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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

Information source: Biogen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: BIIB033 (anti-LINGO-1 mAb) (Drug); Placebo (Other); Interferon Beta-1a (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Number of participants experiencing confirmed improvement of neuro-physical and/or cognitive function and/or disability.

Secondary outcome:

Number of participants experiencing confirmed worsening of neuro-physical and/or cognitive function and/or disability

Number of participants experiencing Adverse Events (AEs)

Number of participants experiencing Severe Adverse Events (SAEs)

BIIB033 population Pharmacokinetics assessment

Eligibility

Minimum age: 18 Years. Maximum age: 58 Years. Gender(s): Both.

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.

Locations and Contacts

London Health Sciences Centre, London, Canada

Montreal Neurological Institute and Hospital, Montreal, Canada

Ottawa Hospital Research Institute, Ottawa K1H8L6, Canada

NEUROSPOL Sro, Havirov 736 01, Czech Republic

Fakultni nemocnice v Motole, Praha 5 150 06, Czech Republic

Hopital Gabriel Montpied, Clermont-Ferrand 63003, France

CHRU Nancy, Nancy 54000, France

Fondation Rothschild, Paris 75019, France

Jahn Ferenc Dél-Pesti Kórház és Rendelöintézet, Budapest 1204, Hungary

Uzsoki Utcai Korhaz, Budapest 1145, Hungary

Pécsi Tudományegyetem, Pécs 7623, Hungary

Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele, Catania 95123, Italy

Azienda Ospedaliera S. Antonio Abate di Gallarate, Gallarate, Italy

Azienda Ospedaliera Universitaria San Martino, Genova 16132, Italy

Unità Operativa S.D. Centro Regionale per lo Studio e la Terapia della Sclerosi Multipla, Roma 133, Italy

Orbis Medisch Centrum, Sittard-Geleen, Netherlands

Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku, Gdansk 80-803, Poland

Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego, Grudziądz 86-300, Poland

Gabriela Klodowska-Duda Neuro-Care NZOZ Site Management Organization, Katowice, Poland

M.A.- Lek A.M.Maciejowscy Spolka Cywilna, Katowice 40-595, Poland

Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n. med. Hanka Hertmanowska, Plewiska, Poland

Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy, Poznan 61-853, Poland

SPZOZ Wojewodzki Szpital Specjalistyczny w Rybniku, Rybnik 44-200, Poland

EUROMEDIS Sp. z o.o., Szczecin 70-215, Poland

Kaluga Regional Hospital, Kaluga, Russian Federation

Republican Clinical Hospital For Rehabilitation Treatment, Kazan 420021, Russian Federation

Krasnoyarsk State Medical Academy, Krasnoyarsk, Russian Federation

City Clinical Hospital # 11, Moscow 127018, Russian Federation

Perm State Medical Academy, Perm 614990, Russian Federation

City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31, Saint-Petersburg 197110, Russian Federation

City Clinical Emergency # 25, Volgograd 400138, Russian Federation

Clinical Center of Serbia, Belgrade 11000, Serbia

Military Medical Academy, Belgrade 11000, Serbia

Clinical Hospital Center Kragujevac, Kragujevac 34000, Serbia

General Hospital Uzice, Uzice, Serbia

Hospital Universitari de Bellvitge, l'Hospitalet de Llobregat, Barceona 8907, Spain

Hospital General Carlos Haya, Malaga 29010, Spain

Hospital Universitario Virgen Macarena, Sevilla 41071, Spain

North Central Neurology Assoc PC, Cullman, Alabama 35058, United States

Phoenix Neurological Associates, Phoenix, Arizona 85018, United States

Raleigh Neurology Associates PA, Raleigh, California, United States

Stanford University Medical Center, Stanford, California, United States

Hospital Universitario Vall d'Hebron, Barcelona, Cataluña 8035, Spain

Immunoe International Research Center, Centennial, Colorado 80112, United States

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szeged, Csongrád 6725, Hungary

Hospital Universitario Reina Sofia, Cordoba, Córdoba 14008, Spain

Fakultni Nemocnice Hradec Kralove, Hradec Králové, Královéhradecký kraj 500 05, Czech Republic

Hôpital Guillaume Et René Laënnec, Nantes, Loire-Atlantique 44805, France

Ospedale San Raffaele S.r.l., Milano, Lombardia 20127, Italy

Azienda Ospedaliera Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari, Montichiari, Lombardia 25018, Italy

King's College Hospital, London, London, City of SE5 9NT, United Kingdom

Prywatny Gabinet Neurologiczny K. Selmaj, Lódz, Lódzkie 93-121, Poland

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid 28222, Spain

Hospital Clinico San Carlos, Madrid, Madrid, Communidad Delaware 28040, Spain

Hôpital Maison Blanche, Reims, Marne 51092, France

Johns Hopkins Hospital, Baltimore, Maryland, United States

Wojskowy Instytut Medyczny, Warszawa, Mazowieckie 00-901, Poland

Michigan Institute For Neurological Disorders, Farmington Hills, Michigan 48334, United States

Washington University, Saint Louis, Missouri 63110, United States

Multiple Sclerosis Center of North Eastern New York, Latham, New York 12110, United States

Hôpital Roger Salengro, Lille, Nord 59000, France

Queen's Medical Centre, Nottingham, Nottinghamshire NG5 1PB, United Kingdom

OMRF Multiple Sclerosis Center of Excellence, Oklahoma City, Oklahoma 73104, United States

Fondazione Istituto San Raffaele G. Giglio di Cefalù, Cefalù, Palermo, Italy

Vseobecna Fakultni Nemocnice V Praze, Praha, Praha, hlavní mesto 128 08, Czech Republic

Clinique Neuro-Outaouais, Gatineau, Quebec J9J 0A5, Canada

Recherche Sepmus, Greenfield Park, Quebec, Canada

Novo-Med Zielinski i wsp. Sp.J., Katowice, Slaskie 40-650, Poland

Hôpital Nord, Amiens, Somme 80054, France

Hospital de Basurto Osakidetza, Bilbao, Vizcaya 48013, Spain

Nemocnice Jihlava Prispevkova Organizace, Jihlava, Vysocina 586 33, Czech Republic

Swedish Medical Center, Seattle, Washington 98122, United States

Erasmus MC, Rotterdam, Zuid-Holland 3015 CE, Netherlands

Krajska Zdravotni As Nemocnice Teplice Oz, Teplice, Ústecký kraj 415 29, Czech Republic

Additional Information

Starting date: August 2013
Last updated: November 14, 2014

Page last updated: August 20, 2015

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