A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 20 March 2023
• Main ID: NCT02576717
• Date of registration: 28/09/2015
• Prospective Registration: Yes
• Primary sponsor: Celgene
• 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
• Date of first enrolment: October 16, 2015
• Target sample size: 2350
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02576717
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Estonia, Georgia, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Moldova, Republic of, New Zealand, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Ukraine, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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.

Exclusion Criteria:



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: RPC1063

Primary Outcome(s)

Adverse Events (AEs) [Time Frame: Up to approximately 7 years]

Adverse events of special interest (AESIs) [Time Frame: Up to approximately 7 years]

Dependence and withdrawal assessment - Hospital Anxiety and Depression Scale (HADS) in 80 participants who discontinue study drug [Time Frame: Up to approximately 7 years]

Suicidality will be assessed in the trial [Time Frame: Up to approximately 7 years]

Dependence and withdrawal assessment - Epworth Sleepiness Scale (ESS) in 80 participants who discontinue study drug [Time Frame: Up to approximately 7 years]

Dependence and withdrawal assessment - Physician's Withdrawal Checklist (PWC-20) in 80 participants who discontinue study drug [Time Frame: Up to approximately 7 years]

Secondary Outcome(s)

Changes in other magnetic resonance imaging variables including number and volume of gadolinium-enhanced T1 lesions, volume of T2 lesions, number of new or enlarging T2 lesions, volume of unenhancing T1 lesions, number of new unenhancing T1 lesions [Time Frame: Up to approximately 7 years]

Multiple Sclerosis Quality of Life 54 [Time Frame: Up to approximately 7 years]

Proportion of patients who are free of new or enlarging T2 lesions at each visit [Time Frame: Up to approximately 7 years]

Multiple Sclerosis Functional Composite (MSFC) and MSFC plus the Low-Contrast Letter Acuity Test (LCLA)) [Time Frame: Up to approximately 7 years]

Normalized Brain Volume, Cortical Grey Matter and Thalamic Volume Loss [Time Frame: Up to approximately 7 years]

Time to onset of disability progression as defined by a sustained worsening in Expanded Disability Status Scale (EDSS) of 1.0 points or more from baseline [Time Frame: Up to approximately 7 years]

The number of gadolinium-enhanced brain magnetic resonance imaging lesions at each visit [Time Frame: Up to approximately 7 years]

Time to first relapse [Time Frame: Up to approximately 7 years]

Annualized relapse rate [Time Frame: Up to approximately 7 years]

Proportion of patients who are free of gadolinium-enhanced lesions at each visit [Time Frame: Up to approximately 7 years]

The number of new or enlarging hyperintense T2-weighted brain magnetic resonance imaging lesions at each visit [Time Frame: Up to approximately 7 years]

Secondary ID(s)

RPC01-3001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors