A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
Public ClinicalTrials.gov record NCT07497087. 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 Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07497087
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 448 participants
Conditions and interventions
Conditions
Interventions
- Placebo matching nerandomilast formulation 1 Drug
- Placebo matching nerandomilast formulation 2 Drug
- Nerandomilast formulation 1 Drug
- Nerandomilast formulation 2 Drug
Drug
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
- Jul 26, 2026
- Primary completion
- Feb 25, 2030
- Completion
- Mar 16, 2030
- Last update posted
- Sep 2, 2026
2026 – 2030
United States locations
- U.S. sites
- 30
- U.S. states
- 17
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | Not yet recruiting |
| Banner - University Medicine Rheumatology Clinic | Phoenix | Arizona | 85006 | Not yet recruiting |
| Arizona Arthritis and Rheumatology Associates - Paradise Valley | Scottsdale | Arizona | 85032 | Not yet recruiting |
| University of California Los Angeles | Los Angeles | California | 90095 | Not yet recruiting |
| Paradigm Clinical Research - San Diego | San Diego | California | 92108 | Recruiting |
| Stanford University School of Medicine | Stanford | California | 94305 | Not yet recruiting |
| Medvin Clinical Research-Whittier-69033 | Whittier | California | 90602 | Recruiting |
| University of Colorado Denver | Aurora | Colorado | 80045 | Not yet recruiting |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | Not yet recruiting |
| Millennium Research - Ormond Beach | Ormond Beach | Florida | 32174 | Recruiting |
| Integral Rheumatology and Immunology Specialist | Plantation | Florida | 33324 | Not yet recruiting |
| BioResearch Partner - South Miami | South Miami | Florida | 33143 | Recruiting |
| Northwestern University | Chicago | Illinois | 60611 | Not yet recruiting |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | Not yet recruiting |
| DelRicht Research-New Orleans-64100 | New Orleans | Louisiana | 70115 | Recruiting |
| Johns Hopkins Hospital | Baltimore | Maryland | 21224 | Not yet recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Not yet recruiting |
| University of Michigan | Ann Arbor | Michigan | 48109 | Not yet recruiting |
| Clinical Research Institute of Michigan, LLC - St. Clair Shores | Saint Clair Shores | Michigan | 48081 | Not yet recruiting |
| M Health Fairview University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | Not yet recruiting |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | Not yet recruiting |
| Hospital for Special Surgery | New York | New York | 10021 | Not yet recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Not yet recruiting |
| Columbia University Medical Center-New York Presbyterian Hospital | New York | New York | 10032 | Not yet recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Not yet recruiting |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | Recruiting |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | Recruiting |
| Arthritis & Rheumatology Institute - Allen | Allen | Texas | 75013 | Recruiting |
| Tekton Research, Inc - West Gate Boulevard | Austin | Texas | 78745 | Recruiting |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | Not yet recruiting |
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 219 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07497087, 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 Sep 2, 2026 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07497087 live on ClinicalTrials.gov.