A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast (NCT06238622)
🩺 Plain-English Summary (8th-Grade Level)
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550. The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (11 items).
Location: University of Alabama at Birmingham — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Any disease that may put the patient at risk when participating in this trial at investigator's discretion.
- Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:
- any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
- any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
- Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore \>14 at Visit 1.
- An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.
- Patient will undergo lung transplantation, with an assigned date of surgery.
- Patients with a Body Mass index (BMI) \<18.5 kg/m² that experienced an additional, unexplained and clinically significant (\>10%) weight loss during the parent trial
- At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial
- Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial. Further exclusion criteria apply.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (373 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- University of Arizona — Tucson, Arizona
- University of Southern California — Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California
- University of California Los Angeles — Los Angeles, California
- University of California Davis — Sacramento, California
- National Jewish Health — Denver, Colorado
- Yale University School of Medicine — New Haven, Connecticut
- Christiana Hospital — Newark, Delaware
- Georgetown University — Washington D.C., District of Columbia
- St. Francis Medical Institute — Clearwater, Florida
- University of Florida — Gainesville, Florida
- Clinical Research Specialists LLC - Kissimmee — Kissimmee, Florida
- Advanced Pulmonary Research Institute — Loxahatchee Groves, Florida
- Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead — Atlanta, Georgia
- The Emory Clinic — Atlanta, Georgia
- Northshore University Health System — Evanston, Illinois
- University of Kansas Medical Center — Kansas City, Kansas
- Tulane Medical Center — New Orleans, Louisiana
- Johns Hopkins Hospital — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts
- St. Elizabeth's Medical Center — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.