A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of BI 1015550 over a period of at least 52 weeks in patients with progressive fibrosing interstitial lung diseases (PF-ILD)

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Croatia, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States (ICTRP)

ICTRP Trial ID
EUCTR2022-001134-11 (ICTRP)

Official title (approved by ethics committee)
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) (BASEC)

Academic 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) - PDE4 Phase III trial in PF-ILD (Fibroneer- ILD) (ICTRP)

Public title
A study to find out whether BI 1015550 improves lung function in people with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) (ICTRP)

Disease under investigation
Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
MedDRA version: 23.1Level: LLTClassification code 10084309Term: Progressive fibrosing interstitial lung diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] (ICTRP)

Intervention under investigation

Product Name: BI 1015550 9 mg Film Coated Tablet
Product Code: BI 1015550
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: None yet
Current Sponsor code: BI 1015550
Other descriptive name: BI 1015550
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: BI 1015550 18 mg Film Coated Tablet
Product Code: BI 1015550
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: None yet
Current Sponsor code: BI 1015550
Other descriptive name: BI 1015550
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 18-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

(ICTRP)

Type of trial
Interventional clinical trial of medicinal product (ICTRP)

Trial design
Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3 (ICTRP)

Inclusion/Exclusion criteria
Gender:
Female: yes
Male: yes

Inclusion criteria:
1. Patients =18 years old at the time of signed informed consent.
2. Signed and dated written informed consent in accordance with ICHGCP
and local
legislation prior to admission to the trial.
3. Diagnosis of progressive fibrosing ILD other than IPF (physician
confirmed;
Section 3.3.1)
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 AF-treatment na?ve 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 corrected for Hemoglobin (Hb) [Visit 1] =25% predicted of
normal at Visit 1.
7. Women of childbearing potential (WOCBP)1 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. MTX, AZA)
need to be on a stable treatment for at least 12 weeks prior to Visit 1
and during the screening period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 441
(ICTRP)

Exclusion criteria:
1. Prebronchodilator FEV1/FVC <0.7 at Visit 1
2. In the opinion of the Investigator, other clinically significant
pulmonary abnormalities.
3. Acute 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 SARS-CoV-2 infection/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. AST or ALT >2.5 x ULN or total Bilirubin >1.5 x ULN at Visit 1.
9. eGFR =30 mL/min/1.73 m2 at Visit 1. (Chronic Kidney Disease
Epidemiology Collaboration [CKD-EPI] formula or Japanese version of
CKD-EPI for Japanese patients)
10. Patients with underlying liver disease (Child Pugh A, B, or C hepatic
impairment).
11. Cardiovascular diseases, any of the following:
a. Severe hypertension (uncontrolled under treatment =160/100 mmHg
at multiple occasions) within 3 months of Visit 1
b. Myocardial infarction, stroke or transient ischemic attack within 6
months of Visit 1
c. Unstable cardiac angina within 6 months of Visit 1
12. Use of any of the following medications: prednisone >15mg/day or
equivalent within 4 weeks of Visit 1; cyclophosphamide, tocilizumab,
mycophenolate, pirfenidone within 8 weeks of Visit 1; rituximab within 6
months of Visit 1.
Further criteria apply.


Primary and secondary end points
Main Objective: The trial will evaluate efficacy and safety of BI 1015550.
The primary objective is to demonstrate a reduction in lung function decline as measured by
the change from baseline in FVC for BI 1015550 when compared to placebo in patients with
progressive fibrosing ILDs.;Secondary Objective: The main secondary objective of the trial is to demonstrate BI 1015550?s ability in reducing the occurrence of clinically meaningful events such as acute ILD exacerbations, hospitalization for respiratory cause or death over the duration of the trial when compared to placebo in patients with progressive fibrosing ILDs.
An additional secondary objective of the trial is to show an effect of BI 1015550 on symptoms and lung function.;Primary end point(s): 1) absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 52;Timepoint(s) of evaluation of this end point: 1) 52 weeks (ICTRP)

Secondary end point(s): 1) key secondary endpoint: 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
2) Time to first acute IPF exacerbation or death over the duration of the trial
3) Time to hospitalization for respiratory cause or death over the duration of the trial
4) Time to absolute decline in FVC % predicted of >10% from baseline or death over the duration of the trial
5) Time to absolute decline in (DLCO) % predicted of >15% from baseline or death over the duration of the trial
6) Time to death over the duration of the trial
7) Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52
8) Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52
9) Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score at Week 52
10) Absolute change from baseline in FVC % predicted at Week 52
11) Absolute change from baseline in DLCO % predicted at Week 52;Timepoint(s) of evaluation of this end point: 1) 30 months
2) 30 months
3) 30 months
4) 30 months
5) 30 months
6) 30 months
7) 52 weeks
8) 52 weeks
9) 52 weeks
10) 52 weeks
11) 52 weeks (ICTRP)

Registration date
11.10.2022 (ICTRP)

Incorporation of the first participant
20.12.2022 (ICTRP)

Secondary sponsors
not available

Additional contacts
DaCT Disclosure & Data Transparency, clintriage.rdg@boehringer-ingelheim.com, 00498002430127, Boehringer Ingelheim Pharma GmbH &Co KG (ICTRP)

Secondary trial IDs
1305-0023, 2022-001134-11-IE (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2022-001134-11 (ICTRP)