Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis. (ASCLEPIOS II)
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ClinicalTrials.gov Identifier: NCT02792231 |
Recruitment Status :
Completed
First Posted : June 7, 2016
Results First Posted : October 19, 2020
Last Update Posted : November 23, 2020
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Condition or disease | Intervention/treatment | Phase |
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Relapsing Multiple Scelrosis | Drug: Ofatumumab subcutaneous injection Drug: Teriflunomide-matching placebo capsules Drug: Teriflunomide capsule Drug: Matching placebo of ofatumumab subcutaneous injections | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 957 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official 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. |
Actual Study Start Date : | August 26, 2016 |
Actual Primary Completion Date : | July 10, 2019 |
Actual Study Completion Date : | October 22, 2020 |

Arm | Intervention/treatment |
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Experimental: OMG 20 mg
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 |
Drug: Ofatumumab subcutaneous injection
Ofatumumab 20 mg prefilled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter Drug: Teriflunomide-matching placebo capsules Placebo capsule, matching in appearance to teriflunomide, taken orally once daily |
Active Comparator: TER 14 mg
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
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Drug: Teriflunomide capsule
Teriflunomide 14 mg oral capsule taken once daily Drug: Matching placebo of ofatumumab subcutaneous injections Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter |
- Annualized Relapse Rate (ARR) (Confirmed Relapses) [ Time Frame: Baseline up to 2.5 years ]ARR was the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). Comparisons were made to the previous rating (the last EDSS rating that did not occur during a relapse).
- 3-month Confirmed Disability Worsening) (3mCDW) Based on EDSS [ Time Frame: Baseline, every 3 months up to 2.5 years ]A 3-month confirmed disability worsening is an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at last 3 months. For patients with a baseline EDSS of 0, the criterion for disability worsening was an increase in EDSS of ≥1.5, for patients with a baseline EDSS of 1 to 5 or ≥5.5, the criterion for disability worsening was an increase in EDSS of ≥1 or ≥0.5, respectively
- 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS [ Time Frame: Baseline, every 3 months up to 2.5 years ]A 6-month confirmed disability worsening (6mCDW) was defined as an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6 months. For patients with a baseline EDSS of 0, the criterion for disability worsening was an increase in EDSS of ≥1.5, for patients with a baseline EDSS of 1 to 5 or ≥5.5, the criterion for disability worsening was an increase in EDSS of ≥1 or ≥0.5, respectively.
- 6-month Confirmed Disability Improvement) (6mCDI ) Based on EDSS [ Time Frame: Baseline, every 3 months up to 2.5 years ]A 6-month confirmed disability improvement is a decrease from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6 months.
- Number of Gd-enhancing T1 Lesions Per MRI Scan [ Time Frame: Baseline, yearly up to 2.5 years ]Total number of Gd-enhancing T1 lesions across all scans per patient adjusted for different number of scans due to variable follow-up time in study
- Number of New or Enlarging T2 Lesions on MRI Per Year (Annualized Lesion Rate) [ Time Frame: Baseline, yearly up to 2.5 years ]Number of new/enlarging T2 lesions on last available MRI scan compared to baseline adjusted for different time of scans versus baseline due to variable follow up time in study
- Neurofilament Light Chain (NfL) Concentration in Serum [ Time Frame: Month 3, 12, 24 ]The NfL concentration (geometric mean concentration) will be estimated by treatment and time point with using a repeated measures model on the basis of all evaluable log-transformed NfL values.
- Annualized Rate of Brain Volume Loss Based on Assessments of Percent Brain Volume Change From Baseline [ Time Frame: Baseline, months 12 and 24 ]Percent change from baseline in brain volume loss (BVL) on all MRI scans adjusted for different time of scan versus baseline due to variable follow up time in study

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792231

Study Director: | Novartis Pharmaceuticals | Novartis |
Documents provided by Novartis ( Novartis Pharmaceuticals ):
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02792231 |
Other Study ID Numbers: |
COMB157G2302 2015-005419-33 ( EudraCT Number ) |
First Posted: | June 7, 2016 Key Record Dates |
Results First Posted: | October 19, 2020 |
Last Update Posted: | November 23, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com |
Relapsing multiple sclerosis Ofatumumab adult OMB157 multiple sclerosis T1 lesions |
T2 lesions relapse GD-enhancing MRI McDonald criteria RRMS SPMS |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases |
Autoimmune Diseases Immune System Diseases Ofatumumab Antibodies, Monoclonal Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs |