Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) (AFFINITY)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies

The primary objective of Part 1 of this study is to evaluate the effects of BIIB033 versus placebo on disability improvement over 72 weeks. The primary objective of Part 2 of this study is to evaluate the long-term safety profile of BIIB033 as an add-on therapy in participants with MS.

The secondary objective of Part 1 is to evaluate the effects of BIIB033 versus placebo on additional measures of disability improvement. The secondary objective of Part 2 is to investigate long-term efficacy (disability improvement) and additional safety measures of BIIB033 as an add-on therapy in participants with MS.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Placebo; Drug: BIIB033 (opicinumab)

• Study Type: Interventional
• Enrollment (Actual): 263
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New Lambton Heights, Australia, NS 2305
    • Research Site
  • Westmead, Australia, 2145
    • Research Site
  • Victoria
    • Box Hill, Victoria, Australia, 3128
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    • Clayton, Victoria, Australia, 3168
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    • Heidelberg, Victoria, Australia, 3084
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    • Melbourne, Victoria, Australia, 3004
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    • Parkville, Victoria, Australia, 3050
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• Belgium
  • Brugge, Belgium, 8000
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  • Bruxelles, Belgium, 1200
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  • Bruxelles, Belgium, 1090
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  • Gent, Belgium, 9000
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  • La Louvière, Belgium, 7100
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  • Leuven, Belgium, 3000
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  • Roeselare, Belgium, 8800
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• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z1
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  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z3
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    • Victoria, British Columbia, Canada, V8R 1J8
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  • Ontario
    • Ottawa, Ontario, Canada, K1H8L6
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    • Toronto, Ontario, Canada, M5B1W8
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  • Quebec
    • Gatineau, Quebec, Canada, J8Y 1W2
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    • Longueuil, Quebec, Canada, J4V2J2
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    • Montreal, Quebec, Canada, H3A 2B4
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• Czechia
  • Brno, Czechia, 65691
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  • Brno, Czechia, 66491
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  • Hradec Kralove, Czechia, 50005
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  • Jihlava, Czechia, 58601
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  • Pardubice, Czechia, 53203
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  • Praha 2, Czechia, 12808
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• France
  • Paris, France, 75013
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  • Bas Rhin
    • Strasbourg Cedex, Bas Rhin, France, 67098
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  • Gard
    • Nimes, Gard, France, 30029
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  • Gironde
    • Bordeaux, Gironde, France, 33076
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  • Haute Garonne
    • Toulouse, Haute Garonne, France, 31059
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  • Herault
    • Montpellier, Herault, France, 34295
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  • Loire Atlantique
    • Nantes Cedex 1, Loire Atlantique, France, 44093
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  • Nord
    • Lille, Nord, France, 59000
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  • Puy De Dome
    • Clermont-Ferrand, Puy De Dome, France, 63003
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  • Rhone
    • Bron Cedex, Rhone, France, 69500
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  • Somme
    • Amiens Cedex 1, Somme, France, 80054
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• Germany
  • Berlin, Germany, 10117
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  • Muenster, Germany, 48149
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  • Baden Wuerttemberg
    • Freiburg, Baden Wuerttemberg, Germany, 79106
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    • Tuebingen, Baden Wuerttemberg, Germany, 72076
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    • Ulm, Baden Wuerttemberg, Germany, 89081
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  • Bavaria
    • Muenchen, Bavaria, Germany, 81675
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  • North Rhine-Westphalia
    • Bochum, North Rhine-Westphalia, Germany, 44791
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    • Duesseldorf, North Rhine-Westphalia, Germany, 40225
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  • Rhineland-Palatinate
    • Trier, Rhineland-Palatinate, Germany, 54292
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  • Saxony
    • Dresden, Saxony, Germany, 1307
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• Hungary
  • Budapest, Hungary, 1145
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  • Budapest, Hungary, 1135
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  • Budapest, Hungary, H-1204
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  • Esztergom, Hungary, 2500
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  • Kistarcsa, Hungary, 2143
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  • Pecs, Hungary, 7623
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• Israel
  • Ramat Gan, Israel, 5262000
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• Italy
  • Genova, Italy, 16132
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  • Messina, Italy, 98124
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  • Milano, Italy, 20132
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  • Milano, Italy, 20133
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  • Napoli, Italy, 80131
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  • Napoli, Italy, 80138
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  • Napoli, Italy, 80055
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  • Pisa, Italy, 56126
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  • Roma, Italy, 185
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  • Verona, Italy, 37134
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  • Brescia
    • Montichiari, Brescia, Italy, 25018
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  • Isernia
    • Pozzilli, Isernia, Italy, 86077
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  • Palermo
    • Cefalù, Palermo, Italy, 90015
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• Netherlands
  • Geleen, Netherlands, 6162 AP
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• Poland
  • Bydgoszcz, Poland, 85-795
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  • Gdansk, Poland, 80-803
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  • Katowice, Poland, 40-650
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  • Katowice, Poland, 40-571
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  • Krakow, Poland, 31-637
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  • Lodz, Poland, 90-324
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  • Lublin, Poland, 20-954
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  • Szczecin, Poland, 70-111
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  • Warszawa, Poland, 04-749
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  • Zabrze, Poland, 41-800
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• Spain
  • Barcelona, Spain, 8035
