Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients (RADIANCE)

Celgene

Status and phase: Completed; Phase 3; Phase 2

Conditions: Relapsing Multiple Sclerosis

Treatments: Drug: Ozanimod; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01628393

RPC01-201-PartA

2012-002714-40 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 258 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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258 participants in 3 patient groups, including a placebo group

Ozanimod 0.5 mg

Experimental group

Description:

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.

Treatment:

Drug: Ozanimod

Ozanimod 1 mg

Experimental group

Description:

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.

Treatment:

Drug: Ozanimod

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Ozanimod

Drug: Placebo