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

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).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Interferon beta-1a; Drug: Placebo to ozanimod; Drug: Ozanimod; Drug: Placebo to interferon beta-1a

• Study Type: Interventional
• Enrollment (Actual): 1346
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belarus
  • Grodno, Belarus, 230017
    • Grodno Clinical Regional Hospital
  • Minsk, Belarus, 220026
    • Minsk Municipal Clinical Hospital 5
  • Minsk, Belarus, 220114
    • Republican Scientific and Practical Centre of Neurology and Neurosurgery
  • Minsk, Belarus, 220116
    • Minsk City Clinical Hospital 9
  • Vitebsk, Belarus, 210037
    • Vitebsk Regional Clinical Hospital
  • Vitebsk, Belarus, 210023
    • Vitebsk Regional Diagnostic Centre
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 51000
    • Clinical Center Banja Luka
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Clinical Center University of Sarajevo
  • Tuzla, Bosnia and Herzegovina, 75000
    • University Clinical Center Tuzla
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Military Medical Academy HBAT
  • Sofia, Bulgaria, 1431
    • University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
  • Sofia, Bulgaria, 1431
    • University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
  • Sofia, Bulgaria, 1113
    • Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv Naum EAD
  • Sofia, Bulgaria, 1309
    • Multiprofile Hospital for Active Treatment National Cardiology Hospital EAD
  • Sofia, Bulgaria, 1527
    • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
  • Sofia, Bulgaria, 1606
    • Military Medical Academy - MHAT
  • Sofia, Bulgaria, 1407
    • Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia
  • Varna, Bulgaria, 9010
    • Multiprofile Hospital for Active Treatment Sveta Marina EAD
• Canada
  • Quebec
    • Gatineau, Quebec, Canada, J9J 0A5
      • Clinique Neuro Outaouais
• Croatia
  • Osijek, Croatia, 31000
    • Clinical Hospital Osijek
  • Varazdin, Croatia, 42000
    • General Hospital Varazdin
  • Zagreb, Croatia, 10000
    • Clinical Hospital Center Zagreb
  • Zagreb, Croatia, 10000
    • Clinical Hospital Sveti Duh
  • Zagreb, Croatia, 10000
    • Clinical Hospital Dubrava
  • Zagreb, Croatia, 10000
    • Clinical Hospital Sestre Milosrdnice
• Czechia
  • Brno, Czechia, 625 00
    • University Hospital Brno
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv Anny v Brne
  • Hradec Kralove, Czechia, 500 05
    • University hospital Hradec Králové
  • Hradec Kralove, Czechia, 500 05
    • Private Neurological Practice Radomir Talab MD
  • Jihlava, Czechia, 586 33
    • Nemocnice Jihlava příspěvková organizace
  • Olomouc, Czechia, 775 20
    • Fakultni Nemocnice Olomouc
  • Praha 2, Czechia, 128 21
    • Vseobecna Fakultni Nemocnice V Praze
  • Teplice, Czechia, 415 29
    • Krajska zdravotni as Nemocnice Teplice oz
• Estonia
  • Tallinn, Estonia, 10138
    • East Tallinn Central Hospital
  • Tallinn, Estonia, 10617
    • West Tallinn Central Hospital
  • Tartu, Estonia, EE-51014
    • Tartu University Hospital
• Georgia
  • Tbilisi, Georgia, 0160
    • Aversi Clinic LTD
  • Tbilisi, Georgia, 179
    • Khechinashvili University Hospital
  • Tbilisi, Georgia, ¿0112
    • LTD MediClubGeorgia
  • Tbilisi, Georgia, ¿0112
    • Sarajishvili Institute of Neurology
  • Tbilisi, Georgia, ¿0186
    • Curatio JSC
  • Tbilisi, Georgia, ¿0186
    • Ltd DEKA
• Germany
  • Berlin, Germany, 13088
    • St. Joseph Krankenhaus Berlin
  • Berlin, Germany, 12163
    • Praxis Dr. Wilfried Luer
  • Brandenburg, Germany, 15755
    • ASKLEPIOS Fachklinikum Teupitz
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus an der TU Dresden
  • Düsseldorf, Germany, 40225
    • Heinrich Heine Universität Düsseldorf
  • Köln, Germany, 50935
    • Datamed GmbH
  • Leipzig, Germany, 04103
    • Universitatsklinikum Leipzig
  • Ludwigshafen am Rhein, Germany, 67063
    • Klinikum der Stadt Ludwigshafen gGmbH
  • Marburg, Germany, 35043
    • Klinikum der Philipps Universitat Marburg
  • Potsdam, Germany, 14471
