Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients (RADIANCE)
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| ClinicalTrials.gov Identifier: NCT01628393 |
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Recruitment Status :
Completed
First Posted : June 26, 2012
Results First Posted : February 11, 2021
Last Update Posted : February 11, 2021
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This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734).
The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Relapsing Multiple Sclerosis | Drug: Ozanimod Drug: Placebo | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 258 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients |
| Actual Study Start Date : | September 18, 2012 |
| Actual Primary Completion Date : | April 13, 2014 |
| Actual Study Completion Date : | May 11, 2016 |
| Arm | Intervention/treatment |
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Experimental: Ozanimod 0.5 mg
Participants received ozanimod 0.5 mg oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and continue to receive ozanimod 0.5 mg weekly for another 96 weeks.
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Drug: Ozanimod
Oral capsule taken once a day
Other Names:
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Experimental: Ozanimod 1 mg
Participants received ozanimod 0.5 mg oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and continue to receive ozanimod 1 mg weekly for another 96 weeks.
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Drug: Ozanimod
Oral capsule taken once a day
Other Names:
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Placebo Comparator: Placebo
Participants received placebo to ozanimod oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and were randomized to receive ozanimod 0.5 mg or 1 mg weekly for 96 weeks.
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Drug: Ozanimod
Oral capsule taken once a day
Other Names:
Drug: Placebo Oral capsule taken once a day |
- Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24 [ Time Frame: From Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24 ]The cumulative number of total GdE lesions on MRI from Week 12 to Week 24. MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
- The Number of Gadolinium-Enhancing Lesions on Brain MRI Scan at Week 24 [ Time Frame: Week 24 ]MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
- The Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions From Week 12 to Week 24 [ Time Frame: Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24 ]
The cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions from Week 12 to Week 24.
MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
- Adjusted Annualized Relapse Rate (ARR) at Week 24 [ Time Frame: Week 24 ]
A relapse was defined as new or worsening neurological symptoms attributable to MS and preceded by a relatively stable or improving neurological state for at least 30 days. Symptoms must have persisted for > 24 hours and not be attributable to confounding clinical factors. Relapses were confirmed when accompanied by objective neurological worsening based on examination by the blinded evaluator, consistent with an increase of ≥ 0.5 on the overall EDSS score relative to the most recent EDSS assessment, or 2 points on one of the functional system scale scores, or 1 point on ≥ two functional system scale scores.
Relapse rate was calculated as the total number of confirmed relapses divided by the total number of days in the study * 365.
ARR was based on a Poisson regression model, adjusted for region, relapses within 24 months before the study, and presence of gadolinium-enhancing lesions at Baseline.
- Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period [ Time Frame: From first dose of study drug up to Week 24, or up to 28 days after the last dose for participants who did not enter the extension period. ]
An adverse event (AE) is any untoward medical occurrence that does not necessarily have a causal relationship with the investigational product (IP), including an abnormal laboratory finding, symptom or disease temporally associated with the use of an IP whether or not considered related to the IP. Serious AEs were events that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, were congenital abnormalities/birth defects, or important medical events which may have required medical intervention to prevent one of the above outcomes.
The investigator assessed the severity of AEs as mild, moderate, or severe, and the relationship of each AE to treatment as unrelated, unlikely, possible, probable, or related based on timing and other known factors such as clinical state, environment, or other therapies.
- Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure [ Time Frame: From the first dose of ozanimod, either in the placebo-controlled or the blinded extension period, up to 4 weeks after the last dose; mean duration of exposure was 25.4, 30.9, 24.6, and 32.3 months in each treatment group respectively. ]
AEs are reported from the start of the placebo-controlled period for participants originally assigned to ozanimod and from the start of the extension period for participants who switched to ozanimod after Week 24.
Serious AEs were events that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, were congenital abnormalities/birth defects, or important medical events which may have required medical intervention to prevent one of the above outcomes.
The investigator assessed the severity of AEs as mild, moderate, or severe, and the relationship of each AE to treatment based on timing and other known factors such as clinical state, environment, or other therapies.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
- Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at Baseline
Exclusion Criteria:
- Secondary or primary progressive multiple sclerosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628393
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Documents provided by Celgene:
| Responsible Party: | Celgene |
| ClinicalTrials.gov Identifier: | NCT01628393 |
| Other Study ID Numbers: |
RPC01-201-PartA 2012-002714-40 ( EudraCT Number ) |
| First Posted: | June 26, 2012 Key Record Dates |
| Results First Posted: | February 11, 2021 |
| Last Update Posted: | February 11, 2021 |
| Last Verified: | January 2021 |
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Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases |
Immune System Diseases Ozanimod Sphingosine 1 Phosphate Receptor Modulators Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |