Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis (OPTIMUM-LT)

June 19, 2025 updated by: Actelion

Multicenter, Non-comparative Extension of Study AC-058B301, to Investigate the Long-term Safety, Tolerability, and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple Sclerosis

The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of this long term extension of the core study AC-058B301 is to characterize the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The AC-058B303 study (extension study) is the long-term extension for the AC-058B301 study (core study). The core study has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with RMS. The subjects are treated with either ponesimod or the active comparator, teriflunomide in the core study. The purpose of this long term extension of the core study is to characterize the long-term safety and control of disease of ponesimod in subjects with RMS. In particular, the study will allow to observe potential adverse events which may only occur after long term treatment with ponesimod. The study will also investigate the effect of re-initiation of ponesimod after a brief interruption in a relatively large population (all subjects treated with ponesimod in the core study and eligible for the extension study) on disease activity in terms of relapses and MS-related MRI lesions. There is currently limited guidance on when a new MS treatment should be started after discontinuation of teriflunomide and the study will contribute with data on safety and efficacy of switching from teriflunomide to ponesimod after an interruption as mandated by the protocol. The study will also allow confirmation of sustained efficacy of ponesimod in terms of relapses, MRI lesions and reduction of disability accumulation during long-term treatment. In addition, combined data from the core study together with the results of the current extension study will allow comparison of MS activity in subjects who were switched from teriflunomide to ponesimod versus those who were treated with ponesimod in both studies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
877