    • St. Josefs-Krankenhaus Potsdam-Sanssouci GmbH
  • Trier, Germany, 54292
    • Krankenhaus Der Barmherzigen Brueder
  • Ulm, Germany, 89079
    • NeuroPoint Akademie
• Hungary
  • Debrecen, Hungary, 4043
    • Kenézy Gyula Kórház És Rendelőintézet
  • Kistarcsa, Hungary, 2143
    • Pest Megyei Flór Ferenc Kórház
• Latvia
  • Riga, Latvia, LV-1015
    • Latvian Maritime Medicine Centre
  • Riga, Latvia, LV1002
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia, LV-1038
    • Riga East Clinical University Hospital clinic Gailezers
• Lithuania
  • Kaunas, Lithuania, LT-50009
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • Klaipeda, Lithuania, LT-5808
    • Klaipeda University Hospital
• Moldova, Republic of
  • Chisinau, Moldova, Republic of, 2004
    • IMSP Institutul de Medicina Urgenta
  • Chisinau, Moldova, Republic of, 2028
    • Institutul de Neurologie si Neurochirurgie
  • Chisinau, Moldova, Republic of, 2005
    • Municipal Clinical Hospital Sf Arhanghel Mihail
• Netherlands
  • Sittard-Geleen, Netherlands, 6162 BG
    • Zuyderland Medisch Centrum
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital
  • Hamilton, New Zealand, 2001
    • Waikato Hospital
• Poland
  • Bydgoszcz, Poland, 85-795
    • B&B Robert Bonek, Pawel Bochniak, Spolka Cywilna
  • Czeladz, Poland, 41-250
    • Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi
  • Gdansk, Poland, 80-803
    • Copernicus Podmiot Leczniczy Sp. z o.o.
  • Jaroslaw, Poland, 37-500
    • Akson Clinical Research Maciejowski Bielecki Sp. Jawna
  • Katowice, Poland, 40-555
    • Niepubliczny Zaklad Opieki Zdrowotnej NEURO-MEDIC
  • Katowice, Poland, 40-595
    • M.A.- Lek A.M.Maciejowscy Spolka Cywilna
  • Katowice, Poland, 40-650
    • Novo-Med Zielinski i wsp. Sp.J.
  • Katowice, Poland, 40-749
    • NEURO- CARE Site Management Organization Gabriela Klodowska-Duda
  • Kielce, Poland, 25-726
    • RESMEDICA Spolka z o.o.
  • Konstancin Jeziorna, Poland, 05-510
    • Niepubliczny Zespol Leczniczo-Rehabilitacyjny Centrum Kompleksowej Rehabilitacji
  • Lublin, Poland, 20-059
    • NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska
  • Lublin, Poland, 20-718
    • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego
  • Lódzkie, Poland, 90-324
    • Centrum Neurologii Krzysztof Selmaj
  • Mazowieckie, Poland, 02-097
    • Samodzielny Publiczny Centralny Szpital Kliniczny
  • Plewiska, Poland, 62-064
    • Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska
  • Podlaskie, Poland, 15-402
    • Niepubliczny Zaklad Opieki Zdrowotnej KENDRON
  • Pomorskie, Poland, 80-299
    • Indywidualna Specjalistyczna Praktyka Lekarska dr nmed Monika Lyczak
  • Poznan, Poland, 61-853
    • Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
  • Rybnik, Poland, 44-200
    • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
  • Rzeszow, Poland, 35-055
    • Centrum Medyczne Medyk
  • Warminsko-mazurskie, Poland, 10-443
    • Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski
  • Warsaw, Poland, 00-739
    • Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej
  • Warszawa, Poland, 02-957
    • Instytut Psychiatrii i Neurologii
  • Warszawa, Poland, 01-697
    • Centrum Medyczne NeuroProtect
  • Warszawa, Poland, 05-077
    • Centrum Medyczne doktorA
• Portugal
  • Almada, Portugal, 2805-267
    • Hospital Garcia de Orta
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar E Universitário de Coimbra EPE
  • Loures, Portugal, 2674-514
    • Hospital Beatriz Angelo
  • Torres Vedras, Portugal, 2560-280
    • Campus Neurologico Senior
• Romania
  • Bucharest, Romania, 022328
    • Fundeni Clinical Institute
  • Bucharest, Romania, 20125
    • Colentina Clinical Hospital
  • Cluj Napoca, Romania, 400012
    • Cluj Clinical County Hospital
  • Constanta, Romania, 900123
    • Cai Ferate Clinical Hospital
  • Sibiu, Romania, 550166
    • Sibiu Emergency County Clinical Hospital
  • Timisoara, Romania, 300736
    • Timisoara Emergency County Clinical Hospital
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Arkhangelsk Regional Clinical Hospital
  • Barnaul, Russian Federation, 656024
