A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases (NCT06806592)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (154 Sites)
Showing the first 25 of 154 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- Mayo Clinic-Arizona — Scottsdale, Arizona
- University of California Los Angeles — Los Angeles, California
- Paradigm Clinical Research - San Diego — San Diego, California
- National Jewish Health — Denver, Colorado
- Yale University School of Medicine — New Haven, Connecticut
- Meris Clinical Research-Brandon-69466 — Brandon, Florida
- Miami VA Healthcare System — Miami, Florida
- Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead — Atlanta, Georgia
- Augusta University — Augusta, Georgia
- Northwestern University — Chicago, Illinois
- The University of Chicago Medical Center — Chicago, Illinois
- Northshore University Health System — Evanston, Illinois
- University of Kansas Medical Center — Kansas City, Kansas
- Massachusetts General Hospital — Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts
- University of Minnesota — Minneapolis, Minnesota
- Mayo Clinic, Rochester — Rochester, Minnesota
- University of Nebraska Medical Center — Omaha, Nebraska
- Northwell Health — Great Neck, New York
- NYU Langone Health — New York, New York
- Columbia University Medical Center-New York Presbyterian Hospital — New York, New York
- Onsite Clinical Solutions — Salisbury, North Carolina
- Southeastern Research Center-Winston Salem-69289 — Winston-Salem, North Carolina
- Cleveland Clinic — Cleveland, Ohio
📞 Contact the Study Coordinator
Phone: (800) 243-0127
Email: clintriage.rdg@boehringer-ingelheim.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.