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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002500-91-PL

Enrollment

2496

Registered

2015-12-01

Start date

2016-01-20

Completion date

Unknown

Last updated

2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Multiple Sclerosis MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: 0.25mg RPC1063 Product Code: RPC1063 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod HCl Current Sponsor code: RPC1063 Concentration unit: mg milligram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: To be eligible to participate in this trial, patients must meet all of the following criteria: 1. Completed one of the parent trials: RPC01-201 or RPC01-301 2. Does not have a condition that would require withdrawal from one of the parent trials (RPC01-201 or RPC01-301) 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) 4. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments 5. 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 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2496 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients that have a condition that would require withdrawal from one of the parent trials (RPC01-201 or RPC01-301)

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Safety Endpoints Safety and tolerability will be characterized in this trial by the incidence, relationship, and type of adverse events, serious adverse events, and adverse events leading to withdrawal from the trial; the incidence, relationship, and type of laboratory abnormalities; vital signs; electrocardiogram results; and physical examination abnormalities. Suicidality (Columbia-Suicide Severity Rating Scale) will be assessed in the trial. In addition, descriptive characterization will be provided for adverse events of special interest including bradycardia and heart conduction abnormalities (electrocardiogram and vital signs), pulmonary effects (forced expiratory volume at 1 second, forced vital capacity, and diffusing capacity of the lung for carbon monoxide measurements), macular edema (optical coherence tomography), hepatic effects (liver function tests), serious or opportunistic infections, and malignancy. In addition, dependence and withdrawal symptoms will be assessed in at least 80 evaluable patients who discontinue study drug using the following assessments: PWC-20, HADS, ESS, vital signs and the C-SSRS. Changes from last on-study-drug assemssment for each withdrawal scale (PWC-20, HADS, ESS, C-SSRS and vital signs) to post study drug Day 1, 4,7,14,21, and 90 will be summarized. Efficacy Endpoints - Annualized relapse rate - Time to first relapse - The number of new or enlarging hyperintense T2-weighted brain magnetic resonance imaging lesions at each visit - The number of gadolinium-enhanced brain magnetic resonance imaging lesions at each visit -Time to onset of disability progression as defined by a sustained worsening in Expanded Disability Status Scale of 1.0 points or more, confirmed after 3 months and after 6 months -Proportion of patients who are free of gadolinium-enhanced lesions at each visit - Proportion of patients who are free of new or enlarging T2 lesions at each visit - Percent change in normalized brain volume	—

Measure

Time frame

Primary end point(s): Safety Endpoints Safety and tolerability will be characterized in this trial by the incidence, relationship, and type of adverse events, serious adverse events, and adverse events leading to withdrawal from the trial; the incidence, relationship, and type of laboratory abnormalities; vital signs; electrocardiogram results; and physical examination abnormalities. Suicidality (Columbia-Suicide Severity Rating Scale) will be assessed in the trial. In addition, descriptive characterization will be provided for adverse events of special interest including bradycardia and heart conduction abnormalities (electrocardiogram and vital signs), pulmonary effects (forced expiratory volume at 1 second, forced vital capacity, and diffusing capacity of the lung for carbon monoxide measurements), macular edema (optical coherence tomography), hepatic effects (liver function tests), serious or opportunistic infections, and malignancy. In addition, dependence and withdrawal symptoms will be assessed in at least 80 evaluable patients who discontinue study drug using the following assessments: PWC-20, HADS, ESS, vital signs and the C-SSRS. Changes from last on-study-drug assemssment for each withdrawal scale (PWC-20, HADS, ESS, C-SSRS and vital signs) to post study drug Day 1, 4,7,14,21, and 90 will be summarized. Efficacy Endpoints - Annualized relapse rate - Time to first relapse - The number of new or enlarging hyperintense T2-weighted brain magnetic resonance imaging lesions at each visit - The number of gadolinium-enhanced brain magnetic resonance imaging lesions at each visit -Time to onset of disability progression as defined by a sustained worsening in Expanded Disability Status Scale of 1.0 points or more, confirmed after 3 months and after 6 months -Proportion of patients who are free of gadolinium-enhanced lesions at each visit - Proportion of patients who are free of new or enlarging T2 lesions at each visit - Percent change in normalized brain volume

—

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: N/A	—

Countries

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

Contacts

Public ContactClinicalTrialDisclosure

Celegene Corporation

ClinicalTrialDisclosure@ppdi.com+19137096862

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026