Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis

NCT02047734 | Completed Phase 3 Results DMC

• 2 other identifiers: RPC01-201-PartB2012-002714-40
• Study Type: interventional
• Target: 1,320
• Locations: 20 countries
• Sites: 291

Brief Summary

This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented within this record. The primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).

Conditions

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Adjusted Annualized Relapse Rate (ARR) at the End of Month 24

  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 confirmed relapses divided by the total number of days in the study \* 365.25. ARR was based on a Poisson regression model, adjusted for region (Eastern Europe vs Rest of the World), age, and the Baseline number of gadolinium-enhancing lesions, and included the natural log transformation of time on study as an offset term.

  At the end of month 24

Secondary Outcomes (10)

• Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months

  24 month treatment period; MRI scans were performed at Months 12 and 24

• Adjusted Mean Number of Gadolinium Enhancing Brain Lesions at Month 24

  Month 24

• Time to Onset of Disability Progression Confirmed After 3 Months

  From first dose to the end of the 24-month treatment period

• Time to Onset of Disability Progression Confirmed After 6 Months

  From first dose to the end of the 24-month treatment period

• Percentage of Participants Who Were Gadolinium Enhancing (GdE) Lesion-Free at Month 24

  Month 24

Study Arms (3)

Ozanimod 0.5 mg

EXPERIMENTAL

Ozanimod 0.5 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.

Drug: Ozanimod; Drug: Interferon beta-1a placebo

Ozanimod1 mg

EXPERIMENTAL

Ozanimod 1 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.

Drug: Ozanimod; Drug: Interferon beta-1a placebo

Interferon β-1a

ACTIVE COMPARATOR

interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.

Drug: Ozanimod placebo; Drug: Interferon beta-1a

Interventions

Ozanimod DRUG

Oral capsule, daily for 24 months

Also known as: RPC1063, Zeposia®

Ozanimod 0.5 mg; Ozanimod1 mg

Ozanimod placebo DRUG

Oral capsule, daily for 24 months

Interferon β-1a

Interferon beta-1a DRUG

Intramuscular injection, 30 µg, weekly for 24 months

Also known as: Avonex

Interferon β-1a

Interferon beta-1a placebo DRUG

Intramuscular injection, weekly for 24 months

Ozanimod 0.5 mg; Ozanimod1 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
• Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at baseline

You may not qualify if:

• Primary progressive multiple sclerosis

Sponsors & Collaborators

• Celgene: lead

Study Sites (299)

Receptos Study Site 115

Phoenix, Arizona, 85004, United States

Location

Xenoscience

Phoenix, Arizona, 85004, United States

Location

Receptos Study Site 118

Phoenix, Arizona, 85013, United States

Location

Saint Josephs Hosptial and Medical Center

Phoenix, Arizona, 85013, United States

Location

Territory Neurology and Research Institute

Tucson, Arizona, 85704, United States

Location

Receptos Study Site 119

Tucson, Arizona, 85741, United States

Location

Alta Bates Summit Medical Center

Berkeley, California, 94705, United States

Location

Receptos Study Site 110

Berkeley, California, 94705, United States

Location

Receptos Study Site 122

Long Beach, California, 90806, United States

Location

Receptos Study Site 112

Sacramento, California, 95817, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Multiple Sclerosis Center at UCSF

San Francisco, California, 94158, United States

Location

Receptos Study Site 120

San Francisco, California, 94158, United States

Location

Denver Neurological Research LLC

Denver, Colorado, 80210, United States

Location

Receptos Study Site 127

Denver, Colorado, 80210, United States

Location

Neurology Associates PA

Maitland, Florida, 32751, United States

Location

Receptos Study Site 114

Maitland, Florida, 32751, United States

Location

Receptos Study Site 124

Pompano Beach, Florida, 33060, United States

Location

Neurostudies Inc

Port Charlotte, Florida, 33952, United States

Location

Receptos Study Site 123

Port Charlotte, Florida, 33952, United States

Location

Infinity Clinical Research LLC

Sunrise, Florida, 33351, United States

Location

West Georgia Sleep Disorder Center and Neurology Associates

Douglasville, Georgia, 30134, United States

Location

Consultants In Neurology

Northbrook, Illinois, 60062, United States

Location

Receptos Study Site 113

Northbrook, Illinois, 60062, United States

Location

Receptos Study Site 121

St Louis, Missouri, 63110, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Receptos Study Site 101

Charlotte, North Carolina, 28204, United States

Location

The Neurological Institute PA

Charlotte, North Carolina, 28204, United States

Location

Neurology and Neuroscience Associates Inc.

Akron, Ohio, 44320, United States

Location

Receptos Study Site 107

Akron, Ohio, 44320, United States

Location

Receptos Study Site 104

Cleveland, Ohio, 44195, United States

Location

Receptos Study Site 109

Philadelphia, Pennsylvania, 19104, United States

Location

Receptos Study Site 102

Seattle, Washington, 98104, United States

Location

The Polyclinic

Seattle, Washington, 98104, United States

Location

Receptos Study Site 125

Tacoma, Washington, 98405, United States

Location

Grodno Clinical Regional Hospital

Grodno, 230017, Belarus

Location

Receptos Study Site 907

Grodno, 230017, Belarus

Location

Gomel Regional Clinical Hospital

Homyel, 246029, Belarus

Location

Receptos Study Site 904

Homyel, 246029, Belarus

Location

Minsk Municipal Clinical Hospital 5

Minsk, 220026, Belarus

Location

Receptos Study Site 902

Minsk, 220026, Belarus

Location

Receptos Study Site 901

Minsk, 220114, Belarus

Location

Republican Scientific and Practical Centre of Neurology and Neurosurgery

Minsk, 220114, Belarus

Location

Minsk City Clinical Hospital 9

Minsk, 220116, Belarus

Location

Receptos Study Site 903

Minsk, 220116, Belarus

Location

Receptos Study Site 905

Vitebsk, 210023, Belarus

Location

Vitebsk Regional Diagnostic Centre

Vitebsk, 210023, Belarus

Location

Receptos Study Site 906

Vitebsk, 210037, Belarus

Location

AZ Sint-Jan AV Brugge

Bruges, 8000, Belgium

Location

Receptos Study Site 256

Bruges, 8000, Belgium

Location

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

Receptos Study Site 255

Brussels, 1200, Belgium

Location

Centre Hospitalier Chretien Clinique Saint Joseph

Montegnée, 4420, Belgium

Location

Receptos Study Site 252

Montegnée, 4420, Belgium

Location

Clinique Saint Pierre

Ottignies, 1340, Belgium

Location

Receptos Study Site 254

Ottignies, 1340, Belgium

Location

Clinical Center University of Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

