A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)

NCT05865886 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 1397-00132022-502835-21-00U1111-1291-2567
• Study Type: interventional
• Target: 22
• Locations: 7 countries
• Sites: 24

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.

Conditions

Cystic Fibrosis; Bronchiectasis

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 1291583 DRUG

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 1291583 DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (24)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Central Florida Pulmonary Group

Altamonte Springs, Florida, 32701, United States

Location

Chest Medicine Associates

South Portland, Maine, 04106, United States

Location

Northwell Health Physician Partners

New York, New York, 10028, United States

Location

Columbia University Medical Center-New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Brussels - UNIV UZ Brussel

Brussels, 1090, Belgium

Location

HOP Arnaud de Villeneuve

Montpellier, 34295, France

Location

Hôpital Cochin

Paris, 75679, France

Location

Hôpital Charles Nicolle

Rouen, 76031, France

Location

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, 45239, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Klinikum der Universität München AÖR

München, 80336, Germany

Location

Azienda Ospedaliera Meyer

Florence, 50139, Italy

Location

Istituto G. Gaslini

Genova, 16147, Italy

Location

IRCCS Fondazione Ospedale Maggiore

Milan, 20122, Italy

Location

AOU San Luigi Gonzaga

Orbassano (TO), 10043, 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

Hospital Universitario Ramon Y Cajal

Madrid, 28049, 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: 39175217 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Cystic Fibrosis; Bronchiectasis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Bronchial 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: June 23, 2026
• Results First Posted: November 18, 2025

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5); DE (4); ES (2); US (7); BE (1); NL (2); FR (3)