AzTrials
AzTrials

Relapsing Multiple SclerosisPhase 3RADIANCENCT02047734

Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis

A Phase 3 study testing Ozanimod and Interferon beta-1a in people with Relapsing Multiple Sclerosis, run by Celgene at 299 sites in 21 countries.

Completed

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

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Relapsing 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
1,320 participants
Where
299 sitesin 21 countries
Study dates
3 Dec 2013to 13 Apr 2017
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
  • Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at baseline

Who cannot join

  • Primary progressive multiple sclerosis

Trial locations and contacts

299 sites in 21 countries.

299 sites in 21 countries

Poland52 sites

  • Receptos Study Site 401

    Bialystok, 15-402

  • Receptos Study Site 423

    Bydgoszcz, 85-654

  • Specjalistyczna Praktyka Lekarska Lek Med Robert Bonek

    Bydgoszcz, 85-654

  • Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi

    Czeladź, 41-250

  • Receptos Study Site 406

    Czeladź, 41-250

  • Receptos Study Site 405

    Gdansk, 80-083

  • Receptos Study Site 425

    Gdansk, 80-299

  • Copernicus PL Sp. z. o.o.

    Gdansk, 80-803

  • NEUROMEDIC Janusz Zbrojkiewicz

    Katowice, 40-555

  • MA LEK AM Maciejowscy SC Centrum Terapii SM

    Katowice, 40-595

  • Receptos Study Site 427

    Katowice, 40-595

  • NovoMed Zielinski i Wspolnicy Spolka Jawna

    Katowice, 40-650

  • Receptos Study Site 426

    Katowice, 40-650

  • NEUROCARE Site Management Organization Gabriela KlodowskaDuda

    Katowice, 40-749

  • Receptos Study Site 407

    Katowice, 40-749

  • Receptos Study Site 417

    Katowice, 40-752

  • Receptos Study Site 424

    Kielce, 25-726

  • RESMEDICA Spolka z o.o.

    Kielce, 25-726

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

    Konstancin-Jeziorna, 05-510

  • Receptos Study Site 404

    Konstancin-Jeziorna, 05-510

  • Krakowska Akademia Neurologii Sp. z. o.o.

    Krakow, 31-305

  • Receptos Study Site 414

    Krakow, 31-305

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 93-121

  • Receptos Study Site 411

    Lodz, 93-121

  • Prof. dr med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny

    Lublin, 20-718

  • Receptos Study Site 412

    Lublin, 20-718

  • Receptos Study Site 420

    Lublin, 20-718

  • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego

    Lublin, 20-718

  • Receptos Study Site 402

    Olsztyn, 10-443

  • Receptos Study Site 415

    Olsztyn, 10-561

  • Wojewodzki Szpital Specjalistyczny

    Olsztyn, 10-561

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

    Plewiska, 62-064

  • Receptos Study Site 421

    Plewiska, 62-064

  • Niepubliczny Zaklad Opieki Zdrowotnej KENDRON

    Podlaskie, 15-402

  • Indywidualna Specjalistyczna Praktyka Lekarska dr nmed Monika Lyczak

    Pomorskie, 80-299

  • Receptos Study Site 408

    Poznan, 60-355

  • Szpital Kliniczny im HSwiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu

    Poznan, 60-355

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

    Poznan, 61-853

  • Receptos Study Site 418

    Poznan, 61-853

  • EUROMEDIS Sp. z.o.o.

    Szczecin, 70-111

  • Receptos Study Site 419

    Szczecin, 70-111

  • Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski

    Warminsko-mazurskie, 10-443

  • Receptos Study Site 410

    Warsaw, 00-739

  • Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej

    Warsaw, 00-739

  • Centrum Medyczne NeuroProtect

    Warsaw, 01-697

  • Receptos Study Site 428

    Warsaw, 01-697

  • Centralny Szpital Kliniczny MSW w Warszawie

    Warsaw, 02-507

  • Receptos Study Site 422

    Warsaw, 02-507

  • Instytut Psychiatrii i Neurologii

    Warsaw, 02-957

  • Receptos Study Site 403

    Warsaw, 02-957

  • Receptos Study Site 413

    Warsaw, 04-141

  • Wojskowy Instytut Medyczny

    Warsaw, 04-141

Other trials in Poland

United States35 sites

  • Neurology and Neuroscience Associates Inc.

