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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2021
  • participants needed
    260
  • sponsor
    Biogen
Updated on 1 April 2021
fumarate
demyelination
tecfidera
relapsing multiple sclerosis

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.

Description

Participants will be randomized in a 1:2:2 ratio to receive the double-blind study treatment (Dimethyl Fumarate, Peginterferon Beta-1a, and placebo). Participants experiencing a confirmed relapse or disability progression or high lesion burden on MRI will have the option to discontinue the blinded study treatment and switch to an alternative therapy or open-label BG00012.

Details
Condition relapsing-remitting multiple sclerosis
Treatment Placebo, dimethyl fumarate, Peginterferon beta-1a
Clinical Study IdentifierNCT03870763
SponsorBiogen
Last Modified on1 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 10 yrs and 17 yrs?
Gender: Male or Female
Do you have relapsing-remitting multiple sclerosis?
Do you have any of these conditions: Do you have relapsing-remitting multiple sclerosis??
Do you have any of these conditions: Do you have relapsing-remitting multiple sclerosis??
Do you have any of these conditions: Do you have relapsing-remitting multiple sclerosis??
Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS
Must have an EDSS score between 0.0 and 5.0
Must have a body weight of 30 kg
Must have experienced 1 relapse in the 12 months prior to randomization (Day 1), or must have evidence of asymptomatic disease activity seen on MRI in the 6 months prior to randomization, or 2 relapses in the 24 months prior to randomization (Day 1). Relapse is defined as the occurrence of a clinical demyelination event regardless of whether the event is a first or subsequent demyelinating event

Exclusion Criteria

Participants having primary progressive, secondary progressive, or progressive RMS
Disorders mimicking MS, such as other demyelinating disorders, systemic autoimmune disorders, metabolic disorders, and infectious disorders
History of clinically significant cardiovascular, pulmonary, GI, hepatic, renal, endocrinologic, hematologic, immunologic, metabolic, dermatologic, growth, developmental, psychiatric (including depression), neurologic (other than MS), and/or other major disease and/or laboratory abnormality indicative thereof, that would preclude participation in a clinical study
Occurrence of an MS relapse within the 30 days prior to randomization (Day 1) and/or the subject has not stabilized from a previous relapse prior to randomization
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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