Systemic Sclerosis study: Nerandomilast formulation
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
- This study is testing whether a new medicine called nerandomilast helps people with systemic sclerosis. It also checks how safe the medicine is and what side effects it causes.
- Who it's for
- You may be able to join if you are an adult with systemic sclerosis that started within the last 7 years.
- What's involved
- You would take a pill twice a day. You might get the real medicine or a pretend pill with no medicine. You would visit the clinic for blood tests and health checks.
- Time commitment
- The study lasts from 1 to about 4 years with regular visits and phone calls.
- 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 is enrolling
- San Diego, California, United States
- Whittier, California, United States
- Ormond Beach, Florida, United States
- South Miami, Florida, United States
- New Orleans, Louisiana, United States
- Saint Clair Shores, Michigan, United States
- New Brunswick, New Jersey, United States
- Philadelphia, Pennsylvania, United States
- Jackson, Tennessee, United States
- Austin, Texas, United States
- Frisco, Texas, United States
- CABA, Argentina
- Maipu, Argentina
- Quilmes, Argentina
- Rosario, Argentina
- Curitiba, Brazil
- Porto Alegre, Brazil
- Salvador, Brazil
- São Paulo, Brazil
- Valinhos, Brazil
+ 42 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at San Diego, California, United States; Whittier, California, United States; Ormond Beach, Florida, United States; South Miami, Florida, United States; New Orleans, Louisiana, United States; Saint Clair Shores, Michigan, United States and 56 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.