    Akron, Ohio, 44320

  • Receptos Study Site 107

    Akron, Ohio, 44320

  • Alta Bates Summit Medical Center

    Berkeley, California, 94705

  • Receptos Study Site 110

    Berkeley, California, 94705

  • Receptos Study Site 101

    Charlotte, North Carolina, 28204

  • The Neurological Institute PA

    Charlotte, North Carolina, 28204

  • Receptos Study Site 104

    Cleveland, Ohio, 44195

  • Denver Neurological Research LLC

    Denver, Colorado, 80210

  • Receptos Study Site 127

    Denver, Colorado, 80210

  • West Georgia Sleep Disorder Center and Neurology Associates

    Douglasville, Georgia, 30134

  • Receptos Study Site 122

    Long Beach, California, 90806

  • Neurology Associates PA

    Maitland, Florida, 32751

  • Receptos Study Site 114

    Maitland, Florida, 32751

  • Consultants In Neurology

    Northbrook, Illinois, 60062

  • Receptos Study Site 113

    Northbrook, Illinois, 60062

  • Receptos Study Site 109

    Philadelphia, Pennsylvania, 19104

  • Receptos Study Site 115

    Phoenix, Arizona, 85004

  • Xenoscience

    Phoenix, Arizona, 85004

  • Receptos Study Site 118

    Phoenix, Arizona, 85013

  • Saint Josephs Hosptial and Medical Center

    Phoenix, Arizona, 85013

  • Receptos Study Site 124

    Pompano Beach, Florida, 33060

  • Neurostudies Inc

    Port Charlotte, Florida, 33952

  • Receptos Study Site 123

    Port Charlotte, Florida, 33952

  • Receptos Study Site 112

    Sacramento, California, 95817

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Multiple Sclerosis Center at UCSF

    San Francisco, California, 94158

  • Receptos Study Site 120

    San Francisco, California, 94158

  • Receptos Study Site 102

    Seattle, Washington, 98104

  • The Polyclinic

    Seattle, Washington, 98104

  • Receptos Study Site 121

    St Louis, Missouri, 63110

  • Washington University

    St Louis, Missouri, 63110

  • Infinity Clinical Research LLC

    Sunrise, Florida, 33351

  • Receptos Study Site 125

    Tacoma, Washington, 98405

  • Territory Neurology and Research Institute

    Tucson, Arizona, 85704

  • Receptos Study Site 119

    Tucson, Arizona, 85741

Other trials in United States

Ukraine32 sites

  • Municipal Medical & Preventive Institution Chernigiv Regional Clinical Hospital

    Chernihiv, 14033

  • Receptos Study Site 805

    Chernihiv, 14033

  • Municipal Institution Chernivtsi Regional Psychiatric Hospital

    Chernivtsi, 58018

  • Receptos Study Site 813

    Chernivtsi, 58018

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

    Dnipropetrovsk, 49027

  • Receptos Study Site 802

    Dnipropetrovsk, 49027

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

    Dnipropetrovsk, 49027

  • Receptos Study Site 815

    Dnipropetrovsk, 49095

  • Receptos Study Site 801

    Ivano-Frankivsk, 76008

  • Regional Clinical Hospital

    Ivano-Frankivsk, 76008

  • Receptos Study Site 814

    Kharkiv, 61103

  • State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya

    Kharkiv, 61103

  • Municipal Institution Kherson City Clinical Hospital

    Kherson, 73000

  • Receptos Study Site 811

    Kherson, 73003

  • Receptos Study Site 818

    Kyiv, 03110

  • Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

    Kyiv, 04107

  • Receptos Study Site 803

    Kyiv, 04107

  • Kyiv City Clinical Hospital 4

    Kyiv, 3110

  • Municipal Institution Lutsk City Clinical Hospital

    Lutsk, 43024

  • Receptos Study Site 816

    Lutsk, 43024

  • Receptos Study Site 817

    Lutsk, 43024

  • Volyn Regional Clinical Hospital

    Lutsk, 43024

  • Lviv Regional Clinical Hospital

    Lviv, 79010

  • Receptos Study Site 812

    Lviv, 79010

  • Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU

    Odesa, 65009

  • Receptos Study Site 810

    Odesa, 65009

  • Municipal Institution Odesa Regional Clinical Hospital

    Odesa, 65025

  • Receptos Study Site 804

    Odesa, 65025

  • Municipal Institution Vinnytsya Regional Psychoneurological Hospital na OI Yushchenko

