Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)

NCT ID: NCT02294058

Last Updated: 2020-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-03
• Study Completion Date: 2016-12-22

Brief Summary

The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).

Conditions

Multiple Sclerosis

Keywords

MS; RMS; Multiple Sclerosis; Relapsing Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Interferon beta-1a

Participants received 30 µg interferon beta-1a by intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally once a day until the last participant had been treated for 12 months.

Group Type: ACTIVE_COMPARATOR

Interferon beta-1a

Intervention Type: DRUG

Administered by intramuscular injection once a week

Placebo to ozanimod

Intervention Type: DRUG

Matching placebo capsules administered orally once a day

Ozanimod 0.5 mg

Participants received ozanimod 0.5 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months.

Group Type: EXPERIMENTAL

Ozanimod

Intervention Type: DRUG

Capsules for oral administration once a day

Placebo to interferon beta-1a

Intervention Type: DRUG

Placebo intramuscular injection once a week

Ozanimod 1 mg

Participants received ozanimod 1 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months.

Group Type: EXPERIMENTAL

Ozanimod

Intervention Type: DRUG

Capsules for oral administration once a day

Placebo to interferon beta-1a

Intervention Type: DRUG

Placebo intramuscular injection once a week

Interventions

Ozanimod

Capsules for oral administration once a day

Intervention Type: DRUG

Interferon beta-1a

Administered by intramuscular injection once a week

Intervention Type: DRUG

Placebo to ozanimod

Matching placebo capsules administered orally once a day

Intervention Type: DRUG

Placebo to interferon beta-1a

Placebo intramuscular injection once a week

Intervention Type: DRUG

Other Intervention Names

RPC1063; Zeposia®; Avonex®; IFN β-1a

Eligibility Criteria

Inclusion Criteria

• Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
• EDSS score between 0 and 5.0 at baseline

Exclusion Criteria

• Primary progressive multiple sclerosis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Sheffiled, MD

Role: STUDY_DIRECTOR

Celgene

Locations

Xenosciences Inc

Phoenix, Arizona, United States

St Josephs Hospital and Medical Center

Phoenix, Arizona, United States

Northwest Neuro Specialists PLLC

Tucson, Arizona, United States

Alta Bates Summit Medical Center

Berkeley, California, United States

Collaborative Neuroscience Network Inc

Long Beach, California, United States

University of California Davis Medical Center

Sacramento, California, United States

Multiple Sclerosis Center at UCSF

San Francisco, California, United States

Denver Neurological Clinic

Denver, Colorado, United States

Neurology Associates PA

Maitland, Florida, United States

Neurology Associates of Ormond Beach

Ormond Beach, Florida, United States

Infinity Clinical Research LLC

Pompano Beach, Florida, United States

Neurostudies Inc

Port Charlotte, Florida, United States

Roskamp Institute

Sarasota, Florida, United States

Axiom Clinical Research of Florida

Tampa, Florida, United States

Meridien Research

Tampa, Florida, United States

West Georgia Sleep Disorder Center and Neurology Associates

Douglasville, Georgia, United States

Consultants In Neurology

Northbrook, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

MidAmerica Neuroscience Research Foundation

Lenexa, Kansas, United States

Associates In Neurology

Lexington, Kentucky, United States

Norton Healthcare

Louisville, Kentucky, United States

Henry Ford Health System

Detroit, Michigan, United States

Michigan State University

East Lansing, Michigan, United States

Minneapolis Clinic of Neurology

Golden Valley, Minnesota, United States

Washington University

St Louis, Missouri, United States

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, United States

Neurology Specialists of Monmouth County PA

West Long Branch, New Jersey, United States

Neuro Medical Care Associates PLLC

Johnson City, New York, United States

Raleigh Neurology Associates PA

Raleigh, North Carolina, United States

Neurology and Neuroscience Associates Inc.

