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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

StatusActive, Not Recruiting
PhasePhase 2
Started2025-11-13
View on ClinicalTrials.gov ↗

Amendment history

2026-08-31
notable
Study Status, Contacts/Locations v24
Enrollment closed, study ongoing
Final enrollment: 81 participants (planned 71)
Study sitesdetails revised at 24 of 46 sites
2026-07-26
minor
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v23
Eligibility criteria+404 characters
[...] n prior to admission to the trial. 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 Womanwoman of childbearing potential (WOCBP) sexual partners must use [...] without an alternative medical cause. In questionable cases ofwherein postmenopausalthe menopausal status is uncertain and cannot be clearly determined, the following should be taken into consideration by the investigator: Women not using sex hormone medication such as hormone rep [...] r cryobiopsy demonstrating a "UIP" or "Proba [...]
Secondary endpoints5 to 8 entries
Absolute change from baseline in FVC (mL) at 24 weeks Absolute change from baseline in DLCO % predicted at 24 weeks Absolute change from baseline in distance walked (m) during 6MWT at 24 weeks
Study sites46 entries, revised
Temple University Hospital
2026-06-22
minor
Study Status, Contacts/Locations v22
Primary completion moved earlier: 2027-04-28 → 2027-03-11
Study sites46 entries, revised
A.O.Azienda Ospedaliera dei Colli
2026-06-08
minor
Study Status, Contacts/Locations, References v21
Completion moved earlier: 2027-11-01 → 2027-06-22
Study sites47→46
2026-05-26
minor
Study Status, Contacts/Locations v20
Study sitesdetails revised at 6 of 47 sites
2026-05-12
minor
Study Status, Contacts/Locations v19
Study sitesdetails revised at 3 of 47 sites
2026-04-28
minor
Study Status, Contacts/Locations v18
Completion pushed: 2027-09-02 → 2027-11-01
Study sites48→47
2026-04-13
minor
Study Status, Contacts/Locations v17
Study sites50→48
2026-03-16
minor
Study Status, Contacts/Locations v16
Study sites50 entries, revised
Fondazione Policlinico Universitario A.Agostino Gemelli IRCCS
2026-03-03
minor
Study Status, Contacts/Locations v15
Study sites49→50
2026-02-22
minor
Study Status, References v14
Re-verified, no change to tracked fields
2026-02-09
minor
Study Status, Contacts/Locations, IPDSharing v13
Study sitesdetails revised at 1 of 49 sites
2026-02-03
minor
Study Status, Contacts/Locations v12
Study sites49 entries, revised
StFondazione Vincent'sPoliclinico HospitalUniversitario SydneyA. Gemelli IRCCS
2026-01-22
minor
Study Status, Contacts/Locations v11
Study sites50→49
2026-01-05
minor
Study Status, Contacts/Locations v10
Study sites50 entries, revised
Hospital Universitario De La Princesa
2025-12-20
minor
Study Status, Contacts/Locations v9
Study sites49→50
2025-12-10
minor
Study Status, Contacts/Locations v8
Study sitesdetails revised at 2 of 49 sites
2025-11-28
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v7
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-11-15→confirmed 2025-11-13
Study sitesdetails revised at 49 of 49 sites
2025-11-11
minor
Study Status v6
Start date2025-11-05→2025-11-15
2025-10-30
minor
Study Status, Study Design, Contacts/Locations v5
Start date2025-10-21→2025-11-05
Enrollment target70→71
Study sites48→49
2025-09-02
minor
Study Status, Contacts/Locations v4
Study sites48 entries, revised
BrusselsCliniques - UNIVUniversitaires Saint-Luc
2025-08-20
minor
Study Status, Contacts/Locations v3
Primary completion date2027-03-31→2027-04-28
Completion date2027-08-05→2027-09-02
Start date2025-09-26→2025-10-21
Study sites45→48
2025-08-05
minor
Study Status, Contacts/Locations v2
Study sites44→45
2025-07-21
minor
Study Status, Contacts/Locations v1
Study sites41→44
2025-06-17
minor
Original filing
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.
Trial Details
NCT Number NCT07036523
Lead Sponsor Boehringer Ingelheim
Conditions Idiopathic Pulmonary Fibrosis
Enrollment 81 participants
Start Date 2025-11-13
Primary Completion 2027-03-11 (estimated)
Study Completion 2027-06-22 (estimated)
Updated on ClinicalTrials.gov 2026-09-25