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Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®) (POINT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02907177
Recruitment Status : Active, not recruiting
First Posted : September 20, 2016
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Actelion

Brief Summary:
This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Ponesimod Other: Placebo Phase 3

Detailed Description:
The study will assess the efficacy, safety, and tolerability of add-on therapy with ponesimod 20 mg vs placebo in adult participants with active relapsing multiple sclerosis (RMS) who are treated with dimethyl fumarate (DMF). Approximately 600 participants who have been receiving DMF for at least 6 months will be randomized in a 1:1 ratio to ponesimod 20 mg or placebo. The study consists of the following study periods: Pre-randomization period; Treatment period; Post-treatment observation period. The study includes one ponesimod treatment arm at the maintenance dose of 20 mg o.d. corresponding to the optimal dose when used as monotherapy based on the Phase 2 dose-finding trial and its ongoing extension. The study includes a placebo comparator arm, but all patients will remain on DMF background therapy throughout the study. Moreover, participants who experience a confirmed relapse or an event of 24-week confirmed disability accumulation (DMF) while on study drug will have the option to switch to an alternative treatment. The treatment period has a variable duration from a minimum of 60 weeks (for the last subject randomized) to a maximum of 156 weeks for the first subjects randomized in the trial and includes a gradual up-titration of ponesimod from a 2 mg starting dose to a 20 mg maintenance dose over a period of 14 days. The total duration of the study will be approximately up to 167 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-blind, Parallel-group, add-on, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : March 10, 2020
Estimated Study Completion Date : March 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ponesimod
Ponesimod
Drug: Ponesimod
One tablet of ponesimod 20 mg administered orally once daily in the morning from Day 15 to EOT. To reduce the first-dose effect of ponesimod, an uptitration scheme will be implemented from Day 1 to Day 14 (with dose strength increasing from 2 mg to 20 mg).

Placebo Comparator: Placebo
Placebo
Other: Placebo
One tablet of matching placebo administered orally once daily in the morning




Primary Outcome Measures :
  1. Annualized relapse rate (ARR) [ Time Frame: From randomization up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Number of confirmed relapses per subject-year


Secondary Outcome Measures :
  1. Time to 12-week confirmed disability accumulation (CDA) [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Time to 12-week confirmed disability accumulation (CDA)

  2. Time to first confirmed relapse [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Time to first confirmed relapse

  3. Mean number of combined unique active lesions (CUALs) per post-baseline scan [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Mean number of combined unique active lesions (CUALs) per post-baseline scan

  4. Longitudinal change over time in fatigue-related symptoms as measured by the symptoms domain of the FSIQ-RMS [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Longitudinal change over time in fatigue-related symptoms as measured by the symptoms domain of the FSIQ-RMS

  5. Longitudinal percent change from baseline over time in brain volume [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Longitudinal percent change from baseline over time in brain volume


Other Outcome Measures:
  1. Treatment-emergent adverse events (AEs) and serious AEs [ Time Frame: From time of first study drug intake up to 30 days after study treatment discontinuation ]
    Treatment-emergent adverse events (AEs) and serious AEs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Signed informed consent prior to initiation of any study-mandated procedure.
  • Women of childbearing potential must have a negative pregnancy test and use reliable methods of contraception
  • Presenting with a diagnosis of MS as defined by the revised (2010) McDonald Diagnostic Criteria for MS with relapsing course from onset (i.e., relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) with superimposed relapses).
  • Ongoing treatment with DMF for at least 6 months prior to screening
  • Active disease after at least 3 months of DMF treatment
  • Ambulatory and with an EDSS score between 0 and 6.0 (inclusive).

