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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9 January 2017 |
Main ID: |
EUCTR2014-002320-27-BG |
Date of registration:
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21/01/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis.
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Scientific title:
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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:
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19/03/2015 |
Target sample size:
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1346 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002320-27 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Double-Dummy
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
Number of treatment arms in the trial: 3
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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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Austria
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Belarus
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Bosnia and Herzegovina
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Brazil
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Bulgaria
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Canada
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Croatia
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Czech Republic
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Estonia
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Georgia
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Germany
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Hungary
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Latvia
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Lithuania
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Moldova, Republic of
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Netherlands
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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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South Africa
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Spain
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Sweden
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Switzerland
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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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PPD Project Manager
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Address:
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3900 Paramount Parkway
NC 27560-7200
Morrisville
United States |
Telephone:
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+1919763 9382 |
Email:
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Peggy.Cooley@ppdi.com |
Affiliation:
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PPD |
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Name:
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PPD Project Manager
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Address:
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3900 Paramount Parkway
NC 27560-7200
Morrisville
United States |
Telephone:
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+1919763 9382 |
Email:
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Peggy.Cooley@ppdi.com |
Affiliation:
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PPD |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. MS, as diagnosed by the revised 2010 McDonald criteria
2. Exhibiting a relapsing clinical course consistent with RMS and history of brain MRI lesions consistent with MS
3. Ages 18-55 years, inclusive
4. EDSS score between 0 and 5.0 at baseline
5. Meet one of the following disease activity criteria:
o At least 1 documented relapse within the last 12 months prior to screening
OR
o At least 1 documented relapse occurred within the last 24 months prior to screening and documented evidence of at least 1 GdE lesion on brain MRI within the last 12 months prior to randomization
6. No history of relapse with onset from 30 days prior to screening until randomization; during this period, patients must have been clinically stable, without systemic corticosteroid treatment or adrenocorticotrophic hormone (ACTH)
7. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
8. Patients of reproduction potential (males and females) must practice an acceptable method of birth control (acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, vasectomy, or double-barrier method [condom or diaphragm with spermicide]) during study participation and for 30 days after their last dose of treatment of study medication or true sexual abstinence (periodic abstinence [calendar, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
9. Patients must have documentation of positive Varicella zoster virus (VZV) IgG antibody status or complete VZV vaccination at least 30 days prior to randomization 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 1346 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1. Primary progressive MS at screening
2. Disease duration of more than 15 years in patients with an EDSS =2.0
3. Contraindications to MRI or Gadolinium contrast, such as known allergy to Gadolinium contrast dyes, renal insufficiency, claustrophobia, body size incompatible with the scanner, pacemaker, cochlear implants, intracranial vascular clips
4. Incompatibility with beta IFN use (e.g. intolerable side effects)
5. Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (ß-hCG) measured during screening
6. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the patient at risk by participating in the study in the opinion of treating investigator
7. Specific cardiac conditions are excluded, including history or presence of:
i. Recent (within the last 6 months) occurrence of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, Class III/IV heart failure, sick sinus syndrome, or severe untreated sleep apnea
ii. Prolonged QTcF interval (QTcF >450 msec males, >470 msec females), or at additional risk for QT prolongation (e.g., hypokalemia, hypomagnesemia, congenital long-QT syndrome, concurrent therapy with QT-prolonging drugs)
iii. Patients with other pre-existing stable cardiac conditions who have not been cleared for the study by an appropriate cardiac evaluation by a cardiologist
iv. Other clinically significant conduction abnormalities or any other significant cardiac condition that could jeopardize a patient’s health or put them at significant safety risk during the course of the study in the opinion of treating investigator
8. Resting heart rate less than 55 bpm at Screening
9. Diabetes mellitus type 1, or uncontrolled diabetes mellitus type 2 with hemoglobin A1c >9% , or diabetic patients with significant co-morbid conditions such as retinopathy or nephropathy
10. History of uveitis
11. Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis [TB] or atypical mycobacterial disease [but excluding fungal infection of nail beds, minor upper respiratory tract infections [URTI] and minor skin infections]) or any major episode of infection that required hospitalization or treatment with IV antibiotics within 30 days of screening or oral antibiotics within 14 days prior to screening
12. History or known presence of recurrent or chronic infection; recurring urinary tract infections could be allowed
13. History of cancer, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved)
14. Suicide attempts in the past or current signs of major depression
15. History of alcohol or drug abuse within 1 year prior to randomization
16. History of or currently active primary or secondary immunodeficiency
17. Prior use of any investigational agent within 6 months prior to enrollment
18. Receipt of a live vaccine within 4 weeks prior to randomization
19. Non-lymphocyte-depleting disease-modifying MS agents must be discontinued from signing of informed consent
20. Previous treatment with lymphocyte-depleting therapies
21. Treatment with other immunosuppressant agents such as azathioprine, cyclosporine, methotrexa
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: 19.0
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 Other descriptive name: RPC1063 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
Product Name: 0.5mg RPC1063 Product Code: RPC1063 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Current Sponsor code: RPC1063 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
Product Name: 1.0mg RPC1063 Product Code: RPC1063 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Current Sponsor code: RPC1063 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
Trade Name: Avonex Product Name: Avonex Pharmaceutical Form: Solution for injection INN or Proposed INN: Interferon beta-1a CAS Number: 220581-49-7 Other descriptive name: INTERFERON BETA-1A Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramuscular use
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Primary Outcome(s)
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Primary end point(s): • Annual relapse rate (ARR) during the treatment period
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Secondary Objective: • To assess the effect of RPC1063 on the proportion of patients with new/enlarging T2 lesions at Month 12 • To evaluate whether the efficacy of RPC1063 is superior to IFN ß-1a in delaying the accumulation of disability, as assessed by the Multiple Sclerosis Functional Composite (MSFC) and visual function as measured by the low-contrast letter acuity test (LCLA) • To evaluate whether the efficacy of RPC1063 is superior to IFN ß-1a in delaying The accumulation of disability, as assessed by the Expanded Disability Status Scale (EDSS) • To assess the effect of RPC1063 on brain atrophy over 12 months • To evaluate the effect of RPC1063 on patient-reported quality of life as assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) • To assess the safety and tolerability of RPC1063 in patients with RMS
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Timepoint(s) of evaluation of this end point: Please see Section E.5.1 above
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Main Objective: To assess whether the clinical efficacy of RPC1063 is superior to interferon (IFN) ß-1a (Avonex®) in reducing the rate of clinical relapses in patients with RMS.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Please see Section E.5.2 above
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Secondary end point(s): • The number of new or enlarging hyperintense T2-weighted brain MRI lesions over 12 months
• The number of GdE brain MRI lesions at Month 12
• Time to onset of disability progression as defined by a sustained worsening in EDSS of 1.0 points or more, confirmed after 3 months and after 6 months
• Proportion of patients who are GdE lesion-free at Month 12
• Proportion of patients who are new or enlarging T2 lesion-free at Month12
• The percent change in normalized brain volume (atrophy) on brain MRI scans from Baseline to Month 12
• Change in MSFC score from Baseline to Month 12 (including the Low-Contrast Letter Acuity Test [LCLA] measurement of visual function as a component)
• Change in MSQOL-54 score from Baseline to Month 12
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Secondary ID(s)
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NCT01628393
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RPC01-301
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2014-002320-27-EE
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Source(s) of Monetary Support
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Celgene International II Sàrl (CIS II)
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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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