A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) With or Without Standard Treatment (NCT07036523)
A Double-blind, Randomised, Placebo-controlled, Parallel Group, Phase IIa Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BI 765423 Administered Intravenously With or Without Standard of Care in Patients With Idiopathic Pulmonary Fibrosis
🩺 Plain-English Summary (8th-Grade Level)
This study is open to adults who are at least 40 years old and have idiopathic pulmonary fibrosis (IPF). People can participate in the study if they have a forced vital capacity (FVC) greater than or equal to 45% of the predicted value and fibrosis of 20% or more confirmed by a high-resolution computed tomography (HRCT) scan. The purpose of this study is to find out if a medicine called BI 765423 can improve lung function in people with IPF. The study will compare BI 765423 with a placebo to see if there is a difference in lung capacity after 3-6 months of treatment and will also look at changes in certain markers related to lung health. Participants are put into two groups randomly, which means by chance. One group receives the study medicine, and the other group receives a placebo. Placebo looks like BI 765423 but does not contain any study medicine. The study medicine is given as an infusion into a vein every four weeks. Participants are in the study for up to 11 months. During the study, participants may continue their regular treatment for IPF. During the study they visit the study site several times for screening, treatment, and follow-up. Doctors regularly test lung function by measuring FVC and take blood samples to measure study endpoints. The results are compared between the two groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 40 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (46 Sites)
Showing the first 25 of 46 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- University of Florida — Gainesville, Florida
- Renstar Medical Research — Ocala, Florida
- University of Iowa Hospitals and Clinics — Iowa City, Iowa
- University of Kansas Medical Center — Kansas City, Kansas
- University of Minnesota — Minneapolis, Minnesota
- The Lung Research Center, LLC — Chesterfield, Missouri
- University of Missouri Health System — Columbia, Missouri
- Columbia University Medical Center-New York Presbyterian Hospital — New York, New York
- Weill Cornell Medical College — New York, New York
- Duke University Medical Center — Durham, North Carolina
- University of Cincinnati Medical Center — Cincinnati, Ohio
- Temple University — Philadelphia, Pennsylvania
- Clinical Trials Center of Middle Tennessee, LLC — Franklin, Tennessee
- University of Virginia Health System — Charlottesville, Virginia
- The Prince Charles Hospital — Chermside, Queensland
- Monash Health — Clayton, Victoria
- Institute for Respiratory Health — Nedlands, Western Australia
- Cliniques Universitaires Saint-Luc — Brussels,
- Yvoir - UNIV UCL de Mont-Godinne — Yvoir,
- Synergy Respiratory Care — Sherwood Park, Alberta
- Kelowna Respirology & Allergy Research — Kelowna, British Columbia
- QEII Health Sciences Centre — Halifax, Nova Scotia
- Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal, Quebec
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH — Essen,
📞 Contact the Study Coordinator
Phone: (800) 243-0127
Email: clintriage.rdg@boehringer-ingelheim.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Idiopathic Pulmonary Fibrosis
- Atezolizumab for Idiopathic Pulmonary Fibrosis — Los Angeles, California
- A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) — Quilmes, Buenos Aires
- A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis — Birmingham, Alabama
- LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) — Birmingham, Alabama
- Yoga Effect on Quality of Life Study Among Patients with Idiopathic Pulmonary Fibrosis — Seattle, Washington
- MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF) — Camperdown, New South Wales
Explore by condition: All Idiopathic Pulmonary Fibrosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.