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Grodno University Hospital
      • Minsk, Belarus, 220026
        • Minsk City Clinical Hospital 5
      • Minsk, Belarus, 220114
        • Republican Scientific Clinical Centre
      • Vitebsk, Belarus, 210037
        • Vitebsk Regional Clinical Hospital
      • Vitebsk, Belarus, 210023
        • Vitebsk Regional Diagnostic Center
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
        • University Clinicl Center Sarajevo
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • UMHAT Sveti Georgi
      • Sofia, Bulgaria, 1309
        • Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic Tokuda Hospital
      • Sofia, Bulgaria, 1431
        • St Ivan Rilski University Multiprofile Hospital For Active Treatment
      • Sofia, Bulgaria, 1431
        • University Multiprofile Hospital for Active Treatment Alexandrovska EAD
      • Sofia, Bulgaria, 1113
        • Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum
      • Sofia, Bulgaria, 1606
        • Military Medical Academy Multiprofile Hospital for Active Treatment Sofia
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z1
        • University of Alberta
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 1J8
        • Royal Jubilee Hospital
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Recherche Sepmus Inc.
  • Croatia
      • Osijek, Croatia, 31000
        • Ch Osijek
      • Zagreb, Croatia, 10000
        • University Hospital Center Zagreb
  • Czechia
      • Brno, Czechia, 65691
        • Fakultní nemocnici Brno
      • Hradec Králové, Czechia, 500 05
        • Fakultni Nemocnice Hradec Kralove
      • Jihlava, Czechia, 586 33
        • Nemocnice Jihlava
      • Ostrava-Poruba, Czechia, 708 52
        • Fakultni Nemocnice Ostrava
      • Pardubice, Czechia, 532 03
        • Pardubicka krajska nemocnice a s
      • Praha 2, Czechia, 128 08
        • Vseobecna Fakultni Nemocnice
      • Praha 5, Czechia, 150 06
        • FN Motol
      • Teplice, Czechia, 415 29
        • Krajska zdravotni, a.s. - Nemocnice Teplice, o.z.
  • Finland
      • Tampere, Finland, 33100
        • Suomen Terveystalo Tampere
      • Turku, Finland, 20520
        • Mehiläinen Neo
  • France
      • Bordeaux cedex, France, 33076
        • Hopital Pellegrin CHU Bordeaux
      • Clermont Ferrand Cedex 1, France, 63003
        • CHU Clermont-Ferrand - Hôpital Gabriel Montpied
      • Nantes Cedex 1, France, 44093
        • Hopital Nord Laennec CHU NANTES
      • Nice, France, 6000
        • Hôpital Pasteur
      • Strasbourg CEDEX, France, 67091
        • Nouvel Hôpital Civil
  • Georgia
      • T'bilisi, Georgia, 0160
        • LTD 'Aversi Clinic'
      • Tbilisi, Georgia, 112
        • P. Sarajishvili Institute of Neurology
      • Tbilisi, Georgia, 114
        • Pineo Medical Ecosystem LTD
      • Tbilisi, Georgia, 179
        • S.Khechinashvili University Hospital
      • Tbilisi, Georgia, 186
        • Curatio, Jsc
  • Germany
      • Dresden, Germany, 1307
        • Universitätsklinikum Carl-Gustav-Carus Dresden
      • Erfurt, Germany, 99089
        • HELIOS Klinikum Erfurt
      • Leipzig, Germany, 04275
        • Panakeia - Arzneimittelforschung GmbH
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg Universität Mainz
  • Greece
      • Athens, Greece, 115 25
        • 401 Military Hospital
      • Athens, Greece, 11521
        • Naval Hospital of Athens
      • Marousi, Greece, 15125
        • Medical Center of Athens
  • Hungary
      • Budapest, Hungary, 1204
        • Jahn Ferenc Del-pesti Korhaz es Rendelointezet
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Kórház
      • Esztergom, Hungary, 2500
        • Valeomed EGÉSZSÉGÜGYI KÖZPONT
      • Győr, Hungary, 9023
        • Petz Aladar Megyei Oktato Korhaz
      • Kistarcsa, Hungary, 2143
        • Kistarcsai Flor Ferenc Korhaz
  • Israel
      • Ashkelon, Israel, 7830604
        • Barzilai Medical Center
      • Haifa, Israel, 3109601
        • Rambam Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center
      • Safed, Israel, 1304300
        • Ziv Medical Center
  • Italy
      • L' Aquila, Italy, 67100
        • Ospedale San Salvatore
      • Roma, Italy, 189
        • Azienda Ospedaliera Sant Andrea
  • Latvia
      • Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital
      • Riga, Latvia, 1015
        • Latvias Juras medicinas centrs Ltd
      • Riga, Latvia, LV-1038
        • Rīgas Austrumu klīniskā universitātes slimnīca
  • Lithuania
      • Kaunas, Lithuania, LT50161
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
      • Šiauliai, Lithuania, 76231
        • VsI Respublikine Siauliu ligonine, V.
  • Mexico
      • Chihuahua, Mexico, 31203
        • Unidad de Investigacion en Salud
      • Nuevo Leon, Mexico, 64060
        • CRI Centro Regiomontano de Investigacion SC
  • Poland
      • Bydgoszcz, Poland, 85 796
        • Neurocentrum Bydgoszcz Sp Z O O
      • Gdansk, Poland, 80-803
        • Copernicus Podmiot Leczniczy Sp. z o.o
      • Katowice, Poland, 40 571
        • Neuro Centrum Centrum Terapii SM
      • Katowice, Poland, 40 686
        • NEURO MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna
      • Konstancin Jeziorna, Poland, 05 510
        • Centrum Kompleksowej Rehabilitacji
      • Ksawerow, Poland, 95 054
        • Centrum Opieki Zdrowotnej Orkan Med
      • Lublin, Poland, 20-410
        • Indywidualna Praktyka Lekarska prof. Konrad Rejdak
      • Poznan, Poland, 61 731
        • Clinical Research Center sp z o o MEDIC R s k
      • Poznan, Poland, 60 355
        • Szpital Kliniczny im Heliodora Swiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Po
      • Poznan, Poland, 61 853
        • NZOZ NEURO KARD Ilkowski i Partnerzy Sp Partnerska Lekarzy
      • Wroclaw, Poland, 51 685
        • WroMedica I Bielicka A Strzalkowska s c
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Coimbra, Portugal, 3000-075
        • Hospitais da universidade de Coimbra
      • Lisboa, Portugal, 1998-018
        • Hosp. Cuf Descobertas
      • Porto, Portugal, 4099-001
        • H. Santo António - Centro Hospitalar do Porto
  • Romania
      • Bucuresti, Romania, 10825
        • Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'
      • Bucuresti, Romania, 22328
        • Institutul Clinic Fundeni
      • Bucuresti, Romania, 50098
        • Spitalul Universitar de Urgenta Bucuresti
      • Timisoara, Romania, 300723
        • Spitalul Clinic Judetean de Urgenta Pius Brinzeu
  • Russian Federation
      • Barnaul, Russian Federation, 656024
        • Barnaul Territorial Clinical Hospital
      • Belgorod, Russian Federation, 308007
        • St. Joseph Belgorod Regional Hospital
      • Bryansk, Russian Federation, 241033
        • Bryansk Regional Hospital #1
      • Ekaterinburg, Russian Federation, 620102
        • Sverdlovsk Region Clinical Hospital #1
      • Kazan, Russian Federation, 420097
        • Research Medical Center Your Health
      • Krasnoyarsk, Russian Federation, 660037
        • Federal State Budgetary Institution
      • Kursk, Russian Federation, 305007
        • State Budgetary Healthcare Institution Kursk Region Kursk Regional Clinical Hospital
      • Moscow, Russian Federation, 117049
        • Clinical City Hospital #1
      • Moscow, Russian Federation, 127015
        • State Health Care Institution Of Moscow
      • Moscow, Russian Federation, 129128
        • Central Clinical Hospital N.A.Semashko
      • Nizhniy Novgorod, Russian Federation, 603155
        • Municipal Clinical Hospital # 3
      • Novosibirsk, Russian Federation, 630007
        • Siberian District Medical Center of Federal Medical-Biological Agency
      • Odintsovo, Russian Federation, 143000
        • Federal Scientific Clinical Center of Physico-Chemical Medicine
      • Perm, Russian Federation, 614990
        • Perm State Medical Academy n.a. E. A. Vagner
      • Pyatigorsk, Russian Federation, 357538
        • City Clinical Hospital # 2
      • Saint Petersburg, Russian Federation, 197022
        • Pavlov First Saint Petersburg State Medical University
      • Samara, Russian Federation, 443095
        • State Healthcare Institution Samara Regional Clinical Hospital named after V.D.Seredavin
      • Smolensk, Russian Federation, 214018
        • Smolensk Regional Clinical Hospital
      • St. Petersburg, Russian Federation, 194354
        • Municipal Multi-Specialty Hospital # 2
      • St. Petersburg, Russian Federation, 197110
        • City Clinical Hospital #31
      • St. Petersburg, Russian Federation, 197376
        • Institute of Human Brain Ras
      • St.Petersburg, Russian Federation, 197706
        • City Hospital# 40
      • Tomsk, Russian Federation, 634050
        • Siberian State Medical University
      • Tver, Russian Federation, 170036
        • Tver Regional Clinical Hospital
      • Velikiy Novgorod, Russian Federation, 214018
        • GUZ Novgorod Regional Clinical Hospital
      • Yaroslavl, Russian Federation, 150003
        • Yaroslavl Clinical Hospital #8
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Hospital Center Zvezdara
      • Belgrade, Serbia, 11000
        • Vojnomedicinska Akademija
      • Kragujevac, Serbia, 34000
        • University Clinical Center Kragujevac
      • Nis, Serbia, 18000
        • University Clinical Center Niš
  • Spain
      • Barcelona, Spain, 8003
        • Hospital del Mar
      • Barcelona, Spain, 8035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 8036
        • Hospital Clinic i Provincial
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Malaga, Spain, 29010
        • Hospital Regional Universitario de Malaga
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Sevilla, Spain, 41950
        • Hospital Vithas Nisa Sevilla
  • Sweden
      • Göteborg, Sweden, 413 45
        • Sahlgrenska Universitetsjukhuset
      • Stockholm, Sweden, 113 65
        • Centrum för neurologi
  • Turkey
      • Trabzon, Turkey, 61080
        • Karadeniz Teknik University Medical Faculty
  • Ukraine
      • Chernihiv, Ukraine, 14001
        • Public Non-profit Enterprise: Chernihiv City Hospital #4 under Chernihiv City Council
      • Chernihiv, Ukraine, 14029
        • Municipal health care institution Chernihiv Regional Hospital
      • Ivano-Frankivsk, Ukraine, 76018
        • Ivano-Frankivsk Regional Clinical Hospital
      • Ivano-Frankivsk, Ukraine, 76493
        • Limited Liability Company 'Neuro Global'
      • Kharkiv, Ukraine, 61103
        • Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center'
      • Kharkiv, Ukraine, 61176
        • Kharkiv Postgrad Academy, Dept of Neurology #1 At Hosp #7
      • Kyiv, Ukraine, 3115
        • National Research Center for Radiation Medicine
      • Lviv, Ukraine, 79000
        • Public Non-Profit Enterprise: Lviv City Clinical Hospital #5
      • Lviv, Ukraine, 79010
        • Lviv Clinical Regional Hospital
      • Odesa, Ukraine, 65009
        • Odessa National Medical University
      • Poltava, Ukraine, 36024
        • ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'
      • Ternopil, Ukraine, 46027
        • Mnce 'Ternopil Regional Clinical Psychoneurology Hospital' of Trb
      • Vinnytsia, Ukraine, 21000
        • Medical Center Salutem LLC
      • Zhytomyr, Ukraine, 10008
        • O.F. Herbachevskyi Regional Clinical Hospital
  • United Kingdom
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hospital
      • Salford, United Kingdom, M6 8HD
        • Salford Royal NHS Foundation Trust
  • United States
    • California
      • Carlsbad, California, United States, 92011
        • The Research Center of Southern California, LLC
      • Pomona, California, United States, 91767
        • The Neurology Group
    • Colorado
      • Denver, Colorado, United States, 80209
        • Mountain View Clinical Research
    • Florida
      • Ormond Beach, Florida, United States, 32174
        • Neurology Associates of Ormond Beach
      • Tampa, Florida, United States, 33612
        • University of South Florida
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Josephson Wallack Munshower Neurology, PC
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Ohio Health
    • Tennessee
      • Franklin, Tennessee, United States, 37064
        • Advanced Neurosciences Institute

