Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis (OPTIMUM)

January 3, 2023 updated by: Actelion

Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Teriflunomide in Subjects With Relapsing Multiple Sclerosis

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1133

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Grodno, Belarus, 230017
        • Investigator Site 3605
      • Minsk, Belarus, 220026
        • Investigator Site 3603
      • Minsk, Belarus, 220114
        • Investigator Site 3602
      • Vitebsk, Belarus, 210023
        • Investigator Site 3606
      • Vitebsk, Belarus, 210037
        • Investigator Site 3604
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Investigator Site 9104
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Investigator Site 2709
      • Sofia, Bulgaria, 1113
        • Investigator Site 2711
      • Sofia, Bulgaria, 1309
        • Investigator Site 2702
      • Sofia, Bulgaria, 1407
        • Investigator Site 2707
      • Sofia, Bulgaria, 1431
        • Investigator Site 2701
      • Sofia, Bulgaria, 1431
        • Investigator Site 2708
      • Sofia, Bulgaria, 1606
        • Investigator Site 2703
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z1
        • Investigator Site 8102
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 1J8
        • Investigator Site 8120
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Investigator Site 8101
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Investigator Site 8113
  • Croatia
      • Osijek, Croatia, 31000
        • Investigator Site 2506
      • Zagreb, Croatia, 10000
        • Investigator Site 2502
      • Zagreb, Croatia, 10000
        • Investigator Site 2508
      • Zagreb, Croatia, 10000
        • Investigator Site 2509
  • Czechia
      • Brno, Czechia, 625 00
        • Investigator Site 3009
      • Brno, Czechia, 656 91
        • Investigator Site 3003
      • Hradec Králové, Czechia, 500 05
        • Investigator Site 3010
      • Jihlava, Czechia, 586 33
        • Investigator Site 3006
      • Ostrava-Poruba, Czechia, 708 52
        • Investigator Site 3002
      • Pardubice, Czechia, 532 03
        • Investigator Site 3007
      • Praha 2, Czechia, 128 08
        • Investigator Site 3001
      • Praha 5, Czechia, 150 06
        • Investigator Site 3008
      • Teplice, Czechia, 415 29
        • Investigator Site 3004
  • Finland
      • Tampere, Finland, 33100
        • Investigator Site 2212
      • Turku, Finland, 20520
        • Investigator Site 2202
  • France
      • Bordeaux Cedex, France, 33076
        • Investigator Site 1713
      • Clermont Ferrand Cedex 1, France, 63003
        • Investigator Site 1703
      • Nantes Cedex 1, France, 44093
        • Investigator Site 1715
      • Nice Cedex 1, France, 06002
        • Investigator Site 1706
      • Strasbourg Cedex, France, 67091
        • Investigator Site 1705
  • Georgia
      • Tbilisi, Georgia, 0112
        • Investigator Site 3905
      • Tbilisi, Georgia, 0160
        • Investigator Site 3904
      • Tbilisi, Georgia, 0179
        • Investigator Site 3903
      • Tbilisi, Georgia, 0179
        • Investigator Site 3906
      • Tbilisi, Georgia, 0194
        • Investigator Site 3902
  • Germany
      • Dresden, Germany, 01307
        • Investigator Site 1113
      • Erfurt, Germany, 99089
        • Investigator Site 1107
      • Leipzig, Germany, 04107
        • Investigator Site 1109
      • Mainz, Germany, 55131
        • Investigator Site 1104
      • Ulm, Germany, 89081
        • Investigator Site 1102
  • Greece
      • Athens, Greece, 11521
        • Investigator Site 1303
      • Athens, Greece, 11525
        • Investigator Site 1301
      • Athens, Greece, 15125
        • Investigator Site 1307
  • Hungary
      • Budapest, Hungary, 1145
        • Investigator Site 2903
      • Budapest, Hungary, 1204
        • Investigator Site 2905
      • Esztergom, Hungary, 2500
        • Investigator Site 2910
      • Gyor, Hungary, 9023
        • Investigator Site 2902
      • Kistarcsa, Hungary, 2143