    Vinnytsia, 21005

  • Receptos Study Site 809

    Vinnytsia, 21005

  • Municipal Institution City Clinical Hospital 6

    Zaporizhzhya, 69035

  • Receptos Study Site 806

    Zaporizhzhya, 69035

Other trials in Ukraine

Russia28 sites

  • Chelyabinsk City Clinical Hospital 3

    Chelyabinsk, 454136

  • Receptos Study Site 701

    Chelyabinsk, 454136

  • Receptos Study Site 704

    Kazan', 420021

  • Republican Clinical Hospital for Rehabilitation Treatment

    Kazan', 420021

  • Receptos Study Site 713

    Kazan', 420101

  • Research Medical Complex Vashe Zdorovie

    Kazan', 420101

  • Central Clinical Hospital 2 na NA Semashko OAO RZhD

    Moscow, 107150

  • Receptos Study Site 712

    Moscow, 107150

  • City Clinical Hospital 1 na NIPirogov

    Moscow, 119049

  • Receptos Study Site 709

    Moscow, 119049

  • City neurology center Sibneuromed LLC

    Novosibirsk, 630091

  • Receptos Study Site 703

    Novosibirsk, 630091

  • Perm State Medical Academy

    Perm, 614990

  • Receptos Study Site 710

    Perm, 614990

  • Receptos Study Site 708

    Saint Petersburg, 194044

  • Russian Medical Military Academy na SMKirov

    Saint Petersburg, 194044

  • Receptos Study Site 716

    Samara, 443095

  • Samara Regional Clinical Hospital named after MI Kalinin

    Samara, 443095

  • City Clinical Hospital 4

    Saransk, 430032

  • Receptos Study Site 715

    Saransk, 430032

  • Receptos Study Site 714

    Saratov, 410012

  • Saratov State Medical University

    Saratov, 410054

  • Receptos Study Site 707

    Smolensk, 214018

  • Smolensk State Medical Academy

    Smolensk, 214018

  • Receptos Study Site 717

    Tyumen, 625000

  • Neftyanik Medical and Sanitary Unit

    Tyumen, 625048

  • Receptos Study Site 711

    Yaroslavl, 150030

  • Yaroslavl Clinical Hospital 8

    Yaroslavl, 150030

Other trials in Russia

Spain21 sites

  • Receptos Study Site 762

    Alicante, Valencia, 03010

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Receptos Study Site 756

    Barcelona, Catalonia, 08003

  • Hospital del Mar

    Barcelona, 08003

  • Receptos Study Site 758

    Barcelona, 08035

  • Hospital Universitario Vall D hebron

    Barcelona, 28040

  • Receptos Study Site 761

    Bilbao, Basque Country, 48013

  • Organizacion Sanitaria Integrada Bilbao Basurto

    Bilbao, 48013

  • Receptos Study Site 759

    Donostia / San Sebastian, Basque Country, 20014

  • Receptos Study Site 760

    Girona, Catalonia, 17007

  • Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Receptos Study Site 757

    Madrid, 28006

  • Receptos Study Site 751

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • Receptos Study Site 754

    Majadahonda (Madrid), 28222

  • Receptos Study Site 763

    Santa Cruz de Tenerife, Canary Islands, 38010

  • Receptos Study Site 755

    Seville, Andalusia, 41009

  • Hospital Universitario Vírgen Macarena

    Seville, 41009

  • Receptos Study Site 752

    Valencia, Valencia, 46026

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

Italy15 sites

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania, 95123

  • Receptos Study Site 654

    Catania, 95123

  • Fondazione Istituto San Raffaele G Giglio di Cefalu

    Cefalù, 90015

  • Receptos Study Site 653

    Cefalù, 90015

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Receptos Study Site 655

    Milan, 20122

  • Receptos Study Site 652

    Milan, 20132

  • Presidio Ospedaliero di Montichiari

    Montichiari, 25018

  • Receptos Study Site 659

    Montichiari, 25018

  • Receptos Study Site 656

    Naples

  • Receptos Study Site 658

    Pavia, 27100

  • Fondazione PTV Policlinico Tor Vergata

    Roma, 00133

  • Receptos Study Site 651

