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

Last updated: May 23, 2023
Sponsor: Biogen
Overall Status: Terminated

Phase

3

Condition

Memory Loss

Multiple Sclerosis

Scar Tissue

Treatment

Peginterferon Beta-1a

Dimethyl Fumarate

Placebo

Clinical Study ID

NCT03870763
800MS301
2018-000516-22
  • Ages 10-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Must have a diagnosis of RRMS as defined by the revised consensus definition forpediatric 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), ormust have evidence of asymptomatic disease activity seen on MRI in the 6 months priorto 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 ofwhether the event is a first or subsequent demyelinating event.

Exclusion

Key Exclusion Criteria:

  • Participants having primary progressive, secondary progressive, or progressive RMS.
  • Disorders mimicking MS, such as other demyelinating disorders, systemic autoimmunedisorders, 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/orother major disease and/or laboratory abnormality indicative thereof, that wouldpreclude participation in a clinical study
  • Occurrence of an MS relapse within the 30 days prior to randomization (Day 1) and/orthe subject has not stabilized from a previous relapse prior to randomization NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 11
Treatment Group(s): 3
Primary Treatment: Peginterferon Beta-1a
Phase: 3
Study Start date:
March 19, 2019
Estimated Completion Date:
July 21, 2022

Study 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.

Connect with a study center

  • Research Site

    Medellín,
    Colombia

    Site Not Available

  • Research Site

    Tallinn, 11315
    Estonia

    Site Not Available

  • Research Site

    Budapest, 1083
    Hungary

    Site Not Available

  • Research Site

    Ar-Ramtha,
    Jordan

    Site Not Available

  • Research Site

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Research Site

    Penang,
    Malaysia

    Site Not Available

  • Research Site

    Petaling Jaya,
    Malaysia

    Site Not Available

  • Research Site

    Petaling Jaya, Selangor,
    Malaysia

    Site Not Available

  • Research Site

    Seberang Jaya,
    Malaysia

    Site Not Available

  • Research Site

    Federal District,
    Mexico

    Site Not Available

  • Research Site

    Guadalajara,
    Mexico

    Site Not Available

  • Research Site

    Morelia,
    Mexico

    Site Not Available

  • Research Site

    Santa Cruz,
    Mexico

    Site Not Available

  • Research Site

    Dammam,
    Saudi Arabia

    Site Not Available

  • Research Site

    Riyadh,
    Saudi Arabia

    Site Not Available

  • Research Site

    Taipei, 10002
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Research Site

    Bangkok,
    Thailand

    Site Not Available

  • Research Site

    Pathumwan,
    Thailand

    Site Not Available

  • Research Site

    Mannouba,
    Tunisia

    Site Not Available

  • Research Site

    Manouba,
    Tunisia

    Site Not Available

  • Research Site

    Monastir,
    Tunisia

    Site Not Available

  • Research Site

    Sfax,
    Tunisia

    Site Not Available

  • Research Site

    Tunis,
    Tunisia

    Site Not Available

  • Research Site

    Ankara,
    Turkey

    Site Not Available

  • Research Site

    Izmir,
    Turkey

    Site Not Available

  • Research Site

    Samsun,
    Turkey

    Site Not Available

  • Research Site

    Raleigh, North Carolina 27607
    United States

    Site Not Available

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