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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02576717




Registration number
NCT02576717
Ethics application status
Date submitted
28/09/2015
Date registered
15/10/2015
Date last updated
30/01/2024

Titles & IDs
Public title
A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
Scientific title
A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients
Secondary ID [1] 0 0
RPC01-3001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RPC1063

Experimental: 1 mg RPC1063 (Ozanimod) oral capsule - 1 mg RPC1063 (Ozanimod) oral capsule daily


Treatment: Drugs: RPC1063
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Experiencing Adverse Events (AEs)
Timepoint [1] 0 0
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Primary outcome [2] 0 0
Number of Participants Experiencing Serious Adverse Events (SAEs)
Timepoint [2] 0 0
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Primary outcome [3] 0 0
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Timepoint [3] 0 0
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Primary outcome [4] 0 0
Number of Participants Experiencing Adverse Events (AEs) Leading to Withdrawal
Timepoint [4] 0 0
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Primary outcome [5] 0 0
Number of Participants Experiencing Adverse Events (AEs) of Special Interest
Timepoint [5] 0 0
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Primary outcome [6] 0 0
Number of Participants With Abnormalities in Blood Absolute Lymphocyte Count (ALC)
Timepoint [6] 0 0
From first dose up until last dose of study treatment (up to approximately 82 months)
Primary outcome [7] 0 0
Number of Participants With Abnormalities in White Blood Cell Count (WBC)
Timepoint [7] 0 0
From first dose up until last dose of study treatment (up to approximately 82 months)
Primary outcome [8] 0 0
Number of Participants With Abnormalities in Blood Absolute Neutrophil Count (ANC)
Timepoint [8] 0 0
From first dose up until last dose of study treatment (up to approximately 82 months)
Primary outcome [9] 0 0
Number of Participants With Abnormalities in Specific Liver Function Tests
Timepoint [9] 0 0
From first dose up until last dose of study treatment (up to approximately 82 months)
Primary outcome [10] 0 0
Number of Participants With Electrocardiogram (ECG) Result Abnormalities
Timepoint [10] 0 0
From first dose to 28-days post last dose (an average of 63 months up to a max of 83 months)
Primary outcome [11] 0 0
Number of Participants With Clinically Relevant Abnormalities in Vital Signs
Timepoint [11] 0 0
At baseline and 60 months after first dose of study therapy
Primary outcome [12] 0 0
Number of Participants With Physical Examination Abnormalities
Timepoint [12] 0 0
At baseline and every 12 months thereafter up until 84 months post first dose.
Primary outcome [13] 0 0
Number of Participants Self-Identifying Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)
Timepoint [13] 0 0
At baseline and every 3 months thereafter up until 78 months post first dose.
Primary outcome [14] 0 0
Number of Participants With Changes in Suicidality From Last Day on Treatment Per the Columbia-Suicide Severity Rating Scale (C-SSRS)
Timepoint [14] 0 0
1, 4, 7, 14, 21, 28, and 90 days post last dose.
Primary outcome [15] 0 0
Change in Physician's Withdrawal Checklist (PWC-20) Total Score From Last Day on Treatment
Timepoint [15] 0 0
1, 4, 7, 14, 21, and 90 days post last dose.
Primary outcome [16] 0 0
Change in Hospital Anxiety and Depression Scale (HADS) Score From Last Day on Treatment
Timepoint [16] 0 0
1, 4, 7, 14, 21, and 90 days post last dose.
Primary outcome [17] 0 0
Changes in Epworth Sleepiness Scale (ESS) Score From Last Day on Treatment
Timepoint [17] 0 0
1, 4, 7, 14, 21, and 90 days post last dose.
Primary outcome [18] 0 0
Changes in Vital Sign Values From Last Day on Treatment
Timepoint [18] 0 0
1, 4, 7, 14, 21, 28, and 90 days post last dose.
Secondary outcome [1] 0 0
Annualized Relapse Rate (ARR)
Timepoint [1] 0 0
From first dose up until last dose of study treatment or data-cutoff date, whichever occurred first (up to approximately 87 months)
Secondary outcome [2] 0 0
Time to First Relapse (TFR)
Timepoint [2] 0 0
Overall: From first dose to first relapse, last dose, or data-cutoff date, whichever occurred first (up to approx 87 months); Visits: 2 weeks post first dose, 3 months post first dose, and every 3 months thereafter up until 81 months post first dose.
Secondary outcome [3] 0 0
Number of Participants Who Were Relapse Free
Timepoint [3] 0 0
From first dose to last dose of study treatment or data-cutoff date, whichever occurred first (up to approximately 87 months)
Secondary outcome [4] 0 0
Average Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions Per Scan at Each Visit
Timepoint [4] 0 0
At 12 months post first dose and every 12 months thereafter up until 72 months post first dose.
Secondary outcome [5] 0 0
Average Number of Gadolinium-Enhanced (GdE) Brain MRI Lesions Per Scan at Each Visit
Timepoint [5] 0 0
At baseline and every 12 months thereafter up until 72 months post first dose.
Secondary outcome [6] 0 0
Time to Onset of Disability Progression as Defined by a Sustained Worsening in Expanded Disability Status Scale (EDSS)
Timepoint [6] 0 0
At 3 and 6 months post first dose.
Secondary outcome [7] 0 0
Number of Participants Free of Gadolinium-Enhanced (GdE) Brain Lesions at Each Visit
Timepoint [7] 0 0
At baseline and every 12 months thereafter up until 72 months post first dose.
Secondary outcome [8] 0 0
Number of Participants Free of New or Enlarging T2 Lesions at Each Visit
Timepoint [8] 0 0
At baseline and every 12 months thereafter up until 72 months post first dose.
Secondary outcome [9] 0 0
Percent Change in Normalized Brain Volume (Atrophy) on Brain MRI Scans From Baseline at Each Visit
Timepoint [9] 0 0
At baseline and every 12 months thereafter up until approximately 87 months post first dose.
Secondary outcome [10] 0 0
Change in Multiple Sclerosis Functional Composite (MSFC) Score From Baseline at Each Applicable Visit
Timepoint [10] 0 0
At baseline and every 12 months thereafter up until 84 months post first dose.
Secondary outcome [11] 0 0
Change in Multiple Sclerosis Quality of Life 54 Score From Baseline at Each Applicable Visit
Timepoint [11] 0 0
At baseline and every 12 months thereafter up until 84 months post first dose.
Secondary outcome [12] 0 0
Change From Baseline in Volume of Gadolinium Enhanced T1 Lesions
Timepoint [12] 0 0
At baseline and every 12 months thereafter up until 72 months post first dose.
Secondary outcome [13] 0 0
Change From Baseline in Volume of T2 Lesions
Timepoint [13] 0 0
At baseline and every 12 months thereafter up until 72 months post first dose.
Secondary outcome [14] 0 0
Change From Baseline in Volume of Unenhancing T1 Lesions
Timepoint [14] 0 0
At baseline and every 12 months thereafter up until 72 months post first dose.
Secondary outcome [15] 0 0
Cumulative Number of New Unenhancing T1 Lesions
Timepoint [15] 0 0
At baseline and every 12 months thereafter up until 72 months post first dose.

