CompletedPhase 2Relapsing and progressiveNCT018641482011-006262-40

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent EndpointOdds Ratio (OR) 2.061.11–3.840.0220
Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent EndpointOdds Ratio (OR) 1.790.97–3.310.0636
Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent EndpointOdds Ratio (OR) 0.660.36–1.210.1771
Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint 0.8931
Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent EndpointOdds Ratio (OR) 0.980.46–2.070.9584

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

GroupValueIntervalNumber analysed
Placebo0.516 proportion of participants91
BIIB033, 3 mg/kg0.511 proportion of participants45
BIIB033, 10 mg/kg0.656 proportion of participants94
BIIB033, 30 mg/kg0.688 proportion of participants91
BIIB033, 100 mg/kg0.412 proportion of participants91

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

GroupParticipants at riskSerious adverse eventsDeaths
Placebo9313 (14.0%)
BIIB033 3 mg/kg454 (8.9%)
BIIB033 10 mg/kg9511 (11.6%)
BIIB033 30 mg/kg9320 (21.5%)
BIIB033 100 mg/kg9216 (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 mobility
  • Primary Efficacy Endpoint:

Other measures (4)

  • Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint

    72 weeks

    Disability progressionThinking and memory
  • Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs

    Up to 84 weeks

    Safety
  • Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84

    Up to 84 weeks

    How the body handles the medicine
  • Secondary 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

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History

    1. Started

      Aug 2013

    2. Main results due

      Dec 2015

    3. Finished

      Mar 2016

    4. Results posted

      May 2017

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