Relapsing-Remitting Multiple Sclerosis (RRMS)Phase 3SUSTAINNCT02881567
Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab
A Phase 3 study testing Daclizumab in people with Relapsing-Remitting Multiple Sclerosis (RRMS), run by Biogen at 11 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis (RRMS)
- What is being tested?
- Daclizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 18 Apr 2017to 12 Sep 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Germany4 sites
Research Site
Dresden, Saxony, 01307
Research Site
Hamburg, 20249
Research Site
Munich, Bavaria, 81675
Research Site
Potsdam, Brandenburg, 14471
United States3 sites
Research Site
Des Moines, Iowa, 50314
Research Site
Milwaukee, Wisconsin, 53501
Research Site
Tampa, Florida, 33612
About this study
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)
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.
- Being tested
- Daclizumab
- Keywords
- Multiple Sclerosis, Daclizumab, Tysabri-Switch
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaclizumabDrug
Also called BIIB019, Zinbryta
High yield formulation
| Study group | Role | What they receive |
|---|---|---|
| Daclizumab | Experimental | Not described Receives: Drug: Daclizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 6
Secondary outcomes (8)
Percentage of Participants Relapse-free at Month 12
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.
Measured: Month 12
Percentage of Participants Experiencing Relapse Requiring Hospitalization and/or Steroid Treatment at Month 12
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.
Measured: Month 12
Annualized Relapse Rate (ARR) at Month 12
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 ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of Month 12, and the ratio then multiplied by 365.
Measured: Month 12
Number of Participants With New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions at Months 6 and 12
New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions were assessed using magnetic resonance imaging (MRI).
Measured: Months 6 and 12
Number of Participants With New and Newly Enlarged T2 Hypointense Lesions at Months 6 and 12
New and newly enlarged T2 Hypointense Lesions were measured by MRI.
Measured: Months 6 and 12
Permanent Discontinuation Rate of Daclizumab at Month 12
Permanent Discontinuation Rate was calculated as the ratio of number of participants who had permanently discontinued daclizumab prior to Month 12 over the total number of participants who received at least 1 dose of daclizumab in the study.
Measured: Month 12
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death or in the view of the Investigator, places the participant at immediate risk of death or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability or results in a birth defect.
Measured: First dose of study drug to within 30 days of last dose (up to 11 months)
Number of Participants With Clinically Relevant Shifts in Laboratory Assessments
Clinical Laboratory assessments were tests of Chemistry and Hematology. The investigator determined if any of the laboratory results were clinically relevant shifts from Baseline.
Measured: First dose of study drug to within 30 days of last dose (up to 11 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study start18 Apr 2017
- Primary completion12 Sep 2018
- Study completion12 Sep 2018
Why it stopped: Study terminated in line with Biogen decision to withdraw Zinbryta from the market and not to pursue further studies of daclizumab in MS.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsing-Remitting Multiple Sclerosis (RRMS)Studies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881567
- Sponsor's protocol ID
- 205MS305
- Other IDs
- 2016-002820-10, 2016
- Acronym
- SUSTAIN
- Status last verified
- Sep 2019
- First submitted
- 24 Aug 2016
- Last updated
- 27 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02881567
- Acronym / sponsor ID
- SUSTAIN / 205MS305
- Keywords
- Multiple Sclerosis, Daclizumab, Tysabri-Switch
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated in line with Biogen decision to withdraw Zinbryta from the market and not to pursue further studies of daclizumab in MS.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Posted 24 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daclizumab | Experimental | Drug: Daclizumab |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaclizumabAlso: BIIB019, ZinbrytaHigh yield formulation | Drug | Daclizumab |
Primary outcome
Percentage of Participants Relapse-free at Month 6
Time frame: 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.
8 secondary outcomes
Percentage of Participants Relapse-free at Month 12
Time frame: Month 12
Percentage of Participants Experiencing Relapse Requiring Hospitalization and/or Steroid Treatment at Month 12
Time frame: Month 12
Annualized Relapse Rate (ARR) at Month 12
Time frame: Month 12
Number of Participants With New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions at Months 6 and 12
Time frame: Months 6 and 12
Number of Participants With New and Newly Enlarged T2 Hypointense Lesions at Months 6 and 12
Time frame: Months 6 and 12
Permanent Discontinuation Rate of Daclizumab at Month 12
Time frame: Month 12
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: First dose of study drug to within 30 days of last dose (up to 11 months)
Number of Participants With Clinically Relevant Shifts in Laboratory Assessments
Time frame: First dose of study drug to within 30 days of last dose (up to 11 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Daclizumab in people with Relapsing-Remitting Multiple Sclerosis (RRMS), run by Biogen at 11 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, United States, Italy, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Relapse-free at Month 6 (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.