Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis (OPTIMUM)

Actelion Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: ponesimod; Drug: teriflunomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02425644

AC-058B301

2012-000540-10 (EudraCT Number)

Details and patient eligibility

About

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

Enrollment: 1,133 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Male and female subjects aged 18 to 55 years with established diagnosis of MS McDonald 2010 with relapsing course from onset (i.e., RRMS and SPMS with superimposed relapses).

Subjects must have active disease evidenced by one or more MS attacks with onset within the period of 12 to 1 months prior to randomization, or by two or more MS attacks with onset within the 24 to 1 months prior to randomization, or with one or more gadolinium-enhancing (Gd+) lesion(s) of the brain on an MRI performed within 6 months prior to randomization.

Enrolled subjects must be ambulatory (EDSS score of up to 5.5 inclusive) and may be treatment-naïve or previously treated with MS disease modifying therapy.

Exclusion criteria

Subjects with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic,ophthalmological conditions) or lactating or pregnant women are not eligible to enter the study.

Subjects with contraindications to MRI or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study are not eligible to enter the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,133 participants in 2 patient groups

Ponesimod

Experimental group

Description:

Subjects to receive 20 mg ponesimod

Treatment:

Drug: ponesimod

Teriflunomide

Active Comparator group

Description:

Subjects to receive 14 mg teriflunomide

Treatment:

Drug: teriflunomide