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed informed consent
  2. Subjects with MS having completed the double-blind treatment in the core study as scheduled
  3. Compliance with teriflunomide elimination procedure
  4. Women of childbearing potential (WOCBP) must have a negative pre-treatment urine pregnancy test, must agree to undertake 4-weekly urine pregnancy tests, and must have been using reliable methods of contraception. Fertile male subjects participating in the study must agree to use a condom.

Exclusion Criteria:

  1. Any of the following cardiovascular conditions on Day 1 pre-dose:

    1. Resting heart rate (HR) < 50 bpm;
    2. Presence of second degree atrioventricular (AV) block or third degree AV block or a QTcF interval > 470 ms (females), > 450 ms (males);

  2. Any of the following alerts from central laboratory at Visit 14 of the core study (EOT) which was confirmed as an alert at repeated testing or not repeated prior to FU1 of the core study:

    1. Lymphocyte count: < 0.2 x 109/L;
    2. Neutrophil count <1.0 × 109/L;
    3. Platelet count < 50 × 109/L;
    4. Creatinine clearance < 30 mL/min
  3. At Visit 14 of the core study (EOT) >30% decrease from core study baseline FEV1 and/or FVC;
  4. Clinically significant, persistent respiratory AEs (e.g., dyspnea) not resolved prior to first dosing in the extension study.
  5. Macular edema at any time between Visit 1 (Screening) in the core study and Day 1 of the extension study.

  6. Presence of the following at core study Visit 14 (EOT, Week 108), FU1, or abbreviated visit FU2, or on Day 1 of the extension study pre-dose:

    1. Suspected opportunistic infection of the CNS or any other infection which, in the opinion of the investigator, contraindicates re-start of the study drug;
    2. Stevens-Johnson syndrome or toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms.
  7. Need for and intention to administer forbidden study treatment-concomitant therapy
  8. Women who are pregnant or lactating.
  9. Male subjects wishing to parent a child;
  10. Treatment with any MS Disease Modifying Therapies;
  11. Any other clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the subject at risk by participating in the study;
  12. Subjects unlikely to comply with the extension study protocol based on investigator best judgment

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ponesimod
20 mg administered orally once daily
Drug: Ponesimod
Ponesimod; Film-coated tablet; Oral use. From Day 1 to Day 14, ponesimod is gradually up-titrated until a maintenance dose of 20 mg is reached from Day 15

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Annualized Confirmed Relapse Rate (ARR)
Time Frame: From randomization in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
ARR: number of confirmed relapses per patient-year. Relapse: new, worsening, or recurrent neurological symptoms that occurred at least 30 days after the onset of a preceding relapse, and that lasted at least 24 hours, in the absence of fever or infection. A confirmed relapse is identified when a patient's symptoms worsen as indicated by an increase in their Expanded Disability Status Scale (EDSS) or Functional Systems (FS) scores, consistent with previous clinically stable assessments. Specific criteria for a confirmed relapse include: An increase of 0.5 points on EDSS; (unless EDSS=0, then requires an increase of 1.0-point); An increase of at least 1.0 point in at least two FS scores; or a 2.0-point increase in one FS score (excluding bladder/bowel and cerebral). Rating individual FS scores is used to rate EDSS along with observations and information concerning gait and use of assistance. EDSS is ordinal clinical rating scale ranging:0 (normal)-10 (death due to MS).
From randomization in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Time From Core Study Randomization to First Confirmed Relapse
Time Frame: From randomization in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Time to first confirmed relapse: date of first confirmed relapse (in either core or extension study) minus date of randomization in core study+1 day. Relapse: new, worsening, or recurrent neurological symptoms that occurred at least 30 days after the onset of a preceding relapse, and that lasted at least 24 hours in absence of fever or infection. A confirmed relapse: when patient's symptoms worsen as indicated by an increase in their EDSS/FS scores, consistent with previous clinically stable assessments. Specific criteria for confirmed relapse are: An increase of 0.5 points on EDSS; (unless EDSS=0, then requires an increase of 1.0-point); An increase of at least 1.0 point in at least two FS scores; or a 2.0-point increase in one FS score (excluding bladder/bowel and cerebral). Rating individual FS scores is used to rate EDSS along with observations and information concerning gait and use of assistance. EDSS is ordinal clinical rating scale ranging:0(normal)-10(death due to MS).
From randomization in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Time to First 12-week Confirmed Disability Accumulation (CDA)
Time Frame: From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Time to first 12-week CDA is defined as start date of the first 12-week CDA minus date of randomization in the core study + 1 day. A 12-week CDA is defined as a 12-week sustained increase from the core baseline EDSS score, which is confirmed at a scheduled visit after 12-weeks. CDA is defined as: (a) Sustained increase of at least 1.5 in EDSS for participants with a core baseline EDSS score of 0; (b) Sustained increase of at least 1.0 in EDSS for participants with a core baseline EDSS score of 1.0 to 5.0; (c) Sustained increase of at least 0.5 in EDSS for participants with a core baseline EDSS score >=5.5, confirmed after 12 weeks. EDSS is an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to MS). Core baseline for efficacy: last non-missing value recorded before or on randomization in the core study for each outcome measure and participant individually.
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Time to First 24-week Confirmed Disability Accumulation (CDA)
Time Frame: From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Time to first 24-week CDA was defined as start date of the first 24-week CDA minus date of randomization in the core study + 1 day. A 24-week CDA was defined as a 24-week sustained increase from the core baseline EDSS score, which is confirmed at a scheduled visit after 24-weeks. CDA was defined as: (a) Sustained increase of at least 1.5 in EDSS for participants with a core baseline EDSS score of 0; (b) Sustained increase of at least 1.0 in EDSS for participants with a core baseline EDSS score of 1.0 to 5.0; (c) Sustained increase of at least 0.5 in EDSS for participants with a core baseline EDSS score >=5.5, confirmed after 24 weeks. EDSS was an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to MS). Core baseline for efficacy: last non-missing value recorded before or on randomization in the core study for each outcome measure and participant individually.
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Percentage of Participants With Absence of Relapses
Time Frame: From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Relapse: new, worsening, or recurrent neurological symptoms that occurred at least 30 days after the onset of a preceding relapse, and that lasted at least 24 hours in absence of fever or infection. A confirmed relapse: when patient's symptoms worsen as indicated by an increase in their EDSS/FS scores, consistent with previous clinically stable assessments. Specific criteria for confirmed relapse: An increase of 0.5 points on EDSS; (unless EDSS=0, then requires an increase of 1.0-point); An increase of at least 1.0 point in at least two FS scores; or a 2.0-point increase in one FS score (excluding bladder/bowel and cerebral). Rating individual FS scores is used to rate EDSS along with observations and information concerning gait and use of assistance. EDSS is ordinal clinical rating scale ranging:0(normal)-10(death due to MS). Core baseline for efficacy: last non-missing value recorded before or on randomization in the core study for each outcome measure and participant individually.
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Change From Baseline in Expanded Disability Status Scale (EDSS)
Time Frame: From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
EDSS is ordinal clinical rating scale based on standard neurological examination for assessing neurological disability and impairment in MS. Seven FS scores were rated on a scale ranged from 0 to 5 or 6 to assess visual, brain, stem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral functions while ambulation was scored on scale ranged from 0 to 12 to assess walking distance and assistance. Individual FS scores were then used in conjugation with ambulation score to obtain EDSS score which ranged from 0 (normal) to 10 (death due to MS) in 0.5 unit increments that represented higher levels of disability. Core baseline for efficacy is defined as the last non-missing value recorded before or on randomization in the core study for each outcome measure and each participant individually.
