Idiopathic Pulmonary Fibrosis (IPF)ReaSoN-IPF/PPFNCT07919015
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis, run by Avraham Unterman at 4 sites in Israel.
Trial summary
Nerandomilast is an oral medicine that slows down the loss of functional residual capacity (FVC) in people with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). It was tested in two large clinical trials in which participants were carefully selected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
- What is being tested?
- Nerandomilast
- How many people
- 70 participants
- Where
- 4 sitesIsrael
- Study dates
- 1 Feb 2026to 30 Sep 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adults with IPF or PPF followed at one of the participating medical centers who initiate nerandomilast as part of routine clinical care during the enrollment period. Since this is a registry-based study, patients need to be included in a prospective ILD registry in order to participate.
Who may be able to join
- Age 18 years or older.
- Physician-confirmed diagnosis of IPF according to current ATS/ERS/JRS/ALAT guidelines, or of PPF (fibrotic interstitial lung disease other than IPF meeting INBUILD criteria for progression).
- Initiating treatment with nerandomilast as part of routine clinical care, with the treatment decision made independently of, and prior to, study enrollment.
- Willing and able to provides written informed consent to participate in the prospective ILD registry of the respective medical center.
Who cannot join
- Prior exposure to nerandomilast, including in a clinical trial or open-label extension study.
- Concurrent participation in an interventional trial of an investigational agent for interstitial lung disease.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel4 sites, 4 recruiting
- Recruiting
Barzilai Medical Center, Ben-Gurion University of the Negev
Ashkelon, 7830604
Ori Wand, MD, 972-8-6745465, oriw@bmc.gov.il
- Recruiting
Rambam Health Care Campus, Technion - Israel Institute of Technology
Haifa, 3109601
Yaniv Dotan, MD, PhD, 972-4-8542648, Y_dotan@rmc.gov.il
- Recruiting
Sheba Medical Center, Tel-HaShomer, Tel-Aviv University
Ramat Gan, 5265601
Liran Levy, MD, 972-3-5302745, Liran.Levy@sheba.health.gov.il
- Recruiting
Tel-Aviv Sourasky University Medical Center, Tel-Aviv University
Tel Aviv, 6423906
Avraham Unterman, MD, MBA, 972-3-6973591, ramiu@tlvmc.gov.il
Doron Cohn-Schwartz, MD, PhD, 972-3-6973591, doroncs@tlvmc.gov.il
About this study
Official title: A Prospective, Multicenter, Observational Real-world Study of Nerandomilast Efficacy and Safety in Patients With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis
Nerandomilast is an oral medicine that slows down the loss of functional residual capacity (FVC) in people with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). It was tested in two large clinical trials in which participants were carefully selected. In everyday practice, patients are often older, have more other illnesses, or take additional medicines, and it is not known whether the benefits seen in the trials also occur outside them.
The Real-world Study of Nerandomilast (ReaSoN-IPF/PPF) follows people with IPF or PPF who begin nerandomilast as part of their usual medical care at several medical centers in Israel. The study does not assign any treatment; the treating physician makes every decision about therapy.
Read more
The main goal is to find out whether lung function declines more slowly once nerandomilast is started. Because patients have breathing tests before they begin the medicine as well as during treatment, each patient is compared with themselves: the rate at which their FVC was declining beforehand is compared with the rate following treatment.
The study also asks how patients feel, using a questionnaire called the K-BILD, and records side effects, hospital admissions, disease exacerbations, and whether patients stop the medicine.
Participants attend their normal clinic visits. They complete the questionnaire before treatment starts and again at 6 to 12 months, and their routine lung function results are collected. No extra tests or visits are required beyond the questionnaire.
- Being tested
- Nerandomilast
- Keywords
- Nerandomilast, BI 1015550, PDE4B inhibitor, Real-world evidence, K-BILD, Forced Vital Capacity, DLCO, Antifibrotic therapy
- 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.
NerandomilastDrug
Either Nerandomilast 9mg twice a day or 18mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| IPF or PPF | Patients who are diagnosed with IPF Receives: Drug: Nerandomilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Proportion of participants experiencing prespecified adverse events (diarrhea, weight loss, nausea, cough, upper respiratory tract infection, dyspnea, nasopharyngitis, worsening of underlying condition, depression, anxiety), reported overall and by severity.
