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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 April 2023
• Main ID: NCT03870763
• Date of registration: 07/03/2019
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: 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
• Scientific title: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis
• Date of first enrolment: March 19, 2019
• Target sample size: 11
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03870763
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Colombia, Estonia, Hungary, Jordan, Korea, Republic of, Malaysia, Mexico, Saudi Arabia, Taiwan, Thailand, Tunisia, Turkey, United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- 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.

Key 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.



Age minimum: 10 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Drug: Placebo

Drug: Dimethyl Fumarate

Drug: Peginterferon Beta-1a

Primary Outcome(s)

Time to First Relapse [Time Frame: Baseline up to Week 96]

Secondary Outcome(s)

Number of Galdolinium(Gd)-Enhancing Lesions [Time Frame: Weeks 48 and 96]

Annualized Relapse Rate [Time Frame: Weeks 48 and 96]

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to Week 100]

Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans [Time Frame: Weeks 48 and 96]

Secondary ID(s)

800MS301

2018-000516-22

Source(s) of Monetary Support

Please refer to primary and secondary sponsors