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Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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)

NCT02881567•Biogen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Must have documented diagnosis of RRMS (McDonald 2010 Criteria) at screening \[Polman 2011\].
•Must have been treated with natalizumab for at least the 12 months prior to screening and have not missed 2 or more consecutive scheduled doses.
•Must be naïve to daclizumab and other forms of daclizumab such as Zenapax® prior to enrollment.
•Must have a confirmed Expanded Disability Status Scale (EDSS) score of 0 to 5.5, inclusive, at screening.
•Female participants of childbearing potential must practice effective contraception from Day -1 and be willing and able to continue contraception for duration of the study.

Exclusion Criteria

•Current participation in another investigational study.
•Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold) \[Lublin 2014\].
•Females breastfeeding, pregnant, or planning to become pregnant; or women who have a positive pregnancy test result during screening.
•History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to screening.
•History of severe hypersensitivity (e.g., anaphylaxis or anaphylactoid reactions) to the active ingredient or any of the excipients.
•History of severe opportunistic infections (including progressive multifocal leukoencephalopathy (PML)) or any clinically significant, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
•Discontinued natalizumab due to suspicion of PML.
•Known active malignancies (participants with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).
•The participant is using another MS therapy concomitantly.
•Known history of human immunodeficiency virus (HIV).
+2 more criteria

Locations (11)

Research Site

Tampa, Florida, United States

Research Site

Des Moines, Iowa, United States

Research Site

Milwaukee, Wisconsin, United States

Research Site

Edmonton, Alberta, Canada

Research Site

Munich, Bavaria, Germany

Research Site

Potsdam, Brandenburg, Germany

Research Site

Dresden, Saxony, Germany

Research Site

Hamburg, Germany

Research Site

Pozzilli, Isernia, Italy

Research Site

Naples, Italy

Key Dates

Start Date

April 18, 2017

Primary Completion Date

September 12, 2018

Completion Date

September 12, 2018

Last Updated

September 27, 2019

Enrollment

ACTUAL participants

Conditions

Relapsing-Remitting Multiple Sclerosis (RRMS)

Interventions

Daclizumab

DRUG

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NCT05304520

Relapsing-Remitting Multiple Sclerosis (RRMS)

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WITHDRAWNPHASE4

Brimonidine Tartrate for the Treatment of Injection Related Erythema

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Relapsing-Remitting Multiple Sclerosis (RRMS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 27, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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