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  • Barcelona, Spain, 08907
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  • Barcelona, Spain, 8036
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  • Cordoba, Spain, 14004
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  • Madrid, Spain, 28006
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  • Sevilla, Spain, 41009
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  • Girona
    • Salt, Girona, Spain, 17190
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  • Madrid
    • Majadahonda, Madrid, Spain, 28222
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  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
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• Switzerland
  • Aarau, Switzerland, 5001
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  • Basel, Switzerland, 4031
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  • Bern, Switzerland, 3010
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  • Lugano, Switzerland, 6903
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  • Zurich, Switzerland, 8091
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• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
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  • Sheffield, United Kingdom, S10 2JF
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  • Swansea, United Kingdom, SA6 6NL
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  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
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    • Plymouth, Devon, United Kingdom, PL6 8DH
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  • Greater London
    • London, Greater London, United Kingdom, SE5 9RS
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    • London, Greater London, United Kingdom, W6 8RF
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  • Greater Manchester
    • Salford, Greater Manchester, United Kingdom, M6 8HD
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  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L9 7LJ
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  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
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  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
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  • Strathclyde
    • Glasgow, Strathclyde, United Kingdom, G51 4TF
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  • Tyne & Wear
    • Newcastle Upon Tyne, Tyne & Wear, United Kingdom, NE1 4LP
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  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS1 3EX
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• United States
  • Alabama
    • Cullman, Alabama, United States, 35058
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  • Arizona
    • Gilbert, Arizona, United States, 85234
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  • California
    • Berkeley, California, United States, 94705
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    • Long Beach, California, United States, 90806
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    • Newport Beach, California, United States, 92663
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    • Orange, California, United States, 92868
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  • Colorado
    • Centennial, Colorado, United States, 80112
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    • Fort Collins, Colorado, United States, 80528
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  • Connecticut
    • Stamford, Connecticut, United States, 06905
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  • District of Columbia
    • Washington, District of Columbia, United States, 20007
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  • Florida
    • Sunrise, Florida, United States, 33351
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    • Tampa, Florida, United States, 33612
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  • Georgia
    • Atlanta, Georgia, United States, 30309
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  • Illinois
    • Chicago, Illinois, United States, 60612
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    • Chicago, Illinois, United States, 60637
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  • Kansas
    • Overland Park, Kansas, United States, 66212
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  • Kentucky
    • Lexington, Kentucky, United States, 40513
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  • Maryland
    • Baltimore, Maryland, United States, 21287
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  • Massachusetts
    • Boston, Massachusetts, United States, 02114
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    • Boston, Massachusetts, United States, 02215
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    • Lexington, Massachusetts, United States, 01805
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    • Wellesley, Massachusetts, United States, 02481
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  • Michigan
    • Farmington Hills, Michigan, United States, 48334
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  • Minnesota
    • Minneapolis, Minnesota, United States, 55422
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  • Missouri
    • Saint Louis, Missouri, United States, 63110
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    • Saint Louis, Missouri, United States, 63131
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  • Nevada
    • Las Vegas, Nevada, United States, 89106
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  • New Jersey
    • Freehold, New Jersey, United States, 07728
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    • Teaneck, New Jersey, United States, 07666
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  • New York
    • Latham, New York, United States, 12110
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    • New York, New York, United States, 10021
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    • Patchogue, New York, United States, 11772
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    • Rochester, New York, United States, 14642
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    • Stony Brook, New York, United States, 11794
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  • North Carolina
    • Durham, North Carolina, United States, 27710
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    • Raleigh, North Carolina, United States, 27607
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  • Ohio
    • Columbus, Ohio, United States, 43214
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    • Dayton, Ohio, United States, 45417
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  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
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  • Oregon
    • Portland, Oregon, United States, 97225
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  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
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    • Willow Grove, Pennsylvania, United States, 19090
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  • Tennessee
    • Knoxville, Tennessee, United States, 37922
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    • Memphis, Tennessee, United States, 38018
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  • Texas
    • Dallas, Texas, United States, 75390-8806
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    • Houston, Texas, United States, 77030
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    • Round Rock, Texas, United States, 78681
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  • Utah
    • Orem, Utah, United States, 84058
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    • Salt Lake City, Utah, United States, 84103
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  • Washington
    • Seattle, Washington, United States, 98122
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    • Seattle, Washington, United States, 98133
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Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria: Part 1

