BI 765423 for Idiopathic Pulmonary Fibrosis

Not yet recruiting at 50 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: Nintedanib, Pirfenidone

Disqualifiers: Acute IPF exacerbation, Airways obstruction, Respiratory infection, Significant PH, Cardiovascular comorbidities, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a medicine called BI 765423 can improve lung function in people with idiopathic pulmonary fibrosis (IPF), a condition where lung tissue becomes scarred over time. Participants will receive either the medicine or a placebo (a look-alike with no active drug) intravenously every four weeks. The trial will compare changes in lung capacity and other lung health markers between the two groups. It suits those diagnosed with IPF, who have moderate lung function, and experience significant lung scarring. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial allows participants to continue their regular treatment for idiopathic pulmonary fibrosis (IPF). However, if you are on nintedanib or pirfenidone, you must have been on them for at least 12 weeks before starting the trial, and you cannot start these medications during the first 12 weeks of the trial.

Is there any evidence suggesting that BI 765423 is likely to be safe for humans?

In a previous study, researchers examined the tolerance of BI 765423, a new treatment for idiopathic pulmonary fibrosis (IPF). The results suggested that participants generally tolerated it well, with no serious side effects reported that required stopping the treatment. However, like any medicine, it may still cause some unwanted effects.

This study is in its early stages, so information on safety remains limited. However, research so far indicates that people can handle the treatment without major problems. Prospective trial participants should discuss any side effects with the doctors, who will monitor health and address any concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for IPF?

Unlike the standard treatments for idiopathic pulmonary fibrosis, which typically include antifibrotic medications like nintedanib and pirfenidone, BI 765423 offers a novel approach by targeting a different pathway involved in the disease. Researchers are excited about BI 765423 because it works by modulating the immune system, potentially reducing inflammation and fibrosis more effectively. This unique mechanism of action could lead to improved outcomes for patients who do not respond well to current therapies.

What evidence suggests that BI 765423 might be an effective treatment for IPF?

Research suggests that BI 765423, which participants in this trial may receive, could improve lung function in people with idiopathic pulmonary fibrosis (IPF), a disease that causes lung tissue to scar. Early findings indicate that BI 765423 targets a protein called interleukin 11 (IL-11), believed to contribute to lung scarring. Studies in mice have shown that blocking IL-11 can reduce lung scarring. Although limited information exists from human studies, these findings provide a promising basis for its potential effectiveness in IPF patients. More research is needed to confirm its efficacy in people with this condition. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults at least 40 years old with idiopathic pulmonary fibrosis (IPF) can join this study. They must have a forced vital capacity (FVC) of 45% or more of the predicted value and at least 20% lung fibrosis confirmed by HRCT scan.

Inclusion Criteria

Patients must have haemoglobin-corrected DLCO ≥20% predicted at Visit 1

Patients must have signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Patients must have a Forced vital capacity (FVC) ≥45% predicted at Visit 1

Exclusion Criteria

I have not had a lung infection needing treatment in the last 4 weeks.

I have breathing issues due to blocked airways.

I haven't had a worsening of my lung condition in the last 12 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Several visits (in-person)

Treatment

Participants receive BI 765423 or placebo as an infusion every four weeks for 3 months

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 weeks

Several visits (in-person)

Long-term monitoring

Participants continue regular treatment for IPF and are monitored for long-term outcomes

8-10 months

What Are the Treatments Tested in This Trial?

Interventions

• BI 765423

Trial Overview The trial is testing BI 765423, given as an infusion every four weeks, against a placebo to see if it improves lung function in IPF patients over three months. Participants are randomly assigned to either the treatment or placebo group.

How Is the Trial Designed?

Group I: BI 765423 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07036523

A Study to Find Out Whether BI 765423 Has an Effect on ... 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 ...

2. pro.boehringer-ingelheim.com pro.boehringer-ingelheim.com/us/medinfo/clinical-trials/nct07036523

Study Details | BIPI Medical & Clinical Resources ... Efficacy of BI 765423 Administered Intravenously With or Without Standard of Care in Patients With Idiopathic Pulmonary Fibrosis. NCT07036523| Phase 2 ...

3. patlynk.com patlynk.com/trial/NCT07036523

BI 765423 and Standard of Care for Idiopathic Pulmonary ... 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 ...

4. clinicaltrials.eu clinicaltrials.eu/trial/study-of-bi-765423-given-by-intravenous-infusion-for-patients-with-idiopathic-pulmonary-fibrosis-with-or-without-standard-treatment/

Study of BI 765423 given by intravenous infusion for ... This study focuses on patients with Idiopathic Pulmonary Fibrosis (IPF), a condition that causes scarring of the lung tissue.

5. synapse.patsnap.com synapse.patsnap.com/drug/20abec04980f4d599154ffc595fcf889

BI-765423 - Drug Targets, Indications, Patents Objective: To investigate the effects of interleukin 11 (IL-11) antagonist on bleomycin (BLM)-induced pulmonary fibrosis in mice. Methods: C57BL/6 mice were ...

6. clinicaltrialsarena.com clinicaltrialsarena.com/news/gri-bio-gri-0621/

GRI Bio reports interim safety outcomes from GRI-0621 trial ... GRI Bio has announced encouraging six-week interim safety outcomes from the ongoing Phase IIa trial of GRI-0621.