Cystic FibrosisPhase 2NCT05865886
A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)
A Phase 2 study testing BI 1291583 in people with Cystic Fibrosis and Bronchiectasis, run by Boehringer Ingelheim at 24 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Bronchiectasis
- What is being tested?
- BI 1291583
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 24 sitesin 7 countries
- Study dates
- 5 Apr 2024to 7 Oct 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
United States7 sites
Central Florida Pulmonary Group
Altamonte Springs, Florida, 32701
Medical University of South Carolina
Charleston, South Carolina, 29425
National Jewish Health
Denver, Colorado, 80206
Northwell Health Physician Partners
New York, New York, 10028
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032
Oregon Health and Sciences University
Portland, Oregon, 97239
Chest Medicine Associates
South Portland, Maine, 04106
Italy5 sites
Azienda Ospedaliera Meyer
Florence, 50139
Istituto G. Gaslini
Genova, 16147
IRCCS Fondazione Ospedale Maggiore
Milan, 20122
AOU San Luigi Gonzaga
Orbassano (TO), 10043
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
Germany4 sites
Charité - Universitätsmedizin Berlin
Berlin, 13353
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239
Medizinische Hochschule Hannover
Hanover, 30625
Klinikum der Universität München AÖR
München, 80336
France3 sites
HOP Arnaud de Villeneuve
Montpellier, 34295
Hôpital Cochin
Paris, 75679
Hôpital Charles Nicolle
Rouen, 76031
Netherlands2 sites
Amsterdam UMC, location VUMC
Amsterdam, 1081 HV
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario Ramon Y Cajal
Madrid, 28049
About this study
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™)
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
- Being tested
- BI 1291583, Placebo to BI 1291583
- Medical subject headings
- Cystic Fibrosis, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1291583Drug
Also called Verducatib
Once daily oral administration of 5 milligram (mg) tablets of BI 1291583 for 12 weeks.
Placebo to BI 1291583Drug
Once daily oral administration of tablets of placebo matching BI 1291583 for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 5 mg BI 1291583 | Experimental | Not described Receives: Drug: BI 1291583 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo to BI 1291583 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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)
Area under the curve of BI 1291583 in plasma over a uniform dosing interval tau=6h after the first dose (AUC0-6) is reported.
Measured: 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)
Area under the curve of BI 1291583 in plasma over a uniform dosing interval tau=6h at steady state (AUC0-6,ss) is reported.
Measured: 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
Maximum measured concentration of BI 1291583 in plasma after the first dose is reported.
Measured: 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
Maximum measured concentration of BI 1291583 in plasma at steady state is reported.
Measured: Before drug administration at Day 85 and 1 hour (h), 3.5h, 6h after administration of BI 1291583 at Day 85.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start5 Apr 2024
- Primary completion7 Oct 2024
- Study completion7 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865886
- Sponsor's protocol ID
- 1397-0013
- Other IDs
- 2022-502835-21-00, U1111-1291-2567
- Status last verified
- May 2026
- First submitted
- 10 May 2023
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Publications
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.
PubMed 39175217