AzTrials
AzTrials

Multiple SclerosisPhase 3SUNBEAMNCT02294058

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

A Phase 3 study testing Ozanimod and Interferon beta-1a in people with Multiple Sclerosis, run by Celgene at 224 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Ozanimod and Interferon beta-1a
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,346 participants
Where
224 sitesin 25 countries
Study dates
3 Dec 2014to 22 Dec 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • Primary progressive multiple sclerosis

Trial locations and contacts

224 sites in 25 countries.

224 sites in 25 countries

United States40 sites

  • Neurology and Neuroscience Associates Inc.

    Akron, Ohio, 44320

  • Alta Bates Summit Medical Center

    Berkeley, California, 94705

  • Neurological Research Institute Inc

    Columbus, Ohio, 43221

  • Denver Neurological Clinic

    Denver, Colorado, 80210

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • West Georgia Sleep Disorder Center and Neurology Associates

    Douglasville, Georgia, 30134

  • Michigan State University

    East Lansing, Michigan, 48824

  • Minneapolis Clinic of Neurology

    Golden Valley, Minnesota, 55422

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Neuro Medical Care Associates PLLC

    Johnson City, New York, 13790

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • EvergreenHealth

    Kirkland, Washington, 98034

  • Hope Neurology MS Center

    Knoxville, Tennessee, 37922

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106

  • MidAmerica Neuroscience Research Foundation

    Lenexa, Kansas, 66214

  • Associates In Neurology

    Lexington, Kentucky, 40513

  • Collaborative Neuroscience Network Inc

    Long Beach, California, 90806

  • Norton Healthcare

    Louisville, Kentucky, 40207

  • Bhupesh Dihenia MD PA

    Lubbock, Texas, 79410

  • Neurology Associates PA

    Maitland, Florida, 32751

  • Center for Neurological Disorders

    Milwaukee, Wisconsin, 53215

  • Consultants In Neurology

    Northbrook, Illinois, 60062

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Xenosciences Inc

    Phoenix, Arizona, 85004

  • St Josephs Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Infinity Clinical Research LLC

    Pompano Beach, Florida, 33060

  • Neurostudies Inc

    Port Charlotte, Florida, 33952

  • Providence Multiple Sclerosis Center

    Portland, Oregon, 97225

  • Raleigh Neurology Associates PA

    Raleigh, North Carolina, 27607

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Multiple Sclerosis Center at UCSF

