NCT02881567

Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab

A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the effects of treatment with daclizumab on the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due to safety concerns. The secondary objectives of this study in this study population are to evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse activity including the annualized relapse rate (ARR) and the proportion of participants experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in participants previously treated with natalizumab.

Conditions

• Relapsing-Remitting Multiple Sclerosis (RRMS)

Interventions

Type	Name	Description
DRUG	Daclizumab	High yield formulation

Timeline

• Start date: 2017-04-18
• Primary completion: 2018-09-12
• Completion: 2018-09-12
• First posted: 2016-08-29
• Last updated: 2019-09-27
• Results posted: 2019-09-24

Locations

11 sites across 5 countries: United States, Canada, Germany, Italy, Puerto Rico

Regulatory

• FDA-regulated drug study