8h after administration of the first dose of BI 1291583 at Day 1.

  • Maximum Measured Concentration of BI 1291583 in Plasma at Steady State

    Before drug administration at Day 85 and 1 hour (h), 3.5h, 6h after administration of BI 1291583 at Day 85.

Study Arms (2)

5 mg BI 1291583

EXPERIMENTAL
Drug: BI 1291583

Placebo

PLACEBO COMPARATOR
Drug: Placebo to BI 1291583

Interventions

BI 1291583DRUG

Once daily oral administration of 5 milligram (mg) tablets of BI 1291583 for 12 weeks.

Also known as: Verducatib
5 mg BI 1291583
Placebo to BI 1291583DRUG

Once daily oral administration of tablets of placebo matching BI 1291583 for 12 weeks.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of patients when signing the informed consent ≥18 years
  • Historical clinical diagnosis of Cystic fibrosis (CF) (symptoms of CF and sweat chloride ≥ 60 mmol/L and/or 2 CF-causing Cystic fibrosis transmembrane conductance regulator (CFTR) mutations)
  • Investigator-confirmed diagnosis of Bronchiectasis (BE) by Computed tomography (CT) scan and clinical history consistent with BE (e.g., cough, chronic sputum production, recurrent respiratory infections). Subjects whose past chest CT records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than 5 years
  • History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients 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 For patients on stable oral or inhaled antibiotics as chronic treatment for BE, at least one exacerbation must have occurred while on stable antibiotics.

You may not qualify if:

  • Moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment) or Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) \> 3.0x Upper limit of normal (ULN) at Visit 1
  • Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula \< 30 mL/min at Visit 1
  • Absolute blood neutrophil count \< 1,000/mm\^3 (equivalent to \< 1000 cells/μL or \< 10\^9 cells/L) at Visit 1
  • Any findings in the medical examination (including blood pressure (BP), pulse rate (PR), or electrocardiogram (ECG)) and/or laboratory value assessed at Visit 1 or during screening period that in the opinion of the investigator may put the patient at risk by participating in the trial
  • Positive serological tests for hepatitis B, hepatitis C (also confirmed with Hepatitis C virus ribonucleic acid (HCV RNA)), or human immunodeficiency virus (HIV) infection, or known infection status.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Northwell Health Physician Partners

New York, New York, 10028, United States

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Charite Universitätsmedizin Berlin KöR

Berlin, 13353, Germany

Location

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, 45239, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

Azienda Ospedaliera Meyer

Florence, 50139, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126, Italy

Location

Amsterdam UMC, location VUMC

Amsterdam, 1081 HV, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

Location

Hospital Universitari Vall D Hebron

Barcelona, 08035, Spain

Location

Related Publications (1)

  • Badorrek P, Diefenbach C, Kogler H, Eleftheraki A, Seitz F, Hohlfeld JM. Novel cathepsin C inhibitor, BI 1291583, intended for treatment of bronchiectasis: Phase I characterization in healthy volunteers. Clin Transl Sci. 2024 Aug;17(8):e13891. doi: 10.1111/cts.13891.

    PMID: 39175217DERIVED

Related Links

MeSH Terms

Conditions

Cystic FibrosisBronchiectasis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesBronchial Diseases

Results Point of Contact

Title
Boehringer Ingelheim, Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 19, 2023

Study Start

April 5, 2024

Primary Completion

October 7, 2024

Study Completion

October 7, 2024

Last Updated

November 18, 2025

Results First Posted

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
More information

Locations

IT(2)DE(4)ES(1)US(2)BE(1)NL(2)