Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis (ReaSoN-IPF/PPF)

October 31, 2026 updated by: Avraham Unterman

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Israel
      • Ashkelon, Israel, 7830604
        • Recruiting
        • Barzilai Medical Center, Ben-Gurion University of the Negev
        • Contact:
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus, Technion - Israel Institute of Technology
        • Contact:
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center, Tel-HaShomer, Tel-Aviv University
        • Contact:
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel-Aviv Sourasky University Medical Center, Tel-Aviv University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Age 18 years or older.
  2. 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).
  3. Initiating treatment with nerandomilast as part of routine clinical care, with the treatment decision made independently of, and prior to, study enrollment.
  4. Willing and able to provides written informed consent to participate in the prospective ILD registry of the respective medical center.

Exclusion Criteria:

  1. Prior exposure to nerandomilast, including in a clinical trial or open-label extension study.
  2. Concurrent participation in an interventional trial of an investigational agent for interstitial lung disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
IPF or PPF

Patients who are diagnosed with IPF
Drug: Nerandomilast

Either Nerandomilast 9mg twice a day or 18mg twice a day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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

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.
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

As for outcome 2, with FVC expressed as percentage of predicted value.
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

As above, for diffusing capacity of the lungs for carbon monoxide, corrected for hemoglobin.
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

Breathlessness and activities, psychological, and chest symptoms domains, each scored 0-100, higher indicating better health status.
Baseline and 6-12 months
Change from baseline in FVC (mL and % predicted)
Time Frame: Baseline and >6 months

Absolute annualized change in forced vital capacity from the pre-treatment baseline measurement.
Baseline and >6 months
Change from baseline in DLCO (% predicted)
Time Frame: Baseline and >6 months

Absolute annualized change in hemoglobin-corrected diffusing capacity from the pre-treatment baseline measurement.
Baseline and >6 months
Incidence of serious adverse events
Time Frame: Through study completion, an average of 9 months

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.
Through study completion, an average of 9 months
Permanent discontinuation of nerandomilast
Time Frame: Through study completion, an average of 9 months

Proportion of participants permanently discontinuing nerandomilast, time to discontinuation, and reason for discontinuation.
Through study completion, an average of 9 months
Dose reduction of nerandomilast
Time Frame: Through study completion, an average of 9 months

Proportion of participants in whom nerandomilast dose is reduced, time to dose reduction, and reason for dose reduction.
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

Number and proportion of participants with at least one acute exacerbation, defined according to published criteria, time to exacerbation.
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 incidence of respiratory-cause hospitalization
Through study completion, an average of 9 months
Annualized all-cause mortality
Time Frame: Through study completion, an average of 9 months

Proportion of participants who die from any cause during follow-up.
Through study completion, an average of 9 months
Annualized incidence of lung transplantation
Time Frame: Through study completion, an average of 9 months

Proportion of participants undergoing lung transplantation during follow-up.
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

Primary and key secondary outcomes reported separately for IPF versus PPF, and for background nintedanib, pirfenidone, or no background antifibrotic therapy.
Through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Avraham Unterman

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rambam Health Care Campus
The Chaim Sheba Medical Center
Barzilai University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0101-21-TLV-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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