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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

5 Oct 2022 → 14 Apr 2025

Decision date (initial)

2024-09-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512803-37-00

EudraCT number

2022-001134-11

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Therapy, Safety

"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 objectives 2

1. "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."
2. An additional secondary objective of the trial is to show an effect of BI 1015550 on symptoms and lung function.

Conditions and MedDRA coding

Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

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; see study protocol)
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 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 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.

Exclusion criteria 9

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. Further exclusion criteria apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 52

Secondary endpoints 11

1. Key secondary endpoint: 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
2. Time to first acute Interstitial Lung Disease (ILD) exacerbation or death over the duration of trial
3. Time to hospitalization for respiratory cause or death over the duration of trial
4. Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial
5. 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
6. Time to death over the duration of 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation

Boehringer Ingelheim International GmbH

Address

Binger Strasse 173

City

Ingelheim Am Rhein

Postcode

55216

Country

Germany

Scientific contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Public contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Third parties 1

Boehringer Ingelheim Espana S.A.

Sponsor organisation

Boehringer Ingelheim Espana S.A.

Address

Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles

City

Barcelona

Postcode

08174

Country

Spain

Sponsor responsibilities

Article 77 compliance

Boehringer Ingelheim International GmbH

Contact point sponsor

Boehringer Ingelheim International GmbH

Article 77 implementation

Boehringer Ingelheim International GmbH

Locations

19 EU/EEA countries · 118 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 163 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications