Nerandomilast in IPF and Progressive Fibrosis: Real-World Data

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, real-world study of nerandomilast used as part of standard treatment for IPF and progressive pulmonary fibrosis. Participants are adults initiating nerandomilast under their physician’s treatment plan at several Israeli centers; no experimental treatment is assigned by the study. Each patient serves as their own comparator by measuring lung function before and after starting therapy. The study will track change in functional outcomes over time and collect patient-reported data, with eligibility based on confirmed IPF or progression-eligible fibrotic ILD and prior treatment decisions. Key safety and registry data will be gathered without randomization or control groups to reflect routine practice.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Doron Cohn-Schwartz, MD, PhD
• Email: doroncs@tlvmc.gov.il
• Phone: 972-3-6973591

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.