Akron, Ohio, United States

Neurological Research Institute Inc

Columbus, Ohio, United States

Providence Multiple Sclerosis Center

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Hope Neurology MS Center

Knoxville, Tennessee, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

Bhupesh Dihenia MD PA

Lubbock, Texas, United States

EvergreenHealth

Kirkland, Washington, United States

The Polyclinic

Seattle, Washington, United States

Neurology of Neurosurgery Associates of Tacoma

Tacoma, Washington, United States

Center for Neurological Disorders

Milwaukee, Wisconsin, United States

Grodno Clinical Regional Hospital

Grodno, , Belarus

Minsk Municipal Clinical Hospital 5

Minsk, , Belarus

Republican Scientific and Practical Centre of Neurology and Neurosurgery

Minsk, , Belarus

Minsk City Clinical Hospital 9

Minsk, , Belarus

Vitebsk Regional Diagnostic Centre

Vitebsk, , Belarus

Vitebsk Regional Clinical Hospital

Vitebsk, , Belarus

Clinical Center Banja Luka

Banja Luka, , Bosnia and Herzegovina

Clinical Center University of Sarajevo

Sarajevo, , Bosnia and Herzegovina

University Clinical Center Tuzla

Tuzla, , Bosnia and Herzegovina

Military Medical Academy HBAT

Pleven, , Bulgaria

Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv Naum EAD

Sofia, , Bulgaria

Multiprofile Hospital for Active Treatment National Cardiology Hospital EAD

Sofia, , Bulgaria

Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD

Sofia, , Bulgaria

Military Medical Academy - MHAT

Sofia, , Bulgaria

Multiprofile Hospital for Active Treatment Sveta Marina EAD

Varna, , Bulgaria

Clinique Neuro Outaouais

Gatineau, Quebec, Canada

Clinical Hospital Osijek

Osijek, , Croatia

General Hospital Varazdin

Varaždin, , Croatia

Clinical Hospital Center Zagreb

Zagreb, , Croatia

Clinical Hospital Dubrava

Zagreb, , Croatia

Clinical Hospital Sestre Milosrdnice

Zagreb, , Croatia

Clinical Hospital Sveti duh

Zagreb, , Croatia

University Hospital Brno

Brno, , Czechia

Fakultni nemocnice u sv Anny v Brne

Brno, , Czechia

Private Neurological Practice Radomir Talab MD

Hradec Králové, , Czechia

University Hospital Hradec Kralove

Hradec Králové, , Czechia

Nemocnice Jihlava prispevkova organizace

Jihlava, , Czechia

Fakultni Nemocnice Olomouc

Olomouc, , Czechia

Vseobecna Fakultni Nemocnice v Praze

Prague, , Czechia

Krajska zdravotni as Nemocnice Teplice oz

Teplice, , Czechia

East Tallinn Central Hospital

