Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

This is a multicenter, longitudinal, single-arm, open-label study to describe the change from 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 all subjects who finish the subject and for those who discontinue, 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.

Official Title

A Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)

Keywords

Multiple Sclerosis RPC-1063 Ozanimod Phase 3b Sclerosis Administration of RPC-1063

Eligibility

You can join if…

Open to people ages 18-65

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.

You CAN'T join if...

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

  • UC Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • SC3 Research - Pasadena accepting new patients
    Pasadena California 91105 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
Sign up for this study
ID
NCT04140305
Phase
Phase 3
Study Type
Interventional
Last Updated