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)
Led by Boehringer Ingelheim · Updated on 2026-05-13
1700
Participants Needed
373
Research Sites
1 weeks
Total Duration
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AI-Summary
Brief Title
Who Can Participate
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Your Study Journey
Trial Site Locations
Research Team
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AI-Summary
What this Trial Is About
Researchers are studying people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with the drug nerandomilast. The study aims to understand how well participants tolerate long-term treatment with nerandomilast and whether it helps improve lung function or delays worsening symptoms, hospitalizations, or death. This is a phase 3 open-label extension trial sponsored by Boehringer Ingelheim.
Participants will take nerandomilast tablets daily for up to 1 year and 10 months. They may continue their usual treatments for pulmonary fibrosis alongside the study treatment. There is no placebo group, and all participants receive nerandomilast during this extension period.
Throughout the study, participants will visit their doctors regularly for health check-ups and lung function tests. Researchers will closely monitor any side effects and changes in lung function, particularly forced vital capacity (FVC), over nearly two years. The study will track time until symptom worsening, hospital visits, or death to assess the treatment's long-term safety and effects.
CONDITIONS
Brief Title
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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) according to protocol
Signed and dated written informed consent before joining the trial
Women of childbearing potential must use highly effective birth control methods with low failure rates
Women taking oral contraceptives must also use a barrier method during intercourse
In France, fertile males must use acceptable birth control methods
You will not qualify if you...
Any disease that may increase risk during trial participation, as judged by the investigator
Suicidality or suicidal behavior at Visit 1, including active suicidal thoughts with intent
Severe depression or high anxiety scores at Visit 1
Recent malignant neoplasm except treated skin or cervical cancers
Planned lung transplantation with a scheduled surgery date
Body mass index below 18.5 kg/m² with significant unexplained weight loss during the parent trial
Ongoing serious adverse events except latent tuberculosis from the parent trial
Need or desire to take restricted medications that could interfere with the trial
Additional exclusion criteria as determined by the investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 99 weeks and 3 days
Participants receive long-term treatment with Nerandomilast to assess safety and efficacy in pulmonary fibrosis.
Regular visits during treatment as per trial schedule
Trial Site Locations
Total: 373 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
3
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
5
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
6
University of California Davis
Sacramento, California, United States, 95817
Actively Recruiting
7
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
8
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
9
Christiana Hospital
Newark, Delaware, United States, 19713
Completed
10
Georgetown University
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
11
St. Francis Medical Institute
Clearwater, Florida, United States, 33765
Completed
12
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
13
Clinical Research Specialists LLC - Kissimmee
Kissimmee, Florida, United States, 34746
Actively Recruiting
14
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, United States, 33470
Actively Recruiting
15
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta, Georgia, United States, 30309
Actively Recruiting
16
The Emory Clinic
Atlanta, Georgia, United States, 30322
Actively Recruiting
17
Northshore University Health System
Evanston, Illinois, United States, 60201
Actively Recruiting
18
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
19
Tulane Medical Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
20
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21224
Actively Recruiting
21
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
22
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
23
St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
Actively Recruiting
24
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
25
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
26
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States, 48073
Actively Recruiting
27
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
28
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
29
The Lung Research Center, LLC
Chesterfield, Missouri, United States, 63017
Actively Recruiting
30
Creighton University
Omaha, Nebraska, United States, 68124
Actively Recruiting
31
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
32
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
33
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
34
Northern Westchester Hospital
Mount Kisco, New York, United States, 10549
Actively Recruiting
35
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
36
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
37
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
38
Southeastern Research Center-Winston Salem-69289
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
39
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
40
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
41
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
42
The Oregon Clinic
Portland, Oregon, United States, 97220
Completed
43
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
44
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
45
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
46
Infinity Medical Research, Inc.
East Providence, Rhode Island, United States, 02914
Actively Recruiting
47
Lowcountry Lung and Critical Care
Charleston, South Carolina, United States, 29406
Actively Recruiting
48
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee, United States, 37067
Actively Recruiting
49
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37204
Actively Recruiting
50
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
51
UT Health San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
52
Renovatio Clinical-The Woodlands-69551
The Woodlands, Texas, United States, 77380
Not Yet Recruiting
53
Intermountain Medical Center-Murray-69497
Murray, Utah, United States, 84107
Actively Recruiting
54
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84108
Actively Recruiting
55
University of Vermont
Burlington, Vermont, United States, 05401
Actively Recruiting
56
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Actively Recruiting
57
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Actively Recruiting
58
University of Wisconsin
Madison, Wisconsin, United States, 53792
Actively Recruiting
59
Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
C.a.b.a, Argentina, 1056
Active, Not Recruiting
60
CEDIC - Centro de Investigacion Clinica
CABA, Argentina, C1060ABN
Active, Not Recruiting
61
Hospital Italiano de Buenos Aires
CABA, Argentina, C1199ABD
Active, Not Recruiting
62
Consultorios Médicos del Buen Ayre
Capital Federal, Argentina, 1425
Active, Not Recruiting
63
CEMER-Centro Medico De Enfermedades Respiratorias
Florida, Argentina, B1602DQD
Active, Not Recruiting
64
Instituto Ave Pulmo - Fundacion Enfisema
Mar del Plata, Argentina, 7600
Active, Not Recruiting
65
INSARES
Mendoza, Argentina, M5500CCG
Active, Not Recruiting
66
Centro Respiratorio de Quilmes
Quilmes, Argentina, B1878FNR
Active, Not Recruiting
67
Instituto Médico de la Fundación Estudios Clínicos
Rosario, Argentina, S2000DEJ
Completed
68
Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Design of an open-label extension trial of nerandomilast (BI 1015550) in patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis (FIBRONEER™-ON).