Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis (ASCLEPIOS I)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02792218 |
|
Recruitment Status :
Active, not recruiting
First Posted : June 7, 2016
Last Update Posted : February 12, 2020
|
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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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 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 930 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 20, 2016 |
| Actual Primary Completion Date : | July 5, 2019 |
| Estimated Study Completion Date : | March 27, 2020 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
| 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 |
Primary Outcome Measures :
- 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 :
- 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.
- 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.
- 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.
- 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
- 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: Baseline, every 3 months up to 2.5 years ]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.
- 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
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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
Information from the National Library of Medicine
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): NCT02792218
Locations
Hide 183 study locations
| United States, Arizona | |
| Novartis Investigative Site | |
| Phoenix, Arizona, United States, 85004 | |
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| Phoenix, Arizona, United States, 85013 | |
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| Berkeley, California, United States, 94705 | |
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| Fullerton, California, United States, 92835 | |
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| Palo Alto, California, United States, 94304 | |
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| Sacramento, California, United States, 95817 | |
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| Washington, District of Columbia, United States, 20007 | |
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| Atlantis, Florida, United States, 33462-6608 | |
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| Delray Beach, Florida, United States, 33445 | |
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| Hollywood, Florida, United States, 33021 | |
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| Loxahatchee Groves, Florida, United States, 33470 | |
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| Savannah, Georgia, United States, 31406 | |
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| Honolulu, Hawaii, United States, 96817 | |
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| Indianapolis, Indiana, United States, 46202 | |
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| Des Moines, Iowa, United States, 50314-2611 | |
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| Chesterfield, Missouri, United States, 63017 | |
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| New Lambton Heights, New South Wales, Australia, 2305 | |
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| St Leonards, New South Wales, Australia, 2065 | |
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| Brasschaat, Belgium, 2930 | |
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| Brugge, Belgium, 8000 | |
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| Liege, Belgium, 4000 | |
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| Pelt, Belgium, 3900 | |
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| Aarhus, Denmark, 8000 | |
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| Nancy, Cedex, France, 54035 | |
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| Hamburg, Germany, 20249 | |
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| Marburg, Germany, 35043 | |
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| Neuburg an der Donau, Germany, 86633 | |
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| Potsdam, Germany, 14471 | |
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| Wiesbaden, Germany, 65191 | |
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| Athens, GR, Greece, 115 25 | |
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| Athens, Greece, 115 28 | |
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| Athens, Greece, 12462 | |
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| Thessaloniki, Greece, GR 54636 | |
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| Budapest, Hungary, 1106 | |
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| Szeged, Hungary, 6725 | |
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| Kolkata, West Bengal, India, 700068 | |
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| Mangalore, India, 575018 | |
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| New Delhi, India, 110029 | |
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| Ashkelon, Israel, 78278 | |
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| Sefad, Israel, 13100 | |
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| Tel Aviv, Israel, 6423906 | |
| Italy | |
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| Milano, MI, Italy, 20132 | |
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| Cefalu, PA, Italy, 90015 | |
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| Roma, RM, Italy, 00189 | |
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| Gallarate, VA, Italy, 21013 | |
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| Napoli, Italy, 80131 | |
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| Mexico, Distrito Federal, Mexico, 03100 | |
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| Guadalajara, Jalisco, Mexico, 44130 | |
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| Sittard-Geleen, BG, Netherlands, 6162 BG | |
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| Amsterdam, Netherlands, 1081 HV | |
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| Rotterdam, Netherlands, 3015 CE | |
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| Bydgoszcz, Poland, 85-796 | |
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| Lodz, Poland, 90 324 | |
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| Guaynabo, Puerto Rico, 00968 | |
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| Kemerovo, Russian Federation, 650066 | |
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| Moscow, Russian Federation, 125367 | |
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| Nizhny Novgorod, Russian Federation, 603155 | |
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| Novosibirsk, Russian Federation, 630007 | |
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| Saint-Petersburg, Russian Federation, 194044 | |
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| Saransk, Russian Federation, 430032 | |
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| Tyumen, Russian Federation, 625000 | |
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| Nitra, Slovakia, 94901 | |
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| Trnava, Slovakia, 917 75 | |
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| L Hospitalet De Llobregat, Catalunya, Spain, 08907 | |
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| Goeteborg, Sweden, 413 45 | |
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| Basel, Switzerland, 4031 | |
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| Khon Kaen, THA, Thailand, 40002 | |
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| Stoke-on-Trent, United Kingdom, ST4 6QG | |
Sponsors and Collaborators
Novartis Pharmaceuticals
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02792218 |
| Other Study ID Numbers: |
COMB157G2301 2015-005418-31 ( EudraCT Number ) |
| First Posted: | June 7, 2016 Key Record Dates |
| Last Update Posted: | February 12, 2020 |
| Last Verified: | February 2020 |
| 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:
|
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 |