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ASCLEPIOS II

A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis.
CompletedPhase 3Relapsing and progressiveNCT027922312015-005419-33

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Annualized Relapse Rate (ARR)rate ratio 0.4160.309–0.560<0.001

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Compared with

Placebo or sham

  • Teriflunomide-matching placebo capsules
  • Matching placebo of ofatumumab subcutaneous injections

Results by group

Annualized Relapse Rate (ARR)

Baseline up to 2.5 years

GroupValueIntervalNumber analysed
OMB 20 mg0.10 number of relapses in a year0.08–0.13469
TER 14 mg0.25 number of relapses in a year0.21–0.3470

OMB 20 mg

0.1

TER 14 mg

0.25

p = <0.001; rate ratio 0.416 (95% CI 0.309–0.560)

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
OMB 20mg48142 (8.7%)0
TER 14mg47437 (7.8%)1

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

  • Annualized Relapse Rate (ARR)

    Baseline up to 2.5 years

    Disability progressionRelapsesBladder, bowel and sexual function

  • Demonstrate that ofatumumab 20 mg sc once every 4 (q4) weeks is superior to teriflunomide 14 mg po once daily in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients with relapsing MS.

    Relapses

Other measures (30)

  • 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Pooled Data

    Baseline, every 3 months up to 2.5 years

    Disability progression

  • 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Study COMB157G2302

    Baseline, every 3 months up to 2.5 years

    Disability progression

  • 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Pooled Data

    Baseline, every 3 months up to 2.5 years

    Disability progression

  • 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Study COMB157G2302

    Baseline, every 3 months up to 2.5 years

    Disability progression

  • 6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Pooled Data

    Baseline, every 3 months up to 2.5 years

    Disability progression

  • 6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Study COMB157G2302

    Baseline, every 3 months up to 2.5 years

    Disability progression

  • Number of Gadolinium-enhancing T1 Lesions Per MRI Scan

    Baseline, yearly up to 2.5 years

    MRI lesions

  • Number of New or Enlarging T2 Lesions on MRI Per Year (Annualized Lesion Rate)

    Baseline, yearly up to 2.5 years

    MRI lesions

  • Neurofilament Light Chain (NfL) Concentration in Serum

    Month 3, 12 and 24

    Blood or spinal fluid markers

  • Annualized Rate of Brain Volume Loss Based on Assessments of Percent Brain Volume Change From Baseline

    Baseline, Months 12 and 24

    MRI lesionsBrain volume loss

Who could take part

Relapsing and progressive · 18 to 55

Inclusion Criteria: * Male or female patients aged 18 to 55 years at Screening * Diagnosis of multiple sclerosis (MS) * Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) with disease activity * Documentation of at least: 1 relapse during the previous 1 year OR 2 relapses during the previous 2 years OR a positive gadolinium-enhancing MRI scan during the year prior to randomization * Disability status at Screening with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5 * Neurologically stable within 1 month prior to randomization Exclusion Criteria: * Patients with primary progressive MS or SPMS without disease activity * Disease duration of more than 10 years in patients with an EDSS score of 2 or less * Patients with an active chronic disease of the immune system other than MS * Patients at risk of developing or having reactivation of hepatitis * Patients with active systemic infections or with neurological findings consistent with PML

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

About this trial

In the sponsor's words

To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis

Papers

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Related trials

History

    1. Started

      Aug 2016

    2. Main results due

      Jul 2019

    3. Finished

      Oct 2020

    4. Results posted

      Oct 2020

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