Clinical trial for Systemic Sclerosis
Official title A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
ClinicalTrials.gov ID: NCT07497087
What this study is testing
What is Nerandomilast formulation 1?
an investigational oral tablet being studied as a potential treatment for systemic sclerosis
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if nerandomilast can improve symptoms and slow disease progression in systemic sclerosis, and how well people tolerate the medicine.
- Who it's for
- Adults 18 years or older with limited or diffuse cutaneous systemic sclerosis that started within 7 years of the first non‑Raynaud’s symptom.
- What's involved
- Participants are randomly assigned to take nerandomilast tablets or identical placebo tablets twice daily, attend regular clinic visits, give blood samples, and undergo checks of skin thickness, lung function, internal organs, overall health, and safety.
- Time commitment
- The study lasts from 1 up to about 4 years with regular site visits and phone calls throughout.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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.
You likely can't join 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Stanford, California, United States
- Whittier, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Ormond Beach, Florida, United States
- Plantation, Florida, United States
- South Miami, Florida, United States
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Saint Clair Shores, Michigan, United States
- Minneapolis, Minnesota, United States
- New Brunswick, New Jersey, United States
+ 196 more site(s).
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Los Angeles, California, United States; San Diego, California, United States; Stanford, California, United States and 210 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.