Eligibility
Key inclusion criteria
Eligibility Criteria:

To be eligible to participate in this trial, patients must meet all of the following
criteria:

1. Completed one of the parent trials

2. Does not have a condition that would require withdrawal from one of the parent trials

3. Has no conditions requiring treatment with a prohibited concomitant medication

4. Is not receiving treatment with any of the following drugs or interventions within the
corresponding timeframe:

At Baseline (Day 1)

- CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg, rifampicin)
Two weeks prior to Baseline (Day 1)

- Monoamine oxidase inhibitors (eg, selegiline, phenelzine)

5. Ability to provide written informed consent and to be compliant with the schedule of
protocol assessments

6. Female patients of childbearing potential:

Must agree to practice a highly effective method of contraception throughout the study
until completion of the 90-day Safety Follow-up Visit. Highly effective methods of
contraception are those that alone or in combination result in a failure rate of a Pearl
index of less than 1% per year when used consistently and correctly.

Acceptable methods of birth control in this study are the following:

- Combined hormonal (estrogen and progestogen containing) contraception, which may be
oral, intravaginal, or transdermal

- Progestogen-only hormonal contraception associated with inhibition of ovulation, which
may be oral, injectable, or implantable

- Placement of an intrauterine device (IUD)

- Placement of an intrauterine hormone-releasing system (IUS)

