drugset / Trial / NCT03958877
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
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-10-18
- Primary completion
- 2027-05-20
- Completion
- 2027-05-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Interferon beta-1a | Protein / enzyme biologic | 30 ug | Intramuscular |
| Subject | peginterferon beta-1a | Protein / enzyme biologic | 125 ug | Subcutaneous |