    San Francisco, California, 94158

  • Roskamp Institute

    Sarasota, Florida, 34243

  • The Polyclinic

    Seattle, Washington, 98104

  • Washington University

    St Louis, Missouri, 63110

  • Neurology of Neurosurgery Associates of Tacoma

    Tacoma, Washington, 98405

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • Meridien Research

    Tampa, Florida, 33634

  • Northwest Neuro Specialists PLLC

    Tucson, Arizona, 85712

  • Neurology Specialists of Monmouth County PA

    West Long Branch, New Jersey, 07764

Other trials in United States

Russia39 sites

  • Arkhangelsk Regional Clinical Hospital

    Arkhangelsk, 163045

  • Regional Clinical Hospital

    Barnaul, 656024

  • Belgorod Regional Clinical Hospital

    Belgorod, 308007

  • Bryansk Regional Hospital 1

    Bryansk, 241033

  • Chelyabinsk City Clinical Hospital 3

    Chelyabinsk, 454136

  • Research Medical Complex Vashe Zdorovie

    Kazan', 420097

  • Kemerovo Regional Clinical Hospital

    Kemerovo, 650066

  • Regional Clinical Hospital

    Khanty-Mansiysk, 628012

  • Kirov City Clinical Hospital 1

    Kirov, 610014

  • Krasnoyarsk State Medical Academy

    Krasnoyarsk, 660022

  • Kursk Regional Clinical Hospital

    Kursk, 305007

  • Central Clinical Hospital 2 na NA Semashko OAO RZhD

    Moscow, 107150

  • City Clinical Hospital 24

    Moscow, 117997

  • City Clinical Hospital 1 na NIPirogov

    Moscow, 119049

  • Research Center of Neurology of RAMS

    Moscow, 125367

  • City Clinical Hospital 11

    Moscow, 127018

  • Nizhniy Novgorod City Hospital 33

    Nizhny Novgorod, 603076

  • City Clinical Hospital 3 Nizhniy Novgorod Geriatrics Centre

    Nizhny Novgorod, 603155

  • Siberian Regional Medical Center

    Novosibirsk, 630007

  • Novosibirsk State Medical University

    Novosibirsk, 630087

  • Penza Regional Clinical Hospital na NN Burdenko

    Penza, 440026

  • Perm State Medical Academy

    Perm, 614045

  • Republican Hospital na VA Baranov

    Petrozavodsk, 185019

  • Pyatigorsk City Hospital 2

    Pyatigorsk, 357538

  • Rostov Regional Clinical Hospital

    Rostov-on-Don, 344015

  • City Hospital 31

    Saint Petersburg, 194354

  • City Hospital Nikolaevskaya Bolnitsa

    Saint Petersburg, 194354

  • St. Petersburg Multi Field City Hospital 2

    Saint Petersburg, 194354

  • First St Petersburg State Medical University na IP Pavlov

    Saint Petersburg, 197022

  • Institute of Human Brain RAN

    Saint Petersburg, 197376

  • City Clinical Hospital 40

    Saint Petersburg, 197706

  • Samara Regional Clinical Hospital named after MI Kalinin

    Samara, 443095

  • Smolensk State Medical Academy

    Smolensk, 214018

  • Siberian State Medical University

    Tomsk, 634050

  • Regional State Budget Institution of Healthcare Tver Regional Clinical Hospital

    Tver', 125170

  • Neftyanik Medical and Sanitary Unit

    Tyumen, 625000

  • Kuvatov Republican Clinical Hospital

    Ufa, 450005

  • Yaroslavl Clinical Hospital 8

    Yaroslavl, 150030

  • Sverdlovsk Regional Clinical Hospital 1

    Yekaterinburg, 620102

Other trials in Russia

Poland25 sites

  • B&B Robert Bonek, Pawel Bochniak, Spolka Cywilna

    Bydgoszcz, 85-795

  • Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi

    Czeladź, 41-250

  • Copernicus Podmiot Leczniczy Sp. z o.o.

    Gdansk, 80-803

  • Akson Clinical Research Maciejowski Bielecki Sp. Jawna

    Jarosław, 37-500

  • Niepubliczny Zaklad Opieki Zdrowotnej NEURO-MEDIC

    Katowice, 40-555

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

    Katowice, 40-595

  • Novo-Med Zielinski i wsp. Sp.J.

    Katowice, 40-650

  • NEURO- CARE Site Management Organization Gabriela Klodowska-Duda

    Katowice, 40-749

  • RESMEDICA Spolka z o.o.

    Kielce, 25-726

  • Niepubliczny Zespol Leczniczo-Rehabilitacyjny Centrum Kompleksowej Rehabilitacji

    Konstancin-Jeziorna, 05-510

  • Centrum Neurologii Krzysztof Selmaj

    Lódzkie, 90-324

  • NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska

    Lublin, 20-059

  • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego

    Lublin, 20-718

  • Samodzielny Publiczny Centralny Szpital Kliniczny

    Mazowieckie, 02-097

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

    Plewiska, 62-064

  • Niepubliczny Zaklad Opieki Zdrowotnej KENDRON

    Podlaskie, 15-402

  • Indywidualna Specjalistyczna Praktyka Lekarska dr nmed Monika Lyczak

    Pomorskie, 80-299

  • Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy

    Poznan, 61-853

  • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku

    Rybnik, 44-200

  • Centrum Medyczne Medyk

    Rzeszów, 35-055

  • Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski

    Warminsko-mazurskie, 10-443

  • Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej

    Warsaw, 00-739

  • Centrum Medyczne NeuroProtect

    Warsaw, 01-697

  • Instytut Psychiatrii i Neurologii

    Warsaw, 02-957

  • Centrum Medyczne doktorA

    Warsaw, 05-077

Other trials in Poland

Ukraine24 sites

  • MI Cherkasy Regional Hospital of Cherkasy Regional Council

    Cherkasy, 18009

  • Hospital 4 of Chernihiv City Council

    Chernihiv, 14001

  • Municipal Treatment and Preventive Institution Chernihiv Regional Clinical Hospital

    Chernihiv, 14029

  • Municipal Institution Chernivtsi Regional Psychiatric Hospital

    Chernivtsi, 58018

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

    Dnipropetrovsk, 49027

  • Ivano Frankivsk City Clinical Hospital 1

    Ivano-Frankivsk, 76000

  • Regional Clinical Hospital.