Exclusion Criteria:

  • Lactating or pregnant women and women intending to become pregnant during the study.
  • Presenting with a diagnosis of MS with progressive course from onset (i.e., primary progressive MS or progressive relapsing MS).
  • Evidence of a relapse of MS with onset within 30 days prior to baseline EDSS assessment.
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907177


Locations
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United States, Alabama
UAB Dpt of Neurology
Birmingham, Alabama, United States, 35233
United States, California
Neuro-Pain Medical Center
Fresno, California, United States, 93710
SC3 Research - Pasadena
Pasadena, California, United States, 91105
Care Access Research - Santa Clarita
Santa Clarita, California, United States, 91321
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Mountain View Clinical Research, Inc
Denver, Colorado, United States, 80209
United States, Connecticut
Associated Neurologists
Danbury, Connecticut, United States, 06810
United States, Florida
Bradenton Research Center
Bradenton, Florida, United States, 34205
Neurology Associates - MS Center of Greater Orlando
Maitland, Florida, United States, 32751
Neurology Assoc of Ormond Beach - CNS Trials
Ormond Beach, Florida, United States, 32174
Suncoast Neuroscience Associates, Inc
Saint Petersburg, Florida, United States, 33713
The MS Center of Vero Beach
Vero Beach, Florida, United States, 32960
United States, Indiana
Fort Wayne Neurological Center - North Office
Fort Wayne, Indiana, United States, 46825
United States, Kansas
University of Kansas Med Center
Kansas City, Kansas, United States, 66160
MidAmerica Neuroscience Research Foundation/Rowe Neurology
Lenexa, Kansas, United States, 66214
United States, Michigan
Henry Ford Health System - Neurology
Detroit, Michigan, United States, 48202
United States, New Mexico
Univ of New Mexico - Health Sciences Center
Albuquerque, New Mexico, United States, 87131
United States, New York
NYU Langone Medical Center - MS Comprehensive Care Center
New York, New York, United States, 10016
United States, Ohio
Riverhills Healthcare, Inc.
Cincinnati, Ohio, United States, 45212
OhioHealth Research Institute
Columbus, Ohio, United States, 43214
United States, Oklahoma
Neurology and Neuromuscular Center
Oklahoma City, Oklahoma, United States, 73102
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital - Dpt Neurology MS Center
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Advanced Neuroscience Institute
Franklin, Tennessee, United States, 37064
United States, Texas
Neurology Center of San Antonio
San Antonio, Texas, United States, 78258
Australia, Victoria
Austin Health - Neuro-Immunology Clinical Research, Education and Support Service
Heidelberg, Victoria, Australia, 3084
Austria
MS Ambulanz Maida
Wien, Austria, 1010
Medizinische Universität Wien, Universitätsklinik für Neurologie
Wien, Austria, 1090
Belgium
Hospital universitair Brussels_neurology department
Brussels, Belgium, 1090
Hospital - Universitair Gent __Neurology Department
Gent, Belgium, 9000
Hospital - Revalidatie & MS Centrum Overpelt_Neurology Department
Overpelt, Belgium, 3900
Bulgaria
"Multiprofile Hospital for Active Treatment of Neurology and Psychiatry - Sveti Naum" EAD - Neurology Clinic for Movement Disorders
Sofia, Bulgaria, 1113
"University Multiprofile Hospital for Active Treatment - Alexandrovska" EAD, Neurology Clinic
Sofia, Bulgaria, 1431
University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EAD, Neurology Clinic
Sofia, Bulgaria, 1431
Canada
University of Alberta
Edmonton, Canada, T6G 1Z1
Czechia
Fakultní nemocnice u sv. Anny Brno, RS Centrum
Brno, Czechia, 656 91