    Roma, 00133

  • Azienda Ospedaliera Universitaria Senese

    Siena, 53100

  • Receptos Study Site 657

    Siena, 53100

Other trials in Italy

Belarus13 sites

  • Grodno Clinical Regional Hospital

    Grodno, 230017

  • Receptos Study Site 907

    Grodno, 230017

  • Gomel Regional Clinical Hospital

    Homyel, 246029

  • Receptos Study Site 904

    Homyel, 246029

  • Minsk Municipal Clinical Hospital 5

    Minsk, 220026

  • Receptos Study Site 902

    Minsk, 220026

  • Receptos Study Site 901

    Minsk, 220114

  • Republican Scientific and Practical Centre of Neurology and Neurosurgery

    Minsk, 220114

  • Minsk City Clinical Hospital 9

    Minsk, 220116

  • Receptos Study Site 903

    Minsk, 220116

  • Receptos Study Site 905

    Vitebsk, 210023

  • Vitebsk Regional Diagnostic Centre

    Vitebsk, 210023

  • Receptos Study Site 906

    Vitebsk, 210037

Other trials in Belarus

Bulgaria12 sites

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

    Sofia, 1113

  • Receptos Study Site 453

    Sofia, 1113

  • Receptos Study Site 454

    Sofia, 1113

  • Receptos Study Site 452

    Sofia, 1309

  • Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia

    Sofia, 1407

  • Receptos Study Site 456

    Sofia, 1407

  • Receptos Study Site 457

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

    Sofia, 1431

  • Receptos Study Site 451

    Sofia, 1527

  • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD

    Sofia, 1527

  • Receptos Study Site 455

    Sofia, 1606

Other trials in Bulgaria

Greece11 sites

  • Evaggelismos General Hospital

    Athens, 10676

  • Receptos Study Site 552

    Athens, 10676

  • Receptos Study Site 554

    Athens, 10676

  • Navy Hospital of Athens

    Athens, 115 21

  • Receptos Study Site 553

    Athens, 11521

  • 401 Military Hospital of Athens

    Athens, 11525

  • Receptos Study Site 551

    Athens, 11525

  • AHEPA University General Hospital of Thessaloniki

    Thessaloniki, 546 36

  • Receptos Study Site 557

    Thessaloniki, 54636

  • Georgios Papanikolaou General Hospital of Thessaloniki

    Thessaloniki, 57010

  • Receptos Study Site 555

    Thessaloniki, 57010

Other trials in Greece

Hungary11 sites

  • Receptos Study Site 352

    Budapest, 1145

  • Uzsoki Utcai Korhaz

    Budapest, 1145

  • Jahn Ferenc DelPesti Korhaz es Rendelointezet

    Budapest, 1204

  • Receptos Study Site 356

    Budapest, 1204

  • Receptos Study Site 354

    Esztergom, 2500

  • Vaszary Kolos Korhaz

    Esztergom, 2500

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2143

  • Receptos Study Site 358

    Kistarcsa, 2143

  • Receptos Study Site 351

    Nyíregyháza, 4400

  • SzabolcsSzatmarBereg Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400

  • Receptos Study Site 355

    Székesfehérvár, 8000

Other trials in Hungary

United Kingdom11 sites

  • Receptos Study Site 965

    Brighton, BN2 5BE

  • Royal Sussex County Hospital

    Brighton East Sussex, BN2 5BE

  • Raigmore Hospital

    Inverness, IV2 3UJ

  • Receptos Study Site 963

    Inverness, IV2 3UJ

  • Kings College Hospital

    London, SE5 9RS

  • Receptos Study Site 961

    London, SE5 9RS

  • National Hospital for Neurology and Neurosurgery

    London, WC1N 3BG

  • Receptos Study Site 967

    London, WC1N 3BG

  • Receptos Study Site 966

    Romford, RM7 0AG

  • Receptos Study Site 964

    Sheffield, S10 2JF

  • Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust

    Sheffield, S10 2JF

Other trials in United Kingdom

Romania10 sites

  • Clinical Hospital of Psychiatry and Neurology Brasov

    Brasov, 500123

  • Receptos Study Site 503

    Brasov, 500123

  • Health Club Medical Center S.R.L.

    Campulung Muscel, 115100

  • Receptos Study Site 502

    Campulung Muscel, 115100

  • Receptos Study Site 501

    Cluj-Napoca, 400347

  • Rehabilitation Clinical Hospital

    Cluj-Napoca, 400347

  • Receptos Study Site 505

    Sibiu, 550166

  • Sibiu Emergency County Clinical Hospital

    Sibiu, 550166

  • Receptos Study Site 506

    Timișoara, 300736

  • Timisoara Emergency County Clinical Hospital

    Timișoara, 300736

Other trials in Romania

Serbia10 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Hospital Centar Zvezdara

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Receptos Study Site 602

    Belgrade, 11000

  • Receptos Study Site 603

    Belgrade, 11000

  • Receptos Study Site 604

    Belgrade, 11000

  • Clinical Hospital Centre Zemun

    Belgrade, 11080

  • Receptos Study Site 601

    Belgrade, 11080

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Receptos Study Site 605

    Kragujevac, 34000

Other trials in Serbia

Belgium8 sites

  • AZ Sint-Jan AV Brugge

    Bruges, 8000

  • Receptos Study Site 256

    Bruges, 8000

  • Cliniques Universitaires St Luc

    Brussels, 1200

  • Receptos Study Site 255

    Brussels, 1200

  • Centre Hospitalier Chretien Clinique Saint Joseph

    Montegnée, 4420

  • Receptos Study Site 252

    Montegnée, 4420

  • Clinique Saint Pierre

    Ottignies, 1340

  • Receptos Study Site 254

    Ottignies, 1340

Other trials in Belgium

Croatia8 sites

  • Clinical Hospital Center Osijek

    Osijek, 31000

  • Receptos Study Site 923

    Osijek, 31000

  • Receptos Study Site 921

    Zagreb, 10 000

  • Receptos Study Site 922

    Zagreb, 10 000

  • Receptos Study Site 924

    Zagreb, 10 000

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

    Zagreb, 10000

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000

  • Clinical Hospital Sveti duh

    Zagreb, 10000

Other trials in Croatia

Georgia6 sites

  • Receptos Study Site 301

    Tbilisi, 0112

  • LTD MediClubGeorgia

    Tbilisi, 0160

  • Receptos Study Site 302

    Tbilisi, 0160

  • Khechinashvili University Hospital

    Tbilisi, 0179

  • Receptos Study Site 303

    Tbilisi, 0179

  • Sarajishvili Institute of Neurology

    Tbilisi, 112

Other trials in Georgia

Moldova5 sites

  • IMSP Institutul de Medicina Urgenta

    Chisinau, 2004

  • Receptos Study Site 932

    Chisinau, 2004

  • Institutul de Neurologie si Neurochirurgie

    Chisinau, 2028

  • Receptos Study Site 931

    Chisinau, 2028

  • Receptos Study Site 933

    Chisinau, 2028

Other trials in Moldova

Slovakia4 sites

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

    Bratislava, 833 05

  • Receptos Study Site 946

    Bratislava, 83305

  • Receptos Study Site 942

    Lučenec, 984 01

  • Receptos Study Site 945

    Trnava, 917 75

Other trials in Slovakia

South Africa3 sites

  • Receptos Study Site 956

    KwaZulu-Natal, 4321

  • Neurology Practice

    Pretoria, 0040

  • Receptos Study Site 953

    Pretoria, 0041

Other trials in South Africa

Bosnia and Herzegovina2 sites

  • Clinical Center University of Sarajevo

    Sarajevo, 71000

  • Receptos Study Site 911

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Canada2 sites

  • University of Alberta MS Clinic

    Edmonton, Alberta, T6G 2G3

  • Receptos Study Site 154

    Edmonton, Alberta, T6G2B7

Other trials in Canada

About this study

Official title: A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients

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).

Read the detailed description

This clinical trial (RPC01-201; RADIANCE) consisted of 2 parts, each reported separately on ClinicalTrials.gov: Part A (NCT01628393) and Part B (this record).

Part A was a phase 2 study in which two doses of ozanimod were administered daily for 24 weeks with an efficacy and safety comparison to a placebo control and is reported separately as ClinicalTrials.gov record NCT01628393.