    Ivano-Frankivsk, 76008

  • State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya

    Kharkiv, 61018

  • Regional Clinical Hospital Center for Emergency Medical Care and Disaster Medicine

    Kharkiv, 61022

  • Municipal Institution of Health Care Kharkiv Clinical City Hospital 7

    Kharkiv, 61176

  • National Research Center for Radiation Medicine, Institute of Clinical Radiology

    Kyiv, 03115

  • Kyiv City Clinical Hospital 4

    Kyiv, 3110

  • Volyn Regional Clinical Hospital

    Lutsk, 43024

  • Lviv Regional Clinical Hospital

    Lviv, 79010

  • Municipal City Clinical Hospital 5

    Lviv, 79044

  • Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU

    Odesa, 65009

  • Municipal Institution Odesa Regional Clinical Hospital

    Odesa, 65025

  • Regional Clinical Hospital na NV Sklifosovskyi

    Poltava, 36024

  • Regional Clinical Center of Neurosurgery and Neurology

    Uzhhorod, 88018

  • Municipal Institution Vinnytsia Regional Psychoneurological Hospital na OI Yushchenko

    Vinnytsia, 21005

  • Municipal Institution City Clinical Hospital 2

    Zaporizhya, 6972

  • Municipal Institution 6th City Clinical Hospital of Zaporizhzhia City Council

    Zaporizhzhya, 69035

  • Municipal Institution Zaporizhzhia

    Zaporizhzhya, 69600

  • Regional Clinical Hospital na OFHerbachevskyi of Zhytomyr Regional Council

    Zhytomyr, 10008

Other trials in Ukraine

Germany12 sites

  • Praxis Dr. Wilfried Luer

    Berlin, 12163

  • St. Joseph Krankenhaus Berlin

    Berlin, 13088

  • Asklepios Fachklinikum Teupitz

    Brandenburg, 15755

  • DataMed GmbH

    Cologne, 50935

  • Universitatsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, 01307

  • Heinrich Heine Universitat Dusseldorf

    Düsseldorf, 40225

  • Universitatsklinikum Leipzig

    Leipzig, 04103

  • Klinikum der Stadt Ludwigshafen gGmbH

    Ludwigshafen am Rhein, 67063

  • Klinikum der Philipps Universitat Marburg

    Marburg, 35043

  • St. Josefs-Krankenhaus Potsdam-Sanssouci GmbH

    Potsdam, 14471

  • Krankenhaus der Barmherzigen Brueder

    Trier, 54292

  • NeuroPoint Akademie

    Ulm, 89079

Other trials in Germany

Bulgaria9 sites

  • Military Medical Academy HBAT

    Pleven, 5800

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

    Sofia, 1113

  • Multiprofile Hospital for Active Treatment National Cardiology Hospital EAD

    Sofia, 1309

  • Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia

    Sofia, 1407

  • University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD

    Sofia, 1527

  • Military Medical Academy - MHAT

    Sofia, 1606

  • Multiprofile Hospital for Active Treatment Sveta Marina EAD

    Varna, 9010

Other trials in Bulgaria

Czechia8 sites

  • University Hospital Brno

    Brno, 625 00

  • Fakultni nemocnice u sv Anny v Brne

    Brno, 656 91

  • Private Neurological Practice Radomir Talab MD

    Hradec Králové, 500 05

  • University Hospital Hradec Kralove

    Hradec Králové, 500 05

  • Nemocnice Jihlava prispevkova organizace

    Jihlava, 586 33

  • Fakultni Nemocnice Olomouc

    Olomouc, 775 20

  • Vseobecna Fakultni Nemocnice v Praze

    Prague, 128 21

  • Krajska zdravotni as Nemocnice Teplice oz

    Teplice, 415 29

Other trials in Czechia

Belarus6 sites

  • Grodno Clinical Regional Hospital

    Grodno, 230017

  • Minsk Municipal Clinical Hospital 5

    Minsk, 220026

  • Republican Scientific and Practical Centre of Neurology and Neurosurgery

    Minsk, 220114

  • Minsk City Clinical Hospital 9

    Minsk, 220116

  • Vitebsk Regional Diagnostic Centre

    Vitebsk, 210023

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210037

Other trials in Belarus

Croatia6 sites

  • Clinical Hospital Osijek

    Osijek, 31000

  • General Hospital Varazdin

    Varaždin, 42000

  • Clinical Hospital Center Zagreb

    Zagreb, 10000

  • Clinical Hospital Dubrava

    Zagreb, 10000

  • Clinical Hospital Sestre Milosrdnice

    Zagreb, 10000

  • Clinical Hospital Sveti duh

    Zagreb, 10000

Other trials in Croatia

Georgia6 sites

  • Aversi Clinic LTD

    Tbilisi, 0160

  • Khechinashvili University Hospital

    Tbilisi, 179

  • LTD MediClubGeorgia

    Tbilisi, ¿0112

  • Sarajishvili Institute of Neurology

    Tbilisi, ¿0112

  • Curatio JSC

    Tbilisi, ¿0186

  • Ltd DEKA

    Tbilisi, ¿0186

Other trials in Georgia

Romania6 sites

  • Fundeni Clinical Institute

    Bucharest, 022328

  • Colentina Clinical Hospital

    Bucharest, 20125

  • Cluj Clinical County Hospital

    Cluj-Napoca, 400012

  • Cai Ferate Clinical Hospital

    Constanța, 900123

  • Sibiu Emergency County Clinical Hospital

    Sibiu, 550166

  • Timisoara Emergency County Clinical Hospital

    Timișoara, 300736

Other trials in Romania

Serbia6 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Hospital Centar Zvezdara

