A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis

A Phase IIa/IIb, Randomised, Double Blind, Placebo-controlled, Parallel-group Dose-finding Study to Examine the Efficacy and Safety of BI 1839100 Administered Orally Over a 12-week Treatment Period in Patients With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis With Clinically Meaningful Cough

Adults 40 years of age and older with idiopathic pulmonary fibrosis (IPF) or 18 years and older with progressive pulmonary fibrosis (PPF) can participate in this study. Only people who have a chronic cough can take part. The purpose of this study is to find out how well BI 1839100 helps reduce coughing in people with IPF or PPF.

Participants who have IPF are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1839100. Participants in 1 group get placebo. Placebo looks like BI 1839100 but does not contain any medicine. Participants take the treatment for 3 months. After 1 month of treatment, participants who take the highest dose will have coughing measured to find out if the medicine works. If it does not work, the study may be stopped. Participants who have IPF are in the study for slightly longer than 4 months. During this time, they visit the study site 7 times. This study will also measure the effects of BI 1839100 on coughing and lung function in a smaller group of people with PPF.

During the study, coughing is measured over 24 hours about once per month using a portable device given to participants to use during the study. Participants fill in questionnaires about their coughing. Doctors also perform breathing tests that measure how well the lungs are working at the site visits. Researchers compare the results between participants who take BI 1839100 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Pulmonary Fibrosis; Progressive Pulmonary Fibrosis
• Intervention / Treatment: Drug: Placebo; Drug: BI 1839100

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

For Idiopathic Pulmonary Fibrosis (IPF) cohort:

• Minimum age: 40 years
• Diagnosis of IPF
• Chronic cough (>8 weeks prior to Visit 1) attributed to IPF and refractory to treatment for known causes (Principal Investigator (PI) assessment)
• Cough Severity visual analogue scale (VAS) ≥30 mm at Visit 1 and Visit 2B
• Forced vital capacity (FVC) ≥45% of predicted normal at Visit 1
• Diffusing capacity of the lungs for carbon monoxide (DLCO) >25% of predicted normal at Visit 1

• Patients may be either:

  • On stable therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration. Combination of nintedanib plus pirfenidone will not be allowed
  • Not on therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 (either antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start AF treatment during the trial
• Patients aged ≥40 years when signing the informed consent

For Progressive Pulmonary Fibrosis (PPF) cohort:

• Minimum age: 18 years
• Diagnosis of PPF
• Chronic cough (>8 weeks prior to Visit 1) attributed to PPF, refractory to treatment for known causes (PI assessment)
• Cough Severity VAS ≥30 mm at Visit 1 and Visit 2B
• FVC ≥45% of predicted normal at Visit 1
• DLCO ≥25% of predicted normal at Visit 1
• If receiving immunomodulatory therapy for interstitial lung disease (ILD), allowed medications include tacrolimus, mycophenolate mofetil, or azathioprine (stable dose for 12 weeks prior to Visit 1)

• Patients may be either:

  • On a stable therapy with nintedanib for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration
  • Not on a therapy with nintedanib for ≥12 weeks prior to Visit 1 (either AF-treatment naïve or previously discontinued) and do not plan to start or re-start AF treatment during the trial
• Patients aged >18 years when signing the informed consent

Further inclusion criteria apply.

Exclusion criteria for IPF and PPF cohorts:

• Acute exacerbation of IPF/PPF within 12 weeks prior to Visit 1
• Forced expiratory volume in 1 second (Forced expiratory volume in 1 second (FEV1))/FVC <0.7 at Visit 1
• Known reversible airflow obstruction/response to bronchodilators
• In the opinion of the Investigator, other clinically significant pulmonary abnormalities, including primary bronchitic and bronchiectatic disorder
• Upper or lower respiratory tract infection within 4 weeks prior to Visit 1
• Ongoing chronic pulmonary infection (e.g. mycobacterial or fungal disease)
• Current smokers (tobacco use within the 6 months prior to Visit 1)
• Initiation or change in supplemental oxygen requirement during 4 weeks prior to Visit 1 Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Phase IIa/IIb, IPF cohort: Placebo	Drug: Placebo; Placebo
Experimental: Phase IIa/IIb, IPF cohort: BI 1839100 low dose	Drug: BI 1839100; BI 1839100
Experimental: Phase IIa/IIb, IPF cohort: BI 1839100 medium dose	Drug: BI 1839100; BI 1839100
Experimental: Phase IIa/IIb, IPF cohort: BI 1839100 high dose	Drug: BI 1839100; BI 1839100
Placebo Comparator: Phase IIb, PPF cohort: Placebo	Drug: Placebo; Placebo
Experimental: Phase IIb, PPF cohort: BI 1839100 high dose	Drug: BI 1839100; BI 1839100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (Cough count (CC)/h)	At baseline, at week 4
IPF cohort - Phase IIb: Change from baseline in 24-h cough frequency (CC/h)	At baseline, at week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Numerical rating scale (NRS) score	NRS: a single-item patient reported outcome measure to assess cough severity on a 11-point numerical rating scale ranging from 0 (no cough) to 10 (worst possible cough) with a recall period of the past 7 days. Higher scores indicate higher severity of cough.	At baseline, at week 4
IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Visual analogue scale (VAS) score (mm)	VAS: the cough severity VAS is scored according to the distance between no cough (0) and the mark set by the participant, with higher distance indicating higher severity of cough.	At baseline, at week 4
IPF cohort - Phase IIb: Cough responder status, defined as a ≥30% reduction in 24-h cough frequency (CC/h)		At baseline, at week 12
IPF cohort - Phase IIb: Absolute change from baseline in Forced vital capacity (FVC) (mL)		At baseline, at week 12
IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity NRS score		At baseline, at week 12
IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity VAS score (mm)		At baseline, at week 12
IPF cohort - Phase IIb: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) symptom cough domain score	L-PF: the L-PF symptom module domain and total scores as well as the L-PF impact module total score ranges from 0 to 100, with higher scores indicating a greater impairment.	At baseline, at week 12
IPF cohort - Phase IIb: Absolute change from baseline in Leicester Cough Questionnaire (LCQ) physical domain score	LCQ: the total score ranges from 3 to 21. A higher score indicates better cough specific quality of life.	At baseline, at week 12

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): July 27, 2024
• Primary Completion (Estimated): July 21, 2025
• Study Completion (Estimated): August 6, 2025

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 1490-0004; 2023-510249-79-00 (Registry Identifier: CTIS); U1111-1301-1311 (Registry Identifier: WHO Registry (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

• IPD Sharing Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'.

For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No