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A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis (105MS306)
EU CTIS ID: 2023-505624-56-00
What this study is testing
This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- [Part I] Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS
- [Part I] Must have an EDSS score between 0.0 and 5.5
- [Part I] 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) or have evidence of asymptomatic disease activity (Gd-enhancing lesions) on brain MRI in the 6 months prior to randomization (Day 1).
- [Part II] Participants who completed the study treatment in Part 1 (Week 96 Visit), as per protocol.
You likely can't join if
- [Part I] Primary progressive, secondary progressive, or progressive relapsing MS. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Participants with these conditions may also have superimposed relapses but are distinguished from relapsing subjects by the lack of clinically stable periods or clinical improvement.
- [Part I] History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
- Known allergy to any component of Avonex or BIIB017 formulation.
- Occurrence of an MS relapse that has occurred within 30 days prior to randomization (Day 1) and/or the participant has not stabilized from a previous relapse prior to randomization (Day 1).
- [Part I] Any previous treatment with PEGylated human IFN β-1a
- [Part II] Any significant changes in medical history occurring after enrolment in Part 1, including laboratory test abnormalities or current clinically significant conditions that, in the opinion of the Investigator, would have excluded the subject's participation in Part 1. The Investigator must re-assess the subject's medical fitness for participation and consider any factors that would preclude treatment.
See the full eligibility criteria
- [Part I] Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS
- [Part I] Must have an EDSS score between 0.0 and 5.5
- [Part I] 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) or have evidence of asymptomatic disease activity (Gd-enhancing lesions) on brain MRI in the 6 months prior to randomization (Day 1).
- [Part II] Participants who completed the study treatment in Part 1 (Week 96 Visit), as per protocol.
- [Part I] Primary progressive, secondary progressive, or progressive relapsing MS. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Participants with these conditions may also have superimposed relapses but are distinguished from relapsing subjects by the lack of clinically stable periods or clinical improvement.
- [Part I] History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
- Known allergy to any component of Avonex or BIIB017 formulation.
- Occurrence of an MS relapse that has occurred within 30 days prior to randomization (Day 1) and/or the participant has not stabilized from a previous relapse prior to randomization (Day 1).
- [Part I] Any previous treatment with PEGylated human IFN β-1a
- [Part II] Any significant changes in medical history occurring after enrolment in Part 1, including laboratory test abnormalities or current clinically significant conditions that, in the opinion of the Investigator, would have excluded the subject's participation in Part 1. The Investigator must re-assess the subject's medical fitness for participation and consider any factors that would preclude treatment.
- [Part II] The subject could not tolerate BIIB017 in Part 1. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Kuwait
- Tunisia
- Saudi Arabia
- Israel
- Russian Federation
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kuwait; Tunisia; Saudi Arabia; Israel; Russian Federation; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.