        • Investigator Site 2909
  • Israel
      • Ashkelon, Israel, 7830604
        • Investigator Site 4005
      • Haifa, Israel, 3109601
        • Investigator Site 4004
      • Jerusalem, Israel, 9112001
        • Investigator Site 4006
      • Zfat, Israel, 13100
        • Investigator Site 4010
  • Italy
      • Cefalu, Italy, 90015
        • Investigator Site 1403
      • Genova, Italy, 16132
        • Investigator Site 1409
      • L'Aquila, Italy, 67100
        • Investigator Site 1413
      • Roma, Italy, 00189
        • Investigator Site 1405
  • Latvia
      • Riga, Latvia, 1015
        • Investigator Site 3401
      • Riga, Latvia, LV-1002
        • Investigator Site 3402
      • Riga, Latvia, LV-1038
        • Investigator Site 3403
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Investigator Site 3502
      • Klaipeda, Lithuania, 92288
        • Investigator Site 3503
      • Siauliai, Lithuania, 76231
        • Investigator Site 3504
  • Mexico
      • Chihuahua, Mexico, 31203
        • Investigator Site 7410
      • Monterrey, Mexico, 64710
        • Investigator Site 7409
  • Poland
      • Bialystok, Poland, 15-270
        • Investigator Site 3219
      • Bydgoszcz, Poland, 85-795
        • Investigator Site 3215
      • Gdansk, Poland, 80-803
        • Investigator Site 3208
      • Katowice, Poland, 40-595
        • Investigator Site 3217
      • Katowice, Poland, 40-752
        • Investigator Site 3203
      • Konstancin-Jeziorna, Poland, 05-510
        • Investigator Site 3205
      • Ksawerow, Poland, 95-054
        • Investigator Site 3216
      • Lublin, Poland, 20-015
        • Investigator Site 3220
      • Poznan, Poland, 60-355
        • Investigator Site 3202
      • Poznan, Poland, 60-848
        • Investigator Site 3214
      • Poznan, Poland, 61-853
        • Investigator Site 3207
      • Wroclaw, Poland, 51-685
        • Investigator Site 3213
  • Portugal
      • Amadora, Portugal, 2720 276
        • Investigator Site 1602
      • Braga, Portugal, 4710-243
        • Investigator Site 1605
      • Coimbra, Portugal, 3000-075
        • Investigator Site 1603
      • Porto, Portugal, 4099-001
        • Investigator Site 1604
  • Romania
      • Bucuresti, Romania, 010825
        • Investigator Site 2807
      • Bucuresti, Romania, 022903
        • Investigator Site 2811
      • Bucuresti, Romania, 050098
        • Investigator Site 2804
      • Timisoara, Romania, 300723
        • Investigator Site 2802
  • Russian Federation
      • Belgorod, Russian Federation, 308007
        • Investigator Site 3818
      • Bryansk, Russian Federation, 241033
        • Investigator Site 3837
      • Ekaterinburg, Russian Federation, 620102
        • Investigator Site 3836
      • Kazan, Russian Federation, 420029
        • Investigator Site 3811
      • Kemerovo, Russian Federation, 650066
        • Investigator Site 3822
      • Krasnoyarsk, Russian Federation, 660037
        • Investigator Site 3814
      • Kursk, Russian Federation, 305007
        • Investigator Site 3823
      • Moscow, Russian Federation, 119049
        • Investigator Site 3831
      • Moscow, Russian Federation, 127015
        • Investigator Site 3803
      • Moscow, Russian Federation, 127015
        • Investigator Site 3840
      • Moscow, Russian Federation, 129128
        • Investigator Site 3810
      • Nizhniy Novgorod, Russian Federation, 603155
        • Investigator Site 3802
      • Nizhny Novgorod, Russian Federation, 603076
        • Investigator Site 3834
      • Novgorod, Russian Federation, 173008
        • Investigator Site 3835
      • Novosibirsk, Russian Federation, 630007
        • Investigator Site 3829
      • Perm, Russian Federation, 614990
        • Investigator Site 3839
      • Pyatigorsk, Russian Federation, 357538
        • Investigator Site 3812
      • Saint Petersburg, Russian Federation, 197110
        • Investigator Site 3813
      • Samara, Russian Federation, 443095
        • Investigator Site 3805
      • Smolensk, Russian Federation, 214019