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Hospital Centre Zemun

    Belgrade, 11080

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Center Nis

    Niš, 18000

Other trials in Serbia

Portugal5 sites

  • Hospital Garcia de Orta

    Almada, 2805-267

  • Hospital de Braga

    Braga, 4710-243

  • Centro Hospitalar E Universitario de Coimbra EPE

    Coimbra, 3000-075

  • Hospital Beatriz Angelo

    Loures, 2674-514

  • Campus Neurologico Senior

    Torres Vedras, 2560-280

Other trials in Portugal

Spain5 sites

  • Hospital Universitario Vall D hebron

    Barcelona, 08035

  • Hospital Arnau de Vilanova

    Lleida, 25198

  • Complejo Hospitalario de Navarra

    Pamplona/ Navarra, 31008

  • Hospital Moises Broggi

    Sant Joan Despí, 08970

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

United Kingdom4 sites

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • Raigmore Hospital

    Inverness, IV2 3UJ

  • Kings College Hospital

    London, SE5 9RS

  • Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust

    Sheffield, S10 2JF

Other trials in United Kingdom

Bosnia and Herzegovina3 sites

  • Clinical Center Banja Luka

    Banja Luka, 51000

  • Clinical Center University of Sarajevo

    Sarajevo, 71000

  • University Clinical Center Tuzla

    Tuzla, 75000

Other trials in Bosnia and Herzegovina

Estonia3 sites

  • East Tallinn Central Hospital

    Tallinn, 10138

  • West Tallinn Central Hospital

    Tallinn, 10617

  • Tartu University Hospital

    Tartu, EE-51014

Other trials in Estonia

Latvia3 sites

  • Latvian Maritime Medicine Centre

    Riga, LV-1015

  • Riga East Clinical University Hospital clinic Gailezers

    Riga, LV-1038

  • Pauls Stradins Clinical University Hospital

    Riga, LV1002

Other trials in Latvia

Moldova3 sites

  • IMSP Institutul de Medicina Urgenta

    Chisinau, 2004

  • Municipal Clinical Hospital Sf Arhanghel Mihail

    Chisinau, 2005

  • Institutul de Neurologie si Neurochirurgie

    Chisinau, 2028

Other trials in Moldova

New Zealand3 sites

  • Auckland City Hospital

    Auckland, 1023

  • Christchurch Hospital

    Christchurch, 8011

  • Waikato Hospital

    Hamilton, 2001

Other trials in New Zealand

Hungary2 sites

  • Kenezy Gyula Korhaz es Rendelointezet

    Debrecen, 4043

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2143

Other trials in Hungary

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, LT-50009

  • Klaipeda University Hospital

    Klaipėda, LT-5808

Other trials in Lithuania

Sweden2 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, SE-41345

  • Karolinska Universitetssjukhuset Solna

    Stockholm, SE-17176

Other trials in Sweden

Canada1 site

  • Clinique Neuro Outaouais

    Gatineau, Quebec, J9J 0A5

Other trials in Canada

Netherlands1 site

  • Zuyderland Medisch Centrum

    Sittard-Geleen, 6162 BG

Other trials in Netherlands

About this study

Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients

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

Being tested
Ozanimod, Interferon beta-1a, Placebo to ozanimod, Placebo to interferon beta-1a
Keywords
MS, RMS, Multiple Sclerosis, Relapsing Multiple Sclerosis
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OzanimodDrug

    Also called RPC1063, Zeposia®

    Capsules for oral administration once a day

  • Interferon beta-1aDrug

    Also called Avonex®, IFN β-1a

    Administered by intramuscular injection once a week

  • Placebo to ozanimodDrug

    Matching placebo capsules administered orally once a day

  • Placebo to interferon beta-1aDrug

    Placebo intramuscular injection once a week

Study groups in NCT02294058
Study groupRoleWhat they receive
