Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS) (SUNBEAM)

Celgene

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: Ozanimod; Drug: Placebo to interferon beta-1a; Drug: Interferon beta-1a; Drug: Placebo to ozanimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT02294058

2014-002320-27 (EudraCT Number)

RPC01-301

Details and patient eligibility

About

The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).

Enrollment: 1,346 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
• 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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1,346 participants in 3 patient groups

Interferon beta-1a

Active Comparator group

Description:

Participants received 30 µg interferon beta-1a by intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally once a day until the last participant had been treated for 12 months.

Treatment:

Drug: Placebo to ozanimod

Drug: Interferon beta-1a

Ozanimod 0.5 mg

Experimental group

Description:

Participants received ozanimod 0.5 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months.

Treatment:

Drug: Placebo to interferon beta-1a

Drug: Ozanimod

Ozanimod 1 mg

Experimental group

Description:

Participants received ozanimod 1 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months.

Treatment:

Drug: Placebo to interferon beta-1a

Drug: Ozanimod