drugset / Trial / NCT03870763

Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants

NCT03870763

Phase 3 Terminated 11 enrolled Biogen
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main objective of the study is to evaluate the efficacy of dimethyl fumarate (Tecfidera) and peginterferon beta-1a (Plegridy), both compared with placebo, in pediatric participants with RRMS. The other objectives of this study are to evaluate the safety and tolerability of dimethyl fumarate and peginterferon beta-1a and to assess the effect of dimethyl fumarate and peginterferon beta-1a, both compared with placebo, on additional clinical and radiological measures of disease activity.

Timeline

Start
2019-03-19
Primary completion
2022-07-21
Completion
2022-07-21

Drugs

EvaluationDrugModalityDoseRoute
Subject dimethyl fumarate Unknown 240 mg Oral
Subject peginterferon beta-1a Protein / enzyme biologic 125 ug Subcutaneous