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Percentage of Participants With No Evidence of Disease Activity (NEDA) Status According to NEDA With Three Components (NEDA-3) at Extension End of Study
Time Frame: From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
NEDA-3 up to extension EOS is defined by the absence of confirmed relapse, gadolinium-enhancing (Gd+ T1) lesions, new or enlarging T2 lesions, and 12-week CDA. If at least one of the criteria was not fulfilled or the participant discontinued treatment prematurely, the participant was not considered to have achieved NEDA-3. Confirmed relapse: when patient's symptoms worsen as indicated by an increase in their EDSS/FS scores, consistent with previous clinically stable assessments. Rating individual FS scores is used to rate EDSS along with observations and information concerning gait and use of assistance. EDSS is ordinal clinical rating scale ranging: 0 (normal)-10 (death due to MS). Core baseline for efficacy is defined as the last non-missing value recorded before or on randomization in the core study for each outcome measure and each participant individually.
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Percentage of Participants With No Evidence of Disease Activity (NEDA) Status According to NEDA With Four Components (NEDA-4) at Extension End of Study
Time Frame: From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
NEDA-4 up to EOS is defined by the absence of confirmed relapse, Gd+ T1 lesions, new or enlarging T2 lesions, 12-week CDA until EOS, and absence of annual brain volume decrease >=0.4% from core baseline up to extension EOS. If at least one of the criteria was not fulfilled or the participant discontinued treatment prematurely, the participant was not considered to have achieved NEDA-4. Confirmed relapse: when patient's symptoms worsen by an increase in their EDSS/FS scores, consistent with previous clinically stable assessments. Rating individual FS scores is used to rate EDSS along with observations and information concerning gait and use of assistance. EDSS is ordinal clinical rating scale ranging: 0 (normal)-10 (death due to MS). Core baseline for efficacy is defined as the last non-missing value recorded before or on randomization in core study for each outcome measure and each participant individually.
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Percent Change From Baseline in Brain Volume (PCBV) Measured by Magnetic Resonance Imaging (MRI)
Time Frame: From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
Percent change from baseline in brain volume (PCBV) measured by MRI were reported. Normalized Brain Volume at core baseline was measured in cubic centimeter (cm^3). Core baseline for efficacy is defined as the last non-missing value recorded before or on randomization in the core study for each outcome measure and each participant individually. In this outcome measure, results were presented for extension end of treatment visit.
From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
Cumulative Number of Combined Unique Active Lesions (CUAL) Measured by MRI
Time Frame: From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
CUALs was calculated as sum of new T1 Gadolinium-enhanced (Gd+) lesions and new or enlarging T2 lesions (without double-counting of lesions) from baseline up to extension EOS based on the Magnetic resonance imaging (MRI). Average number of lesions per patient-year were reported. Results are based on a negative-binomial regression model. Core baseline for efficacy is defined as the last non-missing value recorded before or on randomization in the core study for each outcome measure and each participant individually.
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Number of Gadolinium-enhancing (Gd+) T1 Lesions Measured by MRI
Time Frame: From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
Number of Gd+ T1 lesions measured by MRI were reported. Results are based on a negative-binomial regression model. Core baseline for efficacy is defined as the last non-missing value recorded before or on randomization in the core study for each outcome measure and each participant individually. For this outcome measure, results presented here are for the Extension end-of-treatment visit.
From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
Cumulative Number of New or Enlarging T2 Lesions Measured by MRI
Time Frame: From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Cumulative number of new or enlarging T2 lesions measured by MRI were reported. Average number of lesions per year were reported. Results are based on a negative-binomial regression model. Core baseline for efficacy is defined as the last non-missing value recorded before or on randomization in the core study for each outcome measure and each participant individually.
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Change From Baseline in Volume of MRI Lesions (T2 Lesions and T1 Hypointense Lesions)
Time Frame: From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
Change from baseline in volume of MRI lesions (T2 lesions, T1 hypointense lesions) were reported. Core baseline for efficacy is defined as the last non-missing value recorded before or on randomization in the core study for each outcome measure and each participant individually. In this outcome measure, results were presented for extension end of treatment visit.
From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
Number of Participants With Absence of MRI Lesions (Gd+ T1 Lesions, New or Enlarging T2 Lesions)
Time Frame: From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
Number of participants with absence of MRI lesions (Gd+ T1 lesions, new or enlarging T2 lesions) were reported. Core baseline for efficacy is defined as the last non-missing value recorded before or on randomization in the core study for each outcome measure and each participant individually. In this outcome measure, results were presented for extension end of treatment visit.
From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
Percentage of Gd+ Lesions at Baseline Evolving to Persistent Black Holes (PBHs)
Time Frame: From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
