Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02907177
• Date of registration: 25/08/2016
• Prospective Registration: Yes
• Primary sponsor: Actelion
• Public title: Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®) POINT
• Scientific title: Multicenter, Randomized, Double-blind, Parallel-group, add-on, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
• Date of first enrolment: March 30, 2017
• Target sample size: 136
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02907177
• 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

Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Mexico, Norway, Poland, Portugal, Russian Federation, Spain, Switzerland, United Kingdom, United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed informed consent prior to initiation of any study-mandated procedure.

- Women of childbearing potential must have a negative pregnancy test and use reliable
methods of contraception

- Presenting with a diagnosis of MS as defined by the revised (2010) McDonald Diagnostic
Criteria for MS with relapsing course from onset (i.e., relapsing-remitting multiple
sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) with superimposed
relapses).

- Ongoing treatment with DMF for at least 6 months prior to screening

- Active disease after at least 3 months of DMF treatment

- Ambulatory and with an EDSS score between 0 and 6.0 (inclusive).

Exclusion Criteria:

- Lactating or pregnant women and women intending to become pregnant during the study.

- Presenting with a diagnosis of MS with progressive course from onset (i.e., primary
progressive MS or progressive relapsing MS).

- Evidence of a relapse of MS with onset within 30 days prior to baseline EDSS
assessment.

- Any circumstances or conditions, which, in the opinion of the investigator, may affect
full participation in the study or compliance with the protocol.



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

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Other: Placebo

Drug: Ponesimod

Primary Outcome(s)

Annualized relapse rate (ARR) [Time Frame: From randomization up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years]

Secondary Outcome(s)

Longitudinal percent change from baseline over time in brain volume [Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years]

Longitudinal change over time in fatigue-related symptoms as measured by the symptoms domain of the FSIQ-RMS [Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years]

Mean number of combined unique active lesions (CUALs) per post-baseline scan [Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years]

Time to 12-week confirmed disability accumulation (CDA) [Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years]

Time to first confirmed relapse [Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years]

Secondary ID(s)

AC-058B302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors