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BI 765423 and Standard of Care for Idiopathic Pulmonary Fibrosis

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Study AimThis study is evaluating if the experimental medication BI 765423, when combined with standard of care, can improve lung function in adults with idiopathic pulmonary fibrosis.
What is being tested

BI 765423

+ Placebo
Drug
Who is being recruted

Idiopathic Pulmonary Fibrosis

Over 40 Years
+17 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 2
Interventional
Study Start: November 2025

See protocol details

Summary

Principal SponsorBoehringer Ingelheim
Study ContactBoehringer Ingelheim
Last updated: November 3, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 5, 2025Actual date on which the first participant was enrolled.

This study is focused on adults aged 40 and older who have idiopathic pulmonary fibrosis (IPF), a lung condition that causes scarring and affects breathing. To join, participants must have a specific lung capacity and a certain amount of lung scarring confirmed by a detailed scan. The aim is to see if a new medicine, BI 765423, can help improve lung function in these individuals. The study is important because it hopes to find better treatment options for IPF, a condition with limited therapies currently available, potentially helping those affected to breathe easier and improve their quality of life. Participants are randomly assigned to receive either the BI 765423 medicine or a placebo, which looks like the medicine but has no active ingredients, through a vein infusion every four weeks. They remain in the study for 8 to 10 months, during which they can continue their usual IPF treatments. Throughout the study, participants visit the study site for various tests, including lung function assessments and blood samples, to monitor health and effectiveness of the treatment. Doctors compare results from both groups to determine if the new medicine shows better outcomes and check for any side effects.

Official TitleA 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 
Principal SponsorBoehringer Ingelheim
Study ContactBoehringer Ingelheim
Last updated: November 3, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
71 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 40 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Idiopathic Pulmonary Fibrosis
Criteria
9 inclusion criteria required to participate
Male or female patients. Male patients with Woman of childbearing potential (WOCBP) sexual partners must use contraception (male condom) to avoid exposure via seminal fluid during treatment and for a specific period after last drug intake. Women can only be included if they are of non-childbearing potential, defined as meeting at least one of the below conditions: * Permanently surgically sterilised (hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy) * Postmenopausal, defined as no menses for 12 months without an alternative medical cause. In questionable cases of postmenopausal status: * Women not using sex hormone medication such as hormone replacement therapy may be included if a blood sample confirms levels of follicle stimulating hormone (FSH) \> 40 U/L and estradiol \< 30 ng/L"
Further inclusion criteria apply.
Patients with haemoglobin-corrected diffusing capacity of the lungs for carbon monoxide (DLCO) ≥20% predicted at Visit 1.
Patients with a Forced vital capacity (FVC) ≥45% predicted at Visit 1. Predicted normal values will be calculated according to Global Lung Initiative (GLI).

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8 exclusion criteria prevent from participating
Further exclusion criteria apply.
Life expectancy for any concomitant disease other than IPF \<2.5 years (investigator assessment).
Cardiovascular comorbidities including * Severe hypertension (uncontrolled under treatment≥160/100 mmHg at multiple occasions) within 3 months of Visit 1 * Myocardial infarction, stroke, or transient ischemic attack within 6 months of Visit 1 * Unstable cardiac angina within 6 months of Visit 1
On nintedanib or pirfenidone treatment for less than 12 weeks prior Visit 1, planning to start nintedanib or pirfenidone within the first 12 weeks of investigational medicinal product (IMP) treatment or on combined nintedanib plus pirfenidone treatment. Newly diagnosed patients considered in need of SoC treatment by the treating physician, who would be withheld SoC treatment only for the sake of participation in the trial, should also be excluded.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Group II
Placebo
Study Objectives
Primary Objectives

Secondary Objectives

SP-D=Surfactant protein D

6MWT=6-minute walk test

DLCO=Diffusing Capacity of the Lungs for Carbon Monoxide

SPO2=Oxygen saturation

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 49 locations
Suspended
University of Alabama at BirminghamBirmingham, United StatesSee the location
Suspended
Banner - University Medical Center TucsonTucson, United States
Suspended
University of FloridaGainesville, United States
Suspended
Ocala Lung and Critical CareOcala, United States
Recruiting soon49 Study Centers