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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02576717
Ethics application status
Date submitted
28/09/2015
Date registered
15/10/2015
Date last updated
3/06/2019

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
Safety and tolerability of RPC1063 in patients with RMS as assessed by evaluation of adverse events - Safety as assessed by evaluation of adverse events
Timepoint [1] 0 0
Up to 5 years

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 (oestrogen 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

Male patients:

Must agree to use a latex condom during sexual contact with women of childbearing potential
while participating in the study for at least 75 days after treatment discontinuation.

All patients:

Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus
interruptus), spermicides only, and lactational amenorrhoea method (LAM) are not acceptable
methods of contraception. Female condom and male condom should not be used together.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Arizona
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Kherson
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Poltava
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Uzhhorod
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Vinnytsia
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Ukraine
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Zaporizhia
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Zaporizhzhia
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Zaporizhzhya
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Ukraine
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Zhytomyr
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United Kingdom
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East Sussex
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United Kingdom
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Inverness
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United Kingdom
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London
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United Kingdom
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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/show/NCT02576717
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Sheffield, MD, MBA, MS
Address 0 0
Celgene
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

Summary results
Other publications