1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
2. 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.
3. Patients must be diagnosed with limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc), as defined by LeRoy et al. (1988).
4. Disease onset (defined by first non-RP \[Raynaud's phenomenon\] symptom) must be within 7 years of Visit 1.
5. Trial participants with dcSSc must have evidence of active disease during screening.
6. Trial participants with lcSSc must have evidence of active disease during screening. LcSSc patients must be anti-centromere antibody (ACA) negative.
7. FVC % predicted ≥45% at Visit 1.
8. Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % predicted ≥25% corrected for haemoglobin (Hb) at Visit 1.
9. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control.
10. 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 be if
1. Active, unstable, or uncontrolled vasculitis within 8 weeks prior to Visit 1 or during the screening period.
2. Any suicidal behaviour in the past 2 years.
Clareo Health | A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
