Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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16 May 2022 |
Main ID: |
EUCTR2015-002500-91-GR |
Date of registration:
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04/11/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
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Scientific title:
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A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study |
Date of first enrolment:
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18/11/2015 |
Target sample size:
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2496 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002500-91 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belarus
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Belgium
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Bosnia and Herzegovina
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Bulgaria
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Croatia
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Estonia
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Georgia
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Germany
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Greece
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Hungary
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Italy
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Latvia
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Lithuania
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Moldova, Republic of
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New Zealand
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Poland
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Portugal
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Romania
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Russian Federation
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Serbia
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Slovakia
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South Africa
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Spain
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Sweden
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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ClinicalTrialDisclosure
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Address:
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86 Morris Avenue
07901
NJ
United States |
Telephone:
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+19137096862 |
Email:
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ClinicalTrialDisclosure@celgene.com |
Affiliation:
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Celgene Corporation |
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Name:
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ClinicalTrialDisclosure
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Address:
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86 Morris Avenue
07901
NJ
United States |
Telephone:
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+19137096862 |
Email:
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ClinicalTrialDisclosure@celgene.com |
Affiliation:
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Celgene Corporation |
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Key inclusion & exclusion criteria
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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 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.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. 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: Patients that have a condition that would require withdrawal from one of the parent trials (RPC01-201 or RPC01-301)
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Relapsing Multiple Sclerosis MedDRA version: 20.0
Level: PT
Classification code 10048393
Term: Multiple sclerosis relapse
System Organ Class: 10029205 - Nervous system disorders
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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Product Name: 0.25mg RPC1063 Product Code: RPC1063 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod HCI Current Sponsor code: RPC1063 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25-
Product Name: 1.0mg RPC1063 Product Code: RPC1063 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod HCI Current Sponsor code: RPC1063 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0-
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Primary Outcome(s)
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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 (see Protocol Section 12.4.2 for the complete list of AESIs). Exploratory measurements of immune response (eg, anti-SARS-CoV-2 serology) will be assessed from blood samples collected at trial visits and end of treatment, and the potential association between these measurements and selected endpoints related to safety and/or efficacy. 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 assessment 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 (atrophy) on brain magnetic resonance imaging scans from Baseline at each visit -Change in Multiple Sclerosis Functional Composite score from Baseline at each visit (including the Low-Contrast Letter Acuity Test measurement of visual function as a component) -Change in Multiple Sclerosis Quality of Life 54 score from Baseline at each visit -Changes in other magnetic resonance imaging variables including but not limited to, 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
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Main Objective: To characterize the long-term safety and tolerability of RPC1063 in patients with relapsing multiple sclerosis.
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Secondary Objective: To characterize the long-term efficacy of RPC1063 in patients with relapsing multiple sclerosis.
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Timepoint(s) of evaluation of this end point: Every 3 month visit, every 6 Month Visit for subjects who have completed their 3rd annual visit, follow-up visit and during the unscheduled relapse visit if applicable
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: N/A
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Secondary end point(s): None
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Secondary ID(s)
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RPC01-3001
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2015-002500-91-HU
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Source(s) of Monetary Support
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Celgene International II Sàrl (CIS II)
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Ethics review
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Status: Approved
Approval date: 12/11/2015
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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