A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast
- Conditions
- Idiopathic Pulmonary FibrosisProgressive Pulmonary Fibrosis
- Interventions
- Registration Number
- NCT06238622
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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 nerandomilast or BI 1015550.
The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.
Every participant takes nerandomilast 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1700
- 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
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Any disease that may put the patient at risk when participating in this trial at investigator's discretion.
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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)
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Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore >14 at Visit 1.
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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.
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Patient will undergo lung transplantation, with an assigned date of surgery.
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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
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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
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BI 1015550 treatment group BI 1015550 -
- Primary Outcome Measures
Name Time Method Occurrence of any adverse event over the course of the extension trial (yes/no) i.e. up until the follow-up/end of study visit planned at the latest at week 99 Up to 99 weeks and 3 days
- Secondary Outcome Measures
Name Time Method Time to hospitalisation for respiratory cause or death over the duration of the trial Up to 98 weeks Absolute change from baseline in Forced vital capacity (FVC) (mL) over time Up to 98 weeks Absolute change from baseline in % predicted in Forced vital capacity (FVC) over time Up to 98 weeks Time to absolute decline in FVC % predicted of >10% from baseline over the duration of the trial Up to 98 weeks 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 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 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 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
Trial Locations
- Locations (372)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
University of California Davis
🇺🇸Sacramento, California, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Christiana Hospital
🇺🇸Newark, Delaware, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Scroll for more (362 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United StatesBoehringer IngelheimContact833-602-2368unitedstates@bitrialsupport.com