Non-cystic Fibrosis BronchiectasisPhase 1NCT04656275
A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation
A Phase 1 study testing BI 1323495 in people with Non-cystic Fibrosis Bronchiectasis, run by Boehringer Ingelheim at 3 sites in Germany.
Trial summary
This study is open to adults with non-cystic fibrosis bronchiectasis. The main purpose of this study is to find out how a medicine called BI 1323495 is tolerated by people with non-cystic bronchiectasis. The study tests 2 different doses of BI 1323495. Some of the participants get placebo. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis
- What is being tested?
- BI 1323495
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 3 sitesGermany
- Study dates
- 4 Mar 2021to 19 Jan 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years to 80 years (inclusive) at the time of informed consent signature, male and female (not of childbearing potential) subjects
- --For 'female not of childbearing potential' at least one of the following criteria must be fulfilled:
- Permanently sterile (permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy; tubal ligation is not a method of permanent sterilisation)
- Postmenopausal, defined as at least 1 year of spontaneous amenorrhea without an alternative medical cause (in questionable cases a blood sample with Follicle Stimulating Hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory).
- Men must be vasectomised with documented absence of sperm or use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after the last administration of trial medication if their sexual partner is a woman of childbearing potential (WOCBP)
- Clinical history consistent with non cystic fibrosis bronchiectasis (nCFB) (cough, chronic sputum production and/or recurrent respiratory infections) and proven and documented diagnosis of bronchiectasis by computed tomography (CT) scan including dilated airways compatible with bronchiectasis at initial diagnosis. Bronchiectasis of various etiologies will be allowed, with exclusion criteria as below.
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- Vaccination against Streptococcus pneumoniae in accordance with national vaccination recommendations
- Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation.
- FEV1 ≥ 30 % predicted (post-bronchodilator) at Screening Visit 1.
- Stable (i.e., no dose change) regimen of standard nCFB treatment (including - but not limited to - hypertonic inhalation solutions, mucolytics, Long Acting Muscarinic Agonists (LAMA)/ Long Acting Beta Agonists (LABA) / inhaled corticosteriods (iCS), oral antibiotic maintenance regimen, and physiotherapy), if applicable, administered at least for 4 weeks prior to Screening Visit 1 and throughout the run-in period.
- Regular daily sputum producers with a history of chronic expectoration who are able to provide a typical bronchiectasis sputum sample at Screening Visit 1.
- Sputum neutrophil elastase positive based on point of care test (NEATstik® score ≥ 6) assessment at Visit 2a and Visit 2b.
- Subjects genotyped as UDP-Glucuronosyltransferase-2B17 (UGT2B17) extensive metabolizers prior to randomisation, i.e., carrying at least one functional allele of the UGT2B17 gene (*1/*1 or *1/*2)
Who cannot join
- Any finding in the medical examination (including BP, pulse rate (PR), or ECG) and/or laboratory value and/or any evidence of a concomitant disease assessed as clinically relevant by the investigator.
- Concomitant diagnosis of pulmonary disease other than bronchiectasis, chronic obstructive pulmonary disease (COPD), or asthma.
- A current diagnosis of cystic fibrosis (CF), primary immunodeficiency, active Allergic Bronchopulmonary Aspergillosis (ABPA) (defined by receipt of corticosteroids, anti-fungal treatment or monoclonal antibody treatment), or alpha-1 antitrypsin (A1AT) deficiency as underlying disease.
- A history or current immunodeficiency or are currently being treated (or are planned to be treated) with immunomodulatory drugs (except for iCS or low-dose oral corticosteroids), including disease-modifying anti-rheumatic drugs (DMARDs), and/or Immunglobulin G (IgG) treatments. Other medication that is excluded will be provided in the investigator site file (ISF). On the day of the site visit with lung function measurement, no bronchodilators should be used until after completion of lung function assessment
- Any acute infections defined as infections requiring antibiotic therapy, or Upper Respiratory Tract Infection (URTI). Are currently being treated (or are planned to be treated) for a nontuberculous mycobacterial (NTM) lung infection or tuberculosis.
- A history of invasive pneumococcal disease.
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- Inhaled antibiotic treatment or cycling oral antibiotic treatment with changed dose regimen 4 weeks prior to Screening Visit 1.
- A treatment for a pulmonary exacerbation 4 weeks prior to Screening Visit 1.
- Laboratory confirmed severe acute respiratory syndrome (SARS)-coronavisurs (CoV)-2 infection (PCR positive) within 4 weeks prior to Screening Visit 1.
