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

Celgene

Status and phase: Completed; Phase 3

Conditions: Relapsing Multiple Sclerosis

Treatments: Drug: Ozanimod; Drug: Ozanimod placebo; Drug: Interferon beta-1a; Drug: Interferon beta-1a placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02047734

RPC01-201-PartB

2012-002714-40 (EudraCT Number)

Details and patient eligibility

About

This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented within this record.

The primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).

Full description

This clinical trial (RPC01-201; RADIANCE) consisted of 2 parts, each reported separately on ClinicalTrials.gov: Part A (NCT01628393) and Part B (this record).

Part A was a phase 2 study in which two doses of ozanimod were administered daily for 24 weeks with an efficacy and safety comparison to a placebo control and is reported separately as ClinicalTrials.gov record NCT01628393.

Part B, reported herein, was a phase 3 study in which two doses of ozanimod were administered daily for a 24 month period compared to an active control, interferon β-1a. Participants were allowed to enroll in the open-label extension study RPC01-3001 (NCT02576717) or complete the study with a safety follow-up visit 28 days after their last dose of study treatment.

Enrollment: 1,320 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

• Primary progressive multiple sclerosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,320 participants in 3 patient groups

Ozanimod 0.5 mg

Experimental group

Description:

Ozanimod 0.5 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.

Treatment:

Drug: Interferon beta-1a placebo

Drug: Ozanimod

Ozanimod1 mg

Experimental group

Description:

Ozanimod 1 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.

Treatment:

Drug: Interferon beta-1a placebo

Drug: Ozanimod

Interferon β-1a

Active Comparator group

Description:

interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.

Treatment:

Drug: Ozanimod placebo

Drug: Interferon beta-1a