Receptos Study Site 911

Sarajevo, 71000, Bosnia and Herzegovina

Location

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

Sofia, 1113, Bulgaria

Location

Receptos Study Site 453

Sofia, 1113, Bulgaria

Location

Receptos Study Site 454

Sofia, 1113, Bulgaria

Location

Receptos Study Site 452

Sofia, 1309, Bulgaria

Location

Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia

Sofia, 1407, Bulgaria

Location

Receptos Study Site 456

Sofia, 1407, Bulgaria

Location

Receptos Study Site 457

Sofia, 1431, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

Sofia, 1431, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

Sofia, 1431, Bulgaria

Location

Receptos Study Site 451

Sofia, 1527, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD

Sofia, 1527, Bulgaria

Location

Receptos Study Site 455

Sofia, 1606, Bulgaria

Location

University of Alberta MS Clinic

Edmonton, Alberta, T6G 2G3, Canada

Location

Receptos Study Site 154

Edmonton, Alberta, T6G2B7, Canada

Location

Clinical Hospital Center Osijek

Osijek, 31000, Croatia

Location

Receptos Study Site 923

Osijek, 31000, Croatia

Location

Receptos Study Site 921

Zagreb, 10 000, Croatia

Location

Receptos Study Site 922

Zagreb, 10 000, Croatia

Location

Receptos Study Site 924

Zagreb, 10 000, Croatia

Location

Clinical Hospital Center "Sestre milosrdnice", Clinic of Internal Diseases

Zagreb, 10000, Croatia

Location

Clinical Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

Clinical Hospital Sveti duh

Zagreb, 10000, Croatia

Location

Receptos Study Site 301

Tbilisi, 0112, Georgia

Location

LTD MediClubGeorgia

Tbilisi, 0160, Georgia

Location

Receptos Study Site 302

Tbilisi, 0160, Georgia

Location

Khechinashvili University Hospital

Tbilisi, 0179, Georgia

Location

Receptos Study Site 303

Tbilisi, 0179, Georgia

Location

Sarajishvili Institute of Neurology

Tbilisi, 112, Georgia

Location

Evaggelismos General Hospital

Athens, 10676, Greece

Location

Receptos Study Site 552

Athens, 10676, Greece

Location

Receptos Study Site 554

Athens, 10676, Greece

Location

Navy Hospital of Athens

Athens, 115 21, Greece

Location

Receptos Study Site 553

Athens, 11521, Greece

Location

401 Military Hospital of Athens

Athens, 11525, Greece

Location

Receptos Study Site 551

Athens, 11525, Greece

Location

AHEPA University General Hospital of Thessaloniki

Thessaloniki, 546 36, Greece

Location

Receptos Study Site 557

Thessaloniki, 54636, Greece

Location

Georgios Papanikolaou General Hospital of Thessaloniki

Thessaloniki, 57010, Greece

Location

Receptos Study Site 555

Thessaloniki, 57010, Greece

Location

Receptos Study Site 352

Budapest, 1145, Hungary

Location

Uzsoki Utcai Korhaz

Budapest, 1145, Hungary

Location

Jahn Ferenc DelPesti Korhaz es Rendelointezet

Budapest, 1204, Hungary

Location

Receptos Study Site 356

Budapest, 1204, Hungary

Location

Receptos Study Site 354

Esztergom, 2500, Hungary

Location

Vaszary Kolos Korhaz

Esztergom, 2500, Hungary

Location

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, 2143, Hungary

Location

Receptos Study Site 358

Kistarcsa, 2143, Hungary

Location

Receptos Study Site 351

Nyíregyháza, 4400, Hungary

Location

SzabolcsSzatmarBereg Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, 4400, Hungary

Location

Receptos Study Site 355

Székesfehérvár, 8000, Hungary

Location

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

Catania, 95123, Italy

Location

Receptos Study Site 654

Catania, 95123, Italy

Location

Fondazione Istituto San Raffaele G Giglio di Cefalu

Cefalù, 90015, Italy

Location

Receptos Study Site 653

Cefalù, 90015, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Receptos Study Site 655

Milan, 20122, Italy

Location

Receptos Study Site 652

Milan, 20132, Italy

Location

Presidio Ospedaliero di Montichiari

Montichiari, 25018, Italy

Location

Receptos Study Site 659

Montichiari, 25018, Italy

Location

Receptos Study Site 656

Napoli, Italy

Location

Receptos Study Site 658

Pavia, 27100, Italy

Location

Fondazione PTV Policlinico Tor Vergata

Roma, 00133, Italy

Location

Receptos Study Site 651

Roma, 00133, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

Receptos Study Site 657

Siena, 53100, Italy

Location

IMSP Institutul de Medicina Urgenta

Chisinau, 2004, Moldova

Location

Receptos Study Site 932

Chisinau, 2004, Moldova

Location

Institutul de Neurologie si Neurochirurgie

Chisinau, 2028, Moldova

Location

Receptos Study Site 931

Chisinau, 2028, Moldova

Location

Receptos Study Site 933

Chisinau, 2028, Moldova

Location

Receptos Study Site 401

Bialystok, 15-402, Poland

Location

Receptos Study Site 423

Bydgoszcz, 85-654, Poland

Location

Specjalistyczna Praktyka Lekarska Lek Med Robert Bonek

Bydgoszcz, 85-654, Poland

Location

Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi

Czeladź, 41-250, Poland

Location

Receptos Study Site 406

Czeladź, 41-250, Poland

Location

Receptos Study Site 405

Gdansk, 80-083, Poland

Location

Receptos Study Site 425

Gdansk, 80-299, Poland

Location

Copernicus PL Sp. z. o.o.

Gdansk, 80-803, Poland

Location

NEUROMEDIC Janusz Zbrojkiewicz

Katowice, 40-555, Poland

Location

MA LEK AM Maciejowscy SC Centrum Terapii SM

Katowice, 40-595, Poland

Location

Receptos Study Site 427

Katowice, 40-595, Poland

Location

NovoMed Zielinski i Wspolnicy Spolka Jawna

Katowice, 40-650, Poland

Location

Receptos Study Site 426

Katowice, 40-650, Poland

Location

NEUROCARE Site Management Organization Gabriela KlodowskaDuda

Katowice, 40-749, Poland

Location

Receptos Study Site 407

Katowice, 40-749, Poland

Location

Receptos Study Site 417

Katowice, 40-752, Poland

Location

Receptos Study Site 424

Kielce, 25-726, Poland

Location

RESMEDICA Spolka z o.o.

