A Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)
Sponsor:
Brief Summary:
baseline in cognitive processing speed, measured by the SDMT, in subjects with RMS treated
with ozanimod HCl 1 mg at 3 years.
All subjects will receive orally administered ozanimod HCl 1 mg. The primary efficacy
endpoint is the proportion of subjects with a clinically meaningful increase in raw score of
≥ 4 points or 10% from baseline (improved). The treatment period is 36 months. For subjects
who discontinue the study, there will be a 30-day (± 15 days) and a 90-day (± 10 days) Safety
Follow-up Visit. There is no planned protocol extension following the end of the study.
Approximately 250 subjects with RMS will be recruited for this study.
Subjects with RMS will be enrolled in this study if they have received ≤1 DMT, have an EDSS ≤
3.5, and have been diagnosed with RMS within 5 years of study entry. The Investigator will be
responsible for the overall conduct of the study at the site, confirmation of subject
eligibility, routine study subject clinical management including for MS relapses, and
management of AEs.
Criteria
Below are some criteria for inclusion. Additional Inclusion criteria apply.
1. Subject must understand and voluntarily sign an informed consent form (ICF) prior to
any study-related assessments/procedures being conducted.
2. Subject is willing and able to adhere to the study visit schedule and other protocol
requirements.
3. Subject is male or female 18 to 65 years of age (inclusive) at the time of signing of
the ICF.
4. Subject has a diagnosis of MS according to the 2010 or 2017 Revised McDonald criteria.
5. Subjects has ≤ 5 years since time of RMS diagnosis.
6. Subject has ≤ 1 approved RMS DMT at time of study entry.
Exclusion Criteria:
Following are some criteria that would exclude the subject from participation. Additional
exclusion criteria apply.
Exclusions Related to General Health
1. Subject has any clinically relevant hepatic, neurological, pulmonary,
ophthalmological, endocrine, psychiatric, or other major systemic disease making
implementation of the protocol or interpretation of the study difficult or that would
put the subject at risk by participating in the study. Subjects with mild or moderate
asthma, and subjects with other mild pulmonary disease (eg, chronic obstructive
pulmonary disease [COPD]) may be included in the study.
2. Subject has a presence of other neurologic disorders to explain the progressive
neurologic disability (as defined in the key inclusion criteria) or that might affect
cognition.
3. Subject has a visual or other sensorimotor impairment likely to confound test
performance.
4. Subject has a presence of > 10 GdE lesions on the Baseline brain MRI scan.
5. Subject has a history of developmental disorder (eg, attention-deficit/hyperactivity
disorder [ADHD], learning disability).
Locations
- Arcadia Neurology Center, Arcadia, California, United States, 91006
- Multiple Sclerosis Center of California, Newport Beach, California, United States, 92660-7608
- UC Davis Medical Center, Sacramento, California, United States, 95817