Part B, reported herein, was a phase 3 study in which two doses of ozanimod were administered daily for a 24 month period compared to an active control, interferon β-1a. Participants were allowed to enroll in the open-label extension study RPC01-3001 (NCT02576717) or complete the study with a safety follow-up visit 28 days after their last dose of study treatment.

Being tested
Ozanimod, Ozanimod placebo, Interferon beta-1a, Interferon beta-1a placebo

What participants receive

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

  • OzanimodDrug

    Also called RPC1063, Zeposia®

    Oral capsule, daily for 24 months

  • Ozanimod placeboDrug

    Oral capsule, daily for 24 months

  • Interferon beta-1aDrug

    Also called Avonex

    Intramuscular injection, 30 µg, weekly for 24 months

  • Interferon beta-1a placeboDrug

    Intramuscular injection, weekly for 24 months

Study groups in NCT02047734
Study groupRoleWhat they receive
Ozanimod 0.5 mgExperimentalOzanimod 0.5 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.
Receives: Drug: Ozanimod; Drug: Interferon beta-1a placebo
Ozanimod1 mgExperimentalOzanimod 1 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.
Receives: Drug: Ozanimod; Drug: Interferon beta-1a placebo
Interferon β-1aActive comparatorinterferon 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.
Receives: Drug: Ozanimod placebo; Drug: 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) 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.

    Measured: At the end of month 24

Secondary outcomes (10)

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

    The adjusted mean 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 24 months. MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.

    The adjusted mean per scan over 24 months was based based on a negative binomial regression model using observed data, adjusted for region (Eastern Europe vs. Rest of the World), age at Baseline, and Baseline number of GdE lesions. The natural log transformation of the number of available MRI scans over 24 months is used as an offset term.

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

  2. Adjusted Mean Number of Gadolinium Enhancing Brain Lesions at Month 24

    MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.

    The number of gadolinium-enhancing (GdE) lesions at 24 months was analyzed based on observed data using a negative binomial regression model adjusted for region (Eastern Europe vs Rest of World), Baseline age, and Baseline number of GdE lesions, with natural log transformation of number of available MRI scans over 24 months as an offset term (1 scan for per participant).

    Measured: Month 24

  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 24-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 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 24-month treatment period

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

    Participants were considered lesion free at Month 24 if they did not show evidence of GdE lesions at the Month 24 MRI scan.

    MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.

    Measured: Month 24

  6. Percentage of Participants Who Were New or Enlarging T2 Lesion-Free at Month 24

    MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.

    Measured: Month 24

  7. Percent Change From Baseline in Normalized Brain Volume to Month 24

    Brain volume (a measure of brain atrophy) was measured by brain MRI scans that were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.

    Measured: Baseline and Month 24

  8. Change From Baseline to Month 24 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 24

  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 24

  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), including an abnormal laboratory finding, symptom or disease temporally associated with the use of an IP whether or not considered related to the IP. Serious AEs were events that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, were congenital abnormalities/birth defects, or important medical events which may have required medical intervention to prevent one of the above outcomes.

    The investigator assessed the severity of AEs as mild, moderate, or severe and the relationship of each AE to treatment as unrelated, unlikely, possible, probable, or related based on timing and other known factors such as clinical state, environment, or other therapies.

    Measured: From the first dose of study drug up to the first dose of the open-label extension study RPC01-3001, or up to 28 days after last dose for participants who did not continue into the open-label extension study; median duration of treatment was 24 months.

Timeline

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

  1. First posted28 Jan 2014 (estimated)
  2. Study start3 Dec 2013
  3. Primary completion27 Mar 2017
  4. Study completion13 Apr 2017

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
1,320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02047734
Sponsor's protocol ID
RPC01-201-PartB
Other IDs
2012-002714-40
Acronym
RADIANCE
Status last verified
Jan 2021
First submitted
26 Jan 2014
Last updated
11 Feb 2021
Data monitoring committee
Yes

Publications

  • 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

  • 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.

    PubMed 31492652

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ozanimod and Interferon beta-1a in people with Relapsing Multiple Sclerosis, run by Celgene at 299 sites in 21 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 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 299 sites in Poland, United States, Ukraine, Russia, Spain and 16 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 11 Feb 2021). 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) at the End of Month 24 (time frame: At the end of month 24). 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 NCT02047734, which also lists 3 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 11 Feb 2021.

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