    • Regional Clinical Hospital
  • Belgorod, Russian Federation, 308007
    • Belgorod Regional Clinical Hospital
  • Bryansk, Russian Federation, 241033
    • Bryansk Regional Hospital 1
  • Chelyabinsk, Russian Federation, 454136
    • Chelyabinsk City Clinical Hospital 3
  • Ekaterinburg, Russian Federation, 620102
    • Sverdlovsk Regional Clinical Hospital 1
  • Kazan, Russian Federation, 420097
    • Research Medical Complex Vashe Zdorovie
  • Kemerovo, Russian Federation, 650066
    • Kemerovo Regional Clinical Hospital
  • Khanty-mansiysk, Russian Federation, 628012
    • Regional Clinical Hospital
  • Kirov, Russian Federation, 610014
    • Kirov City Clinical Hospital 1
  • Krasnoyarsk, Russian Federation, 660022
    • Krasnoyarsk State Medical Academy
  • Kursk, Russian Federation, 305007
    • Kursk Regional Clinical Hospital
  • Moscow, Russian Federation, 107150
    • Central Clinical Hospital 2 na NA Semashko OAO RZhD
  • Moscow, Russian Federation, 117997
    • City Clinical Hospital 24
  • Moscow, Russian Federation, 119049
    • City Clinical Hospital 1 na NIPirogov
  • Moscow, Russian Federation, 125367
    • Research Center of Neurology of RAMS
  • Moscow, Russian Federation, 127018
    • City Clinical Hospital 11
  • Nizhny Novgorod, Russian Federation, 603076
    • Nizhniy Novgorod City Hospital 33
  • Nizhny Novgorod, Russian Federation, 603155
    • City Clinical Hospital 3 Nizhniy Novgorod Geriatrics Centre
  • Novosibirsk, Russian Federation, 630007
    • Siberian Regional Medical Center
  • Novosibirsk, Russian Federation, 630087
    • Novosibirsk State Medical University
  • Penza, Russian Federation, 440026
    • Penza Regional Clinical Hospital na NN Burdenko
  • Perm, Russian Federation, 614045
    • Perm State Medical Academy
  • Petrozavodsk, Russian Federation, 185019
    • Republican Hospital na VA Baranov
  • Pyatigorsk, Russian Federation, 357538
    • Pyatigorsk City Hospital 2
  • Rostov on Don, Russian Federation, 344015
    • Rostov Regional Clinical Hospital
  • Samara, Russian Federation, 443095
    • Samara Regional Clinical Hospital named after MI Kalinin
  • Smolensk, Russian Federation, 214018
    • Smolensk State Medical Academy
  • St. Petersburg, Russian Federation, 197022
    • First St Petersburg State Medical University na IP Pavlov
  • St. Petersburg, Russian Federation, 197376
    • Institute of Human Brain RAN
  • St. Petersburg, Russian Federation, 197706
    • City Clinical Hospital 40
  • St. Petersburg, Russian Federation, 194354
    • City Hospital 31
  • St. Petersburg, Russian Federation, 194354
    • City Hospital Nikolaevskaya Bolnitsa
  • St. Petersburg, Russian Federation, 194354
    • St. Petersburg Multi Field City Hospital 2
  • Tomsk, Russian Federation, 634050
    • Siberian State Medical University
  • Tver, Russian Federation, 125170
    • Regional State Budget Institution of Healthcare Tver Regional Clinical Hospital
  • Tyumen, Russian Federation, 625000
    • Neftyanik Medical and Sanitary Unit
  • Ufa, Russian Federation, 450005
    • Kuvatov Republican Clinical Hospital
  • Yaroslavl, Russian Federation, 150030
    • Yaroslavl Clinical Hospital 8
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Belgrade, Serbia, 11000
    • Clinical Hospital Centar Zvezdara
  • Belgrade, Serbia, 11080
    • Clinical Hospital Centre Zemun
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
  • Nis, Serbia, 18000
    • Clinical Center Nis
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d Hebron
  • Lleida, Spain, 25198
    • Hospital Arnau de Vilanova
  • Pamplona/ Navarra, Spain, 31008
    • Complejo Hospitalario de Navarra
  • Sant Joan Despí, Spain, 08970
    • Hospital Moisés Broggi
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
• Sweden
  • Goteborg, Sweden, SE-41345
    • Sahlgrenska Universitetssjukhuset
  • Stockholm, Sweden, SE-17176
    • Karolinska Universitetssjukhuset Solna
• Ukraine
  • Cherkasy, Ukraine, 18009
    • MI Cherkasy Regional Hospital of Cherkasy Regional Council
  • Chernihiv, Ukraine, 14001
    • Hospital 4 of Chernihiv City Council
  • Chernihiv, Ukraine, 14029