Percentage of Gd+ lesions at baseline evolving to PBHs were reported. Core baseline for efficacy is defined as the last non-missing value recorded before or on randomization in the core study for each outcome measure and each participant individually. In this outcome measure, results were presented for extension end of treatment visit.
From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months + 15 days
Number of participants with TEAEs were reported. An AE is any untoward medical event that occurs in a participants being administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as AEs occurring from start of treatment up to treatment end date + 15 days.
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months + 15 days
Number of Participants With Treatment-emergent New Morphological Electrocardiogram (ECG) Abnormalities
Time Frame: From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months + 15 days
Number of participants with treatment-emergent new morphological ECG abnormalities were reported. Treatment-emergent new morphological ECG abnormalities are defined as those ECG abnormalities occurring from start of treatment up to treatment end date + 15 days.
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months + 15 days
Actual Values of 12-lead ECG Measurements up to End of Study Treatment: Heart Rate
Time Frame: From the start of study treatment in the extension study up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Actual values of 12-lead ECG measurements up to end of study treatment: heart rate were reported. In this outcome measure, results were presented for extension end of treatment visit.
From the start of study treatment in the extension study up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Actual Values of 12-lead ECG Measurements up to End of Study Treatment: PR, QRS, QT, QTcB, QTcF
Time Frame: From the start of study treatment in the extension study up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Actual values of 12-lead ECG measurements up to end of study treatment: PR, QRS, QT, QTcB, QTcF were reported. In this outcome measure, results were presented for extension end of treatment visit.
From the start of study treatment in the extension study up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Change in Heart Rate (HR) From Baseline up to End of Study Treatment
Time Frame: From the start of study treatment in the extension study up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Change in heart rate (HR) from baseline up to end of study treatment were reported.
From the start of study treatment in the extension study up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Change in PR, QRS, QT, QTcB, QTcF From Baseline up to End of Study Treatment
Time Frame: From the start of study treatment in the extension study up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Change in PR, QRS, QT, QTcB, QTcF from baseline up to end of study treatment were reported.
From the start of study treatment in the extension study up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Absolute Values in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) Values
Time Frame: From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Absolute values in FEV1 and FVC values were reported. FEV1: the maximal volume of air exhaled from the lungs in 1 second of a forced expiration from a position of full inspiration as measured by spirometer. FVC: the volume of air (in liters) that can be forcibly blown out after full inspiration in the upright position. Extension baseline for safety is the last valid non-missing assessment that is taken on or after EOT visit in the core study, and prior to first study drug intake in the extension study. Results are presented for extension end of treatment visit.
From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Percent Change in (FEV1) and Forced Vital Capacity (FVC) From Baseline (%)
Time Frame: From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Percent change in FEV1 and FVC from baseline (%) were reported. FEV1: the maximal volume of air exhaled from the lungs in 1 second of a forced expiration from a position of full inspiration as measured by spirometer. FVC: the volume of air (in liters) that can be forcibly blown out after full inspiration in the upright position. Extension baseline for safety is the last valid non-missing assessment that is taken on or after EOT visit in the core study, and prior to first study drug intake in the extension study. In this outcome measure, results were presented for extension end of treatment visit.
From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Time Frame: From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months + 15 days
Number of participants with treatment-emergent SAEs were reported. A SAE was defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or was an important medical event. Treatment-emergent SAEs are defined as SAEs occurring from start of treatment up to treatment end date + 15 days.
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months + 15 days
Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs)
Time Frame: From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months + 15 days
Number of participants with treatment-emergent AESIs were reported. AESIs included bradyarrhythmia occurred post-first dose, macular edema, bronchoconstriction, severe liver injury, serious opportunistic infections including progressive multifocal leukoencephalopathy (PML), skin cancer, non-skin malignancy, convulsions, unexpected neurological or psychiatric symptoms/signs (posterior reversible encephalopathy syndrome [PRES], acute disseminated encephalomyelitis [ADEM], and atypical MS relapses). Treatment-emergent AESIs are defined as AESIs occurring from start of treatment up to treatment end date + 15 days.
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months + 15 days
Number of Participants With AE Leading to Premature Discontinuation of Study Treatment
Time Frame: From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months + 15 days
Number of participants with AE leading to premature discontinuation of study treatment were reported. An AE is any untoward medical event that occurs in a participant being administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as AEs occurring from start of treatment up to treatment end date + 15 days.
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months + 15 days
Number of Participants With Treatment-emergent Decrease From Baseline >20% and >30% in FEV1 or FVC
Time Frame: From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months + 15 days
Number of participants with treatment-emergent decrease from baseline >20% and >30% in FEV1 or FVC were reported. Treatment-emergent is defined as events occurring from start of treatment up to treatment end date + 15 days (that is, findings not present at any assessment prior to first treatment in the extension study).
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months + 15 days
Number of Participants With Treatment-emergent Decrease of >20% Points in Percent Predicted FEV1 and FVC From Baseline
Time Frame: From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months + 15 days
Number of participants with treatment-emergent decrease of >20% points in percent predicted FEV1 and FVC from baseline were reported. Treatment-emergent is defined as events occurring from start of treatment up to treatment end date + 15 days (that is, findings not present at any assessment prior to first treatment in the extension study).
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months + 15 days
Number of Participants With a Decrease of >=200 mL or >=12% in FEV1 or FVC From Baseline to EOT
Time Frame: From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Number of participants with a decrease of >=200 mL or >=12% in FEV1 or FVC from baseline to EOT were planned to be reported. Extension baseline for safety is the last valid non-missing assessment that is taken on or after EOT visit in the core study, and prior to first study drug intake in the extension study. This endpoint is not relevant as a substantial proportion of patients continued onto post-treatment disease-modifying therapy (DMT), hence it cannot provide an assessment of reversibility.
From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Change in FEV1 and FVC (% Predicted) From Baseline to End of Treatment (EOT)
Time Frame: From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Change in FEV1 and FVC (% predicted) from baseline to EOT were predicted. Extension baseline for safety is the last valid non-missing assessment that is taken on or after EOT visit in the core study, and prior to first study drug intake in the extension study.
From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Change in FEV1 and FVC (% Predicted) From Baseline to End of Study (EOS)
Time Frame: From extension study baseline up to the end of study in the extension study. The actual time varied for each participant and could be up to 73.2 months
Change in FEV1 and FVC (% predicted) from baseline to EOS were predicted. Extension baseline for safety is the last valid non-missing assessment that is taken on or after EOT visit in the core study, and prior to first study drug intake in the extension study.
From extension study baseline up to the end of study in the extension study. The actual time varied for each participant and could be up to 73.2 months
Absolute Change in Lung Diffusion Capacity as Assessed by Diffusing Capacity for the Lungs Measured Using Carbon Monoxide (DL[CO]) From Baseline
Time Frame: From extension study baseline up to the end of study in the extension study. The actual time varied for each participant and could be up to 73.2 months
Absolute change in lung diffusion capacity as assessed by DL[CO] from baseline were reported. Extension baseline for safety is the last valid non-missing assessment that is taken on or after EOT visit in the core study, and prior to first study drug intake in the extension study.
From extension study baseline up to the end of study in the extension study. The actual time varied for each participant and could be up to 73.2 months
Change in DL[CO] (% Predicted) From Baseline to EOT
Time Frame: From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Change in DL[CO] (% predicted) from baseline to EOT were predicted. Extension baseline for safety is the last valid non-missing assessment that is taken on or after EOT visit in the core study, and prior to first study drug intake in the extension study.
From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Change in DL[CO] (% Predicted) From Baseline to EOS
Time Frame: From extension study baseline up to the end of study in the extension study. The actual time varied for each participant and could be up to 73.2 months
Change in DL[CO] (% predicted) from baseline to EOS were predicted. Extension baseline for safety is the last valid non-missing assessment that is taken on or after EOT visit in the core study, and prior to first study drug intake in the extension study.
From extension study baseline up to the end of study in the extension study. The actual time varied for each participant and could be up to 73.2 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Actual Values of 12-lead ECG Measurements on Day of First Re-initiation (Day 1) of Study Drug: Heart Rate
Time Frame: Extension analysis period: Predose, 1, 2, 3, 4 hours post dose on Day 1 of re-initiation (re-initiation could occur on any day during the treatment period when drug was interrupted for at least 3 consecutive days [up to 71.8 months])
Actual values of 12-lead ECG measurements on day of first Re-initiation (Day 1) of study drug: heart rate were reported.
Extension analysis period: Predose, 1, 2, 3, 4 hours post dose on Day 1 of re-initiation (re-initiation could occur on any day during the treatment period when drug was interrupted for at least 3 consecutive days [up to 71.8 months])
Actual Values of 12-lead ECG Measurements on Day of First Re-initiation (Day 1) of Study Drug: PR, QRS, QT, QTcB, QTcF
Time Frame: Extension analysis period: Predose, 1, 2, 3, 4 hours post dose on Day 1 of re-initiation (re-initiation could occur on any day during the treatment period when drug was interrupted for at least 3 consecutive days [up to 71.8 months])
Actual values of 12-lead ECG measurements on day of first Re-initiation (Day 1) of study drug: PR, QRS, QT, QTcB, QTcF were reported.
Extension analysis period: Predose, 1, 2, 3, 4 hours post dose on Day 1 of re-initiation (re-initiation could occur on any day during the treatment period when drug was interrupted for at least 3 consecutive days [up to 71.8 months])

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Actelion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Tatiana Sidorenko, MD, PhD, Actelion

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC-058B303 (Other Identifier: Janssen Research & Development, LLC)
  • 2016-004719-10 (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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