Measured: Through study completion, an average of 9 months
Secondary outcomes (14)
Difference between the pre-treatment and on-treatment annualized rate of FVC decline (mL/year)
Average for all participants. For each participant, the annualized slope of absolute forced vital capacity over the period preceding nerandomilast initiation (derived from at least two pre-treatment measurements obtained within the previous 24 months) is compared with the annualized slope during 12 months of treatment. Each participant serves as their own control; the outcome is the within-participant difference between the two slopes, in mL/year, with a positive value indicating attenuation of decline on treatment.
Measured: Up to 24 months before initiation and, on average, 6 months after initiation
Difference between pre-treatment and on-treatment annualized rate of FVC decline (% predicted/year)
As for outcome 2, with FVC expressed as percentage of predicted value.
Measured: Up to 24 months before initiation and, on average, 6 months after initiation
Difference between pre-treatment and on-treatment annualized rate of DLCO decline (% predicted/year)
As above, for diffusing capacity of the lungs for carbon monoxide, corrected for hemoglobin.
Measured: Up to 24 months before initiation and, on average, 6 months after initiation
Change from baseline in K-BILD domain scores
Breathlessness and activities, psychological, and chest symptoms domains, each scored 0-100, higher indicating better health status.
Measured: Baseline and 6-12 months
Change from baseline in FVC (mL and % predicted)
Absolute annualized change in forced vital capacity from the pre-treatment baseline measurement.
Measured: Baseline and >6 months
Change from baseline in DLCO (% predicted)
Absolute annualized change in hemoglobin-corrected diffusing capacity from the pre-treatment baseline measurement.
Measured: Baseline and >6 months
Incidence of serious adverse events
Proportion of participants with at least one serious adverse event, defined as an event that is fatal, life-threatening, requires or prolongs hospitalization, or results in persistent or clinically significant disability.
Measured: Through study completion, an average of 9 months
Permanent discontinuation of nerandomilast
Proportion of participants permanently discontinuing nerandomilast, time to discontinuation, and reason for discontinuation.
Measured: Through study completion, an average of 9 months
Dose reduction of nerandomilast
Proportion of participants in whom nerandomilast dose is reduced, time to dose reduction, and reason for dose reduction.
Measured: Through study completion, an average of 9 months
Annualized incidence of acute exacerbation of interstitial lung disease
Number and proportion of participants with at least one acute exacerbation, defined according to published criteria, time to exacerbation.
Measured: Through study completion, an average of 9 months
Annualized incidence of respiratory-cause hospitalization
Annualized incidence of respiratory-cause hospitalization
Measured: Through study completion, an average of 9 months
Annualized all-cause mortality
Proportion of participants who die from any cause during follow-up.
Measured: Through study completion, an average of 9 months
Annualized incidence of lung transplantation
Proportion of participants undergoing lung transplantation during follow-up.
Measured: Through study completion, an average of 9 months
Exploratory: Outcomes stratified by diagnosis, nerandomilast dosage, and background antifibrotic therapy
Primary and key secondary outcomes reported separately for IPF versus PPF, and for background nintedanib, pirfenidone, or no background antifibrotic therapy.
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Feb 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Avraham Unterman
- Sponsor type
- University, hospital or other
- Collaborators
- Rambam Health Care Campus, Barzilai University Medical Center, The Chaim Sheba Medical Center
- Responsible party
- Sponsor-investigator, Avraham Unterman, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919015
- Sponsor's protocol ID
- 0101-21-TLV-A
- Acronym
- ReaSoN-IPF/PPF
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observational Real-world Study of Nerandomilast Efficacy and Safety in Patients With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT07919015
- Acronym / sponsor ID
- ReaSoN-IPF/PPF / 0101-21-TLV-A
- Keywords
- Nerandomilast, BI 1015550, PDE4B inhibitor, Real-world evidence, K-BILD, Forced Vital Capacity, DLCO, Antifibrotic therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Avraham UntermanUniversity, hospital or other
- Collaborators
- Rambam Health Care Campus, Barzilai University Medical Center, The Chaim Sheba Medical Center
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nerandomilast is an oral medicine that slows down the loss of functional residual capacity (FVC) in people with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). It was tested in two large clinical trials in which participants were carefully selected. In everyday practice, patients are often older, have more other illnesses, or take additional medicines, and it is not known whether the benefits seen in the trials also occur outside them.
