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

Cystic Fibrosis Clinical Trial

Official 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™)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865886
• Other study ID #: 1397-0013
• Secondary ID: 2022-502835-21-0
• Status: Recruiting
• Phase: Phase 2
• Start date: January 31, 2024
• Est. completion date: October 24, 2024

Study information

• Verified date: June 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: October 24, 2024
• Est. primary completion date: October 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age of patients when signing the informed consent =18 years

2. 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)

3. 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

4. History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either:

1. at least 2 exacerbations, or

2. 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.

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

Exclusion Criteria:

1. 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

2. Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula < 30 mL/min at Visit 1

3. Absolute blood neutrophil count < 1,000/mm^3 (equivalent to < 1000 cells/µL or < 10^9 cells/L) at Visit 1

4. 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

5. 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.

Related Conditions & MeSH terms

• Bronchiectasis
• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• BI 1291583
BI 1291583
• Placebo
Placebo matching BI 1291583

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
France	HOP Arnaud de Villeneuve	Montpellier
France	HOP Cochin	Paris
France	HOP Charles Nicolle	Rouen
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH	Essen
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Jena	Jena
Italy	Azienda Ospedaliera Meyer	Firenze
Italy	A.O. Univ. Integrata di Verona	Verona
Netherlands	Amsterdam UMC, Locatie AMC	Amsterdam
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Spain	Hospital Vall d'Hebron	Barcelona
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Northwell Health Physician Partners	New York	New York
United States	University of Texas Health Science Center at Tyler	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Italy,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Treatment emergent Adverse Events (TEAEs) up to 16 weeks from first drug administration		up to 16 weeks
Secondary	Relative change from baseline in neutrophil elastase (NE) activity in sputum at week 8 after first drug administration		at week 8
Secondary	Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval (AUCt) for the first dose		up to 8 hours
Secondary	Maximum measured concentration of the analyte in plasma (Cmax) for the first dose		up to 8 hours
Secondary	Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCt,ss)		up to 12 weeks
Secondary	Maximum measured concentration of the analyte in plasma (Cmax) at steady state (Cmax,ss)		up to 12 weeks

External Links

•   Related Info