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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05321082




Registration number
NCT05321082
Ethics application status
Date submitted
4/04/2022
Date registered
11/04/2022

Titles & IDs
Public title
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
Scientific title
A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
Secondary ID [1] 0 0
2022-001134-11
Secondary ID [2] 0 0
1305-0023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Diseases, Interstitial 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 1015550
Treatment: Drugs - Placebo

Experimental: BI 1015550 low dose -

Experimental: BI 1015550 high dose -

Placebo comparator: Placebo -


Treatment: Drugs: BI 1015550
BI 1015550

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

Outcomes
Primary outcome [1] 0 0
Absolute change from baseline in Forced Vital Capacity (FVC) (mL) at Week 52
Timepoint [1] 0 0
at baseline, at week 52
Secondary outcome [1] 0 0
Time to the first occurrence of any of the components of the composite endpoint: time to first acute ILD exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trial
Timepoint [1] 0 0
up to 31 months
Secondary outcome [2] 0 0
Time to first acute Interstitial Lung Disease (ILD) exacerbation or death over the duration of trial
Timepoint [2] 0 0
up to 31 months
Secondary outcome [3] 0 0
Time to hospitalization for respiratory cause or death over the duration of trial
Timepoint [3] 0 0
up to 31 months
Secondary outcome [4] 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 [4] 0 0
up to 31 months
Secondary outcome [5] 0 0
Time to absolute decline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) % predicted of >15% from baseline or death over the duration of the trial
Timepoint [5] 0 0
up to 31 months
Secondary outcome [6] 0 0
Time to death over the duration of trial
Timepoint [6] 0 0
up to 31 months
Secondary outcome [7] 0 0
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52
Timepoint [7] 0 0
at baseline, at week 52
Secondary outcome [8] 0 0
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52
Timepoint [8] 0 0
at baseline, at week 52
Secondary outcome [9] 0 0
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score at Week 52
Timepoint [9] 0 0
at baseline, at week 52
Secondary outcome [10] 0 0
Absolute change from baseline in FVC % predicted at Week 52
Timepoint [10] 0 0
at baseline, at week 52
Secondary outcome [11] 0 0
Absolute change from baseline in DLCO % predicted at Week 52
Timepoint [11] 0 0
at baseline, at week 52

Eligibility
Key inclusion criteria
Inclusion criteria

1. Patients =18 years old at the time of signed informed consent.
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
3. Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed).
4. Patients may be either:

* on a stable therapy* with nintedanib for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. (*stable therapy is defined as a tolerated regimen of nintedanib (with no dose changes) for at least 12 weeks)
* not on treatment with nintedanib for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.
5. Forced Vital Capacity (FVC) =45% of predicted normal at Visit 1.
6. DLCO =25% of predicted normal corrected for hemoglobin (Hb) at Visit 1.
7. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method
8. Patients treated with permitted immunosuppressive agents (other than corticosteroids) for an underlying systemic disease (e.g. Methotrexate (MTX), Azathioprine (AZA)) need to be on a stable treatment for at least 12 weeks prior to Visit 1 and during the screening period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

1. Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) <0.7 at Visit 1
2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
3. Acute Interstitial Lung Disease (ILD) exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).
4. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.
5. Patients having developed ILD due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection/coronavirus disease 2019 (COVID-19) within 12 months of screening (based on investigators judgement).
6. Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to Visit 2 or planned during the trial period, e.g. hip replacement. Registration on lung transplantation list would not be considered as planned major surgery.
7. Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
8. Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) >2.5 x upper limit of normal (ULN) or total Bilirubin >1.5 x ULN at 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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/03/2025
Actual
Sample size
Target
Accrual to date
Final
1178
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, Sydney
Recruitment hospital [3] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Lung Research Queensland - Chermside
Recruitment hospital [6] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [7] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
Lung Research Victoria - Footscray
Recruitment hospital [10] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [11] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [12] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [13] 0 0
Trialswest - Spearwood
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown, Sydney
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2109 - Macquarie Park
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2145 - Westmead
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4032 - Chermside
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4101 - South Brisbane
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5000 - Adelaide
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3011 - Footscray
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3084 - Heidelberg
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3004 - Melbourne
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6150 - Murdoch
Recruitment postcode(s) [12] 0 0
6153 - Spearwood
Recruitment outside Australia
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Country [196] 0 0
Japan
State/province [196] 0 0
Miyagi, Sendai
Country [197] 0 0
Japan
State/province [197] 0 0
Nagasaki, Nagasaki
Country [198] 0 0
Japan
State/province [198] 0 0
Osaka, Osakasayama
Country [199] 0 0
Japan
State/province [199] 0 0
Osaka, Sakai
Country [200] 0 0
Japan
State/province [200] 0 0
Osaka, Takatsuki
Country [201] 0 0
Japan
State/province [201] 0 0
Saitama, Saitama
Country [202] 0 0
Japan
State/province [202] 0 0
Shizuoka, Hamamatsu
Country [203] 0 0
Japan
State/province [203] 0 0
Tochigi, Shimotsuke
Country [204] 0 0
Japan
State/province [204] 0 0
Tokushima, Tokushima
Country [205] 0 0
Japan
State/province [205] 0 0
Tokyo, Bunkyo-ku
Country [206] 0 0
Japan
State/province [206] 0 0
Tokyo, Minato-ku
Country [207] 0 0
Japan
State/province [207] 0 0
Tokyo, Mitaka
Country [208] 0 0
Japan
State/province [208] 0 0
Tokyo, Ota-ku
Country [209] 0 0
Japan
State/province [209] 0 0
Tokyo, Shinjuku-ku
Country [210] 0 0
Japan
State/province [210] 0 0
Wakayama, Wakayama
Country [211] 0 0
Korea, Republic of
State/province [211] 0 0
Bucheon
Country [212] 0 0
Korea, Republic of
State/province [212] 0 0
Seongnam
Country [213] 0 0
Korea, Republic of
State/province [213] 0 0
Seoul
Country [214] 0 0
Malaysia
State/province [214] 0 0
Kajang
Country [215] 0 0
Malaysia
State/province [215] 0 0
Kuala Lumpur
Country [216] 0 0
Malaysia
State/province [216] 0 0
Kuching
Country [217] 0 0
Malaysia
State/province [217] 0 0
Pulau Pinang
Country [218] 0 0
Mexico
State/province [218] 0 0
Cdmx
Country [219] 0 0
Mexico
State/province [219] 0 0
Chihuahua
Country [220] 0 0
Mexico
State/province [220] 0 0
Ciudad de Mexico
Country [221] 0 0
Mexico
State/province [221] 0 0
Coyoacan
Country [222] 0 0
Mexico
State/province [222] 0 0
Guanajuato
Country [223] 0 0
Mexico
State/province [223] 0 0
Monterrey
Country [224] 0 0
Mexico
State/province [224] 0 0
Oaxaca
Country [225] 0 0
Mexico
State/province [225] 0 0
Pachuca
Country [226] 0 0
Netherlands
State/province [226] 0 0
Heerlen
Country [227] 0 0
Netherlands
State/province [227] 0 0
Leiden
Country [228] 0 0
Netherlands
State/province [228] 0 0
Nieuwegein
Country [229] 0 0
Netherlands
State/province [229] 0 0
