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

NCT04140305 | Terminated Phase 3 FDA Drug

• 2 other identifiers: RPC-1063-MS-001U1111-1240-5667
• Study Type: interventional
• Target: 188
• Locations: 3 countries
• Sites: 61

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; RPC-1063; Ozanimod; Phase 3b

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with an increase in raw score of ≥ 4 points or 10% from baseline (improved)

  Symbol Digit Modalities Test

  Up to approximately 3 years

Secondary Outcomes (20)

• Proportion of subjects with a decrease in raw score of ≥ 4 points or 10% from baseline (worsened)

  Up to approximately 3 years

• Proportion of subjects with a raw score change from baseline who do not meet the improved or worsened definition (stable)

  Up to approximately 3 years

• Proportion of subjects with an increase in raw score of ≥ 3 points from baseline

  Up to approximately 3 years

• Proportion of subjects with a decrease in raw score of ≥ 3 points from baseline

  Up to approximately 3 years

• Change from baseline in Symbol Digit Modalities Test (SMDT)

  Up to approximately 3 years

Study Arms (1)

Administration of RPC-1063

EXPERIMENTAL

Patients with relapsing MS will receive RPC-1063 orally:

Drug: RPC-1063

Interventions

RPC-1063 DRUG

Oral capsule

Also known as: Ozanimod

Administration of RPC-1063

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
• Subject is male or female 18 to 65 years of age (inclusive) at the time of signing of the ICF.
• Subject has a diagnosis of MS according to the 2010 or 2017 Revised McDonald criteria.
• Subjects has ≤ 5 years since time of RMS diagnosis.
• Subject has ≤ 1 approved RMS DMT at time of study entry.

You may not qualify if:

• 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.
• Subject has a visual or other sensorimotor impairment likely to confound test performance.
• Subject has a presence of \> 10 GdE lesions on the Baseline brain MRI scan.
• Subject has a history of developmental disorder (eg, attention-deficit/hyperactivity disorder \[ADHD\], learning disability).

Sponsors & Collaborators

• Celgene: lead

Study Sites (61)

Local Institution - 123

Birmingham, Alabama, 35209, United States

Location

Local Institution - 136

Cullman, Alabama, 35058, United States

Location

Local Institution - 153

Mobile, Alabama, 36617, United States

Location

Local Institution - 162

Phoenix, Arizona, 85018, United States

Location

Local Institution - 128

Pasadena, California, 91105, United States

Location

Local Institution - 164

Sacramento, California, 95817, United States

Location

Local Institution - 107

Aurora, Colorado, 80045, United States

Location

Local Institution - 102

Colorado Springs, Colorado, 80907, United States

Location

Local Institution - 144

Fort Collins, Colorado, 80528, United States

Location

Local Institution - 109

Washington D.C., District of Columbia, 20007, United States

Location

Local Institution - 140

Boca Raton, Florida, 33428, United States

Location

Local Institution - 158

Vero Beach, Florida, 32960-4818, United States

Location

Local Institution - 114

Savannah, Georgia, 31406, United States

Location

Northwest Neurology, Ltd

Hoffman Estates, Illinois, 60169, United States

Location

Local Institution - 108

Northbrook, Illinois, 60062, United States

Location

Local Institution - 148

Fort Wayne, Indiana, 46825-1603, United States

Location

Local Institution - 126

Ames, Iowa, 50010, United States

Location

Local Institution - 173

Kansas City, Kansas, 66160, United States

Location

Local Institution - 133

Alexandria, Louisiana, 71301, United States

Location

Local Institution - 152

Detroit, Michigan, 48201, United States

Location

Local Institution - 112

Detroit, Michigan, 48202, United States

Location

Local Institution - 122

St Louis, Missouri, 63110, United States

Location

Local Institution - 143

St Louis, Missouri, 63131, United States

Location

Advanced Neurology Specialists

Great Falls, Montana, 59405, United States

Location

Local Institution - 149

Teaneck, New Jersey, 07666, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

Local Institution - 137

Buffalo, New York, 14202, United States

Location

Local Institution - 160

East Setauket, New York, 11733-3528, United States

Location

Local Institution - 130

New York, New York, 10016, United States

Location

Local Institution - 121

New York, New York, 10021, United States

Location

Local Institution - 146

Patchogue, New York, 11772, United States

Location

Local Institution - 131

Chapel Hill, North Carolina, 27514, United States

Location

Local Institution - 106

Greensboro, North Carolina, 27405, United States

Location

Local Institution - 170

Mooresville, North Carolina, 28117, United States

Location

Raleigh Neurology Associates PA

Raleigh, North Carolina, 27607, United States

Location

Local Institution - 174

Cincinnati, Ohio, 45219, United States

Location

Local Institution - 171

Cleveland, Ohio, 44106, United States

Location

Local Institution - 142

Dayton, Ohio, 45417, United States

Location

Local Institution - 157

Oklahoma City, Oklahoma, 73104, United States

Location

Local Institution - 159

Philadelphia, Pennsylvania, 19107, United States

Location

Local Institution - 169

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Local Institution - 125

Franklin, Tennessee, 37064, United States

Location

Local Institution - 119

Knoxville, Tennessee, 37922, United States

Location

Local Institution - 139

Dallas, Texas, 75246, United States

Location

Local Institution - 113

Round Rock, Texas, 78681, United States

Location

Local Institution - 101

San Antonio, Texas, 78259, United States

Location

Local Institution - 103

Norfolk, Virginia, 23502, United States

Location

Local Institution - 141

Kirkland, Washington, 98034, United States

Location

Local Institution - 168

Seattle, Washington, 98101, United States

Location

Local Institution - 172

Spokane, Washington, 99202, United States

Location

Local Institution - 124

Tacoma, Washington, 98405, United States

Location

Local Institution - 156

Huntington, West Virginia, 25701, United States

Location

Local Institution - 150

Morgantown, West Virginia, 26506, United States

Location

Local Institution - 167

Madison, Wisconsin, 53792, United States

Location

Local Institution - 147

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution - 203

London, Ontario, N6G 2V4, Canada

Location

Local Institution - 204

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution - 206

Montreal, Quebec, H2X 0A9, Canada

Location

Local Institution - 207

Halifax, B3R 1V9, Canada

Location

Local Institution - 166

Guaynabo, 00968, Puerto Rico

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ozanimod

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 25, 2019
• Study Start: January 16, 2020
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

CA (4); US (56); PR (1)