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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Relapsing Multiple Sclerosis	Drug: Ofatumumab subcutaneous injection; Drug: Placebo orally matching to teriflunomide; Drug: Teriflunomide orally; Drug: Placebo subcutanous injection matching to ofatumumab	Phase 3

Detailed Description:

This is a randomized, double-blind, double-dummy, active comparator-controlled, parallel-group, multi-center study with variable treatment duration in approximately 900 patients with relapsing MS. The maximal treatment duration in the study for an individual patient will be 2.5 years.

Eligible patients will be randomized to receive either experimental ofatumumab subcutaneous (sc) injections every 4 weeks or active comparator teriflunomide orally once daily. In order to blind for the different formulations, double-dummy masking will be used i.e. all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo).

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	900 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 :	September 19, 2016
Estimated Primary Completion Date :	May 15, 2019
Estimated Study Completion Date :	May 16, 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Ofatumumab; Syringes for subcutaneous injection Patients will also take a placebo capsules (matching in appearance to teriflunomide)	Drug: Ofatumumab subcutaneous injection; Patients randomized to the ofatumumab arm will receive subcutaneous injections of ofatumumab every 4 weeks Drug: Placebo orally matching to teriflunomide; Placebo orally, matching in appearance to teriflunomide, administered once daily
Active Comparator: Teriflunomide; Oral capsule Patients will also take subcutaneous injections of placebo (syringes matching in appearance to ofatumumab)	Drug: Teriflunomide orally; Patients randomized to the teriflunomide arm will take teriflunomide orally once daily; Other Name: Aubagio Drug: Placebo subcutanous injection matching to ofatumumab; Placebo-containing syringes, matching in appearance to syringes containing ofatumumab, administered every 4 weeks

Outcome Measures

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Primary Outcome Measures :

1. Annualized relapse rate (ARR) [ Time Frame: up to 2.5 years ]
   ARR is the number of confirmed relapses in a year calculated based on cumulative number of relapses by patient adjusted for time-in-study by patient

Secondary Outcome Measures :

1. Time to 3-month confirmed disability worsening 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.
2. Time to 6-month confirmed disability worsening on EDSS [ Time Frame: Baseline, every 3 months up to 2.5 years ]
   A 6-month confirmed disability worsening is an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at last 6 months.
3. Time to 6-month confirmed disability improvement 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.
4. Number of gadolinium (Gd)-enhancing lesions per MRI scan [ Time Frame: Baseline, yearly up to 2.5 years ]
   Total number of Gd-enhancing lesions across all scans per patient adjusted for different number of scans due to variable follow up time in study
5. 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
6. Rate of brain volume loss based on assessments of percentage brain volume change from baseline [ Time Frame: Baseline, yearly up to 2.5 years ]
   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

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Diagnosis of multiple sclerosis (MS)
• Relapsing MS (RRMS or SPMS) course
• 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
• 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

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Novartis Pharmaceuticals	1-888-669-6682	novartis.email@novartis.com
Contact: Novartis Pharmaceuticals	+41613241111

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Sponsors and Collaborators

Novartis Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT02792218 History of Changes
Other Study ID Numbers:	COMB157G2301; 2015-005418-31 ( EudraCT Number )
First Posted:	June 7, 2016
Last Update Posted:	February 27, 2018
Last Verified:	February 2018

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Relapsing multiple sclerosis; Ofatumumab

Additional relevant MeSH terms:

Sclerosis; Multiple 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