drugset / Trial / NCT04480307

Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis

NCT04480307 ↗

Phase 2 Completed 41 enrolled GeNeuro Innovation SAS
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Randomized, double-blind, placebo-controlled Phase IIa clinical study, assessing safety, tolerability, pharmacodynamic effects and pharmacokinetics of temelimab, administered at three different dose levels (18 mg/kg or 36 mg/kg or 54 mg/kg). In this study temelimab is administered subsequently to rituximab therapy, i.e. no co-administration of rituximab and temelimab is done in this study.

Timeline

Start
2020-06-17
Primary completion
2022-01-24
Completion
2022-01-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Temelimab Monoclonal antibody 18 mg/kg Intravenous
Subject Temelimab Monoclonal antibody 36 mg/kg Intravenous
Subject Temelimab Monoclonal antibody 54 mg/kg Intravenous

Indications