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Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered for Twenty-four Weeks in Patients With Relapsing-remitting Multiple Sclerosis

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Trial Profile

Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered for Twenty-four Weeks in Patients With Relapsing-remitting Multiple Sclerosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 09 Jun 2022

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At a glance

  • Drugs Ponesimod (Primary)
  • Indications Multiple sclerosis
  • Focus Therapeutic Use
  • Sponsors Actelion Pharmaceuticals

    • Most Recent Events

    • 06 Jun 2022 Results from EudraCT2008-006786-92 and EudraCT2009-011470-15 evaluating the dose-response relationship of 10, 20 and 40-mg ponesimod and long-term efficacy and safety of ponesimod 20 mg , published in the Neurology
    • 26 Feb 2022 Results of a pooled analysis (AC-058B201 and AC-058B301/OPTIMUM & AC-058B202 and AC-058B303/OPTIMUM-LT studies data) from patients in the ponesimod 20mg assessed the long term safety arm presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2022
    • 29 Apr 2021 Data from two studies (B201 and B301) were used to characterize the PK of ponesimod in multiple sclerosis patients and to explore the relationship between ponesimod plasma concentrations and the temporal evolution of lymphocyte counts, published in the Clinical Pharmacokinetics.

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