A Follow-up Study to Test Long-term Treatment With BI 1015550 in People With Pulmonary Fibrosis Who Took Part in a Previous Study With BI 1015550

Idiopathic Pulmonary Fibrosis Clinical Trial

— FIBRONEER™-ON  

Official title:

An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06238622
• Other study ID #: 1305-0031
• Secondary ID: 2023-507353-15-0
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 1, 2024
• Est. completion date: May 5, 2027

Study information

• Verified date: January 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called BI 1015550 (study 1305-0014 or 1305-0023). The goal of this study is to find out how well people with pulmonary fibrosis tolerate longterm treatment with BI 1015550. The study also tests whether BI 1015550 improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes BI 1015550 as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1700
• Est. completion date: May 5, 2027
• Est. primary completion date: April 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who completed treatment in the parent trials (1305-0014 or 1305-0023) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)

2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control

Exclusion Criteria:

1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion.

2. Patient exhibits suicidality, in the clinical judgment of the investigator or

according to the following criteria at Visit 1:

• any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
• any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)

3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore >14 at Visit 1.

4. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.

5. Patient will undergo lung transplantation, with an assigned date of surgery.

6. Patients with a Body Mass index (BMI) <18.5 kg/m² that experienced an additional, unexplained and clinically significant (>10%) weight loss during the parent trial

7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI) (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial

8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial. Further exclusion criteria apply.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• BI 1015550
BI 1015550

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of any adverse event over the course of the extension trial (yes/no)		Up to 99 weeks and 3 days
Secondary	Absolute change from baseline in Forced vital capacity (FVC) (mL) over time		Up to 98 weeks
Secondary	Absolute change from baseline in % predicted in Forced vital capacity (FVC) over time		Up to 98 weeks
Secondary	Time to absolute decline in FVC % predicted of >10% from baseline over the duration of the trial		Up to 98 weeks
Secondary	Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation, first hospitalisation for respiratory cause, or death (whichever occurs first) over the duration of the trial		Up to 98 weeks
Secondary	Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation or death over the duration of the trial		Up to 98 weeks
Secondary	Time to hospitalisation for respiratory cause or death over the duration of the trial		Up to 98 weeks
Secondary	Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial		Up to 98 weeks
Secondary	Time to relative decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial		Up to 98 weeks

External Links

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