SYNERGY
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint | Odds Ratio (OR) 2.06 | 1.11–3.84 | 0.0220 |
| Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint | Odds Ratio (OR) 1.79 | 0.97–3.31 | 0.0636 |
| Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint | Odds Ratio (OR) 0.66 | 0.36–1.21 | 0.1771 |
| Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint | 0.8931 | ||
| Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint | Odds Ratio (OR) 0.98 | 0.46–2.07 | 0.9584 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Opicinumab
Leucine-rich repeat and immunoglobulin-like domain-containing nogo receptor-interacting protein 1 inhibitor
- Interferon beta-1a
Interferon alpha/beta receptor agonist
Placebo or sham
- Placebo
Results by group
Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint
72 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | 0.516 proportion of participants | 91 | |
| BIIB033, 3 mg/kg | 0.511 proportion of participants | 45 | |
| BIIB033, 10 mg/kg | 0.656 proportion of participants | 94 | |
| BIIB033, 30 mg/kg | 0.688 proportion of participants | 91 | |
| BIIB033, 100 mg/kg | 0.412 proportion of participants | 91 |
p = 0.9584; Odds Ratio (OR) 0.98 (95% CI 0.46–2.07)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Placebo | 93 | 13 (14.0%) | |
| BIIB033 3 mg/kg | 45 | 4 (8.9%) | |
| BIIB033 10 mg/kg | 95 | 11 (11.6%) | |
| BIIB033 30 mg/kg | 93 | 20 (21.5%) | |
| BIIB033 100 mg/kg | 92 | 16 (17.4%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint
72 weeks
Disability progressionThinking and memoryWalking and mobilityPrimary Efficacy Endpoint:
Other measures (4)
Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint
72 weeks
Disability progressionThinking and memoryNumber of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
Up to 84 weeks
SafetyPharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Up to 84 weeks
How the body handles the medicineSecondary Efficacy Endpoints:
Who could take part
Relapsing and progressive · 18 to 58
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Overall Disability Response Score: An integrated endpoint to assess disability improvement and worsening over time in patients with multiple sclerosis.Mult Scler · 2022
Results
Patterning Chronic Active Demyelination in Slowly Expanding/Evolving White Matter MS Lesions.AJNR Am J Neuroradiol · 2020
Results
Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial.Lancet Neurol · 2019
Results
Wilhelm H, Schabet M. The Diagnosis and Treatment of Optic Neuritis. Dtsch Arztebl Int. 2015 Sep 11;112(37):616-25; quiz 626. doi: 10.3238/arztebl.2015.0616.
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History
Started
Aug 2013
Main results due
Dec 2015
Finished
Mar 2016
Results posted
May 2017
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