Fakultní nemocnice Hradec Králové, Neurologická klinika
Hradec Králové, Czechia, 500 05
Nemocnice Jihlava, Neurologické oddělení
Jihlava, Czechia, 586 33
Pardubicka krajska nemocnice, MS Centrum
Pardubice, Czechia, 532 03
Krajská zdravotní a.s. - Nemonice Teplice o.z., RS Centrum
Teplice, Czechia, 415 29
Denmark
Aalborg Universitetshospital, Skleroseklinikken Neurologisk afdelning
Aalborg, Denmark, 9000
Glostrup Hospital, Neurologisk afdelning
Glostrup, Denmark, 2600
France
Hôpital Avicenne, Service de Neurologie
Bobigny, France, 93000
Hosp Gabriel Montpied, Dept Neurology
Clermont Ferrand, France, 63003
Centre Hospitalier Sud Francilien - Service de Neurologie
Corbeil-Essonnes, France, 91100
CHU de Dijon - Hôpital François Miterrand, Service de Neurologie
Dijon, France, 21079
CHRU de Lille - Hôpital Roger Salengro, Service de Neurologie
Lille, France, 59037
Hopital Gui de Chauliac - CHU Montpellier
Montpellier, France, 34295
Hôpital Central - CHU Nancy, Département Neurologie
Nancy, France, 54035
Hôpital Universitaire Carémeau, Service de Neurologie
Nimes, France, 30029
CHI POISSY-Saint Germay en Laye_Service de Neurologie et Réeducation
Poissy, France, 78303
Hosp Pontchaillou, Dept Cardiology
Rennes, France, 35033
Hosp Charles Nicolle Dept Neurology
Rouen, France, 76000
Germany
Zentrum für klinische Forschung Dr. med. Irma Schöll
Bad Homburg, Germany, 61348
Neurologische Klinik und Poliklinik - Universitätsklinikum Carl Gustav Carus, Zentrum für klinische Neurowissenschaften
Dresden, Germany, 01307
Helios Klinikum Erfurt
Erfurt, Germany, 99089
Universitätsklinikum Giessen Klinik und Poliklinik für Neurologie
Giessen, Germany, 35385
Universitätsmedizin Greifswald - Körperschaft des öffentlichen Rechts - Klinik und Poliklinik für Neurologie
Greifswald, Germany, 17475
Medizinische Hochschule Hannover, Neurologie
Hannover, Germany, 30625
AFL Arzneimittelforschung Leipzig GmbH
Leipzig, Germany, 04107
Universitätsklinikum Münster, Klinik für Allgemeine Neurologie
Münster, Germany, 48149
Medizinzentrum Siegerland Weidenau
Siegen, Germany, 57076
NeuroPoint GmbH, Gesellschaft für vorbeugende Gesundheitspflege
Ulm, Germany, 89073
Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz, Studienzentrum Nord-West (Study Center)
Westerstede, Germany, 26655
Greece
Naval Hospital of Athens - Neurology Dpt
Athens, Greece, 11521
401 Military Hospital of Athens - Neurology Dept
Athens, Greece, 11525
Aeginition Hospital - Neurology Department
Athens, Greece, 11528
Medical Center of Athens - Neurology Dpt
Marousi, Greece, 15125
General Hospital of Thessaloniki
Thessaloniki, Greece, 57010
Hungary
Uzsoki utcai Kórház, Neurológiai Osztály
Budapest, Hungary, 1145
Valeomed EGÉSZSÉGÜGYI KÖZPONT
Esztergom, Hungary, 2500
Pest Megyei Flór Ferenc Kórház, Neurológia és Stroke ambulancia
Kistarcsa, Hungary, 2143
Italy
Fondazione Istituto San Raffaele , Unità Operativa di Neurologia
Cefalù, Italy, 90015
Università degli Studi di Firenze - Azienda Ospedaliero Universitaria Careggi - CTO - SOD Neurologia 2
Firenze, Italy, 50139
AOU San Martino di Genova, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DINOGMI)
Genova, Italy, 16132
Istituto Neurologico Carlo Besta, UOC Neurologia 4, Neuroimmunologia e Malattie Neuromuscolari, Centro Sclerosi Multipla
Milano, Italy, 20133
Azienda Ospedaliera Universitaria (AOU) "Federico II" - Centro Regionale Per la Sclerosi Multipla c/o Clinica Neurologica II - Dipartimento di Scienze
Napoli, Italy, 80131
AOU Università degli Studi della Campania L. Vanvitelli - I° Policlinico - DAI di Medicina Interna e Specialistica CS, Centro Sclerosi Multipla
Napoli, Italy, 80138
Azienda Ospedaliero Universitaria San Luigi Gonzaga - Centro Sclerosi Multipla CRESM
