Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex (SYNERGY)
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| ClinicalTrials.gov Identifier: NCT01864148 |
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Recruitment Status :
Completed
First Posted : May 29, 2013
Results First Posted : May 3, 2017
Last Update Posted : May 3, 2017
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Sponsor:
Biogen
Information provided by (Responsible Party):
Biogen
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Brief Summary:
The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex.
Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Sclerosis | Drug: BIIB033 Other: Placebo Drug: Avonex | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 419 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex |
| Study Start Date : | August 2013 |
| Actual Primary Completion Date : | December 2015 |
| Actual Study Completion Date : | March 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
| Arm | Intervention/treatment |
|---|---|
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Experimental: BIIB033, 3 mg/kg
BIIB033 3 mg/kg once every 4 weeks intravenous (IV) infusion up to Week 72. Avonex once-weekly intramuscular (IM) injection up to Week 84. |
Drug: BIIB033
Other Name: anti-LINGO-1 mAb Drug: Avonex Other Name: interferon beta-1a |
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Experimental: BIIB033, 10 mg/kg
BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. |
Drug: BIIB033
Other Name: anti-LINGO-1 mAb Drug: Avonex Other Name: interferon beta-1a |
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Experimental: BIIB033, 30 mg/kg
BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. |
Drug: BIIB033
Other Name: anti-LINGO-1 mAb Drug: Avonex Other Name: interferon beta-1a |
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Experimental: BIIB033, 100 mg/kg
BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. |
Drug: BIIB033
Other Name: anti-LINGO-1 mAb Drug: Avonex Other Name: interferon beta-1a |
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Placebo Comparator: Placebo
Placebo once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. |
Other: Placebo Drug: Avonex Other Name: interferon beta-1a |
Primary Outcome Measures :
- Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint [ Time Frame: 72 weeks ]Estimated proportion of participants experiencing confirmed improvement in any 1 or more of the following components: a ≥1 point decrease in the Expanded Disability Status Scale (EDSS) score from a baseline score of <=6.0 (decrease sustained for ≥3 months); a ≥15% improvement from baseline in time to complete 9-Hole Peg Test (9HPT) by either hand (improvement sustained for ≥3 months for the same hand), where the time is the average time of 2 trials per hand at the same visit; a ≥15% improvement from baseline in time to complete Timed 25-Foot Walk (T25FW) test (improvement sustained for ≥3 months), where the time is the average time of 2 trials at the same visit; or a ≥15% improvement from baseline 3-Second Paced Auditory Serial Addition Test (PASAT-3) score (improvement sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for multiple sclerosis (MS) type, region and baseline component assessments.
Secondary Outcome Measures :
- Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint [ Time Frame: 72 weeks ]Estimated proportion of participants experiencing confirmed clinical worsening in 1 or more components of the multicomponent endpoint (EDSS, T25FW, 9HPT, or PASAT-3) over 72 weeks, defined as: a ≥1.0 point increase in EDSS from a baseline score of ≤5.5 or a ≥0.5 point increase from a baseline score equal to 6.0 (increase sustained for 3 months or greater); a ≥15%worsening from baseline in time to complete T25FW test (worsening sustained for 3 months or greater), where the time is the average of 2 trials at the same visit; a ≥15% worsening from baseline in time to complete 9HPT by either hand (worsening sustained for 3 months or greater for the same hand), where the time is the average of 2 trials for each hand at the same visit; a ≥15% worsening from baseline in PASAT-3 score (worsening sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for MS type, region and baseline component assessments.
- Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs [ Time Frame: Up to 84 weeks ]An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the participant at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above.
- Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84 [ Time Frame: Up to 84 weeks ]
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| Ages Eligible for Study: | 18 Years to 58 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Diagnosis of relapsing remitting MS (RRMS) or onset of secondary progressive MS (SPMS)
- RRMS and SPMS subjects must have evidence of ongoing disease activity within 12 months of enrollment.
- All male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment
Key Exclusion Criteria:
- A MS relapse that has occurred within the 90 days prior to Day 1/Baseline and/or the subject has not stabilized from a previous relapse prior to Screening
- Previous history of clinically significant disease.
- Plans to undergo elective major procedures/surgeries at any time during the study.
- Treatment with any investigational MS drugs within 3 weeks or 5 times the half life (whichever is longer) prior to Day 1/Baseline
- RRMS subjects with any history of inadequate response to any approved interferon β preparation
- History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus
- History or evidence of drug or alcohol abuse within 2 years prior to randomization
Note: Other protocol defined inclusion/exclusion criteria may apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864148
Locations
Show 72 study locations
Sponsors and Collaborators
Biogen
Investigators
| Study Director: | Medical Director | Biogen |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Biogen |
| ClinicalTrials.gov Identifier: | NCT01864148 |
| Other Study ID Numbers: |
215MS201 2011-006262-40 ( EudraCT Number ) |
| First Posted: | May 29, 2013 Key Record Dates |
| Results First Posted: | May 3, 2017 |
| Last Update Posted: | May 3, 2017 |
| Last Verified: | March 2017 |
Additional relevant MeSH terms:
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Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Interferons Interferon-beta Interferon beta-1a Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic |