NCT02881567

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2017

Geographic Reach
5 countries

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

April 18, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

September 24, 2019

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

August 24, 2016

Results QC Date

September 5, 2019

Last Update Submit

September 25, 2019

Conditions

Relapsing-Remitting Multiple Sclerosis (RRMS)

Keywords

Multiple SclerosisDaclizumabTysabri-Switch

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Relapse-free at Month 6

    Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The Kaplan-Meier estimate of the percentage of participants relapse-free at Month 6 is reported.

    Month 6

Secondary Outcomes (8)

  • Percentage of Participants Relapse-free at Month 12

    Month 12

  • Percentage of Participants Experiencing Relapse Requiring Hospitalization and/or Steroid Treatment at Month 12

    Month 12

  • Annualized Relapse Rate (ARR) at Month 12

    Month 12

  • Number of Participants With New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions at Months 6 and 12

    Months 6 and 12

  • Number of Participants With New and Newly Enlarged T2 Hypointense Lesions at Months 6 and 12

    Months 6 and 12

  • +3 more secondary outcomes

Study Arms (1)

Daclizumab

EXPERIMENTAL
Drug: Daclizumab

Interventions

DaclizumabDRUG

High yield formulation

Also known as: BIIB019, Zinbryta
Daclizumab

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • Positive test result for Hepatitis C virus (test for hepatitis C virus antibody \[HCV Ab\]) or hepatitis B virus (test for hepatitis B surface antigen \[HBsAg\] and/or hepatitis B core antibody \[HBcAb\]).
  • The participant has been treated with immunosuppressive or immunomodulating treatments including mitoxantrone, azathioprine, methotrexate, cyclophosphamide, or mycophenolate mofetil.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Tampa, Florida, 33612, United States

Location

Research Site

Des Moines, Iowa, 50314, United States

Location

Research Site

Milwaukee, Wisconsin, 53501, United States

Location

Research Site

Edmonton, Alberta, T6G 2G3, Canada

Location

Research Site

Munich, Bavaria, 81675, Germany

Location

Research Site

Potsdam, Brandenburg, 14471, Germany

Location

Research Site

Dresden, Saxony, 01307, Germany

Location

Research Site

Hamburg, 20249, Germany

Location

Research Site

Pozzilli, Isernia, 86077, Italy

Location

Research Site

Napoli, 80131, Italy

Location

Research Site

Guaynabo, 00968, Puerto Rico

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Interventions

Daclizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Biogen Study Medical Director
Organization
Biogen
clinicaltrials@biogen.com
866-633-4636

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2016

First Posted

August 29, 2016

Study Start

April 18, 2017

Primary Completion

September 12, 2018

Study Completion

September 12, 2018

Last Updated

September 27, 2019

Results First Posted

September 24, 2019

Record last verified: 2019-09

Locations

PR(1)DE(4)IT(2)US(3)CA(1)