A Study to Test Whether Nerandomilast Helps People With Lung Fibrosis Related to Rheumatic Diseases
Public ClinicalTrials.gov record NCT06806592. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double Blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nerandomilast Over at Least 26 Weeks in Patients With Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases (SARD-ILD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06806592
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 414 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 13, 2025 (Actual)
- Primary completion
- Apr 15, 2027 (Estimated)
- Completion
- Apr 28, 2027 (Estimated)
- Last update posted
- Oct 14, 2026
2025 – 2027
United States locations
- U.S. sites
- 31
- U.S. states
- 19
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | — |
| Mayo Clinic-Arizona | Scottsdale | Arizona | 85259 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| Paradigm Clinical Research - San Diego | San Diego | California | 92108 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | — |
| Meris Clinical Research-Brandon-69466 | Brandon | Florida | 33511 | — |
| Miami VA Healthcare System | Miami | Florida | 33125 | — |
| Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead | Atlanta | Georgia | 30309 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Northshore University Health System | Evanston | Illinois | 60201 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55902 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-1230 | — |
| Northwell Health | Great Neck | New York | 11021 | — |
| NYU Langone Health | New York | New York | 10017 | — |
| Columbia University Medical Center-New York Presbyterian Hospital | New York | New York | 10032 | — |
| Onsite Clinical Solutions | Salisbury | North Carolina | 28144 | — |
| Southeastern Research Center-Winston Salem-69289 | Winston-Salem | North Carolina | 27103 | — |
| Temple Lung Center | Philadelphia | Pennsylvania | 19140 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84108 | — |
| Rheumatology and Pulmonary Clinic | Beckley | West Virginia | 25801 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 122 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06806592, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06806592 live on ClinicalTrials.gov.