A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Systemic Sclerosis

In brief

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.

Key facts

Study ID

NCT07497087

Run by

Boehringer Ingelheim

People needed

448

Starts

2026-07-27

Expected to finish

2030-03-17

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
• Patients must be at least 18 years of age and fulfil the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) criteria for SSc.
• Patients must be diagnosed with limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc), as defined by LeRoy et al. (1988).
• Disease onset (defined by first non-RP [Raynaud's phenomenon] symptom) must be within 7 years of Visit 1.
• Trial participants with dcSSc must have evidence of active disease during screening.
• Trial participants with lcSSc must have evidence of active disease during screening. LcSSc patients must be anti-centromere antibody (ACA) negative.
• FVC % predicted ≥45% at Visit 1.
• Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % predicted ≥25% corrected for haemoglobin (Hb) at Visit 1.
• Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control.
• Patients may be either untreated or on stable treatment with permitted immunosuppressive/immunomodulatory agents and/or nintedanib. All treatments must remain stable prior to Visit 2 and during the screening period

You may not qualify if…

• Active, unstable, or uncontrolled vasculitis within 8 weeks prior to Visit 1 or during the screening period.
• Any suicidal behaviour in the past 2 years.
• Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months. Further exclusion criteria apply.

Where it is running

• DelRicht Research-New Orleans-64100 — New Orleans, Louisiana, United States (enrolling)
• Instituto de Investigación Clínica TyT — CABA, Argentina (enrolling)
• BioResearch Partner - South Miami — South Miami, Florida, United States (enrolling)
• Tekton Research, Inc - West Gate Boulevard — Austin, Texas, United States (enrolling)
• Medvin Clinical Research-Whittier-69033 — Whittier, California, United States (enrolling)
• Centro Medico Reumatologico - OMI — CABA, Argentina (enrolling)
• Mautalen- Salud e Investigacion — CABA, Argentina (enrolling)
• Paradigm Clinical Research - San Diego — San Diego, California, United States (enrolling)
• The University of Chicago Medical Center — Chicago, Illinois, United States
• Columbia University Medical Center-New York Presbyterian Hospital — New York, New York, United States
• Stanford University School of Medicine — Stanford, California, United States
• Northwestern University — Chicago, Illinois, United States
• Arizona Arthritis and Rheumatology Associates - Paradise Valley — Scottsdale, Arizona, United States
• Integral Rheumatology and Immunology Specialist — Plantation, Florida, United States
• M Health Fairview University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• Millennium Research - Ormond Beach — Ormond Beach, Florida, United States
• Clinical Research Institute of Michigan, LLC - St. Clair Shores — Saint Clair Shores, Michigan, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Hospital for Special Surgery — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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