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

Relapsing Multiple Sclerosis Clinical Trial

— RADIANCE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628393
• Other study ID #: RPC01-201-PartA
• Secondary ID: 2012-002714-40
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 18, 2012
• Est. completion date: May 11, 2016

Study information

• Verified date: January 2021
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: May 11, 2016
• Est. primary completion date: April 13, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Secondary or primary progressive multiple sclerosis

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Ozanimod
Oral capsule taken once a day
• Placebo
Oral capsule taken once a day

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St-Luc	Brussels
Belgium	Centre Hospitalier Chretien Clinique Saint Joseph	Montegnee
Belgium	Clinique Saint-Pierre	Ottignies
Bulgaria	University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD	Sofia
Georgia	Khechinashvili University Hospital	Tbilisi
Georgia	LTD MediClubGeorgia	Tbilisi
Georgia	Sarajishvili Institute of Neurology	Tbilisi
Greece	401 Military Hospital of Athens	Athens
Greece	Evaggelismos General Hospital	Athens
Greece	Georgios Papanikolaou General Hospital of Thessaloniki	Thessaloniki
Hungary	Vaszary Kolos Korhaz	Esztergom
Italy	Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele	Cantania
Poland	Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi	Czeladz
Poland	Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego	Grudziadz
Poland	NEURO MEDIC Janusz Zbrojkiewicz	Katowice
Poland	NEURO- CARE Site Management Organization Gabriela Klodowska-Duda	Katowice
Poland	Novo-Med Zielinski i wsp. Sp.J.	Katowice
Poland	RESMEDICA Spolka z o.o.	Kielce
Poland	Centrum Kompleksowej Rehabilitacji Sp.z.o.o. Szpital Wielospecjalistyczny	Konstancin Jeziorna
Poland	Centrum Neurologii Krzysztof Selmaj	Lódzkie
Poland	Prof. dr med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny	Lublin
Poland	Wojewodzki Szpital Specjalistyczny	Olsztyn
Poland	Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska	Plewiska
Poland	Niepubliczny Zaklad Opieki Zdrowotnej KENDRON	Podlaskie
Poland	Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy	Poznan
Poland	EUROMEDIS Sp. z.o.o.	Szczecin
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski	Warminsko-mazurskie
Poland	Centralny Szpital Kliniczny MSWIA	Warsaw
Poland	Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Warsaw
Poland	Instytut Psychiatrii i Neurologii	Warszawa
Poland	Wojskowy Instytut Medyczny	Warszawa
Romania	Health Club Medical Center S.R.L.	Campulung
Romania	Rehabilitation Clinical Hospital	Cluj-Napoca
Romania	Colentina Clinical Hospital	Napoca
Romania	Timisoara Emergency County Clinical Hospital	Timisoara
Russian Federation	Republican Clinical Hospital for Rehabilitation Treatment	Kazan
Russian Federation	Research Medical Complex Vashe Zdorovie	Kazan
Russian Federation	City Clinical Hospital 4	Saransk
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Clinical Hospital Centar Zvezdara	Belgrade
Serbia	Clinical Hospital Centre Zemun	Belgrade
Serbia	Military Medical Academy	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac
Spain	Hospital Donostia	San Sebastian
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Ukraine	Municipal Medical & Preventive Institution Chernigiv Regional Clinical Hospital	Chernigiv
Ukraine	Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov	Dnipropetrovsk
Ukraine	Regional Clinical Hospital	Ivano Frankivsk
Ukraine	State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya	Kharkiv
Ukraine	Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital	Kyiv
Ukraine	Volyn Regional Clinical Hospital	Lutsk
Ukraine	Municipal Institution Vinnytsya Regional Psychoneurological Hospital na OI Yushchenko	Vinnytsya
United States	Neurology and Neuroscience Associates Inc.	Akron	Ohio
United States	Alta Bates Summit Medical Center	Berkeley	California
United States	The Neurological Institute PA	Charlotte	North Carolina
United States	Neuro Pain Medical Center	Fresno	California
United States	University of California Davis Medical Center	Sacramento	California
United States	The Polyclinic	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Georgia,  Greece,  Hungary,  Italy,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  Ukraine, 

References & 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 (RADIAN — View Citation

Cohen JA, Comi G, Arnold DL, Bar-Or A, Selmaj KW, Steinman L, Havrdová EK, Cree BA, Montalbán X, Hartung HP, Huang V, Frohna P, Skolnick BE, Kappos L; RADIANCE Trial Investigators. Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extens — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Week 24
Secondary	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.	Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24
Secondary	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.	Week 24
Secondary	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.	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.
Secondary	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.	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.