Kielce, 25-726, Poland

Location

Centrum Kompleksowej Rehabilitacji Sp.z.o.o. Szpital Wielospecjalistyczny

Konstancin-Jeziorna, 05-510, Poland

Location

Receptos Study Site 404

Konstancin-Jeziorna, 05-510, Poland

Location

Krakowska Akademia Neurologii Sp. z. o.o.

Krakow, 31-305, Poland

Location

Receptos Study Site 414

Krakow, 31-305, Poland

Location

Centrum Neurologii Krzysztof Selmaj

Lodz, 93-121, Poland

Location

Receptos Study Site 411

Lodz, 93-121, Poland

Location

Prof. dr med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny

Lublin, 20-718, Poland

Location

Receptos Study Site 412

Lublin, 20-718, Poland

Location

Receptos Study Site 420

Lublin, 20-718, Poland

Location

Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego

Lublin, 20-718, Poland

Location

Receptos Study Site 402

Olsztyn, 10-443, Poland

Location

Receptos Study Site 415

Olsztyn, 10-561, Poland

Location

Wojewodzki Szpital Specjalistyczny

Olsztyn, 10-561, Poland

Location

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

Plewiska, 62-064, Poland

Location

Receptos Study Site 421

Plewiska, 62-064, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej KENDRON

Podlaskie, 15-402, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska dr nmed Monika Lyczak

Pomorskie, 80-299, Poland

Location

Receptos Study Site 408

Poznan, 60-355, Poland

Location

Szpital Kliniczny im HSwiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu

Poznan, 60-355, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy

Poznan, 61-853, Poland

Location

Receptos Study Site 418

Poznan, 61-853, Poland

Location

EUROMEDIS Sp. z.o.o.

Szczecin, 70-111, Poland

Location

Receptos Study Site 419

Szczecin, 70-111, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski

Warminsko-mazurskie, 10-443, Poland

Location

Receptos Study Site 410

Warsaw, 00-739, Poland

Location

Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej

Warsaw, 00-739, Poland

Location

Centrum Medyczne NeuroProtect

Warsaw, 01-697, Poland

Location

Receptos Study Site 428

Warsaw, 01-697, Poland

Location

Centralny Szpital Kliniczny MSW w Warszawie

Warsaw, 02-507, Poland

Location

Receptos Study Site 422

Warsaw, 02-507, Poland

Location

Instytut Psychiatrii i Neurologii

Warsaw, 02-957, Poland

Location

Receptos Study Site 403

Warsaw, 02-957, Poland

Location

Receptos Study Site 413

Warsaw, 04-141, Poland

Location

Wojskowy Instytut Medyczny

Warsaw, 04-141, Poland

Location

Clinical Hospital of Psychiatry and Neurology Brasov

Brasov, 500123, Romania

Location

Receptos Study Site 503

Brasov, 500123, Romania

Location

Health Club Medical Center S.R.L.