• Baseline Expanded Disability Status Scale (EDSS) of 2.0 to 6.0, have a diagnosis of relapsing-remitting multiple sclerosis (RRMS) per the 2010 McDonald's criteria or onset of secondary progressive multiple sclerosis (SPMS) per the Lublin and Reingold criteria, and should have experienced their first MS symptom(s) within the previous 20 years.
• Subjects must have experienced at least 1 of the following within 24 months prior to Day 1/Baseline: a clinical relapse (but not within 24 weeks prior to Day 1/Baseline), gadolinium-enhancing lesions on brain or spinal cord magnetic resonance imaging (MRI), or new T2 lesion(s) on brain or spinal cord MRI.
• Subjects must be on a stable dose of a protocol-specified anti-inflammatory disease-modifying therapy (DMT) (IFNβ [Avonex, Plegridy, Betaferon/Betaseron, or Rebif], dimethyl fumarate (DMF) [Tecfidera], or natalizumab [Tysabri]) for at least 24 weeks prior to enrollment.
• In addition, subjects must have met protocol-defined MRI characteristics using magnetization transfer ratio (MTR) and diffusion tensor imaging (DTI) sequences at Screening/Baseline.

Key Inclusion Criteria: Part 2

-Subjects who complete study treatment (BIIB033 or placebo) at Part 1/Week 72 Visit.

Key Exclusion Criteria: Part 1

• Primary progressive MS
• An MS relapse that has occurred within 24 weeks prior to Day 1/Baseline or the subject has not stabilized from a previous relapse at the time of Screening.
• Treatment with any chemotherapeutic agents (e.g., mitoxantrone, cyclophosphamide, cladribine), cell-depleting monoclonal antibodies (mAbs) (e.g., rituximab, ocrelizumab, alemtuzumab), total lymphoid irradiation, T-cell or T-cell receptor vaccination, or teriflunomide within 1 year prior to Day 1/Baseline.
• Treatment with other anti-inflammatory DMTs (e.g., GA, fingolimod, daclizumab) or plasmapheresis within 24 weeks prior to Day1/Baseline.
• Treatment with Botox for limb spasticity within 24 weeks before Day 1/Baseline.
• Contraindications to MRI, for example, presence of pacemakers or other implanted metal devices (excluding dental braces), an allergy to gadolinium renal impairment, or claustrophobia that cannot be medically managed.
• History of human immunodeficiency virus or other immunodeficient conditions.
• History of malignancy; however, subjects with a history of excised or treated basal cell carcinoma or fewer than 3 squamous cell carcinomas are eligible to participate in this study.

Key Exclusion Criteria: Part 2

• Subjects who did not complete study treatment in Part 1/Week 72 Visit
• Subjects who have a duration >12 weeks between their Part 1/Week 72 Visit and Part 2/Day 1.
• Contraindications to MRI, for example, presence of pacemakers or other implanted metal devices (excluding dental braces), an allergy to Gd, renal impairment, or claustrophobia that cannot be medically managed.
• History of human immunodeficiency virus or other immunodeficient conditions not related to DMT treatment.
• History of malignancy unless enrollment is approved by the Sponsor; subjects with a history of excised or treated basal cell carcinoma or fewer than 3 squamous cell carcinomas are eligible to participate in this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIIB033 (opicinumab) 750 mg; Participants with relapsing multiple sclerosis (RMS) will receive BIIB033 750 milligram (mg) intravenously (IV) as an add-on therapy to a background disease-modifying therapy (DMT) once every 4 weeks over 72 weeks in Part 1 and once every 4 weeks over 96 weeks in Part 2.	Drug: BIIB033 (opicinumab); Administered as specified in the treatment arm
Placebo Comparator: Placebo; Participants with RMS will receive placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks in Part 1 and BIIB033 once every 4 weeks over 96 weeks in Part 2. The placebo looks like BIIB033 but does not contain the active ingredient that is thought to have an effect on MS disease. The placebo used in this study is sterile normal saline (water with a small amount of sodium chloride [salt]).	Drug: Placebo; Administered as specified in the treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Overall Response Score	Overall Response Score is a multicomponent score based on 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the nondominant hand (9HPT-ND). Overall Score was sum of 4 components at each visit and ranges from +4 (improvement) to -4 (worsening). At each visit, each component is given a score relative to baseline (BL): -1 if threshold is met for worsening, 0 if no changes meet threshold criteria, or +1 if threshold is met for improvement. For T25FW and 9HPT improvement is ≥15% decrease in time from BL and worsening is ≥15% increase in time from BL. For EDSS, improvement is: ≥1.0-point decrease in EDSS from a BL score of ≤6.0, and worsening is defined as a ≥1-point increase from a BL score of ≤5.5 or a ≥0.5-point increase from a BL score equal to 6.0. Positive Overall Response Score indicated that there was improvement in more components than there was worsening.	Part 1: Baseline to Week 72
Part 2: Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore 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. A SAE is any untoward medical occurrence that at any dose results in death, life-threatening event, requires inpatient hospitalization, significant disability/incapacity or congenital anomaly.	Part 2: Baseline to Week 169

