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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01864148
First received: May 24, 2013
Last updated: November 14, 2014
Last verified: November 2014
  Purpose

The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing MS when used concurrently with Avonex.

Secondary objectives of this study in this study population are to assess the safety, tolerability, and population PK of BIIB033 when used concurrently with Avonex


Condition Intervention Phase
Multiple Sclerosis
Drug: BIIB033 (anti-LINGO-1 mAb)
Other: Placebo
Drug: Interferon Beta-1a
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Number of participants experiencing confirmed improvement of neuro-physical and/or cognitive function and/or disability. [ Time Frame: Over 72 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants experiencing confirmed worsening of neuro-physical and/or cognitive function and/or disability [ Time Frame: Over 72 weeks ] [ Designated as safety issue: No ]
  • Number of participants experiencing Adverse Events (AEs) [ Time Frame: Up to 84 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants experiencing Severe Adverse Events (SAEs) [ Time Frame: Up to 84 weeks ] [ Designated as safety issue: Yes ]
  • BIIB033 population Pharmacokinetics assessment [ Time Frame: Up to 84 weeks ] [ Designated as safety issue: No ]

Enrollment: 419
Study Start Date: August 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIIB033, 3 mg/kg
BIIB033 3 mg/kg once every 4 weeks intravenous (IV) infusion
Drug: BIIB033 (anti-LINGO-1 mAb)
Administered as specified in the treatment arm
Other Name: anti-LINGO-1 mAb
Drug: Interferon Beta-1a
All participants receive Interferon Beta-1a intramuscular (IM) injections once weekly
Other Name: Avonex
Experimental: BIIB033, 10 mg/kg
BIIB033 10 mg/kg once every 4 weeks IV infusion
Drug: BIIB033 (anti-LINGO-1 mAb)
Administered as specified in the treatment arm
Other Name: anti-LINGO-1 mAb
Drug: Interferon Beta-1a
All participants receive Interferon Beta-1a intramuscular (IM) injections once weekly
Other Name: Avonex
Experimental: BIIB033, 30 mg/kg
BIIB033 30 mg/kg once every 4 weeks IV infusion
Drug: BIIB033 (anti-LINGO-1 mAb)
Administered as specified in the treatment arm
Other Name: anti-LINGO-1 mAb
Drug: Interferon Beta-1a
All participants receive Interferon Beta-1a intramuscular (IM) injections once weekly
Other Name: Avonex
Experimental: BIIB033, 100 mg/kg
BIIB033 100 mg/kg once every 4 weeks IV infusion
Drug: BIIB033 (anti-LINGO-1 mAb)
Administered as specified in the treatment arm
Other Name: anti-LINGO-1 mAb
Drug: Interferon Beta-1a
All participants receive Interferon Beta-1a intramuscular (IM) injections once weekly
Other Name: Avonex
Placebo Comparator: Placebo
Placebo once every 4 weeks IV infusion
Other: Placebo
Participants receive placebo
Drug: Interferon Beta-1a
All participants receive Interferon Beta-1a intramuscular (IM) injections once weekly
Other Name: Avonex

  Eligibility

Ages Eligible for Study:   18 Years to 58 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) or onset of Secondary Progressive Multiple Sclerosis (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 Multiple Sclerosis (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 Multiple Sclerosis (MS) drugs within 3 weeks or 5 times the half life (whichever is longer) prior to Day 1/Baseline
  • Relapsing Remitting Multiple Sclerosis (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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01864148

  Show 74 Study Locations
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01864148     History of Changes
Other Study ID Numbers: 215MS201, EUDRACT #: 2011-006262-40
Study First Received: May 24, 2013
Last Updated: November 14, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Serbia: Medicines and Medical Devices Agency of Serbia
Spain: Spanish Agency of Medicines
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Interferon beta 1a
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Interferon-beta
Interferons
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014