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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
Date last updated
27/06/2024

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
5/10/2022
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
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Lung Research Queensland - Chermside
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The Prince Charles Hospital - Chermside
Recruitment hospital [7] 0 0
Mater Hospital Brisbane - South Brisbane
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Royal Adelaide Hospital - Adelaide
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Lung Research Victoria - Footscray
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Austin Hospital - Heidelberg
Recruitment hospital [11] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [12] 0 0
Fiona Stanley Hospital - Murdoch
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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
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6153 - Spearwood
Recruitment outside Australia
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Bamberg
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Trieste
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Aichi, Seto
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Aichi, Toyoake
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Fukui, Yoshida-gun
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Japan
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Fukuoka, Fukuoka
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Fukuoka, Iizuka
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib, they can continue treatment throughout the study.

The purpose of this study is to find out whether a medicine called BI 1015550 helps people with PF-ILD. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine.

Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.
Trial website
https://clinicaltrials.gov/study/NCT05321082
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries