Last updated 8 days ago
A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
448 patients around the world
Available in Chile, Argentina, United States, Mexico, Brazil, Colombia
Boehringer Ingelheim
18Research sites
448Patients around the world
This study is for people with
Rare diseases
Systemic sclerosis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
Sites
Instituto de Investigaciones Clínicas Quilmes
Sanatorio de la Mujer - Rosario
Mautalen - Salud e Investigación - CABA
Instituto de Investigación Clínica T y T
Centro Médico Reumatológico OMI - Buenos Aires, CABA
Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Hospital das Clínicas Universidade Federal de Pernambuco - UFPE
Hospital Mater Dei Salvador
Hospital do Rim - HRIM– Fundação Oswaldo Ramos
StudyVERANDA™-SSc
SponsorBoehringer Ingelheim
Study typeInterventional
Conditions
Systemic sclerosis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07497087
