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RECRUITING Phase 3

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 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Nerandomilast

Study Locations (20)

California

  • University of Southern California — Los Angeles
  • Cedars-Sinai Medical Center — Los Angeles
  • University of California Los Angeles — Los Angeles
  • University of California Davis — Sacramento

Florida

  • St. Francis Medical Institute — Clearwater
  • University of Florida — Gainesville
  • Clinical Research Specialists LLC - Kissimmee — Kissimmee
  • Advanced Pulmonary Research Institute — Loxahatchee Groves

Georgia

  • Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead — Atlanta
  • The Emory Clinic — Atlanta

Alabama

  • University of Alabama at Birmingham — Birmingham

Arizona

  • University of Arizona — Tucson

Colorado

  • National Jewish Health — Denver

Connecticut

  • Yale University School of Medicine — New Haven

Delaware

  • Christiana Hospital — Newark

Trial Details

FieldValue
Enrollment Target 1,700 participants
Start Date 2024-05-06
Est. Completion 2027-05-05
Phase Phase 3

Sponsor

Boehringer Ingelheim

203 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06238622

The ClinicalTrials.gov registry entry for NCT06238622 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Idiopathic Pulmonary Fibrosis appearing as the primary indexed condition, and to 1 intervention — of which Nerandomilast is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06238622 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06238622 about?

NCT06238622 is a clinical study titled "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". 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 ...

What is the current status of trial NCT06238622?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,700 participants. The study started on 2024-05-06. Estimated completion is 2027-05-05.

What conditions does trial NCT06238622 study?

This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06238622?

The interventions under investigation include: Nerandomilast (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06238622?

This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06238622 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial