1405-0008 - Phase 1c BI 1323495 in non-cystic fibrosis bronchiectasis
Research type
Research Study
Full 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)
IRAS ID
289577
Contact name
James Chalmers
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd
Eudract number
2019-003853-27
Duration of Study in the UK
0 years, 9 months, 18 days
Research summary
Summary of Research
This is a Phase Ic trial of a new experimental treatment called BI 1323495 in patients with non-Cystic Fibrosis bronchiectasis. The study consists of 2 parts. In Part A, eligible participants will be assigned at random, to receive either 30mg of BI 1323495 or placebo, twice daily.
Part B starts if the following conditions are met: The specified number of patients have enrolled in Part A; The dose for Part B has been decided; and periodic safety reviews up to this point have not raised any concerns. In Part B, participants will be assigned at random to receive either a higher dose of BI 1323495 than that tested in Part A, or placebo, twice daily. The dose for Part B will be based upon results of another trial that is currently ongoing. An amendment to this protocol will be written once those results are available.
In both trial parts, after signing informed consent, potential participants will be screened to confirm if they meet the entry criteria for the study. This screening will include a blood test to confirm if the patient is an extensive metaboliser (EM) - patients likely to metabolise medication normally – and only EM patients will be enrolled in this trial. The screening period will also require patients to produce 2 to 3 sputum samples also used to determine if patients are suitable for the study. Once eligibility is confirmed, patients will be assigned at random to receive either BI 1323495 or placebo twice daily for 12 weeks. Following the treatment period (or if a patient withdraws early), patients will be followed up for 2 weeks.
It is planned to include 36 patients with non-Cystic Fibrosis bronchiectasis in trial Parts A and
B: 12 patients in Part A (3:1 randomisation, active:placebo) and 24 patients in Part B (3:1 randomisation, active:placebo).Summary of Results
Study title:
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
This is a summary of results from 1 clinical study.
We thank all study participants. You helped us to answer important questions about BI 1323495 and the treatment of bronchiectasis.What was this study about?
The main purpose of this study was to find out how a medicine called BI 1323495 is tolerated by people with non-cystic fibrosis bronchiectasis.
The study was stopped early. This was because there was new information about BI 1323495, and we did not want to put participants at risk. It was later confirmed that there was no risk to the participants.Who took part in this study?
Adults with non-cystic fibrosis bronchiectasis could take part in this study.
The study was planned for 36 participants. The study was stopped early; therefore, only 7 participants took part in this study. There were 4 men (57%) and 3 women (43%). The youngest participant was 46 years old, and the oldest participant was 64 years old.
This study was done in Germany.How was this study done?
We wanted to find out how people with non-cystic fibrosis bronchiectasis tolerated BI 1323495. To do this, we looked at the number of participants with unwanted effects. Unwanted effects are any health problems that the doctors think were caused by the study medicine. Participants could continue to take their usual medicines for bronchiectasis during the study.
The participants were divided into 2 groups. Participants had between 2 and 3 times the chance of being in the BI 1323495 group as in the placebo group. The groups were:
• BI 1323495 group: participants took 3 tablets of BI 1323495 twice per day
• Placebo group: participants took 3 tablets of placebo twice per day
Placebo tablets looked like BI 1323495 but did not contain any medicine.
The participants and doctors did not know whether the participants were in the BI 1323495 group or in the placebo group.
It was planned to test BI 1323495 for 12 weeks. Because the study stopped early, only 1 participant completed the entire study.
Participants visited the doctors regularly. During these visits, the doctors collected information about the participants’ health and noted any health problems that could have been caused by BI 1323495.What were the results of this study?
In this study, 2 out of 5 participants who received BI 1323495 had unwanted effects. The unwanted effects were low heart rate (bradycardia) and itching skin (pruritus).
None of the unwanted effects were serious. This means that the unwanted effects did not lead to a hospital stay, that they were not life-threatening, and that they did not lead to a disability.
None of the participants who took placebo had unwanted effects.
Because the study was stopped early, there were not enough participants to reach clear conclusions about the results.Is there more information about this study?
You can find further information about this study at these websites:
1. Go to www.clinicaltrialsregister.eu/ctr-search and search for the EudraCT number 2019-003853-27.
2. Go to www.clinicaltrials.gov and search for the NCT number NCT04656275.
Boehringer Ingelheim sponsored this study. For contact details, please visit www.boehringer-ingelheim.com/contact-us.
The full title of the study is: Safety, tolerability, pharmacokinetics, and pharmacodynamics of different oral doses of BI 1323495 versus placebo in patients with non-cystic fibrosis bronchiectasis (randomised, double blind, placebo-controlled, parallel group trial)
This was a Phase I study. This study started in July 2021 and finished early in January 2022.Are there additional studies?
If we do more clinical studies with BI 1323495, you will find them on the websites listed above. To search for these studies, use the words BI 1323495.Important notice
This lay summary is provided as part of Boehringer Ingelheim’s commitment to publicly share clinical study results.
This summary shows only the results from one study and may not represent all of the knowledge about the medicine studied. Other studies may have different results. Usually, more than one study is carried out to find out how well a medicine works and to determine the side effects of a medicine.
This lay summary may include uses, formulations, or treatment regimens for the medicine studied that may be approved or not approved in your country. This lay summary is not intended to promote any product or indication, to guide treatment decisions, or to replace the advice of a healthcare professional.
You should not change your therapy based on the results of this study. Always consult with your treating physician about your therapy.
©2023 Boehringer Ingelheim International GmbHREC name
London - Brent Research Ethics Committee
REC reference
20/LO/1268
Date of REC Opinion
10 Dec 2020
REC opinion
Further Information Favourable Opinion