    • Municipal Treatment and Preventive Institution Chernihiv Regional Clinical Hospital
  • Chernivtsi, Ukraine, 58018
    • Municipal Institution Chernivtsi Regional Psychiatric Hospital
  • Dnipropetrovsk, Ukraine, 49027
    • Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov
  • Ivano Frankivsk, Ukraine, 76008
    • Regional Clinical Hospital.
  • Ivano Frankivsk, Ukraine, 76000
    • Ivano Frankivsk City Clinical Hospital 1
  • Kharkiv, Ukraine, 61018
    • State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya
  • Kharkiv, Ukraine, 61022
    • Regional Clinical Hospital Center for Emergency Medical Care and Disaster Medicine
  • Kharkiv, Ukraine, 61176
    • Municipal Institution of Health Care Kharkiv Clinical City Hospital 7
  • Kyiv, Ukraine, 03115
    • National Research Center for Radiation Medicine, Institute of Clinical Radiology
  • Kyiv, Ukraine, 3110
    • Kyiv City Clinical Hospital 4
  • Lutsk, Ukraine, 43024
    • Volyn Regional Clinical Hospital
  • Lviv, Ukraine, 79010
    • Lviv Regional Clinical Hospital
  • Lviv, Ukraine, 79044
    • Municipal City Clinical Hospital 5
  • Odesa, Ukraine, 65025
    • Municipal Institution Odesa Regional Clinical Hospital
  • Odesa, Ukraine, 65009
    • Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU
  • Poltava, Ukraine, 36024
    • Regional Clinical Hospital na NV Sklifosovskyi
  • Uzhhorod, Ukraine, 88018
    • Regional Clinical Center of Neurosurgery and Neurology
  • Vinnytsia, Ukraine, 21005
    • Municipal Institution Vinnytsia Regional Psychoneurological Hospital na OI Yushchenko
  • Zaporizhya, Ukraine, 6972
    • Municipal Institution City Clinical Hospital 2
  • Zaporizhzhia, Ukraine, 69600
    • Municipal Institution Zaporizhzhia
  • Zaporizhzhia, Ukraine, 69035
    • Municipal Institution 6th City Clinical Hospital of Zaporizhzhia City Council
  • Zhytomyr, Ukraine, 10008
    • Regional Clinical Hospital na OFHerbachevskyi of Zhytomyr Regional Council
• United Kingdom
  • Cardiff, United Kingdom, CF14 4XW
    • University Hospital of Wales
  • Inverness, United Kingdom, IV2 3UJ
    • Raigmore Hospital
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • Sheffield, United Kingdom, S10 2JF
    • Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Xenosciences Inc
    • Phoenix, Arizona, United States, 85013
      • St Josephs Hospital and Medical Center
    • Tucson, Arizona, United States, 85712
      • Northwest Neuro Specialists PLLC
  • California
    • Berkeley, California, United States, 94705
      • Alta Bates Summit Medical Center
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network Inc
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • San Francisco, California, United States, 94158
      • Multiple Sclerosis Center at UCSF
  • Colorado
    • Denver, Colorado, United States, 80210
      • Denver Neurological Clinic
  • Florida
    • Maitland, Florida, United States, 32751
      • Neurology Associates PA
    • Ormond Beach, Florida, United States, 32174
      • Neurology Associates of Ormond Beach
    • Pompano Beach, Florida, United States, 33060
      • Infinity Clinical Research LLC
    • Port Charlotte, Florida, United States, 33952
      • Neurostudies Inc
    • Sarasota, Florida, United States, 34243
      • Roskamp Institute
    • Tampa, Florida, United States, 33609
      • Axiom Clinical Research of Florida
    • Tampa, Florida, United States, 33634
      • Meridien Research
  • Georgia
    • Douglasville, Georgia, United States, 30134
      • West Georgia Sleep Disorder Center and Neurology Associates
  • Illinois
    • Northbrook, Illinois, United States, 60062
      • Consultants in Neurology
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
    • Lenexa, Kansas, United States, 66214
      • MidAmerica Neuroscience Research Foundation
  • Kentucky
    • Lexington, Kentucky, United States, 40513
      • Associates in Neurology
    • Louisville, Kentucky, United States, 40207
      • Norton Healthcare
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • East Lansing, Michigan, United States, 48824
      • Michigan State University
