Idiopathic Pulmonary FibrosisPhase 1NCT03422068
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.
A Phase 1 study testing BI 1015550 in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 11 sites in 7 countries.
Trial 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. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 11 sitesin 7 countries
- Study dates
- 16 Mar 2018to 10 Jul 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
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.
- 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
Show all 24Show fewer
- 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
- Patient is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
- Male patients who do not agree to minimize the risk of female partners becoming pregnant from first dosing day until two months after the study completion. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive used for at least two months prior), true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient), or surgically sterilized, including vasectomy.
- Females who are not surgically sterilised or who are not postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of Follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory).
- Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC <0.7) at visit 1
- Patients who have previously been treated with nintedanib or pirfenidone within 30 days of visit 1.
- Positive fecal occult blood (no retest allowed),
- Positive testing for hematuria if confirmed by microscopic urine analysis (retest allowed)
- Any lifetime history of suicidal behavior (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior)
- Any suicidal ideation of type 2 to 5 on the C-SSRS in the past 12 months (i.e. active suicidal thought without method, intent or plan; active suicidal thought with method, but without intent or plan; active suicidal thought with method and intent but without specific plan; or active suicidal thought with method, intent and plan).
Trial locations and contacts
11 sites in 7 countries.
11 sites in 7 countries
Finland2 sites
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, 00290
TYKS
Turku, 20520
Germany2 sites
Fraunhofer ITEM
Hanover, 30625
Universitätsklinikum Heidelberg
Heidelberg, 69126
Netherlands2 sites
St. Antonius ziekenhuis, locatie Nieuwegein
Nieuwegein, 3435 CM
Erasmus Medisch Centrum
Rotterdam, 3015 CE
United Kingdom2 sites
Royal Brompton Hospital
London, SW3 6NP
Southampton General Hospital
Southampton, SO16 6YD
About this study
Official title: Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF) on no Background Anti-fibrotic Therapy.
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
- Being tested
- BI 1015550, Placebo
- 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®
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).
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Maximum measured concentration (Cmax) of the BI 1015550 in plasma on Day 1.
Measured: 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
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.
Measured: 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
Maximum measured concentration (Cmax,ss) of the BI 1015550 in plasma at steady state over a uniform dosing interval τ on Day 14.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start16 Mar 2018
- Primary completion1 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422068
- Sponsor's protocol ID
- 1305-0012
- Other IDs
- 2017-002736-16, 2017
- Status last verified
- Oct 2025
- First submitted
- 22 Jan 2018
- Last updated
- 28 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF) on no Background Anti-fibrotic Therapy.
- ClinicalTrials.gov ID
- NCT03422068
- Acronym / sponsor ID
- 1305-0012
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 28 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18 mg BI 1015550 | Experimental | Drug: BI 10155503 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. |
| Placebo | Placebo comparator | Drug: Placebo3 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 1015550Also: Nerandomilast, JASCAYD®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). | Drug | 18 mg BI 1015550 |
| Placebo3 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. | Drug | Placebo |
Primary outcome
Percentage of Participants With Drug-related Adverse Events (AEs) On-treatment
Time frame: 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.
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.
4 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 1015550 in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 11 sites in 7 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 24 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 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Finland, Germany, Netherlands, United Kingdom, Denmark and 2 more countries. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Drug-related Adverse Events (AEs) On-treatment (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2025.