A Phase 2 interventional study of BI 765423 and Placebo in Idiopathic Pulmonary Fibrosis, sponsored by Boehringer Ingelheim. Active, not recruiting at 46 sites in 10 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
Among 36 studies in Idiopathic Pulmonary Fibrosis by Boehringer Ingelheim — 1 open to participants now, 3 under way, 1 of them phase 3. Idiopathic Pulmonary Fibrosis · Boehringer Ingelheim.
Among the 36 studies in Idiopathic Pulmonary Fibrosis by Boehringer Ingelheim, this one is the 12th largest by enrollment of the 18 interventional ones that give a count, is the only one that started in 2025, is one of 7 in phase 2, and was the 34th registered.
576 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 123 are open to participants now.
Browse Idiopathic Pulmonary Fibrosis studies →1 of the 36 studies in Idiopathic Pulmonary Fibrosis by Boehringer Ingelheim is open now, in 8 countries. Recruiting first, the newest first:
Boehringer Ingelheim · Sites in United States, Belgium, Finland and 5 more countries
By country, each count listing its studies:
Of the 86 Idiopathic Pulmonary Fibrosis studies recruiting now, 56 (65%) set no upper age limit and 8 (9%) stop at 75 or younger; 3 take children under 18; 15 take healthy volunteers.
This study: 40 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
36 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 1 started in 2025.
This study's enrollment of 81 is above the median of 55 across 389 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Median enrollment 109 across the 18 interventional studies, 212 across the 16 observational. Of the 31 that completed or were terminated, 26 (84%) have results posted.
This tab as a report to print or save as PDF → With an account.
Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 62 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.
2 of the studies in Idiopathic Pulmonary Fibrosis by Boehringer Ingelheim that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06238622Phase 3Boehringer IngelheimA Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast | 2027-04-28 |
| NCT07036523Boehringer IngelheimA 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 | 2027-03-11 |
Among the 36 studies in Idiopathic Pulmonary Fibrosis by Boehringer Ingelheim, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Male or female patients. Male patients must not donate sperm while taking part in this study and for a specific period after the last dose of the IMP. Male patients with woman of (WOCBP) sexual partners must use (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:
, defined as no menses for 12 months without an alternative medical cause. In questionable cases wherein the menopausal status is uncertain and cannot be clearly determined, the following should be taken into consideration by the investigator:
Patients with a high-resolution computed tomography (HRCT) taken within 12 months of Visit 1 (or during the screening period, if not available) confirming "UIP" or "probable UIP" HRCT pattern consistent with the clinical diagnosis of IPF by central review (prior to Visit 2).
Further inclusion criteria apply.
Exclusion criteria:
Significant PH defined by any of the following:
Cardiovascular comorbidities including
Further exclusion criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BI 765423
Drug: Placebo
BI 765423
Placebo to BI 765423
Absolute change from baseline in FVC (mL) at 12 weeks
Time frame: Baseline, 12 weeks
Absolute change from baseline in log 10- transformed SP-D plasma concentration at 12 weeks
SP-D=Surfactant protein D
Time frame: Baseline, 12 weeks
Absolute change from baseline in distance walked (m) during 6MWT at 12 weeks
6MWT=6-minute walk test
Time frame: Baseline, 12 weeks
Absolute change from baseline in FVC % predicted at 12 weeks
Time frame: Baseline, 12 weeks
Absolute change from baseline in DLCO % predicted at 12 weeks
DLCO=Diffusing Capacity of the Lungs for Carbon Monoxide
Time frame: Baseline, 12 weeks
Absolute change from baseline in SpO2 on room air at rest at 12 weeks
SPO2=Oxygen saturation
Time frame: Baseline, 12 weeks
Absolute change from baseline in FVC (mL) at 24 weeks
Time frame: Baseline, 24 weeks
Absolute change from baseline in DLCO % predicted at 24 weeks
Time frame: Baseline, 24 weeks
Absolute change from baseline in distance walked (m) during 6MWT at 24 weeks
The six-minute walk test (6MWT) is a self-paced performance outcome test of walking capacity. Patients are asked to walk as far as possible in 6 min along a flat corridor.
Time frame: Baseline, 24 weeks
Plan to share: Yes — Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Access criteria: For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor'spublication plan); 2. and upon signing of a legal agreement.
Data sharing details ↗ · www.clinicalstudies.boehringer-ingelheim.com
Started Nov 2025 (actual). Primary completion is estimated for Mar 2027, 15 months after the start.
Of 63 industry-sponsored phase 2 interventional studies under Idiopathic Pulmonary Fibrosis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 48. This study's planned 15 months is below that.
Counting every sponsor, half of 76 studies reached it within 30 months; a quarter within 21 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: BI 765423
Idiopathic Pulmonary Fibrosis →