Tallinn, , Estonia

West Tallinn Central Hospital

Tallinn, , Estonia

Tartu University Hospital

Tartu, , Estonia

Aversi Clinic LTD

Tbilisi, , Georgia

Khechinashvili University Hospital

Tbilisi, , Georgia

LTD MediClubGeorgia

Tbilisi, , Georgia

Sarajishvili Institute of Neurology

Tbilisi, , Georgia

Curatio JSC

Tbilisi, , Georgia

Ltd DEKA

Tbilisi, , Georgia

Praxis Dr. Wilfried Luer

Berlin, , Germany

St. Joseph Krankenhaus Berlin

Berlin, , Germany

Asklepios Fachklinikum Teupitz

Brandenburg, , Germany

DataMed GmbH

Cologne, , Germany

Universitatsklinikum Carl Gustav Carus an der TU Dresden

Dresden, , Germany

Heinrich Heine Universitat Dusseldorf

Düsseldorf, , Germany

Universitatsklinikum Leipzig

Leipzig, , Germany

Klinikum der Stadt Ludwigshafen gGmbH

Ludwigshafen am Rhein, , Germany

Klinikum der Philipps Universitat Marburg

Marburg, , Germany

St. Josefs-Krankenhaus Potsdam-Sanssouci GmbH

Potsdam, , Germany

Krankenhaus der Barmherzigen Brueder

Trier, , Germany

NeuroPoint Akademie

Ulm, , Germany

Kenezy Gyula Korhaz es Rendelointezet

Debrecen, , Hungary

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, , Hungary

Latvian Maritime Medicine Centre

Riga, , Latvia

Riga East Clinical University Hospital clinic Gailezers

Riga, , Latvia

Pauls Stradins Clinical University Hospital

Riga, , Latvia

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, , Lithuania

Klaipeda University Hospital

Klaipėda, , Lithuania

IMSP Institutul de Medicina Urgenta

Chisinau, , Moldova

Municipal Clinical Hospital Sf Arhanghel Mihail

Chisinau, , Moldova

Institutul de Neurologie si Neurochirurgie

Chisinau, , Moldova

Zuyderland Medisch Centrum

Sittard-Geleen, , Netherlands

Auckland City Hospital

Auckland, , New Zealand

Christchurch Hospital

Christchurch, , New Zealand

Waikato Hospital

Hamilton, , New Zealand

B&B Robert Bonek, Pawel Bochniak, Spolka Cywilna

Bydgoszcz, , Poland

Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi

Czeladź, , Poland

Copernicus Podmiot Leczniczy Sp. z o.o.

Gdansk, , Poland

Akson Clinical Research Maciejowski Bielecki Sp. Jawna

Jarosław, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej NEURO-MEDIC

Katowice, , Poland

M.A.- Lek A.M.Maciejowscy Spolka Cywilna

Katowice, , Poland

Novo-Med Zielinski i wsp. Sp.J.

Katowice, , Poland

NEURO- CARE Site Management Organization Gabriela Klodowska-Duda

Katowice, , Poland

RESMEDICA Spolka z o.o.

