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Completed

NCT Number: NCT05865886

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

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.

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Key information

Conditions

Cystic Fibrosis Bronchial Diseases Bronchiectasis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brussels - UNIV UZ Brussel, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patients must be able to provide spontaneous or induced sputum samples. Further inclusion criteria apply.

Exclusion criteria

  • 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.

Further exclusion criteria apply.

Treatment and study plan

BI 1291583

Drug

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

Other names: Verducatib

Placebo to BI 1291583

Drug

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

Primary outcomes

  1. Occurrence of Any Treatment Emergent Adverse Events

    Time frame: 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.

    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.

Secondary outcomes

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

    Time frame: 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.

    Relative change from baseline in neutrophil elastase (NE) activity, in sputum, at Week 8 after first drug administration is reported.

    Relative change from baseline at Week 8 in neutrophil elastase was calculated as below: Relative fluorescence unit (RFU) at Week 8-Relative fluorescence unit at baseline)*100%/Relative fluorescence unit at baseline.

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

    Time frame: 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 after the first dose (AUC0-6) is reported.

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

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

    Area under the curve of BI 1291583 in plasma over a uniform dosing interval tau=6h at steady state (AUC0-6,ss) is reported.

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

    Time frame: 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 after the first dose is reported.

  5. Maximum Measured Concentration of BI 1291583 in Plasma at Steady State

    Time frame: 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 at steady state is reported.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Evaluating Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BI 1291583 One Tablet Once Daily Over 12 Weeks Versus Placebo in Adult Patients With Cystic Fibrosis Bronchiectasis (Clairafly™)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 19, 2023
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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