Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients

NCT01628393 | Completed Phase 2 Results DMC

• 2 other identifiers: RPC01-201-PartA2012-002714-40
• Study Type: interventional
• Target: 258
• Locations: 13 countries
• Sites: 58

Brief Summary

This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734). The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).

Conditions

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24

  The cumulative number of total GdE lesions on MRI from Week 12 to Week 24. MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.

  From Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24

Secondary Outcomes (5)

• The Number of Gadolinium-Enhancing Lesions on Brain MRI Scan at Week 24

  Week 24

• The Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions From Week 12 to Week 24

  Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24

• Adjusted Annualized Relapse Rate (ARR) at Week 24

  Week 24

• Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period

  From first dose of study drug up to Week 24, or up to 28 days after the last dose for participants who did not enter the extension period.

• Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure

  From the first dose of ozanimod, either in the placebo-controlled or the blinded extension period, up to 4 weeks after the last dose; mean duration of exposure was 25.4, 30.9, 24.6, and 32.3 months in each treatment group respectively.

Study Arms (3)

Ozanimod 0.5 mg

EXPERIMENTAL

Participants received ozanimod 0.5 mg oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and continue to receive ozanimod 0.5 mg weekly for another 96 weeks.

Drug: Ozanimod

Ozanimod 1 mg

EXPERIMENTAL

Participants received ozanimod 0.5 mg oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and continue to receive ozanimod 1 mg weekly for another 96 weeks.

Drug: Ozanimod

Placebo

PLACEBO COMPARATOR

Participants received placebo to ozanimod oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and were randomized to receive ozanimod 0.5 mg or 1 mg weekly for 96 weeks.

Drug: Ozanimod; Drug: Placebo

Interventions

Ozanimod DRUG

Oral capsule taken once a day

Also known as: RPC1063, Zeposia®

Ozanimod 0.5 mg; Ozanimod 1 mg; Placebo

Placebo DRUG

Oral capsule taken once a day

Placebo

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:

• Secondary or primary progressive multiple sclerosis

Sponsors & Collaborators

• Celgene: lead

Study Sites (58)

Alta Bates Summit Medical Center

Berkeley, California, 94705, United States

Location

Neuro Pain Medical Center

Fresno, California, 93710, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, 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

The Polyclinic

Seattle, Washington, 98104, United States

Location

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

Location

Centre Hospitalier Chretien Clinique Saint Joseph

Montegnée, 4420, Belgium

Location

Clinique Saint-Pierre

Ottignies, 1340, Belgium

Location

University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

Sofia, 1431, Bulgaria

Location

Sarajishvili Institute of Neurology

Tbilisi, 0112, Georgia

Location

LTD MediClubGeorgia

Tbilisi, 0160, Georgia

Location

Khechinashvili University Hospital

Tbilisi, 0179, Georgia

Location

Evaggelismos General Hospital

Athens, 10676, Greece

Location

401 Military Hospital of Athens

Athens, 11525, Greece

Location

Georgios Papanikolaou General Hospital of Thessaloniki

Thessaloniki, 57010, Greece

Location

Vaszary Kolos Korhaz

Esztergom, 2500, Hungary

Location

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

Cantania, 95123, Italy

Location

Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi

Czeladź, 41-250, Poland

Location

Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego

Grudziądz, 86-300, Poland

Location

Novo-Med Zielinski i wsp. Sp.J.

Katowice, 40-650, Poland

Location

NEURO- CARE Site Management Organization Gabriela Klodowska-Duda

Katowice, 40-749, Poland

Location

NEURO MEDIC Janusz Zbrojkiewicz

Katowice, 40-752, 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

Centrum Neurologii Krzysztof Selmaj

Lódzkie, 90-324, Poland

Location

Prof. dr med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny

Lublin, 20-718, 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

Niepubliczny Zaklad Opieki Zdrowotnej KENDRON

Podlaskie, 15-402, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy

Poznan, 61-853, Poland

Location

EUROMEDIS Sp. z.o.o.

Szczecin, 70-111, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski

Warminsko-mazurskie, 10-443, Poland

Location

Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej

Warsaw, 00-739, Poland

Location

Wojskowy Instytut Medyczny

Warsaw, 00-909, Poland

Location

Centralny Szpital Kliniczny MSWIA

Warsaw, 02-507, Poland

Location

Instytut Psychiatrii i Neurologii

Warsaw, 02-957, Poland

Location

Health Club Medical Center S.R.L.

Campulung Muscel, 115100, Romania

Location

Colentina Clinical Hospital

Cluj-Napoca, 400001, Romania

Location

Rehabilitation Clinical Hospital

Cluj-Napoca, 400347, Romania

Location

Timisoara Emergency County Clinical Hospital

Timișoara, 300736, Romania

Location

Republican Clinical Hospital for Rehabilitation Treatment

Kazan', 420021, Russia

Location

Research Medical Complex Vashe Zdorovie

Kazan', 420097, Russia

Location

City Clinical Hospital 4

Saransk, 430032, 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

Clinical Hospital Centre Zemun

Belgrade, 11080, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Hospital Donostia

Donostia / San Sebastian, 20014, 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

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

Dnipropetrovsk, 49027, Ukraine

Location

Regional Clinical Hospital

Ivano-Frankivsk, 76008, Ukraine

Location

State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya

Kharkiv, 61103, Ukraine

Location

Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

Kyiv, 04107, Ukraine

Location

Volyn Regional Clinical Hospital

Lutsk, 43024, Ukraine

Location

Municipal Institution Vinnytsya Regional Psychoneurological Hospital na OI Yushchenko

Vinnytsia, 21005, Ukraine

Location

Related Publications (2)

• Cohen JA, Arnold DL, Comi G, Bar-Or A, Gujrathi S, Hartung JP, Cravets M, Olson A, Frohna PA, Selmaj KW; RADIANCE Study Group. Safety and efficacy of the selective sphingosine 1-phosphate receptor modulator ozanimod in relapsing multiple sclerosis (RADIANCE): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2016 Apr;15(4):373-81. doi: 10.1016/S1474-4422(16)00018-1. Epub 2016 Feb 12.

  PMID: 26879276 RESULT

• Cohen JA, Comi G, Arnold DL, Bar-Or A, Selmaj KW, Steinman L, Havrdova EK, Cree BA, Montalban X, Hartung HP, Huang V, Frohna P, Skolnick BE, Kappos L; RADIANCE Trial Investigators. Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extension of a randomized phase II study. Mult Scler. 2019 Aug;25(9):1255-1262. doi: 10.1177/1352458518789884. Epub 2018 Jul 25.

  PMID: 30043658 RESULT

MeSH Terms

Interventions

ozanimod

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 2
• 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: June 22, 2012
• First Posted: June 26, 2012
• Study Start: September 18, 2012
• Primary Completion: April 13, 2014
• Study Completion: May 11, 2016
• Last Updated: February 11, 2021
• Results First Posted: February 11, 2021

Record last verified: 2021-01

Locations

GE (3); GR (3); US (6); PL (19); SE (5); BE (3); BU (1); RO (4); IT (1); ES (2); UA (7); HU (1); RU (3)