Campulung Muscel, 115100, Romania

Location

Receptos Study Site 502

Campulung Muscel, 115100, Romania

Location

Receptos Study Site 501

Cluj-Napoca, 400347, Romania

Location

Rehabilitation Clinical Hospital

Cluj-Napoca, 400347, Romania

Location

Receptos Study Site 505

Sibiu, 550166, Romania

Location

Sibiu Emergency County Clinical Hospital

Sibiu, 550166, Romania

Location

Receptos Study Site 506

Timișoara, 300736, Romania

Location

Timisoara Emergency County Clinical Hospital

Timișoara, 300736, Romania

Location

Chelyabinsk City Clinical Hospital 3

Chelyabinsk, 454136, Russia

Location

Receptos Study Site 701

Chelyabinsk, 454136, Russia

Location

Receptos Study Site 704

Kazan', 420021, Russia

Location

Republican Clinical Hospital for Rehabilitation Treatment

Kazan', 420021, Russia

Location

Receptos Study Site 713

Kazan', 420101, Russia

Location

Research Medical Complex Vashe Zdorovie

Kazan', 420101, Russia

Location

Central Clinical Hospital 2 na NA Semashko OAO RZhD

Moscow, 107150, Russia

Location

Receptos Study Site 712

Moscow, 107150, Russia

Location

City Clinical Hospital 1 na NIPirogov

Moscow, 119049, Russia

Location

Receptos Study Site 709

Moscow, 119049, Russia

Location

City neurology center Sibneuromed LLC

Novosibirsk, 630091, Russia

Location

Receptos Study Site 703

Novosibirsk, 630091, Russia

Location

Perm State Medical Academy

Perm, 614990, Russia

Location

Receptos Study Site 710

Perm, 614990, Russia

Location

Receptos Study Site 708

Saint Petersburg, 194044, Russia

Location

Russian Medical Military Academy na SMKirov

Saint Petersburg, 194044, Russia

Location

Receptos Study Site 716

Samara, 443095, Russia

Location

Samara Regional Clinical Hospital named after MI Kalinin

Samara, 443095, Russia

Location

City Clinical Hospital 4

Saransk, 430032, Russia

Location

Receptos Study Site 715

Saransk, 430032, Russia

Location

Receptos Study Site 714

Saratov, 410012, Russia

Location

Saratov State Medical University

Saratov, 410054, Russia

Location

Receptos Study Site 707

Smolensk, 214018, Russia

Location

Smolensk State Medical Academy

Smolensk, 214018, Russia

Location

Receptos Study Site 717

Tyumen, 625000, Russia

Location

Neftyanik Medical and Sanitary Unit

Tyumen, 625048, Russia

Location

Receptos Study Site 711

Yaroslavl, 150030, Russia

Location

Yaroslavl Clinical Hospital 8

Yaroslavl, 150030, Russia

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Clinical Hospital Centar Zvezdara

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

Receptos Study Site 602

Belgrade, 11000, Serbia

Location

Receptos Study Site 603

Belgrade, 11000, Serbia

Location

Receptos Study Site 604

Belgrade, 11000, Serbia

Location

Clinical Hospital Centre Zemun

Belgrade, 11080, Serbia

Location

Receptos Study Site 601

Belgrade, 11080, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Receptos Study Site 605

Kragujevac, 34000, Serbia

Location

University Hospital Bratislava - Hospital ak. L. Derera, II Neurology Clinic

Bratislava, 833 05, Slovakia

Location

Receptos Study Site 946

Bratislava, 83305, Slovakia

Location

Receptos Study Site 942

Lučenec, 984 01, Slovakia

Location

Receptos Study Site 945

Trnava, 917 75, Slovakia

Location

Receptos Study Site 956

KwaZulu-Natal, 4321, South Africa

Location

Neurology Practice

Pretoria, 0040, South Africa

Location

Receptos Study Site 953

Pretoria, 0041, South Africa

Location

Receptos Study Site 755

Seville, Andalusia, 41009, Spain

Location

Receptos Study Site 761

Bilbao, Basque Country, 48013, Spain

Location

Receptos Study Site 759

Donostia / San Sebastian, Basque Country, 20014, Spain

Location

Receptos Study Site 763

Santa Cruz de Tenerife, Canary Islands, 38010, Spain

Location

Receptos Study Site 756

Barcelona, Catalonia, 08003, Spain

Location

Receptos Study Site 760

Girona, Catalonia, 17007, Spain

Location

Receptos Study Site 762

Alicante, Valencia, 03010, Spain

Location

Receptos Study Site 752

Valencia, Valencia, 46026, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Receptos Study Site 758

Barcelona, 08035, Spain

Location

Hospital Universitario Vall D hebron

Barcelona, 28040, Spain

Location

Organizacion Sanitaria Integrada Bilbao Basurto

Bilbao, 48013, Spain

Location

Hospital Universitari de Girona Dr Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Receptos Study Site 757

Madrid, 28006, Spain

Location

Receptos Study Site 751

Madrid, 28040, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, 28222, Spain

Location

Receptos Study Site 754

Majadahonda (Madrid), 28222, Spain

Location

Hospital Universitario Vírgen Macarena

Seville, 41009, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Municipal Medical & Preventive Institution Chernigiv Regional Clinical Hospital

