BI 765423 for Idiopathic Pulmonary Fibrosis

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

71 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 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 8-10 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.

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+