        • Investigator Site 3825
      • St. Petersburg, Russian Federation, 194354
        • Investigator Site 3808
      • St. Petersburg, Russian Federation, 197022
        • Investigator Site 3833
      • St. Petersburg, Russian Federation, 197376
        • Investigator Site 3807
      • St. Petersburg, Russian Federation, 197706
        • Investigator Site 3815
      • Tomsk, Russian Federation, 634050
        • Investigator Site 3801
      • Tver, Russian Federation, 170026
        • Investigator Site 3819
      • Yaroslavl, Russian Federation, 150030
        • Investigator Site 3842
    • Altai Krai
      • Barnaul, Altai Krai, Russian Federation, 656024
        • Investigator Site 3821
  • Serbia
      • Belgrade, Serbia, 11000
        • Investigator Site 2601
      • Belgrade, Serbia, 11000
        • Investigator Site 2606
      • Belgrade, Serbia, 11080
        • Investigator Site 2607
      • Kragujevac, Serbia, 34000
        • Investigator Site 2603
      • Nis, Serbia, 18000
        • Investigator Site 2602
  • Spain
      • Barcelona, Spain, 08003
        • Investigator Site 1509
      • Barcelona, Spain, 08035
        • Investigator Site 1505
      • Barcelona, Spain, 08036
        • Investigator Site 1504
      • Madrid, Spain, 28006
        • Investigator Site 1502
      • Malaga, Spain, 29010
        • Investigator Site 1501
      • Sevilla, Spain, 41009
        • Investigator Site 1506
  • Sweden
      • Goteborg, Sweden, 413 45
        • Investigator Site 2103
      • Stockholm, Sweden, 141 86
        • Investigator Site 2110
      • Stockholm, Sweden, 171 76
        • Investigator Site 2101
  • Turkey
      • Trabzon, Turkey, 61080
        • Investigator Site 9004
  • Ukraine
      • Chernihiv, Ukraine, 14001
        • Investigator Site 3714
      • Chernihiv, Ukraine, 14029
        • Investigator Site 3701
      • Ivano-Frankivsk, Ukraine, 76008
        • Investigator Site 3713
      • Ivano-Frankivsk, Ukraine, 76018
        • Investigator Site 3711
      • Kharkiv, Ukraine, 61103
        • Investigator Site 3723
      • Kharkiv, Ukraine, 61176
        • Investigator Site 3724
      • Kyiv, Ukraine, 03115
        • Investigator Site 3716
      • Lviv, Ukraine, 79000
        • Investigator Site 3715
      • Lviv, Ukraine, 79010
        • Investigator Site 3721
      • Odessa, Ukraine, 65009
        • Investigator Site 3703
      • Poltava, Ukraine, 36011
        • Investigator Site 3717
      • Ternopil, Ukraine, 46027
        • Investigator Site 3730
      • Vinnytsia, Ukraine, 21005
        • Investigator Site 3718
      • Zaporizhia, Ukraine, 69000
        • Investigator Site 3722
      • Zhytomyr, Ukraine, 10008
        • Investigator Site 3725
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Investigator Site 2015
      • Lancashire, United Kingdom, PR2 9HT
        • Investigator Site 2021
      • Salford, United Kingdom, M6 8HD
        • Investigator Site 2003
  • United States
    • California
      • Carlsbad, California, United States, 92011
        • Investigator Site 8045
      • Pomona, California, United States, 91767
        • Investigator Site 8311
    • Colorado
      • Denver, Colorado, United States, 80209
        • Investigator Site 8036
    • Florida
      • Ormond Beach, Florida, United States, 32174
        • Investigator Site 8065
      • Tampa, Florida, United States, 33612
        • Investigator Site 8018
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Investigator Site 8013
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Investigator Site 8040
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Investigator Site 8006
    • Tennessee
      • Franklin, Tennessee, United States, 37064
        • Investigator Site 8015
    • Utah
      • Orem, Utah, United States, 84058
        • Investigator Site 8042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male and female subjects aged 18 to 55 years with established diagnosis of MS McDonald 2010 with relapsing course from onset (i.e., RRMS and SPMS with superimposed relapses).