- Bilateral tubal occlusion

- Vasectomised partner

- Sexual abstinence.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/01/2023
Sample size
Target
Accrual to date
Final
2494
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Nevada
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Belarus
State/province [11] 0 0
Gomel
Country [12] 0 0
Belarus
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Grodno
Country [13] 0 0
Belarus
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Minsk
Country [14] 0 0
Belarus
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Vitebsk
Country [15] 0 0
Belgium
State/province [15] 0 0
Brugge
Country [16] 0 0
Belgium
State/province [16] 0 0
Bruxelles
Country [17] 0 0
Belgium
State/province [17] 0 0
Montegnee
Country [18] 0 0
Bosnia and Herzegovina
State/province [18] 0 0
Banja Luka
Country [19] 0 0
Bosnia and Herzegovina
State/province [19] 0 0
Sarajevo
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Sofia
Country [21] 0 0
Croatia
State/province [21] 0 0
Osijek
Country [22] 0 0
Croatia
State/province [22] 0 0
Zagreb
Country [23] 0 0
Estonia
State/province [23] 0 0
Tallinn
Country [24] 0 0
Estonia
State/province [24] 0 0
Tartu
Country [25] 0 0
Georgia
State/province [25] 0 0
Tbilisi
Country [26] 0 0
Germany
State/province [26] 0 0
Leipzig
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Germany
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Potsdam
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Germany
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Ulm
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Greece
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Athens
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Greece
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Thessaloniki
Country [31] 0 0
Hungary
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Budapest
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Hungary
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Esztergom
Country [33] 0 0
Hungary
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Kistarcsa
Country [34] 0 0
Hungary
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Nyiregyhaza
Country [35] 0 0
Italy
State/province [35] 0 0
Catania
Country [36] 0 0
Italy
State/province [36] 0 0
Cefalu
Country [37] 0 0
Italy
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Milan
Country [38] 0 0
Italy
State/province [38] 0 0
Montichiari
Country [39] 0 0
Italy
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Roma
Country [40] 0 0
Latvia
State/province [40] 0 0
Riga
Country [41] 0 0
Lithuania
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Kauno Apskritis
Country [42] 0 0
Lithuania
State/province [42] 0 0
Klaipeda
Country [43] 0 0
Moldova, Republic of
State/province [43] 0 0
Chisinau
Country [44] 0 0
New Zealand
State/province [44] 0 0
Christchurch
Country [45] 0 0
New Zealand
State/province [45] 0 0
Hamilton
Country [46] 0 0
Poland
State/province [46] 0 0
Mazowieckie
Country [47] 0 0
Poland
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Bialystok
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Poland
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Bydgoszcz
Country [49] 0 0
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Czeladz
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Gdansk
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Jaroslaw
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Katowice
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Kielce
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Konstancin Jeziorna
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Krakow
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Lublin
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Lódzkie
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Olsztyn
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Plewiska
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Pomorskie
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Poznan
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Rybnik
Country [63] 0 0
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Rzeszow
Country [64] 0 0
Poland
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Szczecin
Country [65] 0 0
Poland
State/province [65] 0 0
Warminsko-mazurskie
Country [66] 0 0
Poland
State/province [66] 0 0
Warsaw
Country [67] 0 0
Poland
State/province [67] 0 0
Warszawa
Country [68] 0 0
Portugal
State/province [68] 0 0
Braga
Country [69] 0 0
Portugal
State/province [69] 0 0
Coimbra
Country [70] 0 0
Portugal
State/province [70] 0 0
Torres Vedras
Country [71] 0 0
Romania
State/province [71] 0 0
Brasov
Country [72] 0 0
Romania
State/province [72] 0 0
Bucharest
Country [73] 0 0
Romania
State/province [73] 0 0
Campulung
Country [74] 0 0
Romania
State/province [74] 0 0
Cluj Napoca
Country [75] 0 0
Romania
State/province [75] 0 0
Cluj-Napoca
Country [76] 0 0
Romania
State/province [76] 0 0
Constanta
Country [77] 0 0
Romania
State/province [77] 0 0
Timisoara
Country [78] 0 0
Serbia
State/province [78] 0 0
Belgrade
Country [79] 0 0
Serbia
State/province [79] 0 0
Kragujevac
Country [80] 0 0
Serbia
State/province [80] 0 0
Nis
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Slovakia
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Bratislava
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Slovakia
State/province [82] 0 0
Lucenec
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Slovakia
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Trnava
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South Africa
State/province [84] 0 0
Pretoria
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Spain
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Barcelona
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Spain
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Bilbao
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Spain
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Girona
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
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Pamplona/ Navarra
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Spain
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San Sebastian
Country [92] 0 0
Spain
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Sant Joan Despí
Country [93] 0 0
Spain
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Sevillla
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Spain
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Valencia
Country [95] 0 0
Sweden
State/province [95] 0 0
Goteborg
Country [96] 0 0
Ukraine
State/province [96] 0 0
Cherkasy
Country [97] 0 0
Ukraine
State/province [97] 0 0
Chernihiv
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Ukraine
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Chernivtsi
Country [99] 0 0
Ukraine
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Dnipropetrovsk
Country [100] 0 0
Ukraine
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Ivano Frankivsk
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Ukraine
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Ivano-Frankivsk
Country [102] 0 0
Ukraine
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Kharkiv
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Ukraine
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Kherson
Country [104] 0 0
Ukraine
State/province [104] 0 0
Kyiv
Country [105] 0 0
Ukraine
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Lutsk
Country [106] 0 0
Ukraine
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Lviv
Country [107] 0 0
Ukraine
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Odesa
Country [108] 0 0
Ukraine
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Poltava
Country [109] 0 0
Ukraine
State/province [109] 0 0
Uzhhorod
Country [110] 0 0
Ukraine
State/province [110] 0 0
Vinnytsia
Country [111] 0 0
Ukraine
State/province [111] 0 0
Zaporizhia
Country [112] 0 0
Ukraine
State/province [112] 0 0
Zaporizhzhia
Country [113] 0 0
Ukraine
State/province [113] 0 0
Zaporizhzhya
Country [114] 0 0
Ukraine
State/province [114] 0 0
Zhytomyr
Country [115] 0 0
United Kingdom
State/province [115] 0 0
East Sussex
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Inverness
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with
relapsing multiple sclerosis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02576717
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT02576717