Kielce, , Poland

Niepubliczny Zespol Leczniczo-Rehabilitacyjny Centrum Kompleksowej Rehabilitacji

Konstancin-Jeziorna, , Poland

Centrum Neurologii Krzysztof Selmaj

Lódzkie, , Poland

NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska

Lublin, , Poland

Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego

Lublin, , Poland

Samodzielny Publiczny Centralny Szpital Kliniczny

Mazowieckie, , Poland

Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska

Plewiska, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej KENDRON

Podlaskie, , Poland

Indywidualna Specjalistyczna Praktyka Lekarska dr nmed Monika Lyczak

Pomorskie, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy

Poznan, , Poland

SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku

Rybnik, , Poland

Centrum Medyczne Medyk

Rzeszów, , Poland

Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski

Warminsko-mazurskie, , Poland

Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej

Warsaw, , Poland

Centrum Medyczne NeuroProtect

Warsaw, , Poland

Instytut Psychiatrii i Neurologii

Warsaw, , Poland

Centrum Medyczne doktorA

Warsaw, , Poland

Hospital Garcia de Orta

Almada, , Portugal

Hospital de Braga

Braga, , Portugal

Centro Hospitalar E Universitario de Coimbra EPE

Coimbra, , Portugal

Hospital Beatriz Angelo

Loures, , Portugal

Campus Neurologico Senior

Torres Vedras, , Portugal

Fundeni Clinical Institute

Bucharest, , Romania

Colentina Clinical Hospital

Bucharest, , Romania

Cluj Clinical County Hospital

Cluj-Napoca, , Romania

Cai Ferate Clinical Hospital

Constanța, , Romania

Sibiu Emergency County Clinical Hospital

Sibiu, , Romania

Timisoara Emergency County Clinical Hospital

Timișoara, , Romania

Arkhangelsk Regional Clinical Hospital

Arkhangelsk, , Russia

Regional Clinical Hospital

Barnaul, , Russia

Belgorod Regional Clinical Hospital

Belgorod, , Russia

Bryansk Regional Hospital 1

Bryansk, , Russia

Chelyabinsk City Clinical Hospital 3

Chelyabinsk, , Russia

Research Medical Complex Vashe Zdorovie

Kazan', , Russia

Kemerovo Regional Clinical Hospital

Kemerovo, , Russia

Regional Clinical Hospital

Khanty-Mansiysk, , Russia

Kirov City Clinical Hospital 1

Kirov, , Russia

Krasnoyarsk State Medical Academy

Krasnoyarsk, , Russia

Kursk Regional Clinical Hospital

Kursk, , Russia

Central Clinical Hospital 2 na NA Semashko OAO RZhD

Moscow, , Russia

City Clinical Hospital 24

Moscow, , Russia

City Clinical Hospital 1 na NIPirogov

Moscow, , Russia

Research Center of Neurology of RAMS

Moscow, , Russia

City Clinical Hospital 11

Moscow, , Russia

Nizhniy Novgorod City Hospital 33

Nizhny Novgorod, , Russia

City Clinical Hospital 3 Nizhniy Novgorod Geriatrics Centre

Nizhny Novgorod, , Russia

Siberian Regional Medical Center

Novosibirsk, , Russia

Novosibirsk State Medical University

Novosibirsk, , Russia

Penza Regional Clinical Hospital na NN Burdenko

Penza, , Russia

Perm State Medical Academy

Perm, , Russia

Republican Hospital na VA Baranov

Petrozavodsk, , Russia

Pyatigorsk City Hospital 2

Pyatigorsk, , Russia

Rostov Regional Clinical Hospital

Rostov-on-Don, , Russia

City Hospital 31

Saint Petersburg, , Russia

City Hospital Nikolaevskaya Bolnitsa

Saint Petersburg, , Russia

St. Petersburg Multi Field City Hospital 2

Saint Petersburg, , Russia

First St Petersburg State Medical University na IP Pavlov

Saint Petersburg, , Russia

Institute of Human Brain RAN

Saint Petersburg, , Russia

City Clinical Hospital 40

Saint Petersburg, , Russia

Samara Regional Clinical Hospital named after MI Kalinin

Samara, , Russia

Smolensk State Medical Academy

Smolensk, , Russia

Siberian State Medical University

Tomsk, , Russia

Regional State Budget Institution of Healthcare Tver Regional Clinical Hospital

Tver', , Russia

Neftyanik Medical and Sanitary Unit

Tyumen, , Russia

Kuvatov Republican Clinical Hospital

Ufa, , Russia

Yaroslavl Clinical Hospital 8

Yaroslavl, , Russia

Sverdlovsk Regional Clinical Hospital 1

Yekaterinburg, , Russia

Clinical Center of Serbia

Belgrade, , Serbia

Clinical Hospital Centar Zvezdara

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

Clinical Hospital Centre Zemun

Belgrade, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

Clinical Center Nis

Niš, , Serbia

Hospital Universitario Vall D hebron

Barcelona, , Spain

Hospital Arnau de Vilanova

Lleida, , Spain

Complejo Hospitalario de Navarra

Pamplona/ Navarra, , Spain

Hospital Moises Broggi

Sant Joan Despí, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Karolinska Universitetssjukhuset Solna

Stockholm, , Sweden

MI Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, , Ukraine

Hospital 4 of Chernihiv City Council

Chernihiv, , Ukraine

Municipal Treatment and Preventive Institution Chernihiv Regional Clinical Hospital

Chernihiv, , Ukraine

Municipal Institution Chernivtsi Regional Psychiatric Hospital

Chernivtsi, , Ukraine

Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov

Dnipropetrovsk, , Ukraine

Ivano Frankivsk City Clinical Hospital 1

Ivano-Frankivsk, , Ukraine

Regional Clinical Hospital.