Subjects must have active disease evidenced by one or more MS attacks with onset within the period of 12 to 1 months prior to randomization, or by two or more MS attacks with onset within the 24 to 1 months prior to randomization, or with one or more gadolinium-enhancing (Gd+) lesion(s) of the brain on an MRI performed within 6 months prior to randomization.

Enrolled subjects must be ambulatory (EDSS score of up to 5.5 inclusive) and may be treatment-naïve or previously treated with MS disease modifying therapy.

Exclusion Criteria:

Subjects with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic,ophthalmological conditions) or lactating or pregnant women are not eligible to enter the study.

Subjects with contraindications to MRI or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study are not eligible to enter the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ponesimod
Subjects to receive 20 mg ponesimod
Drug: ponesimod
film-coated tablet with 20 mg ponesimod, administered orally once daily in the morning
Other Names:
  • ACT-128800
Active Comparator: Teriflunomide
Subjects to receive 14 mg teriflunomide
Drug: teriflunomide
film-coated tablet with 14 mg teriflunomide, administered orally once daily in the morning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized Confirmed Relapse Rate
Time Frame: From randomization to end of study (Week 108)
Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of Multiple sclerosis (MS), not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicates overall functional impairment assessing Visual,Brain Stem,Pyramidal,Cerebellar,Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS in conjunction with observations and information concerning gait and use of assistance. EDSS is ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10(death due to MS).
From randomization to end of study (Week 108)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Fatigue-related Symptoms as Measured by the Symptoms Domain of the Fatigue Symptom and Impact Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS) Score to Week 108
Time Frame: Baseline to Week 108
The FSIQ-RMS is a 20-item Patient Reported Outcomes (PRO) measure to evaluate fatigue-related symptoms and the impacts of those symptoms on the lives of people. The FSIQ-RMS symptom domain (FSIQ-RMS-S) consists of seven items assessing fatigue-related symptoms daily with a recall period of 24 hours measured on an 11-point numeric rating scale; the (normalized) symptom domain score ranges from 0 to 100 with a higher score indicating greater fatigue. This domain was completed on 7 consecutive days. A negative change from baseline indicates an improvement in fatigue symptoms.
Baseline to Week 108
Cumulative Number of Combined Unique Active Lesions (CUAL) Per Year From Baseline to Week 108
Time Frame: Baseline to Week 108
CUALs was calculated as sum of new Gadolinium-enhanced (Gd+) T1 lesions plus new or enlarging T2 lesions (without double-counting of lesions) from baseline based on the Magnetic resonance imaging (MRI) scans up to Week 108. Average number of lesions per year were reported.
Baseline to Week 108
12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS
Time Frame: Baseline to Week 60 and 108 Weeks
A 12-week CDA was defined as an increase of at least 1.5 in Expanded Disability Status Scale (EDSS) for participants with a baseline EDSS score of 0.0 or an increase of at least 1.0 in EDSS for participants with a baseline EDSS score of 1.0 to 5.0, or an increase of at least 0.5 in EDSS for participants with a baseline EDSS score greater than or equal to (>=) 5.5, which was confirmed after 12 weeks. Baseline EDSS was defined as the last EDSS score recorded prior to randomization. EDSS is an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to MS).
Baseline to Week 60 and 108 Weeks
24-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS
Time Frame: Baseline to 60 Weeks and 108 Weeks
A 24-week CDA was defined as an increase of at least 1.5 in EDSS for participants with a baseline EDSS score of 0.0 or an increase of at least 1.0 in EDSS for participants with a baseline EDSS score of 1.0 to 5.0, or an increase of at least 0.5 in EDSS for participants with a baseline EDSS score >= 5.5, which was confirmed after 24 weeks. Baseline EDSS was defined as the last EDSS score recorded prior to randomization. The EDSS is an ordinal scale ranging from 0 (normal neurological exam) to 10 (death to MS).
Baseline to 60 Weeks and 108 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Investigators

  • Study Director: Tatiana Scherz, MD, PhD, Actelion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2015

Primary Completion (Actual)

May 16, 2019

Study Completion (Actual)

May 16, 2019

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 24, 2015

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-058B301
  • 2012-000540-10 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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