SUNBEAM

Ozanimod

SUNBEAM showed that once-daily ozanimod reduced relapses more than weekly intramuscular interferon beta-1a.

Phase
Phase III
Population
Relapsing multiple sclerosis (RMS)
Controlled period
Dec 3, 2014 — Dec 22, 2016

What was compared

RandomizedDouble-blindDouble-dummyActive-controlled
Intervention

Ozanimod 1.0 mg

Orally once daily

n=447
Comparator

Interferon beta-1a

30 μg intramuscularly once weekly

n=448

Additional randomized arm

Ozanimod 0.5 mg

Orally once dailyn=451
1,346 randomizedMinimum 12 months controlled phase

Primary endpoint

Prespecified outcome

Annualized relapse rate

Treatment period, minimum 12 months

Outcome figure

Primary endpoint results

Intervention Comparator or reference

Annualized relapse rate

Relapses per participant-year

Treatment period, minimum 12 months
Ozanimod 1.0 mg
0.18
Ozanimod 0.5 mg
0.24
Interferon beta-1a
0.35

Rate ratios 0.52 (P<0.0001) and 0.69 (P=0.0013) versus interferon.

Selected secondary outcomes

Treatment discontinuation

2.9%, 1.5%, and 3.6% discontinued for adverse events, respectively.

MRI

Key inflammatory MRI outcomes favored ozanimod.

Study population

Randomized
1,346 randomized
Age
Mean 35.6 years; eligible 18–55
Sex
894 women (66%)
Disability
EDSS 0–5.0
Disease definition
Relapsing MS with recent clinical or MRI activity

Who entered the trial

Key inclusion criteria

  • Defined based on McDonald criteria 2010
  • EDSS 0–5.0
  • Recent relapse or a combination of relapse and gadolinium-enhancing MRI activity

Key exclusion criteria

  • Primary progressive multiple sclerosis
  • Protocol-defined cardiac, hepatic, ophthalmic, immune, or infection risks
  • Pregnancy or other contraindication to the study regimens

Safety signal

  • Serious adverse-event incidence was low and similar across groups.
  • No clinically significant first-dose bradycardia, high-grade atrioventricular block, or serious opportunistic infection was reported in ozanimod-treated participants.

Why it mattered

SUNBEAM supplied active-comparator pivotal evidence for a more receptor-selective oral S1P-modulator strategy.

Important limitation

Follow-up varied with a minimum of 12 months, limiting disability and uncommon-safety conclusions compared with longer fixed-duration trials.

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