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A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis

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Trial Profile

A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 10 Feb 2022

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At a glance

  • Drugs Natalizumab (Primary) ; Natalizumab (Primary)
  • Indications Multiple sclerosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms REFINE
  • Sponsors Biogen

    • Most Recent Events

    • 28 Apr 2021 According to a Biogen media release, the company has has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its supplemental Biologic License Application (sBLA) for a new subcutaneous (SC) route of administration of TYSABRI (natalizumab) to treat relapsing multiple sclerosis (MS). The CRL indicates that the FDA is unable to approve the company's filing as submitted. The company is evaluating the CRL and will determine next steps in the U.S.
    • 07 Apr 2021 According to a Biogen media release, based on data from the DELIVER and REFINE studies, the European Commission (EC) has granted marketing authorization for a subcutaneous (SC) injection of TYSABRI (natalizumab) to treat relapsing-remitting multiple sclerosis (MS).
    • 19 Sep 2020 Results from RESTORE (n=175) developing model for efficacy of natalizumab extended interval dosing and retrospectively validating Models using data from REFINE, published in the Journal of Clinical Pharmacology
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