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Idiopathic Pulmonary FibrosisPhase 2NCT06241560

A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood

A Phase 2 study testing BI 1015550 and Pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are 40 years and older. The purpose of this study is to find out whether a medicine called pirfenidone changes the amount of a medicine called BI 1015550 in the blood. Some people may take more than one medicine at a time. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
BI 1015550 and Pirfenidone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesin 2 countries
Study dates
5 Mar 2026to 7 Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients aged ≥40 years old at the time of signed consent
  • Patients with idiopathic pulmonary fibrosis (IPF) and an indication/no contraindication for treatment with pirfenidone based on investigator's judgement.
  • Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
  • Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
  • Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OC) also have to use one barrier method

Who cannot join

  • Patients with a significant disease or condition other than IPF, which in the opinion of the investigator, may put the patient at risk because of participation, interfere with study procedures, or cause concern regarding the patient's ability to participate in the study
  • Acute IPF exacerbation within 1 month prior to Visit 1 and/or during the screening period (investigator-determined).
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 x ULN or total Bilirubin >1.5 x upper limit of normal (ULN) at Visit 1
  • Patients with underlying liver cirrhosis (Child Pugh C hepatic impairment)
  • Cardiovascular diseases, any of the following:
  • Severe hypertension (uncontrolled under treatment ≥160/100 mmHg at multiple occasions) within 3 months of Visit 1
Show all 12Show fewer
  • Myocardial infarction, stroke or transient ischemic attack within 6 months of Visit 1
  • Unstable cardiac angina within 6 months of Visit 1
  • Chronic kidney disease with estimated glomerular filtration rate (eGFR) less than 90 ml/min/1.73 m^2 at Visit 1/screening (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula or Japanese version of CKD-EPI for Japanese patients)
  • Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
  • Relevant chronic or acute infections including but not limited to human immunodeficiency virus (HIV) and viral hepatitis
  • Further exclusion criteria apply

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Georgia2 sites

  • LTD The First Medical Center

    Tbilisi, 0180

  • LTD "Aversi clinic"

    Tbilisi, 160

Other trials in Georgia

United States1 site

  • Renovatio Clinical-The Woodlands-69551

    The Woodlands, Texas, 77380

Other trials in United States

About this study

Official title: An Open-label, Single-group Trial to Evaluate the Effect of Pirfenidone on the Pharmacokinetics of a Single Oral Dose of BI 1015550

This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are 40 years and older. The purpose of this study is to find out whether a medicine called pirfenidone changes the amount of a medicine called BI 1015550 in the blood. Some people may take more than one medicine at a time. Therefore, it is important to understand how different medicines influence one another.

Participants take one dose of BI 1015550 as a tablet. Participants then take one tablet of pirfenidone 3 times a day for one week. The dose is then increased to 2 tablets 3 times a day for the second week. In the third week the dose is increased further to 3 tablets 3 times a day. Participants then take another dose of BI 1015550 as a tablet.

Participants are in the study for a little over 1 month. During this time, they visit the study site 15 times. Two of the visits include overnight stays at the study site. The study staff also contacts the participants by phone. During the visits, the doctors collect information about participants' health and take blood samples from the participants. They compare the amount of pirfenidone and BI 1015550 in the blood. Doctors also regularly check participants' health and take note of any unwanted effects.

Being tested
BI 1015550, Pirfenidone
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 1015550Drug

    Also called Nerandomilast, JASCAYD®

    BI 1015550

  • PirfenidoneDrug

    Also called Esbriet

    Pirfenidone

Study groups in NCT06241560
Study groupRoleWhat they receive
BI 1015550, then Pirfenidone + BI 1015550ExperimentalNot described
Receives: Drug: BI 1015550; Drug: Pirfenidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

    Measured: Up to day 34

  2. Maximum measured concentration of nerandomilast in plasma (Cmax)

    Measured: Up to day 34

Secondary outcomes (1)

  1. Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Measured: Up to day 34

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2024
  2. Study start5 Mar 2026
  3. Primary completion5 Aug 2026
  4. Study completion7 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06241560
Sponsor's protocol ID
1305-0035
Status last verified
Aug 2026
First submitted
29 Jan 2024
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 1015550 and Pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Georgia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) (time frame: Up to day 34). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06241560.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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