This Study Tests Different Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF). The Study Tests How BI 1015550 is Taken up by the Body and How Well it is Tolerated.

NCT03422068 | Completed Phase 1 Results

• 2 other identifiers: 1305-00122017-002736-16
• Study Type: interventional
• Target: 15
• Locations: 7 countries
• Sites: 11

Brief Summary

The primary objective is to investigate safety and tolerability of BI 1015550 in patients with IPF. The secondary objectives are to evaluate the pharmacokinetics (PK) of BI 1015550 in patients with IPF.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Drug-related Adverse Events (AEs) On-treatment

  The analysis of AEs was based on the concept of treatment-emergent AEs (TEAEs). All AEs which occurred through the treatment phase and throughout the residual effect period (REP) were considered as on treatment. Treatment period was 4 weeks for patients entered after approval of a global protocol amendment at 12 Feb 2019 or 12 weeks for those entered before approval.

  From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.

Secondary Outcomes (4)

• Area Under the Concentration-time Curve (AUCτ,1) of the BI 1015550 in Plasma Over a Uniform Dosing Interval τ After Administration of the First Dose on Day 1

  On Day 1, within 2 hours before morning dose and at 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after morning dose.

• Maximum Measured Concentration (Cmax) of the BI 1015550 in Plasma on Day 1

  On Day 1, within 2 hours before morning dose and at 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after morning dose.

• Area Under the Concentration-time Curve (AUCτ,ss) of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval τ on Day 14

  On Day 14, within 2 hours before morning dose and at 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after morning dose.

• Maximum Measured Concentration (Cmax,ss) of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval τ on Day 14

  On Day 14, within 2 hours before morning dose and at 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after morning dose.

Study Arms (2)

18 mg BI 1015550

EXPERIMENTAL

3 tablets of 6 milligram (mg) of BI 101550 (total: 18 mg) were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily (bid). Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.

Drug: BI 1015550

Placebo

PLACEBO COMPARATOR

3 tablets of Placebo, matching in size and weight to BI 1015550 6 milligram (mg) tablet, were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily. Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.

Drug: Placebo

Interventions

BI 1015550 DRUG

3 tablets of 6 milligram (mg) of BI 101550 (total: 18 mg) were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily (bid).

Also known as: Nerandomilast, JASCAYD®

18 mg BI 1015550

Placebo DRUG

3 tablets of Placebo, matching in size and weight to BI 1015550 6 milligram (mg) tablet, were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily.

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent prior to admission to the study in accordance with ICH Harmonised Tripartite Guideline for Good Clinical Practice (ICH-GCP) and local legislation
• Male or female patients aged ≥40 years at visit 1.
• A clinical diagnosis of IPF based on ATS/ERS/JRS/ALAT 2011 guideline within the previous 5 years as confirmed by the investigator based on chest high-resolution computed tomography (HRCT) scan taken within 12 months of visit 1 and confirmed by central review prior to visit 2.
• Forced Vital Capacity (FVC) ≥50% of predicted normal at visit 1
• Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin \[Hb\] \[Visit 1\]): \> 30% of predicted normal at visit 1

You may not qualify if:

• 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.
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Surgery of the GI tract that could interfere with PK of the trial medication (except appendectomy)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders including but not limited to mood disorders.
• Evidence of active infection (chronic or acute) based on clinical exam or laboratory findings.
• History of allergy or hypersensitivity to the trial medication or its excipients
• Use of drugs within 30 days prior to administration of trial medication that are known to influence the results of the trial including time between start of the Q-wave and the end of the T-wave in an electrocardiogram (QT) / QT interval corrected for heart rate using the method of Fridericia (QTcF) or Bazett (QTcB) (QTc)
• A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening
• A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
• Participation in another trial where an investigational drug has been administered within 30 days or less than 5 half-lives (whichever is greater) of the respective drug prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug.
• Inability to refrain from smoking on trial days
• Alcohol abuse (consumption of more than 20 g per day)
• Active drug abuse
• Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
• Inability to comply with dietary regimen required for the trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (11)

Odense University Hospital

Odense, 5000 C, Denmark

Location

HYKS Keuhkosairauksien tutkimusyksikkö

Helsinki, 00290, Finland

Location

TYKS

Turku, 20520, Finland

Location

Fraunhofer ITEM

Hanover, 30625, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69126, Germany

Location

Poli Univ A. Gemelli

Roma, 00168, Italy

Location

St. Antonius ziekenhuis, locatie Nieuwegein

Nieuwegein, 3435 CM, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 CE, Netherlands

Location

Hospital de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

BI 1015550

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The trial was halted after the first dose group (18 milligram (mg) of BI 1015550 twice daily (bid)) as the predicted gMean (based on pharmacokinetic modelling) for the next higher dosage group (24mg bid) exceeded the predefined exposure threshold.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: February 5, 2018
• Study Start: March 16, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 10, 2019
• Last Updated: November 28, 2025
• Results First Posted: November 28, 2025

Record last verified: 2025-10

Locations

NL (2); ES (1); FI (2); DE (2); DK (1); IT (1); GB (2)