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NCT06806592 · ClinicalTrials.gov registry record · Phase 3
A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
A Phase 3 study of Interstitial Lung Diseases and Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT06806592: Recruiting Phase 3 study of Interstitial Lung Diseases and Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases, sponsored by Boehringer Ingelheim.
NCT06806592 is a Phase 3 study of Interstitial Lung Diseases and Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 400 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06806592, a Phase 3 study of Interstitial Lung Diseases and Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
QILD will be assessed via quantitative high-resolution computed tomography (qHRCT). QILD are quantitative measures of different radiological patterns associated with lung fibrosis. QLF is a measure of reticulation with architectural distortion. QGGO is a measure of ground glass opacities (i.e. hazy or cloudy areas) within the lung. QHC is a measure of HC within the lung. QILD is the sum of QLF, QGGO, and QHC. Quantification of HRCT scans will be performed centrally via a machine learning algori
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 |
What NCT06806592 shows while recruiting
NCT06806592 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
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.
NCT06806592 names 20 study sites across 13 states, led by Illinois, California, Florida.
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.
What interventions are being tested in trial NCT06806592?
The interventions under investigation include: Nerandomilast (DRUG), Placebo matching nerandomilast (DRUG).
Who is sponsoring clinical trial NCT06806592?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06806592's enrollment target sits among peer trials
400 923rd of 2000 higher than 1,039 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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