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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06238622




Registration number
NCT06238622
Ethics application status
Date submitted
25/01/2024
Date registered
2/02/2024

Titles & IDs
Public title
A Follow-up Study to Test Long-term Treatment With BI 1015550 in People With Pulmonary Fibrosis Who Took Part in a Previous Study With BI 1015550
Scientific title
An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)
Secondary ID [1] 0 0
2023-507353-15-00
Secondary ID [2] 0 0
1305-0031
Universal Trial Number (UTN)
Trial acronym
FIBRONEER™-ON
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 1015550

Experimental: BI 1015550 treatment group -


Treatment: Drugs: BI 1015550
BI 1015550
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of any adverse event over the course of the extension trial (yes/no)
Timepoint [1] 0 0
Up to 99 weeks and 3 days
Secondary outcome [1] 0 0
Absolute change from baseline in Forced vital capacity (FVC) (mL) over time
Timepoint [1] 0 0
Up to 98 weeks
Secondary outcome [2] 0 0
Absolute change from baseline in % predicted in Forced vital capacity (FVC) over time
Timepoint [2] 0 0
Up to 98 weeks
Secondary outcome [3] 0 0
Time to absolute decline in FVC % predicted of >10% from baseline over the duration of the trial
Timepoint [3] 0 0
Up to 98 weeks
Secondary outcome [4] 0 0
Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation, first hospitalisation for respiratory cause, or death (whichever occurs first) over the duration of the trial
Timepoint [4] 0 0
Up to 98 weeks
Secondary outcome [5] 0 0
Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation or death over the duration of the trial
Timepoint [5] 0 0
Up to 98 weeks
Secondary outcome [6] 0 0
Time to hospitalisation for respiratory cause or death over the duration of the trial
Timepoint [6] 0 0
Up to 98 weeks
Secondary outcome [7] 0 0
Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial
Timepoint [7] 0 0
Up to 98 weeks
Secondary outcome [8] 0 0
Time to relative decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial
Timepoint [8] 0 0
Up to 98 weeks

Eligibility
Key inclusion criteria
1. Patients who completed treatment in the parent trials (1305-0014 or 1305-0023) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion.
2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:

* any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
* any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore >14 at Visit 1.
4. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.
5. Patient will undergo lung transplantation, with an assigned date of surgery.
6. Patients with a Body Mass index (BMI) <18.5 kg/m² that experienced an additional, unexplained and clinically significant (>10%) weight loss during the parent trial
7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI) (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial
8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.

Further exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
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
24/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/05/2027
Actual
Sample size
Target
1700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Lung Research Queensland - Chermside
Recruitment hospital [5] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [8] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [9] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [10] 0 0
Trialswest - Spearwood
Recruitment hospital [11] 0 0
Macquarie University - Macquarie Park
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
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3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment postcode(s) [9] 0 0
6153 - Spearwood
Recruitment postcode(s) [10] 0 0
2109 - Macquarie Park
Recruitment outside Australia
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One Tree Hill, Auckland
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Papatoetoe
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State/province [207] 0 0
Tauranga South
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Norway
State/province [208] 0 0
Bergen
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Norway
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Oslo
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Poland
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Gdansk
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Katowice
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Swidnik
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Warsaw
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Portugal
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Braga
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Lisboa
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Matosinhos
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Vila Nova de Gaia
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Puerto Rico
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Guaynabo
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Saudi Arabia
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Riyadh
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Nis
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Singapore
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Taiwan
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Taichung
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Thailand
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Thailand
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Muang
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Thailand
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Thailand
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Turkey
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Antalya
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Exeter
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Lancaster
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Southampton

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/NCT06238622