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Percentage of Participants With 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND	EDSS measures disability status over time in MS on a scale ranging from 0 to 10, with higher scores indicating more disability. For EDSS, improvement is defined as a ≥1.0-point decrease in EDSS from a BL score of ≤6.0. T25FW is a quantitative mobility and leg function performance test based on a timed walk over 25 feet that is averaged between two completed trials. Longer time indicates slower walking. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs. Longer time indicates poorer upper limb function. For T25FW and 9HPT ≥15% decrease in time from BL indicates improvement.	Part 1: Baseline to Week 72
Part 1: Percentage of Participants With 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, or 3-Second Paced Auditory Serial Addition Test (PASAT-3)	EDSS measures disability status over time in MS (scale range: 0-10), higher scores=more disability and improvement defined as ≥1.0-point decrease in EDSS from BL score ≤6.0. T25FW is quantitative mobility and leg function performance test, where timed walk over 25 feet that is averaged between two completed trials. Longer time=slower walking. 9HPT is quantitative test of upper extremity function, measures time to place 9 pegs into 9 holes and then remove pegs. Longer time=poorer upper limb function. PASAT assesses auditory information processing speed. In 3-second PASAT, numbers are presented at a rate of 1 every 3 seconds with scores (range 0-120), higher scores=better working memory. For T25FW and 9HPT ≥15% decrease in time from BL is improvement. For PASAT ≥15% increase from BL is improvement.	Part 1: Baseline to Week 72
Part 1: Percentage of Participants With 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND, and Without Confirmed Worsening in Any of the 4 Assessments During the 72 Weeks of the Study	EDSS measures disability status over time in MS on a scale ranging from 0 to 10, with higher scores indicating more disability. For EDSS, improvement is defined as a ≥1.0-point decrease in EDSS from a BL score of ≤6.0, and worsening is defined as a ≥1-point increase from a BL score of ≤5.5 or a ≥0.5-point increase from a BL score equal to 6.0. T25FW is a quantitative mobility and leg function performance test based on a timed walk over 25 feet that is averaged between two completed trials. Longer time indicates slower walking. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs. Longer time indicates poorer upper limb function. For T25FW and 9HPT ≥15% decrease in time from BL indicates improvement and ≥15% increase in time from BL indicates worsening.	Part 1: Baseline to Week 72
Part 1: Percentage of Participants With 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, and Symbol Digit Modalities Test (SDMT)	EDSS measures disability status over time in MS on a scale (range 0-10), higher scores=more disability. For EDSS, improvement is: a ≥1.0-point decrease in EDSS from a BL score of ≤6.0. T25FW is a quantitative mobility and leg function performance test based on a timed walk over 25 feet that is averaged between two completed trials. Longer time=slower walking. 9HPT is quantitative test of upper extremity function that measures time it takes to place 9 pegs into 9 holes and then remove pegs. Longer time=poorer upper limb function. For T25FW and 9HPT ≥15% decrease in time from BL indicates improvement. The SDMT measures time to pair abstract geometric symbols with specific numbers. The score is the number of correctly coded items (range 0-110) in 90 seconds, higher scores=better outcome. Improvement is: ≥4-point increase from BL.	Part 1: Baseline to Week 72
Part 1: Percentage of Participants With 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND (20% Thresholds for T25FW and 9HPT)	EDSS measures disability status over time in MS on a scale ranging from 0 to 10, with higher scores indicating more disability. For EDSS, improvement is defined as a ≥1.0-point decrease in EDSS from a BL score of ≤6.0. T25FW is a quantitative mobility and leg function performance test based on a timed walk over 25 feet that is averaged between two completed trials. Longer time indicates slower walking. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs. Longer time indicates poorer upper limb function. For T25FW and 9HPT ≥15% decrease in time from BL indicates improvement.	Part 1: Baseline to Week 72