Orbassano, Italy, 10043
IRCCS NEUROMED - Istituto Neurologico Mediterraneo - Unità Operativa di Neurologia I
Pozzilli, Italy, 86077
Azienda Ospedaliera S. Andrea di Roma - Unità Operativa Complessa di Neurologia
Roma, Italy, 00189
Azienda Ospedaliera Universitaria Senese - Dipartimento di Scienze Neurologiche e neurosensoriali - UOSA Neurologia Sperimentale
Siena, Italy, 53100
Mexico
Unidad de Investigacion en Salud de Chihuahua SC, Médica Sur, Unidad de Neurociencias
Tlalpan, DF, Mexico, 14050
Desarrollo Ético en Investigación Clínica S.C .
Guadalajara, Jalisco, Mexico, 44500
Axis Heilsa S. de R.L. de C.V. (Althian)
Nuevo Leon, Monterrey, Mexico, 64060
Unidad de Investigación de Salud en Chihuahua
Chihuahua, Mexico, 31203
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Neurologii i Oddziat Udarowy
Bialystok, Poland, 15-276
B&B Robert Bonek, Pawel Bochniak S.C
Bydgoszcz, Poland, 85-795
COPERNICUS - Podmiot Leczniczy Sp. z o.o.
Gdansk, Poland, 80-803
Centrum Terapii SM
Katowice, Poland, 40-571
Neuro-Medic Janusz Zbrojkiewicz Poradnia Weilospecjalistyczna
Katowice, Poland, 40-752
Centrum Kompleksowej Rehabilitacji
Konstancin-Jeziorna, Poland, 05-510
Centrum Opieki Zdrowotnej Orkan - Med.
Ksawerów, Poland, 95-054
Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna
Warszawa, Poland, 02-957
WroMedica, J. Bielicka A. Strzałkowska SC
Wroclaw, Poland, 51-685
Portugal
Centro Hospitalar de Lisboa Central
Lisboa, Portugal, 1169-050
Hospital de Santa Maria - Neurology Department
Lisboa, Portugal, 1649-035
Centro Hospitalar de São João, E.P.E. - Hospital de São João - Neurology Department
Porto, Portugal, 4200-319
Russian Federation
State Budgetary Healthcare Institution Regional Clinical Hospital No 3
Chelyabinsk, Russian Federation, 454021
Center of Professional Therapy, LLC
Krasnodar, Russian Federation, 350051
Moscow State Budgetary Healthcare Institution Filatov City Clinical Hospital No.15 of Moscow Health Department
Moscow, Russian Federation, 111539
Neuro-Clinic, LLC
Moscow, Russian Federation, 117186
Moscow State Budgetary Healthcare Institution Pirogov City Clinical Hospital No. 1 of Moscow Health Department
Moscow, Russian Federation, 119049
Moscow State Budgetary Healthcare Institution City Clinical Hospital No. 24 of Moscow Health Department
Moscow, Russian Federation, 127015
Spain
Hospital Santa Creu I Sant Pau - Neurology Dpt
Barcelona, Spain, 08041
Hosp Virgen de la Arrixaca, Neurology
El Palmar, Spain, 30120
Hosp Gregorio Marañón, Neurology
Madrid, Spain, 28007
Hospital Clinico San Carlos, Neurology
Madrid, Spain, 28040
Hospital Santa Caterina - Neurology Department
Salt, Spain, 17190
Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Neurology Department 2
Santiago de Compostela, Spain, 15703
Hospital Universitario Virgen Macarena - Neurofisiology Department
Sevilla, Spain, 41009
Centro de Neurologia Avanzada, Neurology
Sevilla, Spain, 41013
Switzerland
Univeritätsspital Basel Neurologie, Neurologische Klinik und Poliklinik
Basel, Switzerland, 4031
Ospedale Regionale di Lugano - Civico e Italiano, Neurologia, Lugano
Lugano, Switzerland, 6903
United Kingdom
Queen Square MS Centre / NMR research Unit UCL Institute of Neurology
London, United Kingdom, WC1N 3BG
Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom, ST4 6QG
Sponsors and Collaborators
Actelion
Investigators
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Study Director: Tatiana Scherz, MD, PhD Actelion

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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02907177    
Other Study ID Numbers: AC-058B302
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs