Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 January 2023
• Main ID: NCT02425644
• Date of registration: 21/04/2015
• Prospective Registration: Yes
• Primary sponsor: Actelion
• Public title: Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis OPTIMUM
• Scientific title: Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Teriflunomide in Subjects With Relapsing Multiple Sclerosis
• Date of first enrolment: June 4, 2015
• Target sample size: 1133
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02425644
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Belarus, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, Czechia, Finland, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Tatiana Scherz, MD, PhD
• Affiliation: Actelion

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: teriflunomide

Drug: ponesimod

Primary Outcome(s)

Annualized Confirmed Relapse Rate [Time Frame: From randomization to end of study (Week 108)]

Secondary Outcome(s)

12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS [Time Frame: Baseline to Week 60 and 108 Weeks]

Change From Baseline in Fatigue-related Symptoms as Measured by the Symptoms Domain of the Fatigue Symptom and Impact Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS) Score to Week 108 [Time Frame: Baseline to Week 108]

Cumulative Number of Combined Unique Active Lesions (CUAL) Per Year From Baseline to Week 108 [Time Frame: Baseline to Week 108]

24-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS [Time Frame: Baseline to 60 Weeks and 108 Weeks]

Secondary ID(s)

2012-000540-10

AC-058B301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/06/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02425644