Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 21 July 2021
• Main ID: NCT02792218
• Date of registration: 02/06/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis ASCLEPIOS I
• Scientific title: A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis
• Date of first enrolment: September 20, 2016
• Target sample size: 930
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02792218
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Bulgaria, Canada, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Puerto Rico, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United States

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Multiple Sclerosis

Intervention(s)

Drug: Ofatumumab subcutaneous injection

Drug: Teriflunomide capsule

Drug: Teriflunomide-matching placebo capsules

Drug: Matching placebo of ofatumumab subcutaneous injections

Primary Outcome(s)

Annualized Relapse Rate (ARR) (Confirmed Relapses) [Time Frame: Baseline up to 2.5 years]

Secondary Outcome(s)

Number of New or Enlarging T2 Lesions on MRI Per Year (Annualized Lesion Rate) [Time Frame: Baseline, yearly up to 2.5 years]

3-month Confirmed Disability Worsening (3mCDW) Based on EDSS [Time Frame: Baseline, every 3 months up to 2.5 years]

6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS [Time Frame: Baseline, every 3 months up to 2.5 years]

6-month Confirmed Disability Worsening (6mCDW) Based on EDSS [Time Frame: Baseline, every 3 months up to 2.5 years]

Annualized Rate of Brain Volume Loss Based on Assessments of Percent Brain Volume Change From Baseline [Time Frame: Baseline, months 12 and 24]

Neurofilament Light Chain (NfL) Concentration in Serum [Time Frame: Month 3, 12 and 24]

Number of Gd-enhancing T1 Lesions Per MRI Scan [Time Frame: Baseline, yearly up to 2.5 years]

Secondary ID(s)

COMB157G2301

2015-005418-31

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02792218