Rotterdam
Country [230] 0 0
New Zealand
State/province [230] 0 0
Hamilton
Country [231] 0 0
New Zealand
State/province [231] 0 0
One Tree Hill, Auckland
Country [232] 0 0
New Zealand
State/province [232] 0 0
Papatoetoe
Country [233] 0 0
New Zealand
State/province [233] 0 0
Tauranga South
Country [234] 0 0
Norway
State/province [234] 0 0
Bergen
Country [235] 0 0
Norway
State/province [235] 0 0
Lørenskog
Country [236] 0 0
Norway
State/province [236] 0 0
Oslo
Country [237] 0 0
Poland
State/province [237] 0 0
Gdansk
Country [238] 0 0
Poland
State/province [238] 0 0
Katowice
Country [239] 0 0
Poland
State/province [239] 0 0
Swidnik
Country [240] 0 0
Poland
State/province [240] 0 0
Warsaw
Country [241] 0 0
Portugal
State/province [241] 0 0
Braga
Country [242] 0 0
Portugal
State/province [242] 0 0
Lisboa
Country [243] 0 0
Portugal
State/province [243] 0 0
Matosinhos
Country [244] 0 0
Portugal
State/province [244] 0 0
Vila Nova de Gaia
Country [245] 0 0
Puerto Rico
State/province [245] 0 0
Guaynabo
Country [246] 0 0
Saudi Arabia
State/province [246] 0 0
Dammam
Country [247] 0 0
Saudi Arabia
State/province [247] 0 0
Riyadh
Country [248] 0 0
Serbia
State/province [248] 0 0
Belgrade
Country [249] 0 0
Serbia
State/province [249] 0 0
Kragujevac
Country [250] 0 0
Serbia
State/province [250] 0 0
Nis
Country [251] 0 0
Serbia
State/province [251] 0 0
Sremska Kamenica
Country [252] 0 0
Singapore
State/province [252] 0 0
Singapore
Country [253] 0 0
Slovenia
State/province [253] 0 0
Golnik
Country [254] 0 0
South Africa
State/province [254] 0 0
Cape Town
Country [255] 0 0
South Africa
State/province [255] 0 0
Durban
Country [256] 0 0
Spain
State/province [256] 0 0
Alicante
Country [257] 0 0
Spain
State/province [257] 0 0
Barcelona
Country [258] 0 0
Spain
State/province [258] 0 0
Bilbao
Country [259] 0 0
Spain
State/province [259] 0 0
El Palmar
Country [260] 0 0
Spain
State/province [260] 0 0
Galdakao
Country [261] 0 0
Spain
State/province [261] 0 0
Girona
Country [262] 0 0
Spain
State/province [262] 0 0
Granada
Country [263] 0 0
Spain
State/province [263] 0 0
L'Hospitalet de Llobregat
Country [264] 0 0
Spain
State/province [264] 0 0
Madrid
Country [265] 0 0
Spain
State/province [265] 0 0
Malaga
Country [266] 0 0
Spain
State/province [266] 0 0
Oviedo
Country [267] 0 0
Spain
State/province [267] 0 0
Pozuelo de Alarcón
Country [268] 0 0
Spain
State/province [268] 0 0
Santander
Country [269] 0 0
Spain
State/province [269] 0 0
Santiago de Compostela
Country [270] 0 0
Spain
State/province [270] 0 0
Sevilla
Country [271] 0 0
Sweden
State/province [271] 0 0
Uppsala
Country [272] 0 0
Switzerland
State/province [272] 0 0
Basel
Country [273] 0 0
Switzerland
State/province [273] 0 0
Bern
Country [274] 0 0
Taiwan
State/province [274] 0 0
Changhua
Country [275] 0 0
Taiwan
State/province [275] 0 0
Kaohsiung
Country [276] 0 0
Taiwan
State/province [276] 0 0
Taichung
Country [277] 0 0
Taiwan
State/province [277] 0 0
Tainan
Country [278] 0 0
Taiwan
State/province [278] 0 0
Taipei
Country [279] 0 0
Thailand
State/province [279] 0 0
Bangkok Noi
Country [280] 0 0
Thailand
State/province [280] 0 0
Hat Yai
Country [281] 0 0
Thailand
State/province [281] 0 0
Khon Kaen
Country [282] 0 0
Thailand
State/province [282] 0 0
Muang
Country [283] 0 0
Thailand
State/province [283] 0 0
Ratchatewi
Country [284] 0 0
Turkey
State/province [284] 0 0
Ankara
Country [285] 0 0
Turkey
State/province [285] 0 0
Antalya
Country [286] 0 0
Turkey
State/province [286] 0 0
Bursa
Country [287] 0 0
Turkey
State/province [287] 0 0
Istanbul
Country [288] 0 0
Turkey
State/province [288] 0 0
Yenimahalle/ANKARA
Country [289] 0 0
United Kingdom
State/province [289] 0 0
Aberdeen
Country [290] 0 0
United Kingdom
State/province [290] 0 0
Birmingham
Country [291] 0 0
United Kingdom
State/province [291] 0 0
Bristol
Country [292] 0 0
United Kingdom
State/province [292] 0 0
Edinburgh
Country [293] 0 0
United Kingdom
State/province [293] 0 0
Exeter
Country [294] 0 0
United Kingdom
State/province [294] 0 0
Lancaster
Country [295] 0 0
United Kingdom
State/province [295] 0 0
Leeds
Country [296] 0 0
United Kingdom
State/province [296] 0 0
Londonderry
Country [297] 0 0
United Kingdom
State/province [297] 0 0
London
Country [298] 0 0
United Kingdom
State/province [298] 0 0
Manchester
Country [299] 0 0
United Kingdom
State/province [299] 0 0
Oxford
Country [300] 0 0
United Kingdom
State/province [300] 0 0
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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)?
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
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/NCT05321082