Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063) (ENLIGHTEN)

Celgene

Status and phase: Active, not recruiting; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: RPC-1063

Study type: Interventional

Funder types: Industry

Identifiers

NCT04140305

RPC-1063-MS-001

U1111-1240-5667 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion 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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Administration of RPC-1063

Experimental group

Description:

Patients with relapsing MS will receive RPC-1063 orally:

Treatment:

Drug: RPC-1063