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

ClinicalTrials.gov ID: NCT06238622

Public ClinicalTrials.gov record NCT06238622. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 9, 2026, 4:28 AM EDT

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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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06238622
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Boehringer Ingelheim; Industry
Enrollment: 1,700 participants

Conditions and interventions

Conditions

Interventions

Nerandomilast Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 5, 2024
Primary completion: Apr 27, 2027
Completion: May 4, 2027
Last update posted: Aug 19, 2026

2024 – 2027

United States locations

U.S. sites: 58
U.S. states: 34
U.S. cities: 49

Facility	City	State	ZIP	Site status
University of Alabama at Birmingham	Birmingham	Alabama	35233	Active, not recruiting
University of Arizona	Tucson	Arizona	85724	Active, not recruiting
University of Southern California	Los Angeles	California	90033	Active, not recruiting
Cedars-Sinai Medical Center	Los Angeles	California	90048	Active, not recruiting
University of California Los Angeles	Los Angeles	California	90095	Active, not recruiting
University of California Davis	Sacramento	California	95817	Recruiting
National Jewish Health	Denver	Colorado	80206	Active, not recruiting
Yale University School of Medicine	New Haven	Connecticut	06510	Active, not recruiting
Christiana Hospital	Newark	Delaware	19713	Completed
Georgetown University	Washington D.C.	District of Columbia	20007	Active, not recruiting
St. Francis Medical Institute	Clearwater	Florida	33765	Completed
University of Florida	Gainesville	Florida	32610	Active, not recruiting
Clinical Research Specialists LLC - Kissimmee	Kissimmee	Florida	34746	Active, not recruiting
Advanced Pulmonary Research Institute	Loxahatchee Groves	Florida	33470	Active, not recruiting
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead	Atlanta	Georgia	30309	Active, not recruiting
The Emory Clinic	Atlanta	Georgia	30322	Active, not recruiting
Northshore University Health System	Evanston	Illinois	60201	Active, not recruiting
University of Kansas Medical Center	Kansas City	Kansas	66160	Active, not recruiting
Tulane Medical Center	New Orleans	Louisiana	70112	Active, not recruiting
Johns Hopkins Hospital	Baltimore	Maryland	21224	Active, not recruiting
Massachusetts General Hospital	Boston	Massachusetts	02114	Active, not recruiting
Brigham and Women's Hospital	Boston	Massachusetts	02115	Active, not recruiting
St. Elizabeth's Medical Center	Boston	Massachusetts	02135	Active, not recruiting
Beth Israel Deaconess Medical Center	Boston	Massachusetts	02215	Active, not recruiting
University of Michigan	Ann Arbor	Michigan	48109	Active, not recruiting
Corewell Health William Beaumont University Hospital	Royal Oak	Michigan	48073	Active, not recruiting
University of Minnesota	Minneapolis	Minnesota	55455	Active, not recruiting
Mayo Clinic, Rochester	Rochester	Minnesota	55905	Active, not recruiting
The Lung Research Center, LLC	Chesterfield	Missouri	63017	Active, not recruiting
Creighton University	Omaha	Nebraska	68124	Recruiting
University of Nebraska Medical Center	Omaha	Nebraska	68198	Recruiting
Renown Regional Medical Center	Reno	Nevada	89502	Active, not recruiting
Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	03756	Completed
Northern Westchester Hospital	Mount Kisco	New York	10549	Recruiting
Columbia University Medical Center-New York Presbyterian Hospital	New York	New York	10032	Active, not recruiting
NewYork-Presbyterian/Weill Cornell Medical Center	New York	New York	10065	Active, not recruiting
Duke University Medical Center	Durham	North Carolina	27710	Active, not recruiting
Southeastern Research Center-Winston Salem-69289	Winston-Salem	North Carolina	27103	Active, not recruiting
University of Cincinnati	Cincinnati	Ohio	45267	Active, not recruiting
Cleveland Clinic	Cleveland	Ohio	44195	Active, not recruiting
The Ohio State University Wexner Medical Center	Columbus	Ohio	43210	Active, not recruiting
The Oregon Clinic	Portland	Oregon	97220	Completed
University of Pennsylvania	Philadelphia	Pennsylvania	19104	Active, not recruiting
Temple University	Philadelphia	Pennsylvania	19140	Active, not recruiting
Allegheny General Hospital	Pittsburgh	Pennsylvania	15212	Active, not recruiting
Infinity Medical Research, Inc.	East Providence	Rhode Island	02914	Completed
Lowcountry Lung and Critical Care	Charleston	South Carolina	29406	Active, not recruiting
Clinical Trials Center of Middle Tennessee, LLC	Franklin	Tennessee	37067	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	37204	Active, not recruiting
Baylor University Medical Center	Dallas	Texas	75246	Active, not recruiting
UT Health San Antonio	San Antonio	Texas	78229	Recruiting
Renovatio Clinical-The Woodlands-69551	The Woodlands	Texas	77380	Recruiting
Intermountain Medical Center-Murray-69497	Murray	Utah	84107	Active, not recruiting
University of Utah Health Sciences Center	Salt Lake City	Utah	84108	Active, not recruiting
University of Vermont	Burlington	Vermont	05401	Active, not recruiting
Inova Fairfax Hospital	Falls Church	Virginia	22042	Active, not recruiting
Virginia Mason Medical Center	Seattle	Washington	98101	Active, not recruiting
University of Wisconsin	Madison	Wisconsin	53792	Active, not recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 315 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06238622, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 19, 2026 · Synced Sep 9, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06238622 live on ClinicalTrials.gov.

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