Interferon beta-1aActive comparatorParticipants 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.
Receives: Drug: Interferon beta-1a; Drug: Placebo to ozanimod
Ozanimod 0.5 mgExperimentalParticipants 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.
Receives: Drug: Ozanimod; Drug: Placebo to interferon beta-1a
Ozanimod 1 mgExperimentalParticipants 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.
Receives: Drug: Ozanimod; Drug: Placebo to interferon beta-1a

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adjusted Annualized Relapse Rate (ARR) During the Treatment Period

    The relapse rate was based on confirmed relapses. A relapse was defined as new or worsening neurological symptoms attributable to MS and preceded by a relatively stable or improving neurological state for at least 30 days. Symptoms must have persisted for > 24 hours and not be attributable to confounding clinical factors. Relapses were confirmed when accompanied by objective neurological worsening based on examination by the blinded evaluator, consistent with an increase of ≥ 0.5 on the overall EDSS score relative to the most recent EDSS assessment, or 2 points on one of the functional system scale scores, or 1 point on ≥ two functional system scale scores.

    Relapse rate was calculated as the total number of relapses divided by the total number of days in the study * 365.25.

    ARR was adjusted for region (Eastern Europe vs rest of world), Baseline age, and Baseline number of gadolinium-enhancing lesions; the natural log transformation of time on study was included as an offset term.

    Measured: 12 months

Secondary outcomes (10)

  1. Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months

    The number of new or enlarging hyperintense T2-weighted brain MRI lesions per scan was based on the cumulative number of new or enlarging T2 lesions since Baseline over treatment period.

    Measured: 12 month treatment period; MRI scans were assessed at Month 6 and Month 12

  2. Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12

    Measured: Month 12

  3. Time to Onset of Disability Progression Confirmed After 3 Months

    EDSS is used to quantify disability and disability progression over time in MS. Based on a neurological examination, 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \& bladder, cerebral, and other functions) are scored from 0 (no disability) to 5 or 6 (more severe disability). Ambulation is assessed based on distance the patient is able to walk, whether assistance is required or restrictions are present.

    The EDSS score ranges from 0 (normal) to 10 (death due to MS) in 0.5 unit increments.

    Disability progression is defined by a sustained worsening in EDSS score of 1.0 point or more confirmed after 3 months. Time to onset of disability progression was calculated from the date of first dose to the date of the first visit at which the 1.0 point increase in EDSS was met using Kaplan-Meier methods. Participants without a sustained disease progression event were censored on the date of their last assessment or last dose of study drug, whichever was later.

    Measured: From first dose to the end of the 12-month treatment period

  4. Time to Onset of Disability Progression Confirmed After 6 Months

    EDSS is used to quantify disability and disability progression over time in MS. Based on a neurological examination, 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \& bladder, cerebral, and other functions) are scored from 0 (no disability) to 5 or 6 (more severe disability). Ambulation is assessed based on distance the patient is able to walk, whether assistance is required or restrictions are present.

