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Active, not recruiting Phase 3 Interventional

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.

ClinicalTrials.gov public records Last synced Oct 29, 2026, 12:34 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
1,666 participants

Conditions and interventions

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
Sep 26, 2024 (Actual)
Primary completion
Apr 28, 2027 (Estimated)
Completion
May 7, 2027 (Estimated)
Last update posted
Oct 28, 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 —
University of Arizona Tucson Arizona 85724 —
University of Southern California Los Angeles California 90033 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
University of California Los Angeles Los Angeles California 90095 —
University of California Davis Sacramento California 95817 —
National Jewish Health Denver Colorado 80206 —
Yale University School of Medicine New Haven Connecticut 06510 —
Christiana Hospital Newark Delaware 19713 —
Georgetown University Washington D.C. District of Columbia 20007 —
St. Francis Medical Institute Clearwater Florida 33765 —
University of Florida Gainesville Florida 32610 —
Clinical Research Specialists LLC - Kissimmee Kissimmee Florida 34746 —
Advanced Pulmonary Research Institute Loxahatchee Groves Florida 33470 —
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead Atlanta Georgia 30309 —
The Emory Clinic Atlanta Georgia 30322 —
Northshore University Health System Evanston Illinois 60201 —
University of Kansas Medical Center Kansas City Kansas 66160 —
Tulane Medical Center New Orleans Louisiana 70112 —
Johns Hopkins Hospital Baltimore Maryland 21224 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Brigham and Women's Hospital Boston Massachusetts 02115 —
St. Elizabeth's Medical Center Boston Massachusetts 02135 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
University of Michigan Ann Arbor Michigan 48109 —
Corewell Health William Beaumont University Hospital Royal Oak Michigan 48073 —
University of Minnesota Minneapolis Minnesota 55455 —
Mayo Clinic, Rochester Rochester Minnesota 55905 —
The Lung Research Center, LLC Chesterfield Missouri 63017 —
Creighton University Omaha Nebraska 68124 —
University of Nebraska Medical Center Omaha Nebraska 68198 —
Renown Regional Medical Center Reno Nevada 89502 —
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03756 —
Northern Westchester Hospital Mount Kisco New York 10549 —
New York Presbyterian Hospital -Columbia University New York New York 10032 —
NewYork-Presbyterian/Weill Cornell Medical Center New York New York 10065 —
Duke University Medical Center Durham North Carolina 27710 —
Southeastern Research Center-Winston Salem-69289 Winston-Salem North Carolina 27103 —
University of Cincinnati Cincinnati Ohio 45267 —
Cleveland Clinic Cleveland Ohio 44195 —
The Ohio State University Wexner Medical Center Columbus Ohio 43210 —
The Oregon Clinic Portland Oregon 97220 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Temple University Philadelphia Pennsylvania 19140 —
Allegheny General Hospital Pittsburgh Pennsylvania 15212 —
Infinity Medical Research, Inc. East Providence Rhode Island 02914 —
Lowcountry Lung and Critical Care Charleston South Carolina 29406 —
Clinical Trials Center of Middle Tennessee, LLC Franklin Tennessee 37067 —
Vanderbilt University Medical Center Nashville Tennessee 37204 —
Baylor University Medical Center Dallas Texas 75246 —
UT Health San Antonio San Antonio Texas 78229 —
Renovatio Clinical-The Woodlands-69551 The Woodlands Texas 77380 —
Intermountain Medical Center-Murray-69497 Murray Utah 84107 —
University of Utah Health Sciences Center Salt Lake City Utah 84108 —
University of Vermont Burlington Vermont 05401 —
Inova Fairfax Hospital Falls Church Virginia 22042 —
Virginia Mason Medical Center Seattle Washington 98101 —
University of Wisconsin Madison Wisconsin 53792 —

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 317 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 Oct 28, 2026 · Synced Oct 29, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06238622 live on ClinicalTrials.gov.

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