Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2018-000516-22-EE
• Date of registration: 17/12/2018
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec Research Limited
• Public title: Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 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: 14/01/2019
• Target sample size: 340
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-000516-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Colombia, Croatia, Estonia, Greece, Hungary, Israel, Italy, Jordan, Korea, Republic of, Malaysia, Mexico, Portugal, Russian Federation, Saudi Arabia, Serbia, Taiwan, Thailand, Tunisia, Turkey, United States

Contacts

• Name: 800MS301 Clinical Trial Team
• Affiliation: Biogen Idec Research Limited

• Name: 800MS301 Clinical Trial Team
• Affiliation: Biogen Idec Research Limited

Key inclusion & exclusion criteria

Inclusion 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 =2 relapses in
the 24 months prior to randomization (Day 1).

Note: Other protocol inclusion criteria may apply.
Are the trial subjects under 18? yes
Number of subjects for this age range: 340
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
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 Exclusion criteria may apply


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: TECFIDERA
Product Name: BG00012
Product Code: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: PEGINTERFERON BETA-1A
CAS Number: 1211327-92-2
Current Sponsor code: BIIB017
Other descriptive name: PEGINTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: up to
Concentration number: 125-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: Secondary objectives: to evaluate the safety and
tolerability of BG00012 and BIIB017 and to assess the
effect of BG00012 and BIIB017, both compared with
placebo, on additional clinical and radiological measures
of disease activity.

Main Objective: The primary objective of the study is to evaluate the efficacy of BG00012 and BIIB017, both
compared with placebo, in pediatric subjects with RRMS.

Timepoint(s) of evaluation of this end point: week 96

Primary end point(s): -The primary endpoint that relates to primary objective is the TTFR.

Secondary Outcome(s)

Secondary end point(s): -Occurrence of adverse events (AEs) and serious adverse events (SAEs)
- Number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Weeks 48 and 96
- Number of Gd-enhancing lesions at Baseline and at Weeks 48 and 96
- Annualized relapse rate at Weeks 48 and 96

Timepoint(s) of evaluation of this end point: - total new lesions weeks 48 and 96
- relapse rate and proportion subjects experiencing 1 or more relapse (week 48 and 96)
-degree of disability progression up to week 24

Secondary ID(s)

2018-000516-22-PT

800MS301

Source(s) of Monetary Support

Biogen Idec Research Limited

Ethics review

Status: Approved
Approval date:
Contact: