Clinical trial NCT02881567: Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Relapsing-Remitting Multiple Sclerosis (RRMS)
Keywords: Multiple Sclerosis
Daclizumab
Tysabri-Switch
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2016-08-29
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Key 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.

Key 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).
* 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants Relapse-free at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of Participants Relapse-free at Month 12
timeFrame: Month 12
measure: Percentage of Participants Experiencing Relapse Requiring Hospitalization and/or Steroid Treatment at Month 12
timeFrame: Month 12
measure: Annualized Relapse Rate (ARR) at Month 12
timeFrame: Month 12
measure: Number of Participants With New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions at Months 6 and 12
timeFrame: Months 6 and 12
measure: Number of Participants With New and Newly Enlarged T2 Hypointense Lesions at Months 6 and 12
timeFrame: Months 6 and 12
measure: Permanent Discontinuation Rate of Daclizumab at Month 12
timeFrame: Month 12
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: First dose of study drug to within 30 days of last dose (up to 11 months)
measure: Number of Participants With Clinically Relevant Shifts in Laboratory Assessments
timeFrame: First dose of study drug to within 30 days of last dose (up to 11 months)
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Des Moines
country: United States
facility: Research Site
state: Iowa
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Muenchen
country: Germany
facility: Research Site
state: Bayern
city: Potsdam
country: Germany
facility: Research Site
state: Brandenburg
city: Dresden
country: Germany
facility: Research Site
state: Sachsen
city: Hamburg
country: Germany
facility: Research Site
city: Pozzilli
country: Italy
facility: Research Site
state: Isernia
city: Napoli
country: Italy
facility: Research Site
city: Guaynabo
country: Puerto Rico
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: