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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05321069




Registration number
NCT05321069
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 Idiopathic Pulmonary Fibrosis (IPF)
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 Idiopathic Pulmonary Fibrosis (IPF)
Secondary ID [1] 0 0
2022-001091-34
Secondary ID [2] 0 0
1305-0014
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic 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
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 IPF exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trial
Timepoint [1] 0 0
up to 30 months
Secondary outcome [2] 0 0
Time to first acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation or death over the duration of trial
Timepoint [2] 0 0
up to 30 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 30 months
Secondary outcome [4] 0 0
Time to absolute decline in FVC % predicted of >10% from baseline or death over the duration of the trial
Timepoint [4] 0 0
up to 30 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 30 months
Secondary outcome [6] 0 0
Time to death over the duration of trial
Timepoint [6] 0 0
up to 30 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 =40 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 Idiopathic Pulmonary Fibrosis (IPF)
4. Patients may be either:

* on a stable therapy* with nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. Combination of nintedanib plus pirfenidone is not allowed. (*stable therapy is defined as the individually and general tolerated regimen of either nintedanib or pirfenidone (no dose changes) for at least 12 weeks.)
* not on a treatment with nintedanib or pirfenidone 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. Diffusing Capacity (of Lung) for Carbon Monoxide (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
Minimum age
40 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 Idiopathic Pulmonary Fibrosis (IPF) 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. Confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) not fully recovered according to investigator judgement within the 4 weeks prior to randomization (Visit 2).
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
19/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/11/2024
Actual
Sample size
Target
Accrual to date
Final
1177
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
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Royal Prince Alfred Hospital - Camperdown
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Westmead Hospital - Westmead
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Lung Research Queensland - Chermside
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The Prince Charles Hospital - Chermside
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Mater Hospital Brisbane - South Brisbane
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Princess Alexandra Hospital - Woolloongabba
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Lung Research Victoria - Footscray
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Austin Hospital - Heidelberg
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The Alfred Hospital - Melbourne
Recruitment hospital [11] 0 0
Fiona Stanley Hospital - Murdoch
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Trialswest - Spearwood
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2605 - Canberra
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2050 - Camperdown
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2145 - Westmead
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4032 - Chermside
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4101 - South Brisbane
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4102 - Woolloongabba
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3011 - Footscray
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3084 - Heidelberg
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3004 - Melbourne
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6150 - Murdoch
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6153 - Spearwood
Recruitment outside Australia
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Hemer
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Ireland
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Dublin 15
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Catania
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Italy
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Firenze
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Italy
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Foggia
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Milano
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Modena
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Padova
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Roma
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Italy
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Siena
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Italy
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Torrette Di Ancona (Ancona)
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Japan
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Aichi, Seto
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Japan
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Aichi, Toyoake
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Japan
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Chiba, Chiba
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Chiba, Narita
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Japan
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Fukui, Yoshida-gun
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Japan
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Fukuoka, Fukuoka
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Japan
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Fukuoka, Iizuka
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Fukuoka, Kurume
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Japan
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Japan
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Japan
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Hiroshima, Hiroshima
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Tokyo, Shinjuku-ku
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Wakayama, Wakayama
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Korea, Republic of
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Bucheon
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Seongnam
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Seoul
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Kajang
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Malaysia
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Kuala Lumpur
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Hamilton
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One Tree Hill, Auckland
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State/province [195] 0 0
Papatoetoe
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Bergen
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Gdansk
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Swidnik
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Poland
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Warsaw
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Coimbra
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Guaynabo
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Cape Town
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Bilbao
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Galdakao
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Girona
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Granada
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Spain
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L'Hospitalet de Llobregat
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Lugo
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Spain
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Spain
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Santander
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Spain
State/province [224] 0 0
Santiago de Compostela
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Spain
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Sevilla
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Spain
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Valencia
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Linköping
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Changhua
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Taiwan
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Taiwan
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Thailand
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Bangkok Noi
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Thailand
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Hat Yai
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Thailand
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Khon Kaen
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Thailand
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Muang
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Oxford

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/NCT05321069