- Household contact with an individual with confirmed SARS-CoV-2 infection within 4 weeks prior to Screening Visit 1.
- Further exclusion criteria apply
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
IKF Pneumologie GmbH & Co. KG
Frankfurt, 60596
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
KLB Gesundheitsforschung Lübeck GmbH
Lübeck, 23552
About this study
Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Different Oral Doses of BI 1323495 Bid Versus Placebo in Patients With Non-cystic Fibrosis Bronchiectasis (Randomised, Double-blind, Placebo-controlled, Parallel Group Trial)
This study is open to adults with non-cystic fibrosis bronchiectasis. The main purpose of this study is to find out how a medicine called BI 1323495 is tolerated by people with non-cystic bronchiectasis.
The study tests 2 different doses of BI 1323495. Some of the participants get placebo. It is decided by chance who gets BI 1323495 and who gets placebo. Participants take BI 1323495 or placebo as tablets twice a day for 3 months. Placebo tablets look like BI 1323495 tablets but do not contain any medicine. Participants can also continue taking standard medicines for noncystic bronchiectasis throughout the study.
Participants are in the study for about 4 months. During this time, the participants visit the study site about 11 times and get about 2 phone calls. At the visits, doctors check the health of the participants and note any health problems that could have been caused by BI 1323495.
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Being tested
- BI 1323495, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1323495Drug
BI 1323495
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BI 1323495 treatment group (part 1) | Experimental | Part 1 Receives: Drug: BI 1323495 |
| BI 1323495 treatment group (part 2) | Experimental | Part 2 Receives: Drug: BI 1323495 |
| Placebo group | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Drug-related Adverse Events (AEs)
Number of participants with drug-related adverse events (AEs) is presented. Participants with treatment-emergent drug-related Adverse Events (AEs) is reported.
Measured: From drug administration until 12:00 AM on day after last administration of study drug + 7 days residual effect period (REP) or 12:00 AM on day after last contact date, which ever occurs first. Up to 13 weeks.
Secondary outcomes (4)
Change From Baseline to Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98 in Absolute Neutrophil Elastase (NE) Activity in Sputum
The change from baseline to Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98 in absolute neutrophil elastase (NE) activity in sputum is reported. The baseline value was calculated as the mean of the baseline values (at day -6, -2, day 1 predose). RFU is the standard output of a florescence reader. RFU (ex 360 nm, em460 nm).
Measured: At baseline Day -6, Day -2, Day 1 before the first dose and at Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98.
Change From Baseline to Week 12 (at Week 2, Week 4, Week 8, Week 12) in Neutrophil Cell Count in Sputum
The change from baseline to week 12 (at Week 2, Week 4, Week 8, Week 12) in absolute neutrophil cell count in sputum is reported. The baseline value was calculated as the mean of the baseline values (at day -6, -2, day 1 predose).
RFU: Relative fluorescence unit
Measured: At baseline Day -6, Day -2, Day 1 before the first dose and at at Week 2, Week 4, Week 8, Week 12 during treatment.
Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts)
The change of NE activity from baseline to Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98 in whole blood after stimulation with zymosan (normalized to neutrophil counts) is reported.
Relative fluorescence unit (RFU) is the standard output of a florescence reader. RFU (ex 360 nm, em460 nm).
Measured: At baseline Day 1, 2.5 hours (hrs) before the first dose and at Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98.
Change From Baseline to Week 12 in Absolute Post-bronchodilator Forced Expiratory Volume in One Second, FEV1
The change from baseline to week 12 (at Week 2, Week 8, Week 12) in absolute post-bronchodilator forced expiratory volume in one second (FEV1).
Measured: At baseline Day -2 before the first dose and at at Week 2, Week 8, Week 12 during treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start4 Mar 2021
- Primary completion20 Dec 2021
- Study completion19 Jan 2022
Why it stopped: Company decision
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.
- Other trials for Non-cystic Fibrosis BronchiectasisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 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
- NCT04656275
- Sponsor's protocol ID
- 1405-0008
- Other IDs
- 2019-003853-27, 2019
- Status last verified
- Nov 2024
- First submitted
- 1 Dec 2020
- Last updated
- 27 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Different Oral Doses of BI 1323495 Bid Versus Placebo in Patients With Non-cystic Fibrosis Bronchiectasis (Randomised, Double-blind, Placebo-controlled, Parallel Group Trial)
- ClinicalTrials.gov ID
- NCT04656275
- Acronym / sponsor ID
- 1405-0008
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Posted 5 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is open to adults with non-cystic fibrosis bronchiectasis. The main purpose of this study is to find out how a medicine called BI 1323495 is tolerated by people with non-cystic bronchiectasis.