The Real-world Study of Nerandomilast (ReaSoN-IPF/PPF) follows people with IPF or PPF who begin nerandomilast as part of their usual medical care at several medical centers in Israel. The study does not assign any treatment; the treating physician makes every decision about therapy.
The main goal is to find out whether lung function declines more slowly once nerandomilast is started. Because patients have breathing tests before they begin the medicine as well as during treatment, each patient is compared with themselves: the rate at which their FVC was declining beforehand is compared with the rate following treatment.
The study also asks how patients feel, using a questionnaire called the K-BILD, and records side effects, hospital admissions, disease exacerbations, and whether patients stop the medicine.
Participants attend their normal clinic visits. They complete the questionnaire before treatment starts and again at 6 to 12 months, and their routine lung function results are collected. No extra tests or visits are required beyond the questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPF or PPF | – | Drug: NerandomilastPatients who are diagnosed with IPF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adults with IPF or PPF followed at one of the participating medical centers who initiate nerandomilast as part of routine clinical care during the enrollment period. Since this is a registry-based study, patients need to be included in a prospective ILD registry in order to participate.
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Physician-confirmed diagnosis of IPF according to current ATS/ERS/JRS/ALAT guidelines, or of PPF (fibrotic interstitial lung disease other than IPF meeting INBUILD criteria for progression).
- Initiating treatment with nerandomilast as part of routine clinical care, with the treatment decision made independently of, and prior to, study enrollment.
- Willing and able to provides written informed consent to participate in the prospective ILD registry of the respective medical center.
Key exclusion criteria (2 listed)
- Prior exposure to nerandomilast, including in a clinical trial or open-label extension study.
- Concurrent participation in an interventional trial of an investigational agent for interstitial lung disease.
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 |
|---|---|---|
| NerandomilastEither Nerandomilast 9mg twice a day or 18mg twice a day | Drug | IPF or PPF |
Primary outcome
Adverse events
Time frame: Through study completion, an average of 9 months
Proportion of participants experiencing prespecified adverse events (diarrhea, weight loss, nausea, cough, upper respiratory tract infection, dyspnea, nasopharyngitis, worsening of underlying condition, depression, anxiety), reported overall and by severity.
14 secondary outcomes
Difference between the pre-treatment and on-treatment annualized rate of FVC decline (mL/year)
Time frame: Up to 24 months before initiation and, on average, 6 months after initiation
Difference between pre-treatment and on-treatment annualized rate of FVC decline (% predicted/year)
Time frame: Up to 24 months before initiation and, on average, 6 months after initiation
Difference between pre-treatment and on-treatment annualized rate of DLCO decline (% predicted/year)
Time frame: Up to 24 months before initiation and, on average, 6 months after initiation
Change from baseline in K-BILD domain scores
Time frame: Baseline and 6-12 months
Change from baseline in FVC (mL and % predicted)
Time frame: Baseline and >6 months
Change from baseline in DLCO (% predicted)
Time frame: Baseline and >6 months
Incidence of serious adverse events
Time frame: Through study completion, an average of 9 months
Permanent discontinuation of nerandomilast
Time frame: Through study completion, an average of 9 months
Dose reduction of nerandomilast
Time frame: Through study completion, an average of 9 months
Annualized incidence of acute exacerbation of interstitial lung disease
Time frame: Through study completion, an average of 9 months
Annualized incidence of respiratory-cause hospitalization
Time frame: Through study completion, an average of 9 months
Annualized all-cause mortality
Time frame: Through study completion, an average of 9 months
Annualized incidence of lung transplantation
Time frame: Through study completion, an average of 9 months
Exploratory: Outcomes stratified by diagnosis, nerandomilast dosage, and background antifibrotic therapy
Time frame: Through study completion, an average of 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Pulmonary Fibrosis (IPF)
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Active, not recruitingPhase 2
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Idiopathic Pulmonary Fibrosis (IPF)
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis, run by Avraham Unterman at 4 sites in Israel.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doron Cohn-Schwartz, MD, PhD (972-3-6973591, doroncs@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Through study completion, an average of 9 months). 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 5 Nov 2026.