drugset / Trial / NCT05532163

A Study to Investigate the Radiological Onset of Action After Treatment Initiation With Subcutaneous (SC) Natalizumab in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)

NCT05532163

Phase 4 Terminated 1 enrolled Biogen
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the radiological efficacy of SC natalizumab over time through Week 24 in natalizumab-naïve participants, as measured by brain magnetic resonance imaging (MRI). The secondary objectives of this study are to evaluate additional lesion-related radiological efficacy measures over time, relapse-based clinical efficacy measures, disability improvement and worsening (EDSS), pharmacokinetic and pharmacodynamic parameters, the immunogenicity of repeated doses, and safety in treatment-naïve participants of SC natalizumab.

Timeline

Start
2023-01-23
Primary completion
2023-10-09
Completion
2023-10-09

Drugs

EvaluationDrugModalityDoseRoute
Subject natalizumab Monoclonal antibody 300 mg Subcutaneous