Ivano-Frankivsk, , Ukraine

State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya

Kharkiv, , Ukraine

Regional Clinical Hospital Center for Emergency Medical Care and Disaster Medicine

Kharkiv, , Ukraine

Municipal Institution of Health Care Kharkiv Clinical City Hospital 7

Kharkiv, , Ukraine

National Research Center for Radiation Medicine, Institute of Clinical Radiology

Kyiv, , Ukraine

Kyiv City Clinical Hospital 4

Kyiv, , Ukraine

Volyn Regional Clinical Hospital

Lutsk, , Ukraine

Lviv Regional Clinical Hospital

Lviv, , Ukraine

Municipal City Clinical Hospital 5

Lviv, , Ukraine

Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU

Odesa, , Ukraine

Municipal Institution Odesa Regional Clinical Hospital

Odesa, , Ukraine

Regional Clinical Hospital na NV Sklifosovskyi

Poltava, , Ukraine

Regional Clinical Center of Neurosurgery and Neurology

Uzhhorod, , Ukraine

Municipal Institution Vinnytsia Regional Psychoneurological Hospital na OI Yushchenko

Vinnytsia, , Ukraine

Municipal Institution City Clinical Hospital 2

Zaporizhya, , Ukraine

Municipal Institution 6th City Clinical Hospital of Zaporizhzhia City Council

Zaporizhzhia, , Ukraine

Municipal Institution Zaporizhzhia

Zaporizhzhia, , Ukraine

Regional Clinical Hospital na OFHerbachevskyi of Zhytomyr Regional Council

Zhytomyr, , Ukraine

University Hospital of Wales

Cardiff, , United Kingdom

Raigmore Hospital

Inverness, , United Kingdom

Kings College Hospital

London, , United Kingdom

Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust

Sheffield, , United Kingdom

Countries

Argentina; Austria; Colombia; Mexico; Peru; United States; Belarus; Bosnia and Herzegovina; Bulgaria; Canada; Croatia; Czechia; Estonia; Georgia; Germany; Hungary; Latvia; Lithuania; Moldova; Netherlands; New Zealand; Poland; Portugal; Romania; Russia; Serbia; Spain; Sweden; Ukraine; United Kingdom

References

Comi G, Kappos L, Selmaj KW, Bar-Or A, Arnold DL, Steinman L, Hartung HP, Montalban X, Kubala Havrdova E, Cree BAC, Sheffield JK, Minton N, Raghupathi K, Ding N, Cohen JA; SUNBEAM Study Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial. Lancet Neurol. 2019 Nov;18(11):1009-1020. doi: 10.1016/S1474-4422(19)30239-X. Epub 2019 Sep 3.

Reference Type: BACKGROUND

PMID: 31492651 (View on PubMed)

Cree B, et al. The RADIANCE and SUNBEAM phase 3 studies of ozanimod in relapsing multiple sclerosis: study design and baseline characteristics. Presented at the 69th Annual American Academy of Neurology Meeting, April 22-28, 2017, Boston, MA. Abstract No. P6-344

Reference Type: RESULT

Harris S, Comi G, Cree BAC, Arnold DL, Steinman L, Sheffield JK, Maddux R, Southworth H, Kappos L, Cohen JA. Glial Fibrillary Acidic Protein as a Marker of Disease in Relapsing Multiple Sclerosis: Post Hoc Analysis of Phase 3 Ozanimod Trials. Eur J Neurol. 2025 Jun;32(6):e70222. doi: 10.1111/ene.70222.

Reference Type: DERIVED

PMID: 40462564 (View on PubMed)

DeLuca J, Schippling S, Montalban X, Kappos L, Cree BAC, Comi G, Arnold DL, Hartung HP, Sheffield JK, Liu H, Silva D, Cohen JA. Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS. Mult Scler Relat Disord. 2021 Feb;48:102673. doi: 10.1016/j.msard.2020.102673. Epub 2020 Dec 10.

Reference Type: DERIVED

PMID: 33454584 (View on PubMed)

Other Identifiers

2014-002320-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RPC01-301

Identifier Type: -

Identifier Source: org_study_id