A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
Boehringer Ingelheim · NCT07497087
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 448
- US sites recruiting
- 11
- Study start
- July 27, 2026
- Record last updated
- October 14, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Placebo matching nerandomilast formulation 1; Placebo matching nerandomilast formulation 2; Nerandomilast formulation 1; Nerandomilast formulation 2
Conditions: Systemic Sclerosis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Recruiting US locations
Paradigm Clinical Research - San Diego
San Diego, CA 92108
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Medvin Clinical Research-Whittier-69033
Whittier, CA 90602
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Millennium Research - Ormond Beach
Ormond Beach, FL 32174
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
BioResearch Partner - South Miami
South Miami, FL 33143
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
DelRicht Research-New Orleans-64100
New Orleans, LA 70115
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Clinical Research Institute of Michigan, LLC - St. Clair Shores
Saint Clair Shores, MI 48081
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Rutgers Robert Wood Johnson Medical School
New Brunswick, NJ 08901
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Thomas Jefferson University
Philadelphia, PA 19107
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
West Tennessee Research Institute
Jackson, TN 38305
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Tekton Research, Inc - West Gate Boulevard
Austin, TX 78745
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Arthritis & Rheumatology Institute - Frisco
Frisco, TX 75035
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Study contacts (from the official record)
- Boehringer Ingelheim · 1-800-243-0127 · clintriage.rdg@boehringer-ingelheim.com