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • Minneapolis Clinic of Neurology
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Cleveland Clinic Lou Ruvo Center for Brain Health
  • New Jersey
    • West Long Branch, New Jersey, United States, 07764
      • Neurology Specialists of Monmouth County PA
  • New York
    • Johnson City, New York, United States, 13790
      • Neuro Medical Care Associates PLLC
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates PA
  • Ohio
    • Akron, Ohio, United States, 44320
      • Neurology and Neuroscience Associates Inc.
    • Columbus, Ohio, United States, 43221
      • Neurological Research Institute Inc
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Multiple Sclerosis Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Hope Neurology MS Center
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston
    • Lubbock, Texas, United States, 79410
      • Bhupesh Dihenia MD PA
  • Washington
    • Kirkland, Washington, United States, 98034
      • EvergreenHealth
    • Seattle, Washington, United States, 98104
      • The Polyclinic
    • Tacoma, Washington, United States, 98405
      • Neurology of Neurosurgery Associates of Tacoma
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Center for Neurological Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Drug: Interferon beta-1a; Administered by intramuscular injection once a week; Other Names: Avonex®; IFN β-1a; Drug: Placebo to ozanimod; Matching placebo capsules administered orally once a day
EXPERIMENTAL: 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.	Drug: Ozanimod; Capsules for oral administration once a day; Other Names: RPC1063; Zeposia®; Drug: Placebo to interferon beta-1a; Placebo intramuscular injection once a week
EXPERIMENTAL: 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.	Drug: Ozanimod; Capsules for oral administration once a day; Other Names: RPC1063; Zeposia®; Drug: Placebo to interferon beta-1a; Placebo intramuscular injection once a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 month treatment period; MRI scans were assessed at Month 6 and Month 12
Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12		Month 12
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.	From first dose to the end of the 12-month treatment period
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.	From first dose to the end of the 12-month treatment period
Percentage of Participants Who Were Gadolinium Enhancing Lesion-Free at Month 12	MRI scans were analyzed by blinded centralized reading facility.	Month 12
Percentage of Participants Who Were T2 Lesion-Free at Month 12	MRI scans were analyzed by blinded centralized reading facility.	Month 12
Percent Change From Baseline in Normalized Brain Volume at Month 12	Brain volume (a measure of brain atrophy) was analyzed by MRI.	Baseline to Month 12
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.	Baseline to Month 12
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.	Baseline to Month 12
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.	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.

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: James Sheffiled, MD, Celgene

Publications and helpful links

General 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.
• 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
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 3, 2014
• Primary Completion (ACTUAL): December 22, 2016
• Study Completion (ACTUAL): December 22, 2016

Study Registration Dates

• First Submitted: August 5, 2014
• First Submitted That Met QC Criteria: November 14, 2014
• First Posted (ESTIMATE): November 19, 2014

Study Record Updates

• Last Update Posted (ACTUAL): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Relapsing Multiple Sclerosis; MS; RMS
• 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; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Adjuvants, Immunologic; Sphingosine 1 Phosphate Receptor Modulators; Interferons; Interferon beta-1a; Interferon-beta; Ozanimod
• Other Study ID Numbers: RPC01-301; 2014-002320-27 (EUDRACT_NUMBER)