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Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis (ASCLEPIOS I)

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Novartis

Status and phase

Completed
Phase 3

Conditions

Relapsing Multiple Sclerosis

Treatments

Drug: Teriflunomide capsule
Drug: Matching placebo of ofatumumab subcutaneous injections
Drug: Ofatumumab subcutaneous injection
Drug: Teriflunomide-matching placebo capsules

Study type

Interventional

Funder types

Industry

Identifiers

NCT02792218
2015-005418-31 (EudraCT Number)
COMB157G2301

Details and patient eligibility

About

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

Full description

This was a randomized, double-blind, double-dummy, active comparator-controlled, parallel-group, multi-center study with variable treatment duration in approximately 900 patients with relapsing multiple sclorosis (RMS). The maximal treatment duration in the study for an individual patient was 2.5 years.

Eligible patients were randomized to receive either experimental ofatumumab subcutaneous (s.c.) injections every 4 weeks or active comparator teriflunomide orally once daily. The dose regimen for ofatumumab for this study was a loading dose regimen of 20 mg at Day 1, Day 7 and Day 14, followed by a maintenance dose regimen of 20 mg administered every 4 weeks starting at Week 4. In order to blind for the different formulations, double-dummy masking was used i.e. all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo).

Enrollment

930 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 to 55 years of age
  • Diagnosis of multiple sclerosis (MS)
  • Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)
  • At least 1 relapse during the previous 1 year or 2 relapses during the previous 2 years or a positive gadolinium-enhancing MRI scan in previous year
  • Expanded disability status scale (EDSS) score of 0 to 5.5

Exclusion criteria

  • Primary progressive MS
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

930 participants in 2 patient groups

OMB 20 mg
Experimental group
Description:
Ofatumumab 20 mg pre-filled syringes for subcutaneous injectionon on days 1 ,7 ,14, week 4 and every 4 weeks thereafter and a teriflunomide- matching placebo, taken orally once daily
Treatment:
Drug: Teriflunomide-matching placebo capsules
Drug: Ofatumumab subcutaneous injection
TER 14 mg
Active Comparator group
Description:
Teriflunomide 14 mg oral capsule taken once daily and matching placebo for subcutaneous injections to ofatumumab on days 1, 7, 14, week 4 and every 4 weeks thereafter
Treatment:
Drug: Matching placebo of ofatumumab subcutaneous injections
Drug: Teriflunomide capsule

Trial documents
2

Trial contacts and locations

166

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Data sourced from clinicaltrials.gov

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