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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06360094




Registration number
NCT06360094
Ethics application status
Date submitted
8/04/2024
Date registered
11/04/2024

Titles & IDs
Public title
A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis
Scientific title
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
Secondary ID [1] 0 0
2023-510249-79-00
Secondary ID [2] 0 0
1490-0004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Progressive Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 1839100
Treatment: Drugs - Placebo

Placebo comparator: Phase IIa/IIb, IPF cohort: Placebo -

Experimental: Phase IIa/IIb, IPF cohort: BI 1839100 low dose -

Experimental: Phase IIa/IIb, IPF cohort: BI 1839100 medium dose -

Experimental: Phase IIa/IIb, IPF cohort: BI 1839100 high dose -

Placebo comparator: Phase IIb, PPF cohort: Placebo -

Experimental: Phase IIb, PPF cohort: BI 1839100 high dose -


Treatment: Drugs: BI 1839100
BI 1839100

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (Cough count (CC)/h)
Timepoint [1] 0 0
At baseline, at week 4
Primary outcome [2] 0 0
IPF cohort - Phase IIb: Change from baseline in 24-h cough frequency (CC/h)
Timepoint [2] 0 0
At baseline, at week 12
Secondary outcome [1] 0 0
IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Numerical rating scale (NRS) score
Timepoint [1] 0 0
At baseline, at week 4
Secondary outcome [2] 0 0
IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Visual analogue scale (VAS) score (mm)
Timepoint [2] 0 0
At baseline, at week 4
Secondary outcome [3] 0 0
IPF cohort - Phase IIb: Cough responder status, defined as a =30% reduction in 24-h cough frequency (CC/h)
Timepoint [3] 0 0
At baseline, at week 12
Secondary outcome [4] 0 0
IPF cohort - Phase IIb: Absolute change from baseline in Forced vital capacity (FVC) (mL)
Timepoint [4] 0 0
At baseline, at week 12
Secondary outcome [5] 0 0
IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity NRS score
Timepoint [5] 0 0
At baseline, at week 12
Secondary outcome [6] 0 0
IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity VAS score (mm)
Timepoint [6] 0 0
At baseline, at week 12
Secondary outcome [7] 0 0
IPF cohort - Phase IIb: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) symptom cough domain score
Timepoint [7] 0 0
At baseline, at week 12
Secondary outcome [8] 0 0
IPF cohort - Phase IIb: Absolute change from baseline in Leicester Cough Questionnaire (LCQ) physical domain score
Timepoint [8] 0 0
At baseline, at week 12

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/08/2025
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Lung Research Victoria - Footscray
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3011 - Footscray
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Mississippi
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
China
State/province [10] 0 0
Chengdu
Country [11] 0 0
Finland
State/province [11] 0 0
Helsinki
Country [12] 0 0
Finland
State/province [12] 0 0
Oulu
Country [13] 0 0
Finland
State/province [13] 0 0
Turku
Country [14] 0 0
France
State/province [14] 0 0
Caen
Country [15] 0 0
Germany
State/province [15] 0 0
Bamberg
Country [16] 0 0
Japan
State/province [16] 0 0
Fukui, Yoshida-gun
Country [17] 0 0
Japan
State/province [17] 0 0
Fukuoka, Fukuoka
Country [18] 0 0
Japan
State/province [18] 0 0
Hyogo, Himeji
Country [19] 0 0
Japan
State/province [19] 0 0
Kanagawa, Yokohama
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Bucheon
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Busan
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seongnam
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seoul
Country [24] 0 0
Malaysia
State/province [24] 0 0
Kuching, Sarawak
Country [25] 0 0
New Zealand
State/province [25] 0 0
Christchurch
Country [26] 0 0
New Zealand
State/province [26] 0 0
Hamilton
Country [27] 0 0
New Zealand
State/province [27] 0 0
One Tree Hill, Auckland
Country [28] 0 0
Singapore
State/province [28] 0 0
Singapore
Country [29] 0 0
Spain
State/province [29] 0 0
Alicante
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Galdakao
Country [32] 0 0
Spain
State/province [32] 0 0
Sevilla
Country [33] 0 0
Sweden
State/province [33] 0 0
Uppsala
Country [34] 0 0
Taiwan
State/province [34] 0 0
Kaohsiung
Country [35] 0 0
Thailand
State/province [35] 0 0
Bangkok
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Lancaster

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
clintriage.rdg@boehringer-ingelheim.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06360094