The study tests 2 different doses of BI 1323495. Some of the participants get placebo. It is decided by chance who gets BI 1323495 and who gets placebo. Participants take BI 1323495 or placebo as tablets twice a day for 3 months. Placebo tablets look like BI 1323495 tablets but do not contain any medicine. Participants can also continue taking standard medicines for noncystic bronchiectasis throughout the study.
Participants are in the study for about 4 months. During this time, the participants visit the study site about 11 times and get about 2 phone calls. At the visits, doctors check the health of the participants and note any health problems that could have been caused by BI 1323495.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI 1323495 treatment group (part 1) | Experimental | Drug: BI 1323495Part 1 |
| BI 1323495 treatment group (part 2) | Experimental | Drug: BI 1323495Part 2 |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 years to 80 years (inclusive) at the time of informed consent signature, male and female (not of childbearing potential) subjects
- --For 'female not of childbearing potential' at least one of the following criteria must be fulfilled:
- Clinical history consistent with non cystic fibrosis bronchiectasis (nCFB) (cough, chronic sputum production and/or recurrent respiratory infections) and proven and documented diagnosis of bronchiectasis by computed tomography (CT) scan including dilated airways compatible with bronchiectasis at initial diagnosis. Bronchiectasis of various etiologies will be allowed, with exclusion criteria as below.
- Vaccination against Streptococcus pneumoniae in accordance with national vaccination recommendations
- Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation.
Key exclusion criteria (11 listed)
- Any finding in the medical examination (including BP, pulse rate (PR), or ECG) and/or laboratory value and/or any evidence of a concomitant disease assessed as clinically relevant by the investigator.
- Concomitant diagnosis of pulmonary disease other than bronchiectasis, chronic obstructive pulmonary disease (COPD), or asthma.
- A current diagnosis of cystic fibrosis (CF), primary immunodeficiency, active Allergic Bronchopulmonary Aspergillosis (ABPA) (defined by receipt of corticosteroids, anti-fungal treatment or monoclonal antibody treatment), or alpha-1 antitrypsin (A1AT) deficiency as underlying disease.
- A history or current immunodeficiency or are currently being treated (or are planned to be treated) with immunomodulatory drugs (except for iCS or low-dose oral corticosteroids), including disease-modifying anti-rheumatic drugs (DMARDs), and/or Immunglobulin G (IgG) treatments. Other medication that is excluded will be provided in the investigator site file (ISF). On the day of the site visit with lung function measurement, no bronchodilators should be used until after completion of lung function assessment
- Any acute infections defined as infections requiring antibiotic therapy, or Upper Respiratory Tract Infection (URTI). Are currently being treated (or are planned to be treated) for a nontuberculous mycobacterial (NTM) lung infection or tuberculosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 1323495BI 1323495 | Drug | BI 1323495 treatment group (part 1), BI 1323495 treatment group (part 2) |
| PlaceboPlacebo | Drug | Placebo group |
Primary outcome
Number of Subjects With Drug-related Adverse Events (AEs)
Time frame: From drug administration until 12:00 AM on day after last administration of study drug + 7 days residual effect period (REP) or 12:00 AM on day after last contact date, which ever occurs first. Up to 13 weeks.
Number of participants with drug-related adverse events (AEs) is presented. Participants with treatment-emergent drug-related Adverse Events (AEs) is reported.
4 secondary outcomes
Change From Baseline to Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98 in Absolute Neutrophil Elastase (NE) Activity in Sputum
Time frame: At baseline Day -6, Day -2, Day 1 before the first dose and at Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98.
Change From Baseline to Week 12 (at Week 2, Week 4, Week 8, Week 12) in Neutrophil Cell Count in Sputum
Time frame: At baseline Day -6, Day -2, Day 1 before the first dose and at at Week 2, Week 4, Week 8, Week 12 during treatment.
Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts)
Time frame: At baseline Day 1, 2.5 hours (hrs) before the first dose and at Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98.
Change From Baseline to Week 12 in Absolute Post-bronchodilator Forced Expiratory Volume in One Second, FEV1
Time frame: At baseline Day -2 before the first dose and at at Week 2, Week 8, Week 12 during treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.mystudywindow.com/msw/datatransparency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 1323495 in people with Non-cystic Fibrosis Bronchiectasis, run by Boehringer Ingelheim at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Drug-related Adverse Events (AEs) (time frame: From drug administration until 12:00 AM on day after last administration of study drug + 7 days residual effect period (REP) or 12:00 AM on day after last contact date, which ever occurs first. Up to 13 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.