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Completed Phase 3 Interventional Results available

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

ClinicalTrials.gov ID: NCT05321082

Public ClinicalTrials.gov record NCT05321082. 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 27, 2026, 11:28 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

A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

Brief summary

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

This study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with PF-ILD. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine. Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.

Study identification

NCT ID
NCT05321082
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
1,178 participants

Conditions and interventions

Interventions

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
Nov 16, 2022 (Actual)
Primary completion
Dec 18, 2024 (Actual)
Completion
Apr 14, 2025 (Actual)
Last update posted
Jan 9, 2026

2022 – 2025

United States locations

U.S. sites
59
U.S. states
32
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 19718 —
St. Francis Medical Institute Clearwater Florida 33765 —
University of Florida Health Shands Hospital Gainesville Florida 32610 —
Clinical Research Specialists LLC Kissimmee Florida 34746 —
Advanced Pulmonary Research Institute Loxahatchee Groves Florida 33470 —
Destin Pulmonary Critical Care Santa Rosa Beach Florida 32459 —
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead Atlanta Georgia 30309 —
The Emory Clinic Atlanta Georgia 30322 —
Evanston Hospital Pulmonary Clinic Evanston Illinois 60201 —
University of Kansas Medical Center Kansas City Kansas 66160 —
Tulane University Hospital and Clinic 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 —
Infinity Medical Research North Dartmouth Massachusetts 02747 —
University of Michigan Health System Ann Arbor Michigan 48109-5314 —
Beaumont Health Royal Oak Michigan 48073 —
University of Minnesota Minneapolis Minnesota 55455 —
Mayo Clinic, Rochester Rochester Minnesota 55905 —
Washington University School of Medicine St Louis Missouri 63110 —
University of Nebraska Medical Center Omaha Nebraska 68198 —
Renown Regional Medical Center Reno Nevada 89502 —
Stony Brook University Medical Center Commack New York 11725 —
Lenox Hill Hospital New York New York 10021 —
Columbia University Medical Center-New York Presbyterian Hospital 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-61365 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 —
Jefferson Health Honickman Center Philadelphia Pennsylvania 19107 —
Temple University Hospital 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 - Vanderbilt Lung Institute at 100 Oaks Nashville Tennessee 37204 —
Baylor University Medical Center Dallas Texas 75246 —
Premier Pulmonary Critical Care and Sleep Medicine Denison Texas 75020 —
UT Health San Antonio San Antonio Texas 78229 —
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 341 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05321082, 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 Jan 9, 2026 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05321082 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →