RELAPSING MULTIPLE SCLEROSIS
Conditions
Brief summary
Cumulative number of new GdE T1 hyperintense lesions over Week 8 and Week 12, as measured by brain MRI
Detailed description
Cumulative number of new and/or enlarging T2 weighted hyperintense lesions detected over Week 8 and Week 12, Number of new GdE T1 hyperintense lesions at Week 4, Week 8, and Week 12, Change from baseline in volume of T2 lesions at Week 12, Change from baseline in serum NfL at Week 12, Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs of special interest, (AESI), as defined by the Common Terminology of Criteria for Adverse Events (CTCAE) Version 5.0
Interventions
Sponsors
Zenas Biopharma (USA) LLC
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative number of new GdE T1 hyperintense lesions over Week 8 and Week 12, as measured by brain MRI | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative number of new and/or enlarging T2 weighted hyperintense lesions detected over Week 8 and Week 12, Number of new GdE T1 hyperintense lesions at Week 4, Week 8, and Week 12, Change from baseline in volume of T2 lesions at Week 12, Change from baseline in serum NfL at Week 12, Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs of special interest, (AESI), as defined by the Common Terminology of Criteria for Adverse Events (CTCAE) Version 5.0 | — |
Countries
Austria, Belgium, Croatia, Czechia, Denmark, Finland, Greece, Italy, Poland, Spain
Outcome results
None listed