Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy,
      safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The
      AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of
      this long term extension of the core study AC-058B301 is to characterize the long-term
      safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.
    

Detailed description: 
      The AC-058B303 study (extension study) is the long-term extension for the AC-058B301 study
      (core study). The core study has been designed to investigate the efficacy, safety and
      tolerability of ponesimod in subjects with RMS. The subjects are treated with either
      ponesimod or the active comparator, teriflunomide in the core study. The purpose of this long
      term extension of the core study is to characterize the long-term safety and control of
      disease of ponesimod in subjects with RMS. In particular, the study will allow to observe
      potential adverse events which may only occur after long term treatment with ponesimod. The
      study will also investigate the effect of re-initiation of ponesimod after a brief
      interruption in a relatively large population (all subjects treated with ponesimod in the
      core study and eligible for the extension study) on disease activity in terms of relapses and
      MS-related MRI lesions. There is currently limited guidance on when a new MS treatment should
      be started after discontinuation of teriflunomide and the study will contribute with data on
      safety and efficacy of switching from teriflunomide to ponesimod after an interruption as
      mandated by the protocol. The study will also allow confirmation of sustained efficacy of
      ponesimod in terms of relapses, MRI lesions and reduction of disability accumulation during
      long-term treatment. In addition, combined data from the core study together with the results
      of the current extension study will allow comparison of MS activity in subjects who were
      switched from teriflunomide to ponesimod versus those who were treated with ponesimod in both
      studies. A vaccination sub-study will be conducted in a sub-set of up to 50 eligible study
      participants from selected countries who consent to be vaccinated with the Janssen
      coronavirus disease-2019 (COVID-19) vaccine (Ad26.COV2.S) to investigate the immune response
      induced by the Janssen COVID-19 vaccine.
    

Intervention name(s): Ponesimod
Intervention type(s): Drug
Intervention description(s): Ponesimod; Film-coated tablet; Oral use. From Day 1 to Day 14, ponesimod is gradually up-titrated until a maintenance dose of 20 mg is reached from Day 15
Intervention MeSH terms: Ponesimod
Intervention model: Single Group Assignment
Intervention model description: This is a single-group open-label extension study to investigate long-term safety, tolerability and control of disease of ponesimod 20 mg in subjects with RMS. Statistical analyses will be descriptive and therefore all endpoints are exploratory in nature. All exploratory endpoints are listed under primary outcomes.
Masking: None (Open Label)
Primary purpose: Treatment