    The EDSS score ranges from 0 (normal) to 10 (death due to MS) in 0.5 unit increments.

    Disability progression is defined by a sustained worsening in EDSS score of 1.0 point or more confirmed after 6 months. Time to onset of disability progression was calculated from the date of first dose to the date of the first visit at which the 1.0 point increase in EDSS was met using Kaplan-Meier methods. Participants without a sustained disease progression event were censored on the date of their last assessment or last dose of study drug, whichever was later.

    Measured: From first dose to the end of the 12-month treatment period

  5. Percentage of Participants Who Were Gadolinium Enhancing Lesion-Free at Month 12

    MRI scans were analyzed by blinded centralized reading facility.

    Measured: Month 12

  6. Percentage of Participants Who Were T2 Lesion-Free at Month 12

    MRI scans were analyzed by blinded centralized reading facility.

    Measured: Month 12

  7. Percent Change From Baseline in Normalized Brain Volume at Month 12

    Brain volume (a measure of brain atrophy) was analyzed by MRI.

    Measured: Baseline to Month 12

  8. Change From Baseline to Month 12 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test

    The MSFC-LCLA is a battery including the following 4 individual scales:

    • Timed 25-Foot Walk is an ambulation measure of walking 25 feet with time taken recorded in seconds
    • 9-Hole Peg Test (9HPT) is a quantitative measure of upper extremity (arm and hand) function
    • Symbol Digit Modalities Test (SDMT) is a measure of executive cognitive function that assesses processing speed, flexibility, and calculation ability
    • Low-Contrast Letter Acuity Test (LCLA) used a standardized set of charts to assess low contrast visual acuity, charts are scored according to the number of letters that are identified correctly

    Z-scores were calculated for for each component and averaged to create an overall composite score, using the study population as the reference population. A z-score represents the number of standard deviations a patient's test result is higher (z > 0) or lower (z < 0) than the average test result (z = 0) of the reference population. A positive change indicates improvement.

    Measured: Baseline to Month 12

  9. Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores

    The MSQOL-54 is a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument. The instrument includes 12 subscales, two summary scores, and two single-item measures.

    The two summary scores - physical health and mental health - are derived from a weighted combination of scale scores.

    The physical health composite score includes Physical function, Health perceptions, Energy/fatigue, Role limitations - physical, Pain, Sexual function, Social function, and Health distress.

    The mental health composite score includes Health distress, Overall quality of life, Emotional well-being, Role limitations - emotional, and Cognitive function.

    Each composite summary score has a range from 0 to 100 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.

    Measured: Baseline to Month 12

  10. Number of Participants With Treatment Emergent Adverse Events

    An adverse event (AE) is any untoward medical occurrence that does not necessarily have a causal relationship with the investigational product (IP). An AE can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom or disease temporally associated with the use of an IP whether or not considered related to the IP. A serious AE (SAE) is any untoward medical occurrence or effect that results in death, is life-threatening, requires hospitalization or prolongation of existing inpatient hospitalization. The investigator assessed the severity of AEs as mild, moderate, or severe.

    Measured: From the first dose of study drug until 28 days following the last dose of study drug; mean exposure to study drug was 13.5 months for interferon beta-1a and 13.6 months for each ozanimod group.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2014 (estimated)
  2. Study start3 Dec 2014
  3. Primary completion22 Dec 2016
  4. Study completion22 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,346 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02294058
Sponsor's protocol ID
RPC01-301
Other IDs
2014-002320-27, 2014
Acronym
SUNBEAM
Status last verified
Nov 2020
First submitted
5 Aug 2014
Last updated
25 Nov 2020
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31492651

  • 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

  • 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.

    PubMed 40462564

  • 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.

    PubMed 33454584

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ozanimod and Interferon beta-1a in people with Multiple Sclerosis, run by Celgene at 224 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 224 sites in United States, Russia, Poland, Ukraine, Germany and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjusted Annualized Relapse Rate (ARR) During the Treatment Period (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02294058, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.

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SUNBEAM Clinical Trial NCT02294058 | AzTrials