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Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis

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
CompletedPhase 2Relapsing MSNCT010062652008-006786-92

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24Treatment effect (rate ratio) 0.2260.133–0.384<0.0001
Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24Treatment effect (rate ratio) 0.1700.100–0.289<0.0001
Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24Treatment effect (rate ratio) 0.5660.337–0.9520.0318

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • ACT-128800 Dose 1
  • ACT-128800 Dose 2
  • ACT-128800 Dose 3
  • Ponesimod

    Sphingosine 1-phosphate receptor Edg-1 agonist

Placebo or sham

  • Placebo

Results by group

Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24

From Week 12 to 24

GroupValueIntervalNumber analysed
Ponesimod 40 mg1.4 Lesions3.24 (Standard Deviation)93
Ponesimod 20 mg1.1 Lesions1.96 (Standard Deviation)98
Ponesimod 10 mg3.5 Lesions7.27 (Standard Deviation)88
Placebo6.2 Lesions13.42 (Standard Deviation)110

Ponesimod 40 mg

1.4

Ponesimod 20 mg

1.1

Ponesimod 10 mg

3.5

Placebo

6.2

p = <0.0001; Treatment effect (rate ratio) 0.226 (95% CI 0.133–0.384)

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Ponesimod 40 mg1193 (2.5%)0
Ponesimod 20 mg1147 (6.1%)0
Ponesimod 10 mg1087 (6.5%)0
Placebo1215 (4.1%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24

    From Week 12 to 24

    MRI lesions

  • • Cumulative number of new gadolinium-enhancing lesions per patient recorded on T1-weighted MRI scans at Weeks 12, 16, 20, and 24 after study drug initiation.

    MRI lesions

Other measures (2)

  • Annualized Confirmed Relapse Rate

    Up to 24 weeks

    Disability progressionRelapsesWalking and mobilityBladder, bowel and sexual function

  • Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From Baseline to Week 24

    Baseline to Week 24

    Disability progressionRelapsesWalking and mobilityBladder, bowel and sexual function

Who could take part

Relapsing MS · 18 to 55

Inclusion Criteria: * Adult males and females * Diagnosis of RRMS as defined by the revised (2005) McDonald Diagnostic Criteria for Multiple Sclerosis (MS). * Signed inform consent prior to initiation of any study-mandated procedure. Exclusion Criteria: * A diagnosis of MS categorized as primary progressive or secondary progressive or progressive relapsing. * Patients currently treated for an autoimmune disorder other than MS. * Contraindications for MRI. * Ongoing bacterial, viral, or fungal infection. * History or presence of malignancy. Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.

Papers

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Related trials

History

    1. Started

      Oct 2009

    2. Main results due

      Jun 2011

    3. Finished

      Jul 2011

    4. Results posted

      Jun 2021

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