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A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
NCT06806592 · View on ClinicalTrials.gov ↗
Study Summary
Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease. Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Conditions Studied
Interventions
- DRUG Nerandomilast
- DRUG Placebo matching nerandomilast
Study Locations (20)
Illinois
- Northwestern University — Chicago
- The University of Chicago Medical Center — Chicago
- Northshore University Health System — Evanston
California
- University of California Los Angeles — Los Angeles
- Paradigm Clinical Research - San Diego — San Diego
Florida
- Meris Clinical Research-Brandon-69466 — Brandon
- Miami VA Healthcare System — Miami
Georgia
- Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead — Atlanta
- Augusta University — Augusta
Massachusetts
- Massachusetts General Hospital — Boston
- Brigham and Women's Hospital — Boston
Minnesota
- University of Minnesota — Minneapolis
- Mayo Clinic, Rochester — Rochester
Alabama
- University of Alabama at Birmingham — Birmingham
Arizona
- Mayo Clinic-Arizona — Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2025-09-13 |
| Est. Completion | 2027-07-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06806592
The ClinicalTrials.gov registry entry for NCT06806592 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 400 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 Interstitial Lung Diseases appearing as the primary indexed condition, and to 2 interventions — 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: NCT06806592 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Illinois, California, Florida. 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 NCT06806592 about?
NCT06806592 is a clinical study titled "A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases". Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of ...
What is the current status of trial NCT06806592?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2025-09-13. Estimated completion is 2027-07-30.
What conditions does trial NCT06806592 study?
This clinical trial studies the following conditions: Interstitial Lung Diseases, Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06806592?
The interventions under investigation include: Nerandomilast (DRUG), Placebo matching nerandomilast (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06806592?
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 NCT06806592 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.
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