Multiple Sclerosis Clinical Trial

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

Summary

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.

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Full 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. A vaccination sub-study will be conducted in a sub-set of up to 50 eligible study participants from selected countries who consent to be vaccinated with the Janssen coronavirus disease-2019 (COVID-19) vaccine (Ad26.COV2.S) to investigate the immune response induced by the Janssen COVID-19 vaccine.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Signed informed consent
Subjects with MS having completed the double-blind treatment in the core study as scheduled
Compliance with teriflunomide elimination procedure
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:

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

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

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:

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

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:

Suspected opportunistic infection of the CNS or any other infection which, in the opinion of the investigator, contraindicates re-start of the study drug;
Stevens-Johnson syndrome or toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms.
Need for and intention to administer forbidden study treatment-concomitant therapy
Women who are pregnant or lactating.
Male subjects wishing to parent a child;
Treatment with any MS Disease Modifying Therapies;
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;
Subjects unlikely to comply with the extension study protocol based on investigator best judgment

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

877

Study ID:

NCT03232073

Recruitment Status:

Active, not recruiting

Sponsor:

Actelion

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There are 145 Locations for this study

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The Research Center of Southern California, LLC
Carlsbad California, 92011, United States
The Neurology Group
Pomona California, 91767, United States
Mountain View Clinical Research
Denver Colorado, 80209, United States
Neurology Associates of Ormond Beach
Ormond Beach Florida, 32174, United States
University of South Florida
Tampa Florida, 33612, United States
Josephson Wallack Munshower Neurology, PC
Indianapolis Indiana, 46256, United States
Raleigh Neurology Associates
Raleigh North Carolina, 27607, United States
Ohio Health
Columbus Ohio, 43214, United States
Advanced Neurosciences Institute
Franklin Tennessee, 37064, United States
Grodno University Hospital
Grodno , 23001, Belarus
Minsk City Clinical Hospital 5
Minsk , 22002, Belarus
Republican Scientific Clinical Centre
Minsk , 22011, Belarus
Vitebsk Regional Diagnostic Center
Vitebsk , 21002, Belarus
Vitebsk Regional Clinical Hospital
Vitebsk , 21003, Belarus
University Clinicl Center Sarajevo
Sarajevo , 71000, Bosnia and Herzegovina
UMHAT Sveti Georgi
Plovdiv , 4002, Bulgaria
Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum
Sofia , 1113, Bulgaria
Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead
Sofia , 1309, Bulgaria
Acibadem City Clinic Tokuda Hospital
Sofia , 1407, Bulgaria
St Ivan Rilski University Multiprofile Hospital For Active Treatment
Sofia , 1431, Bulgaria
University Multiprofile Hospital for Active Treatment Alexandrovska EAD
Sofia , 1431, Bulgaria
Military Medical Academy, Multiprofile Hospital for Active Treatment -Sofia
Sofia , 1606, Bulgaria
University of Alberta
Edmonton Alberta, T6G 1, Canada
Royal Jubilee Hospital
Victoria British Columbia, V8R 1, Canada
Ottawa Hospital
Ottawa Ontario, K1H 8, Canada
Recherche Sepmus Inc.
Greenfield Park Quebec, J4V 2, Canada
Ch Osijek
Osijek , 31000, Croatia
University Hospital Center Zagreb
Zagreb , 10000, Croatia
Fakultní nemocnici Brno
Brno , 65691, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové , 500 0, Czechia
