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Clinical Trials List

Protocol Number1305-0031

NCT Number(ClinicalTrials.gov Identfier)NCT06238622

2024-07-01 - 2027-11-28

Phase III

Not yet recruiting1

Recruiting7

ICD-10J84.10

Pulmonary fibrosis, unspecified

ICD-10J84.112

Idiopathic pulmonary fibrosis

ICD-10J84.114

Acute interstitial pneumonitis

ICD-10J98.19

Other pulmonary collapse

ICD-9516.3

Idiopathic fibrosing alveolitis

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)

Trial Applicant

Boehringer Ingelheim
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2025/11/05

Investigators and Locations

Principal Investigator 林慶雄無

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator HAO-CHIEN WANG 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pin-Kuei Fu 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃國棟無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator D.W. Peng 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Joung-Liang Lan 無

China Medical University Hospital

Co-Principal Investigator

黃建中無

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chau-Chyun Sheu 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

莊政皓無
鄭孟軒無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tang-Hsiu Huang

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Idiopathic Pulmonary Fibrosis 、Progressive Pulmonary Fibrosis

Objectives

The aim of this trial was to understand the long-term tolerability of BI 1015550 in patients with pulmonary fibrosis. This trial also examined whether BI 1015550 could improve lung function and symptoms in participants.

Test Drug

BI 1015550

Active Ingredient

0400000100
0400000100

Dosage Form

110

Dosage

9 mg/Film-coated tablets
18 mg/Film-coated tablets

Endpoints

The primary efficacy endpoint was whether any adverse events occurred in the patient during the extended trial (yes/no).

Inclution Criteria

Inclusion Criteria:

Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
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

Exclusion Criteria:

Any disease that may put the patient at risk when participating in this trial at investigator's discretion.
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)
Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore >14 at Visit 1.
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.
Patient will undergo lung transplantation, with an assigned date of surgery.
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
At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial
Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.

The Estimated Number of Participants

Taiwan

50 participants
Global

1700 participants