Evaluating safety, efficacy and pharmacokinetics of a modified regimen of ublituximab (ENHANCE)

Relapsing multiple sclerosis

Part A: The proportion of participants with no change or reduction in number of T1 Gd-enhancing lesions from baseline to Week 48, Part B: PK (AUC) over the first 16 weeks (AUC0-W16), Part C: Proportion of participants with no change or reduction in number of T1 Gd-enhancing lesions

Part A: The proportion of participants free of T1 Gd-enhancing lesions at Week 48, Part A: The proportion of participants experiencing IRRs as reported by the Investigator, Part A: Treatment Satisfaction Questionnaire for Medication (TSQM-9) scores at Week 24 and Week 48, Part A: Pharmacokinetics of ublituximab, Part B: The proportion of participants who experience any grade treatment-emergent adverse events (TEAEs), Part B: The proportion of participants experiencing IRR as reported by the Investigator, Part B: The number of T1 Gd-enhancing lesions per MRI scan at Week 24 and Week 48, Part B: PK (Cmax) at Day 1 and Day 15, Part B: The proportion of participants with CD19+ B-cell counts below a specific level at all timepoints, Part C: Proportion of participants free of T1 Gd-enhancing lesions, Part C: The proportion of participants experiencing IRRs as reported by the Investigator, Part C: Treatment Satisfaction Questionnaire for Medication (TSQM-9) scores at each timepoint, Part C: Change from baseline in PROMIS-Fatigue-MS-8a at each timepoint, Part C: Neuro-QOL at each timepoint

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Poland