Nemocnice Jihlava
Jihlava , 586 3, Czechia
Fakultni nemocnice Ostrava
Ostrava-Poruba , 708 5, Czechia
Pardubicka krajska nemocnice a.s.
Pardubice , 532 0, Czechia
Vseobecna Fakultní Nemocnice
Praha 2 , 128 0, Czechia
FN Motol
Praha 5 , 150 0, Czechia
Krajska zdravotni, a.s. - Nemocnice Teplice, o.z.
Teplice , 415 2, Czechia
Suomen Terveystalo Tampere
Tampere , 33100, Finland
Mehilainen NEO
Turku , 20520, Finland
Hôpital Pellegrin CHU Bordeaux
Bordeaux cedex , 33076, France
CHU Clermont-Ferrand - Hopital Gabriel Montpied
Clermont Ferrand Cedex 1 , 63003, France
Hôpital Nord Laennec - CHU NANTES
Nantes Cedex 1 , 44093, France
Hopital PASTEUR
Nice , 6000, France
Nouvel Hôpital Civil
Strasbourg CEDEX , 67091, France
LTD 'Aversi Clinic'
T'bilisi , 0160, Georgia
P. Sarajishvili Institute of Neurology
Tbilisi , 112, Georgia
Pineo Medical Ecosystem Ltd
Tbilisi , 114, Georgia
S.Khechinashvili University Hospital
Tbilisi , 179, Georgia
Curatio, Jsc
Tbilisi , 186, Georgia
Universitätsklinikum Carl-Gustav-Carus Dresden
Dresden , 1307, Germany
Helios Klinikum Erfurt
Erfurt , 99089, Germany
Panakeia - Arzneimittelforschung GmbH
Leipzig , 04275, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz , 55131, Germany
401 Military Hospital
Athens , 115 2, Greece
Naval Hospital of Athens
Athens , 11521, Greece
Medical Center of Athens
Marousi , 15125, Greece
Uzsoki Utcai Korhaz
Budapest , 1145, Hungary
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest , 1204, Hungary
Valeomed EGÉSZSÉGÜGYI KÖZPONT
Esztergom , 2500, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr , 9023, Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa , 2143, Hungary
Barzilai Medical Center
Ashkelon , 78306, Israel
Rambam Medical Center
Haifa , 31096, Israel
Hadassah Medical Center
Jerusalem , 91120, Israel
Ziv Medical Center
Safed , 13043, Israel
Ospedale San Salvatore
L' Aquila , 67100, Italy
Azienda Ospedaliera Sant Andrea
Roma , 189, Italy
Pauls Stradins Clinical University Hospital
Riga , 1002, Latvia
Latvias Juras medicinas centrs Ltd
Riga , 1015, Latvia
Rīgas Austrumu klīniskā universitātes slimnīca
Riga , LV-10, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas , LT501, Lithuania
VsI Respublikine Siauliu ligonine, V.
Šiauliai , 76231, Lithuania
Unidad de Investigacion En Salud
Chihuahua , 31203, Mexico
CRI Centro Regiomontano de Investigacion SC
Nuevo Leon , 64060, Mexico
Neurocentrum Bydgoszcz Sp Z O O
Bydgoszcz , 85-79, Poland
Copernicus Podmiot Leczniczy Sp. z o.o
Gdansk , 80-80, Poland
NeuroCentrum. Centrum Terapii SM
Katowice , 40-57, Poland
NEURO-MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna
Katowice , 40-68, Poland
Centrum Kompleksowej Rehabilitacji
Konstancin-Jeziorna , 05-51, Poland
Centrum Opieki Zdrowotnej Orkan-Med
Ksawerow , 95-05, Poland
Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
Lublin , 20-01, Poland
Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Po
Poznan , 60-35, Poland
Clinical Research Center sp. z o.o MEDIC-R s.k.
Poznan , 61-73, Poland
NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partnerska Lekarzy
Poznan , 61-85, Poland
WroMedica I.Bielicka, A.Strzałkowska s.c.
Wrocław , 51-68, Poland
Hospital de Braga
Braga , 4710-, Portugal
Hospitais da universidade de Coimbra
Coimbra , 3000-, Portugal
Hosp. Cuf Descobertas
Lisboa , 1998-, Portugal
H. Santo António - Centro Hospitalar do Porto
Porto , 4099-, Portugal
Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'
Bucuresti , 10825, Romania
Institutul Clinic Fundeni
Bucuresti , 22328, Romania
Spitalul Universitar de Urgenta Bucuresti
Bucuresti , 50098, Romania
Spitalul Clinic Judetean de Urgenta 'Pius Brinzeu'
Timisoara , 30072, Romania
Barnaul Territorial Clinical Hospital
Barnaul, Altai Krai , 65602, Russian Federation
St. Joseph Belgorod Regional Hospital
Belgorod , 30800, Russian Federation
Bryansk Regional Hospital #1
Bryansk , 24103, Russian Federation
Sverdlovsk Region Clinical Hospital #1
Ekaterinburg , 62010, Russian Federation
Research Medical Center Your Health
Kazan , 42009, Russian Federation
Federal State Budgetary Institution
Krasnoyarsk , 66003, Russian Federation
State Budgetary Healthcare Institution Kursk Region Kursk Regional Clinical Hospital
Kursk , 30500, Russian Federation
Clinical City Hospital #1
Moscow , 11704, Russian Federation
State Health Care Institution Of Moscow
Moscow , 12701, Russian Federation
Central Clinical Hospital N.A.Semashko
Moscow , 12912, Russian Federation
Municipal Clinical Hospital # 3
Nizhniy Novgorod , 60315, Russian Federation
Siberian District Medical Center of Federal Medical-Biological Agency
Novosibirsk , 63000, Russian Federation
Federal Scientific Clinical Center of Physico-Chemical Medicine
Odintsovo , 14300, Russian Federation
Perm State Medical Academy n.a. E. A. Vagner
Perm , 61499, Russian Federation
City Clinical Hospital # 2
Pyatigorsk , 35753, Russian Federation
Pavlov First Saint Petersburg State Medical University
Saint Petersburg , 19702, Russian Federation
State Healthcare Institution Samara Regional Clinical Hospital named after V.D.Seredavin
Samara , 44309, Russian Federation
Smolensk Regional Clinical Hospital
Smolensk , 21401, Russian Federation
Municipal Multi-Specialty Hospital # 2
St. Petersburg , 19435, Russian Federation
City Clinical Hospital #31
St. Petersburg , 19711, Russian Federation
Institute of Human Brain Ras
St. Petersburg , 19737, Russian Federation
City Hospital# 40
St.Petersburg , 19770, Russian Federation
Siberian State Medical University
Tomsk , 63405, Russian Federation
Tver Regional Clinical Hospital
Tver , 17003, Russian Federation
GUZ Novgorod Regional Clinical Hospital
Velikiy Novgorod , 21401, Russian Federation
Yaroslavl Clinical Hospital #8
Yaroslavl , 15000, Russian Federation
Clinical Hospital Center Zvezdara
Belgrade , 11000, Serbia
Vojnomedicinska Akademija
Belgrade , 11000, Serbia
University Clinical Center Kragujevac
Kragujevac , 34000, Serbia
University Clinical Center NIS
Nis , 18000, Serbia
Hospital del Mar
Barcelona , 8003, Spain
Hospital Vall d'Hebron
Barcelona , 8035, Spain
Hospital Clinic I Provincial
Barcelona , 8036, Spain
Hospital Universitario de La Princesa
Madrid , 28006, Spain
Hospital Regional Universitario de Malaga
Malaga , 29010, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain
Hospital Vithas Nisa Sevilla
Sevilla , 41950, Spain
Sahlgrenska Universitetsjukhuset
Göteborg , 413 4, Sweden
Centrum för Neurologi
Stockholm , 113 6, Sweden
Karadeniz Teknik University Medical Faculty
Trabzon , 61080, Turkey
Public Non-profit Enterprise: Chernihiv City Hospital #4 under Chernihiv City Council
Chernihiv , 14001, Ukraine
Municipal health care institution Chernihiv Regional Hospital
Chernihiv , 14029, Ukraine
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk , 76018, Ukraine
Limited Liability Company 'Neuro Global'
Ivano-Frankivsk , 76493, Ukraine
Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center'
Kharkiv , 61103, Ukraine
Kharkiv Postgrad Academy, Dept of Neurology #1 At Hosp #7
Kharkiv , 61176, Ukraine
National Research Center for Radiation Medicine
Kyiv , 3115, Ukraine
Public Non-Profit Enterprise: Lviv City Clinical Hospital #5
Lviv , 79000, Ukraine
Lviv Clinical Regional Hospital
Lviv , 79010, Ukraine
Odessa National Medical University
Odesa , 65009, Ukraine
ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'
Poltava , 36024, Ukraine
Mnce 'Ternopil Regional Clinical Psychoneurology Hospital' of Trb
Ternopil , 46027, Ukraine
Public Institution Vinnitsa O.I. Yuschenko Regional Neuropsychiatric Hospital
Vinnytsia , 21005, Ukraine
O.F. Herbachevskyi Regional Clinical Hospital
Zhytomyr , 10008, Ukraine
Royal Preston Hospital
Preston , PR2 9, United Kingdom
Salford Royal NHS Foundation Trust
Salford , M6 8H, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

877

Study ID:

NCT03232073

Recruitment Status:

Active, not recruiting

Sponsor:


Actelion

How clear is this clinincal trial information?

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