Part 2: Overall Response Score		Part 2: Baseline to Week 96
Part 2: Percentage of Participants With 24-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND		Part 2: Baseline to Week 108
Part 2: Percentage of Participants With 24-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, or PASAT-3		Part 2: Baseline to Week 108
Part 2: Percentage of Participants With 24-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND, and Without Confirmed Worsening in Any of the 4 Assessments During the 96 Weeks of the Study		Part 2: Baseline to Week 96
Part 2: Percentage of Participants With 24-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, and SDMT		Part 2: Baseline to Week 108
Part 2: Percentage of Participants With 24-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND (20% Thresholds for T25FW and 9HPT)		Part 2: Baseline to Week 108
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values	Laboratory assessments including hematology and blood chemistry were evaluated for safety. Criteria for abnormality: In 10^9/liter (L) [white blood cells <3.0/>16, neutrophils <1.5/ >13.5, lymphocytes <0.8/ >12, monocytes >2.5, eosinophils >1.6, basophils >1.6, platelets <=75/ >=700], hemoglobin <=95 [female (F)] or <=115 [male (M)] or >=175 (F) or >=190 (M) gram per liter (g/L), hematocrit <=32 (F) or <=37 (M) or >=54 (F) or >=60 (M) percentage (%), red blood cells <=3.5/ >=6.4 10^12/L, in millimoles per liter (mmol/L) [sodium <=126/ >=156, potassium <=3/ >=6, chloride <=90/ >=118, bicarbonate <=16/ >=35, calcium <=2/ >=3, phosphorous <=0.5491/ >=1.7119, glucose (non-fasting) <=2.2/>=13.75], AST/SGOT >=3x upper limit of normal (ULN), ALT/SGPT >=3xULN, alkaline phosphatase >=3xULN, creatinine >=1.5xULN, total bilirubin >=1.5xULN, total protein <=45/ >=100 g/L, albumin <=25 g/L, uric acid >=501.5 (F)/>=619.5 (M) micromole (umol)/L	Part 2: Baseline to Week 96
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values	The ECG result was classified as "normal", "abnormal", "abnormal, not adverse event", or "abnormal, adverse event". Shift to 'abnormal, not adverse event' included shift from normal or unknown to 'abnormal, not adverse event'. Shift to 'abnormal, adverse event' included shift from normal or unknown to 'abnormal, adverse event'.	Part 2: Baseline to Week 96
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Vital Signs Values	Vital sign measurements including temperature, pulse rate (supine), systolic blood pressure (BP) and diastolic (supine) BP were evaluated for safety. Criteria for abnormalities: Temperature: >38 degree celsius (◦C) or >=1 ◦C increase from baseline (BL); Pulse: [>100 beats per minute (bpm) or increase from BL of >30 bpm] or (<40 bpm or decrease from BL of >20 bpm); Systolic BP: [>160 millimeters of mercury (mmHg)/increase from BL of >40 mmHg] or (<90 mmHg/decrease from BL of >30 mmHg); Diastolic BP: (>100 mmHg/increase from BL of >30 mmHg) or (<45 mmHg/decrease from BL of >20 mmHg).	Part 2: Baseline to Week 96
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values	Criteria for abnormality was defined as a >7% increase or decrease in weight at the specified time point.	Part 2: Baseline, Week 12, 24, 36, 48, 72 and 96
Part 2: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit	C-SSRS systematically assess suicidal ideation and behavior rating scale. It rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent and behaviors". The scale identifies specific behaviors ranging from "preparatory acts or behavior" to "suicide" which may be indicative of an individual's intent to complete suicide.	Part 2: Baseline to Week 96

Collaborators and Investigators

• Sponsor: Biogen

Publications and helpful links

General Publications

• Hanf KJM, Arndt JW, Liu Y, Gong BJ, Rushe M, Sopko R, Massol R, Smith B, Gao Y, Dalkilic-Liddle I, Lee X, Mojta S, Shao Z, Mi S, Pepinsky RB. Functional activity of anti-LINGO-1 antibody opicinumab requires target engagement at a secondary binding site. MAbs. 2020 Jan-Dec;12(1):1713648. doi: 10.1080/19420862.2020.1713648.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): February 12, 2021
• Study Completion (Actual): February 12, 2021

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 17, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: DMT; Remyelination; Re-myelination; LINGO-1; Anti-LINGO-1; Opicinumab
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 215MS202; 2017-001224-22 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No