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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
NCT03958877 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG BIIB017 (peginterferon beta-1a)
- DRUG Interferon beta type 1a
Study Locations (20)
Other
- MHATNP 'Sv.Naum', EAD — Sofia
- Children's Hospital Zagreb — Zagreb
- Clinical Hospital Center 'Sestre Milosrdnice' — Zagreb
- University Hospital Centre Zagreb — Zagreb
- Fakultni nemocnice Hradec Kralove — Hradec Králové
California
- UC San Diego Health — La Jolla
North Carolina
- UNC Hospitals — Chapel Hill
Virginia
- Meridian Clinical Research — Norfolk
Buenos Aires
- Hospital Italiano de Buenos Aires — Ciudad Autonoma Buenos Aires
Victoria
- Royal Children's Hospital — Parkville
East Flanders
- Universitair Ziekenhuis Ghent — Ghent
Wallonia
- Clinique CHC MontLégia — Liège
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2019-10-18 |
| Est. Completion | 2027-05-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03958877
The ClinicalTrials.gov registry entry for NCT03958877 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Multiple Sclerosis, Relapsing-Remitting appearing as the primary indexed condition, and to 2 interventions — of which BIIB017 (peginterferon beta-1a) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03958877 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Other, California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03958877 about?
NCT03958877 is a clinical study titled "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". 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...
What is the current status of trial NCT03958877?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 152 participants. The study started on 2019-10-18. Estimated completion is 2027-05-20.
What conditions does trial NCT03958877 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Relapsing-Remitting. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03958877?
The interventions under investigation include: BIIB017 (peginterferon beta-1a) (DRUG), Interferon beta type 1a (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03958877?
This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03958877 being conducted?
This trial has 20 study locations across California, North Carolina, Virginia, Buenos Aires, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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