A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis (NCT07497087)
A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)
🩺 Plain-English Summary (8th-Grade Level)
Nerandomilast is being developed to help people with systemic sclerosis by potentially improving symptoms and slowing disease progression. This study is open to adults who are at least 18 years old and have systemic sclerosis (SSc). People can join the study if they have limited or diffuse cutaneous SSc with disease onset within 7 years of the first non-Raynaud's symptom. The purpose of this study is to find out whether a medicine called nerandomilast helps people with systemic sclerosis. This study also aims to find out how well nerandomilast is tolerated in people with systemic sclerosis. 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 the tablets twice a day. Participants are in the study for 1 to about 4 years. During this time, they visit the study site regularly and get phone calls from the site staff. During study visits participants regularly have blood samples taken and doctors check changes in skin thickening, lung function, and internal organs, overall health and the safety and tolerability of study treatment in people with SSc. The results are compared between the groups 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 (246 Sites)
Showing the first 25 of 246 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- Banner - University Medicine Rheumatology Clinic — Phoenix, Arizona
- Arizona Arthritis and Rheumatology Associates - Paradise Valley — Scottsdale, Arizona
- University of California Los Angeles — Los Angeles, California
- Paradigm Clinical Research - San Diego — San Diego, California
- Stanford University School of Medicine — Stanford, California
- Medvin Clinical Research-Whittier-69033 — Whittier, California
- University of Colorado Denver — Aurora, Colorado
- Georgetown University — Washington D.C., District of Columbia
- Millennium Research - Ormond Beach — Ormond Beach, Florida
- Integral Rheumatology and Immunology Specialist — Plantation, Florida
- BioResearch Partner - South Miami — South Miami, Florida
- Northwestern University — Chicago, Illinois
- The University of Chicago Medical Center — Chicago, Illinois
- DelRicht Research-New Orleans-64100 — New Orleans, Louisiana
- Johns Hopkins Hospital — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Clinical Research Institute of Michigan, LLC - St. Clair Shores — Saint Clair Shores, Michigan
- M Health Fairview University of Minnesota Medical Center — Minneapolis, Minnesota
- Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey
- Hospital for Special Surgery — New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York
- Columbia University Medical Center-New York Presbyterian Hospital — New York, New York
- University of Pennsylvania — Philadelphia, Pennsylvania
📞 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.
More studies in Systemic Sclerosis
- KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis — Palo Alto, California
- Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) — Scottsdale, Arizona
- Hyaluronidase for Sclerodactyly in Systemic Sclerosis Trial — Charleston, South Carolina
- A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis — Scottsdale, Arizona
- Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis — New York, New York
- Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis — Houston, Texas
Explore by condition: All Systemic Sclerosis clinical trials
💡 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.