Chernihiv, 14033, Ukraine

Location

Receptos Study Site 805

Chernihiv, 14033, Ukraine

Location

Municipal Institution Chernivtsi Regional Psychiatric Hospital

Chernivtsi, 58018, Ukraine

Location

Receptos Study Site 813

Chernivtsi, 58018, Ukraine

Location

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

Dnipropetrovsk, 49027, Ukraine

Location

Receptos Study Site 802

Dnipropetrovsk, 49027, Ukraine

Location

State Institution Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine

Dnipropetrovsk, 49027, Ukraine

Location

Receptos Study Site 815

Dnipropetrovsk, 49095, Ukraine

Location

Receptos Study Site 801

Ivano-Frankivsk, 76008, Ukraine

Location

Regional Clinical Hospital

Ivano-Frankivsk, 76008, Ukraine

Location

Receptos Study Site 814

Kharkiv, 61103, Ukraine

Location

State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya

Kharkiv, 61103, Ukraine

Location

Municipal Institution Kherson City Clinical Hospital

Kherson, 73000, Ukraine

Location

Receptos Study Site 811

Kherson, 73003, Ukraine

Location

Receptos Study Site 818

Kyiv, 03110, Ukraine

Location

Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

Kyiv, 04107, Ukraine

Location

Receptos Study Site 803

Kyiv, 04107, Ukraine

Location

Kyiv City Clinical Hospital 4

Kyiv, 3110, Ukraine

Location

Municipal Institution Lutsk City Clinical Hospital

Lutsk, 43024, Ukraine

Location

Receptos Study Site 816

Lutsk, 43024, Ukraine

Location

Receptos Study Site 817

Lutsk, 43024, Ukraine

Location

Volyn Regional Clinical Hospital

Lutsk, 43024, Ukraine

Location

Lviv Regional Clinical Hospital

Lviv, 79010, Ukraine

Location

Receptos Study Site 812

Lviv, 79010, Ukraine

Location

Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU

Odesa, 65009, Ukraine

Location

Receptos Study Site 810

Odesa, 65009, Ukraine

Location

Municipal Institution Odesa Regional Clinical Hospital

Odesa, 65025, Ukraine

Location

Receptos Study Site 804

Odesa, 65025, Ukraine

Location

Municipal Institution Vinnytsya Regional Psychoneurological Hospital na OI Yushchenko

Vinnytsia, 21005, Ukraine

Location

Receptos Study Site 809

Vinnytsia, 21005, Ukraine

Location

Municipal Institution City Clinical Hospital 6

Zaporizhzhya, 69035, Ukraine

Location

Receptos Study Site 806

Zaporizhzhya, 69035, Ukraine

Location

Receptos Study Site 965

Brighton, BN2 5BE, United Kingdom

Location

Royal Sussex County Hospital

Brighton East Sussex, BN2 5BE, United Kingdom

Location

Raigmore Hospital

Inverness, IV2 3UJ, United Kingdom

Location

Receptos Study Site 963

Inverness, IV2 3UJ, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Receptos Study Site 961

London, SE5 9RS, United Kingdom

Location

National Hospital for Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

Location

Receptos Study Site 967

London, WC1N 3BG, United Kingdom

Location

Receptos Study Site 966

Romford, RM7 0AG, United Kingdom

Location

Receptos Study Site 964

Sheffield, S10 2JF, United Kingdom

Location

Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust

Sheffield, S10 2JF, United Kingdom

Location

Related Publications (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

  RESULT

• Cohen JA, Comi G, Selmaj KW, Bar-Or A, Arnold DL, Steinman L, Hartung HP, Montalban X, Kubala Havrdova E, Cree BAC, Sheffield JK, Minton N, Raghupathi K, Huang V, Kappos L; RADIANCE Trial Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurol. 2019 Nov;18(11):1021-1033. doi: 10.1016/S1474-4422(19)30238-8. Epub 2019 Sep 3.

  PMID: 31492652 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.

  PMID: 40462564 DERIVED

MeSH Terms

Interventions

ozanimod; Interferon beta-1a

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email:

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2014
• First Posted: January 28, 2014
• Study Start: December 3, 2013
• Primary Completion: March 27, 2017
• Study Completion: April 13, 2017
• Last Updated: February 11, 2021
• Results First Posted: February 11, 2021

Record last verified: 2021-01

Locations

SE (10); BO (2); GE (6); ES (21); MO (5); IT (15); SL (4); US (35); ZA (3); HU (11); RO (10); BE (13); GR (11); CR (8); UA (32); PL (52); BU (12); GB (11); CA (2); RU (28)