Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex

Multiple Sclerosis Clinical Trial

— SYNERGY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864148
• Other study ID #: 215MS201
• Secondary ID: EUDRACT #: 2011-
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2013
• Last updated: December 20, 2016
• Start date: August 2013
• Est. completion date: March 2016

Study information

• Verified date: December 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• 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 SerbiaSpain: Spanish Agency of MedicinesCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUnited States: Food and Drug AdministrationRussia: Ministry of Health of the Russian FederationItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 58 Years

Eligibility

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 ß 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.

Study Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• BIIB033 (anti-LINGO-1 mAb)
Administered as specified in the treatment arm

Other:
• Placebo
Participants receive placebo

Drug:
• Interferon Beta-1a
All participants receive Interferon Beta-1a intramuscular (IM) injections once weekly

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London
Czech Republic	NEUROSPOL Sro	Havirov
Czech Republic	Fakultni Nemocnice Hradec Kralove	Hradec Králové	Královéhradecký kraj
Czech Republic	Nemocnice Jihlava Prispevkova Organizace	Jihlava	Vysocina
Czech Republic	Vseobecna Fakultni Nemocnice V Praze	Praha	Praha, hlavní mesto
Czech Republic	Fakultni nemocnice v Motole	Praha 5
Czech Republic	Krajska Zdravotni As Nemocnice Teplice Oz	Teplice	Ústecký kraj
France	Hôpital Nord	Amiens	Somme
France	Hopital Gabriel Montpied	Clermont-Ferrand
France	Hôpital Roger Salengro	Lille	Nord
France	CHRU Nancy	Nancy
France	Hôpital Guillaume Et René Laënnec	Nantes	Loire-Atlantique
France	Fondation Rothschild	Paris
France	Hôpital Maison Blanche	Reims	Marne
Hungary	Jahn Ferenc Dél-Pesti Kórház és Rendelöintézet	Budapest
Hungary	Uzsoki Utcai Korhaz	Budapest
Hungary	Pécsi Tudományegyetem	Pécs
Hungary	Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ	Szeged	Csongrád
Italy	Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele	Catania	Sicilia
Italy	Fondazione Istituto San Raffaele G. Giglio di Cefalù	Cefalù	Palermo
Italy	Azienda Ospedaliera S. Antonio Abate di Gallarate	Gallarate	Varese
Italy	Azienda Ospedaliera Universitaria San Martino	Genova	Liguria
Italy	Ospedale San Raffaele S.r.l.	Milano	Lombardia
Italy	Azienda Ospedaliera Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari	Montichiari	Lombardia
Italy	Unità Operativa S.D. Centro Regionale per lo Studio e la Terapia della Sclerosi Multipla	Roma	Lazio
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland
Netherlands	Orbis Medisch Centrum	Sittard-Geleen
Poland	Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku	Gdansk
Poland	Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego	Grudziadz
Poland	Gabriela Klodowska-Duda Neuro-Care NZOZ Site Management Organization	Katowice
Poland	M.A.- Lek A.M.Maciejowscy Spolka Cywilna	Katowice
Poland	Novo-Med Zielinski i wsp. Sp.J.	Katowice	Slaskie
Poland	Prywatny Gabinet Neurologiczny K. Selmaj	Lódz	Lódzkie
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
Poland	SPZOZ Wojewodzki Szpital Specjalistyczny w Rybniku	Rybnik
Poland	EUROMEDIS Sp. z o.o.	Szczecin
Poland	Wojskowy Instytut Medyczny	Warszawa	Mazowieckie
Russian Federation	Kaluga Regional Hospital	Kaluga
Russian Federation	Republican Clinical Hospital For Rehabilitation Treatment	Kazan
Russian Federation	Krasnoyarsk State Medical Academy	Krasnoyarsk
Russian Federation	City Clinical Hospital # 11	Moscow
Russian Federation	Perm State Medical Academy	Perm
Russian Federation	City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31	Saint-Petersburg
Russian Federation	City Clinical Emergency # 25	Volgograd
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Military Medical Academy	Belgrade
Serbia	Clinical Hospital Center Kragujevac	Kragujevac
Serbia	General Hospital Uzice	Uzice
Spain	Hospital Universitario Vall d'Hebron	Barcelona	Cataluña
Spain	Hospital de Basurto Osakidetza	Bilbao	Vizcaya
Spain	Hospital Universitario Reina Sofia	Cordoba	Córdoba
Spain	Hospital Universitari de Bellvitge	l'Hospitalet de Llobregat, Barceona
Spain	Hospital Clinico San Carlos	Madrid	Madrid, Communidad Delaware
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid
Spain	Hospital General Carlos Haya	Malaga
Spain	Hospital Universitario Virgen Macarena	Sevilla
United Kingdom	King's College Hospital	London	London, City of
United Kingdom	Queen's Medical Centre	Nottingham	Nottinghamshire
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Immunoe International Research Center	Centennial	Colorado
United States	North Central Neurology Assoc PC	Cullman	Alabama
United States	Michigan Institute For Neurological Disorders	Farmington Hills	Michigan
United States	Multiple Sclerosis Center of North Eastern New York	Latham	New York
United States	OMRF Multiple Sclerosis Center of Excellence	Oklahoma City	Oklahoma
United States	Phoenix Neurological Associates	Phoenix	Arizona
United States	Raleigh Neurology Associates PA	Raleigh	California
United States	Washington University	Saint Louis	Missouri
United States	Swedish Medical Center	Seattle	Washington
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  France,  Hungary,  Italy,  Netherlands,  Poland,  Russian Federation,  Serbia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing confirmed improvement of neuro-physical and/or cognitive function and/or disability.		Over 72 weeks	No
Secondary	Number of participants experiencing confirmed worsening of neuro-physical and/or cognitive function and/or disability		Over 72 weeks	No
Secondary	Number of participants experiencing Adverse Events (AEs)		Up to 84 weeks	Yes
Secondary	Number of participants experiencing Severe Adverse Events (SAEs)		Up to 84 weeks	Yes
Secondary	BIIB033 population Pharmacokinetics assessment		Up to 84 weeks	No