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Relapsing Multiple SclerosisPhase 2/3RADIANCENCT01628393

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

A Phase 2/3 study testing Ozanimod in people with Relapsing Multiple Sclerosis, run by Celgene at 58 sites in 13 countries.

Completed

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

Official record
Search all trials

Trial summary

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… 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
258 participants
Where
58 sitesin 13 countries
Study dates
18 Sep 2012to 11 May 2016
Phase
Phase 2/3
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

  • Secondary or primary progressive multiple sclerosis

Trial locations and contacts

58 sites in 13 countries.

58 sites in 13 countries

Poland19 sites

  • Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi

    Czeladź, 41-250

  • Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego

    Grudziądz, 86-300

  • Novo-Med Zielinski i wsp. Sp.J.

    Katowice, 40-650

  • NEURO- CARE Site Management Organization Gabriela Klodowska-Duda

    Katowice, 40-749

  • NEURO MEDIC Janusz Zbrojkiewicz

    Katowice, 40-752

  • RESMEDICA Spolka z o.o.

    Kielce, 25-726

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

    Konstancin-Jeziorna, 05-510

  • Centrum Neurologii Krzysztof Selmaj

    Lódzkie, 90-324

  • Prof. dr med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny

    Lublin, 20-718

  • Wojewodzki Szpital Specjalistyczny

    Olsztyn, 10-561

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

    Plewiska, 62-064

  • Niepubliczny Zaklad Opieki Zdrowotnej KENDRON

    Podlaskie, 15-402

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

    Poznan, 61-853

  • EUROMEDIS Sp. z.o.o.

    Szczecin, 70-111

  • Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski

    Warminsko-mazurskie, 10-443

  • Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej

    Warsaw, 00-739

  • Wojskowy Instytut Medyczny

    Warsaw, 00-909

  • Centralny Szpital Kliniczny MSWIA

    Warsaw, 02-507

  • Instytut Psychiatrii i Neurologii

    Warsaw, 02-957

Other trials in Poland

Ukraine7 sites

  • Municipal Medical & Preventive Institution Chernigiv Regional Clinical Hospital

    Chernihiv, 14033

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

    Dnipropetrovsk, 49027

  • Regional Clinical Hospital

    Ivano-Frankivsk, 76008

  • State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya

    Kharkiv, 61103

  • Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

    Kyiv, 04107

  • Volyn Regional Clinical Hospital

    Lutsk, 43024

  • Municipal Institution Vinnytsya Regional Psychoneurological Hospital na OI Yushchenko

    Vinnytsia, 21005

Other trials in Ukraine

United States6 sites

  • Neurology and Neuroscience Associates Inc.

    Akron, Ohio, 44320

  • Alta Bates Summit Medical Center

    Berkeley, California, 94705

  • The Neurological Institute PA

    Charlotte, North Carolina, 28204

  • Neuro Pain Medical Center

    Fresno, California, 93710

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • The Polyclinic

    Seattle, Washington, 98104

Other trials in United States

Serbia5 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Hospital Centar Zvezdara

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Hospital Centre Zemun

    Belgrade, 11080

  • Clinical Center Kragujevac

    Kragujevac, 34000

Other trials in Serbia

Romania4 sites

  • Health Club Medical Center S.R.L.

    Campulung Muscel, 115100

  • Colentina Clinical Hospital

    Cluj-Napoca, 400001

  • Rehabilitation Clinical Hospital

    Cluj-Napoca, 400347

  • Timisoara Emergency County Clinical Hospital

    Timișoara, 300736

Other trials in Romania

Belgium3 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • Centre Hospitalier Chretien Clinique Saint Joseph

    Montegnée, 4420

  • Clinique Saint-Pierre

    Ottignies, 1340

Other trials in Belgium

Georgia3 sites

  • Sarajishvili Institute of Neurology

    Tbilisi, 0112

  • LTD MediClubGeorgia

    Tbilisi, 0160

  • Khechinashvili University Hospital

    Tbilisi, 0179

Other trials in Georgia

Greece3 sites

  • Evaggelismos General Hospital

    Athens, 10676

  • 401 Military Hospital of Athens

    Athens, 11525

  • Georgios Papanikolaou General Hospital of Thessaloniki

    Thessaloniki, 57010

Other trials in Greece

Russia3 sites

  • Republican Clinical Hospital for Rehabilitation Treatment

    Kazan', 420021

  • Research Medical Complex Vashe Zdorovie

    Kazan', 420097

  • City Clinical Hospital 4

    Saransk, 430032

Other trials in Russia

Spain2 sites

  • Hospital Donostia

    Donostia / San Sebastian, 20014

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

Bulgaria1 site

  • University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

    Sofia, 1431

Other trials in Bulgaria

Hungary1 site

  • Vaszary Kolos Korhaz

    Esztergom, 2500

Other trials in Hungary

Italy1 site

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Cantania, 95123

Other trials in Italy

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 (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).

Being tested
Ozanimod, 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 taken once a day

  • PlaceboDrug

    Oral capsule taken once a day

Study groups in NCT01628393
Study groupRoleWhat they receive
Ozanimod 0.5 mgExperimentalParticipants 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.
Receives: Drug: Ozanimod
Ozanimod 1 mgExperimentalParticipants 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.
Receives: Drug: Ozanimod
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Ozanimod; Drug: Placebo

What is being measured

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

  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.

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

Secondary outcomes (5)

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

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

    Measured: Week 24

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

    The cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions 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.

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

  3. Adjusted Annualized Relapse Rate (ARR) at Week 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.

    ARR was based on a Poisson regression model, adjusted for region, relapses within 24 months before the study, and presence of gadolinium-enhancing lesions at Baseline.

    Measured: Week 24

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

    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 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.

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

    AEs are reported from the start of the placebo-controlled period for participants originally assigned to ozanimod and from the start of the extension period for participants who switched to ozanimod after Week 24.

    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 based on timing and other known factors such as clinical state, environment, or other therapies.

    Measured: 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.

Timeline

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

  1. First posted26 Jun 2012 (estimated)
  2. Study start18 Sep 2012
  3. Primary completion13 Apr 2014
  4. Study completion11 May 2016

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01628393
Sponsor's protocol ID
RPC01-201-PartA
Other IDs
2012-002714-40
Acronym
RADIANCE
Status last verified
Jan 2021
First submitted
22 Jun 2012
Last updated
11 Feb 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26879276

  • 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.

    PubMed 30043658

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ozanimod in people with Relapsing Multiple Sclerosis, run by Celgene at 58 sites in 13 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 58 sites in Poland, Ukraine, United States, Serbia, Romania and 8 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24 (time frame: From Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 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 NCT01628393, which also lists 2 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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