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Multiple SclerosisPhase 3POINTNCT02907177

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®)

A Phase 3 study testing Ponesimod in people with Multiple Sclerosis, run by Actelion at 119 sites in 20 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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®). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Ponesimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
136 participants
Where
119 sitesin 20 countries
Study dates
30 Mar 2017to 26 Mar 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

119 sites in 20 countries.

119 sites in 20 countries

United States26 sites

  • Univ of New Mexico - Health Sciences Center

    Albuquerque, New Mexico, 87131

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • UAB Dpt of Neurology

    Birmingham, Alabama, 35233

  • Bradenton Research Center

    Bradenton, Florida, 34205

  • Riverhills Healthcare, Inc.

    Cincinnati, Ohio, 45212

  • OhioHealth Research Institute

    Columbus, Ohio, 43214

  • Associated Neurologists

    Danbury, Connecticut, 06810

  • Mountain View Clinical Research, Inc

    Denver, Colorado, 80209

  • Henry Ford Health System - Neurology

    Detroit, Michigan, 48202

  • Fort Wayne Neurological Center - North Office

    Fort Wayne, Indiana, 46825

  • Advanced Neuroscience Institute

    Franklin, Tennessee, 37064

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • University of Kansas Med Center

    Kansas City, Kansas, 66160

  • MidAmerica Neuroscience Research Foundation/Rowe Neurology

    Lenexa, Kansas, 66214

  • Neurology Associates - MS Center of Greater Orlando

    Maitland, Florida, 32751

  • NYU Langone Medical Center - MS Comprehensive Care Center

    New York, New York, 10016

  • Neurology and Neuromuscular Center

    Oklahoma City, Oklahoma, 73102

  • Neurology Assoc of Ormond Beach - CNS Trials

    Ormond Beach, Florida, 32174

  • SC3 Research - Pasadena

    Pasadena, California, 91105

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital - Dpt Neurology MS Center

    Philadelphia, Pennsylvania, 19107

  • Neurology Center of San Antonio

    San Antonio, Texas, 78258

  • Care Access Research - Santa Clarita

    Santa Clarita, California, 91321

  • Suncoast Neuroscience Associates, Inc

    St. Petersburg, Florida, 33713

  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

    Torrance, California, 90502

  • The MS Center of Vero Beach

    Vero Beach, Florida, 32960

Other trials in United States

France11 sites

  • Hôpital Avicenne, Service de Neurologie

    Bobigny, 93000

  • Hosp Gabriel Montpied, Dept Neurology

    Clermont-Ferrand, 63003

  • Centre Hospitalier Sud Francilien - Service de Neurologie

    Corbeil-Essonnes, 91100

  • CHU de Dijon - Hôpital François Miterrand, Service de Neurologie

    Dijon, 21079

  • CHRU de Lille - Hôpital Roger Salengro, Service de Neurologie

    Lille, 59037

  • Hopital Gui de Chauliac - CHU Montpellier

    Montpellier, 34295

  • Hôpital Central - CHU Nancy, Département Neurologie

    Nancy, 54035

  • Hôpital Universitaire Carémeau, Service de Neurologie

    Nîmes, 30029

  • CHI POISSY-Saint Germay en Laye_Service de Neurologie et Réeducation

    Poissy, 78303

  • Hosp Pontchaillou, Dept Cardiology

    Rennes, 35033

  • Hosp Charles Nicolle Dept Neurology

    Rouen, 76000

Other trials in France

Germany11 sites

  • Zentrum für klinische Forschung Dr. med. Irma Schöll

    Bad Homburg, 61348

  • Neurologische Klinik und Poliklinik - Universitätsklinikum Carl Gustav Carus, Zentrum für klinische Neurowissenschaften

    Dresden, 01307

  • Helios Klinikum Erfurt

    Erfurt, 99089

  • Universitätsklinikum Giessen Klinik und Poliklinik für Neurologie

    Giessen, 35385

  • Universitätsmedizin Greifswald - Körperschaft des öffentlichen Rechts - Klinik und Poliklinik für Neurologie

    Greifswald, 17475

  • Medizinische Hochschule Hannover, Neurologie

    Hanover, 30625

  • AFL Arzneimittelforschung Leipzig GmbH

    Leipzig, 04107

  • Universitätsklinikum Münster, Klinik für Allgemeine Neurologie

    Münster, 48149

  • Medizinzentrum Siegerland Weidenau

    Siegen, 57076

  • NeuroPoint GmbH, Gesellschaft für vorbeugende Gesundheitspflege

    Ulm, 89073

  • Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz, Studienzentrum Nord-West (Study Center)

    Westerstede, 26655

Other trials in Germany

Italy10 sites

  • Fondazione Istituto San Raffaele , Unità Operativa di Neurologia

    Cefalù, 90015

  • Università degli Studi di Firenze - Azienda Ospedaliero Universitaria Careggi - CTO - SOD Neurologia 2

    Florence, 50139

  • AOU San Martino di Genova, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DINOGMI)

    Genova, 16132

  • Istituto Neurologico Carlo Besta, UOC Neurologia 4, Neuroimmunologia e Malattie Neuromuscolari, Centro Sclerosi Multipla

    Milan, 20133

  • Azienda Ospedaliera Universitaria (AOU) "Federico II" - Centro Regionale Per la Sclerosi Multipla c/o Clinica Neurologica II - Dipartimento di Scienze

    Naples, 80131

  • AOU Università degli Studi della Campania L. Vanvitelli - I° Policlinico - DAI di Medicina Interna e Specialistica CS, Centro Sclerosi Multipla

    Naples, 80138

  • Azienda Ospedaliero Universitaria San Luigi Gonzaga - Centro Sclerosi Multipla CRESM

    Orbassano, 10043

  • IRCCS NEUROMED - Istituto Neurologico Mediterraneo - Unità Operativa di Neurologia I

    Pozzilli, 86077

  • Azienda Ospedaliera S. Andrea di Roma - Unità Operativa Complessa di Neurologia

    Roma, 00189

  • Azienda Ospedaliera Universitaria Senese - Dipartimento di Scienze Neurologiche e neurosensoriali - UOSA Neurologia Sperimentale

    Siena, 53100

Other trials in Italy

Poland9 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Neurologii i Oddziat Udarowy

    Bialystok, 15-276

  • B&B Robert Bonek, Pawel Bochniak S.C

    Bydgoszcz, 85-795

  • COPERNICUS - Podmiot Leczniczy Sp. z o.o.

    Gdansk, 80-803

  • Centrum Terapii SM

    Katowice, 40-571

  • Neuro-Medic Janusz Zbrojkiewicz Poradnia Weilospecjalistyczna

    Katowice, 40-752

  • Centrum Kompleksowej Rehabilitacji

    Konstancin-Jeziorna, 05-510

  • Centrum Opieki Zdrowotnej Orkan - Med.

    Ksawerów, 95-054

  • Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna

    Warsaw, 02-957

  • WroMedica, J. Bielicka A. Strzałkowska SC

    Wroclaw, 51-685

Other trials in Poland

Spain8 sites

  • Hospital Santa Creu I Sant Pau - Neurology Dpt

    Barcelona, 08041

  • Hosp Virgen de la Arrixaca, Neurology

    El Palmar, 30120

  • Hosp Gregorio Marañón, Neurology

    Madrid, 28007

  • Hospital Clinico San Carlos, Neurology

    Madrid, 28040

  • Hospital Santa Caterina - Neurology Department

    Salt, 17190

  • Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Neurology Department 2

    Santiago de Compostela, 15703

  • Hospital Universitario Virgen Macarena - Neurofisiology Department

    Seville, 41009

  • Centro de Neurologia Avanzada, Neurology

    Seville, 41013

Other trials in Spain

Russia6 sites

  • State Budgetary Healthcare Institution Regional Clinical Hospital No 3

    Chelyabinsk, 454021

  • Center of Professional Therapy, LLC

    Krasnodar, 350051

  • Moscow State Budgetary Healthcare Institution Filatov City Clinical Hospital No.15 of Moscow Health Department

    Moscow, 111539

  • Neuro-Clinic, LLC

    Moscow, 117186

  • Moscow State Budgetary Healthcare Institution Pirogov City Clinical Hospital No. 1 of Moscow Health Department

    Moscow, 119049

  • Moscow State Budgetary Healthcare Institution City Clinical Hospital No. 24 of Moscow Health Department

    Moscow, 127015

Other trials in Russia

Czechia5 sites

  • Fakultní nemocnice u sv. Anny Brno, RS Centrum

    Brno, 656 91

  • Fakultní nemocnice Hradec Králové, Neurologická klinika

    Hradec Králové, 500 05

  • Nemocnice Jihlava, Neurologické oddělení

    Jihlava, 586 33

  • Pardubicka krajska nemocnice, MS Centrum

    Pardubice, 532 03

  • Krajská zdravotní a.s. - Nemonice Teplice o.z., RS Centrum

    Teplice, 415 29

Other trials in Czechia

Greece5 sites

  • Naval Hospital of Athens - Neurology Dpt

    Athens, 11521

  • 401 Military Hospital of Athens - Neurology Dept

    Athens, 11525

  • Aeginition Hospital - Neurology Department

    Athens, 11528

  • Medical Center of Athens - Neurology Dpt

    Marousi, 15125

  • General Hospital of Thessaloniki

    Thessaloniki, 57010

Other trials in Greece

Mexico4 sites

  • Unidad de Investigación de Salud en Chihuahua

    Chihuahua City, 31203

  • Desarrollo Ético en Investigación Clínica S.C .

    Guadalajara, Jalisco, 44500

  • Axis Heilsa S. de R.L. de C.V. (Althian)

    Nuevo León, Monterrey, 64060

  • Unidad de Investigacion en Salud de Chihuahua SC, Médica Sur, Unidad de Neurociencias

    Tlalpan, Mexico City, 14050

Other trials in Mexico

United Kingdom4 sites

  • Queen Square MS Centre / NMR research Unit UCL Institute of Neurology

    London, WC1N 3BG

  • Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital

    Oxford, OX3 9DU

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

  • University Hospitals of North Midlands NHS Trust

    Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

Belgium3 sites

  • Hospital universitair Brussels_neurology department

    Brussels, 1090

  • Hospital - Universitair Gent __Neurology Department

    Ghent, 9000

  • Hospital - Revalidatie & MS Centrum Overpelt_Neurology Department

    Overpelt, 3900

Other trials in Belgium

Bulgaria3 sites

  • "Multiprofile Hospital for Active Treatment of Neurology and Psychiatry - Sveti Naum" EAD - Neurology Clinic for Movement Disorders

    Sofia, 1113

  • "University Multiprofile Hospital for Active Treatment - Alexandrovska" EAD, Neurology Clinic

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EAD, Neurology Clinic

    Sofia, 1431

Other trials in Bulgaria

Hungary3 sites

  • Uzsoki utcai Kórház, Neurológiai Osztály

    Budapest, 1145

  • Valeomed EGÉSZSÉGÜGYI KÖZPONT

    Esztergom, 2500

  • Pest Megyei Flór Ferenc Kórház, Neurológia és Stroke ambulancia

    Kistarcsa, 2143

Other trials in Hungary

Portugal3 sites

  • Centro Hospitalar de Lisboa Central

    Lisbon, 1169-050

  • Hospital de Santa Maria - Neurology Department

    Lisbon, 1649-035

  • Centro Hospitalar de São João, E.P.E. - Hospital de São João - Neurology Department

    Porto, 4200-319

Other trials in Portugal

Austria2 sites

  • MS Ambulanz Maida

    Vienna, 1010

  • Medizinische Universität Wien, Universitätsklinik für Neurologie

    Vienna, 1090

Other trials in Austria

Denmark2 sites

  • Aalborg Universitetshospital, Skleroseklinikken Neurologisk afdelning

    Aalborg, 9000

  • Glostrup Hospital, Neurologisk afdelning

    Glostrup Municipality, 2600

Other trials in Denmark

Switzerland2 sites

  • Univeritätsspital Basel Neurologie, Neurologische Klinik und Poliklinik

    Basel, 4031

  • Ospedale Regionale di Lugano - Civico e Italiano, Neurologia, Lugano

    Lugano, 6903

Other trials in Switzerland

Australia1 site

  • Austin Health - Neuro-Immunology Clinical Research, Education and Support Service

    Heidelberg, VC, 3084

Other trials in Australia

Canada1 site

  • University of Alberta

    Edmonton, T6G 1Z1

Other trials in Canada

About this study

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®)

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®).

Read the 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.

Being tested
Ponesimod, Placebo
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PonesimodDrug

    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).

  • PlaceboOther

    One tablet of matching placebo administered orally once daily in the morning

Study groups in NCT02907177
Study groupRoleWhat they receive
PonesimodExperimentalPonesimod
Receives: Drug: Ponesimod
PlaceboPlacebo comparatorPlacebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized Confirmed Relapse Rate (ARR)

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

    Measured: Through study completion, an average of 68 weeks

Secondary outcomes (3)

  1. Percentage of Participants With 12-Week Confirmed Disability Accumulation (CDA) as Assessed by Kaplan Meier Estimate at Week 96

    Percentage of participants with 12-week CDA as assessed by Kaplan Meier estimate at week 96 was defined as an increase of at least 1.5 in Expanded Disability Status Scale (EDSS) for participants with a baseline EDSS score of 0.0 or an increase of at least 1.0 in EDSS for participants with a baseline EDSS score of 1.0 to 5.0, or an increase of at least 0.5 in EDSS for participants with a baseline EDSS score greater than or equal to (>=) 5.5, which was confirmed after 12 weeks. Baseline EDSS was defined as the last EDSS score recorded prior to randomization. EDSS is an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to MS).

    Measured: Week 96

  2. Percentage of Participants Experiencing a Confirmed Relapse as Assessed by Kaplan Meier Estimate at Week 96

    Percentage of participants experiencing a confirmed relapse as assessed by Kaplan Meier estimate at week 96 was reported. The time to first confirmed relapse (in days) is defined as [Date of first confirmed relapse minus Date of randomization plus 1] in days. Relapse: Occurrence of acute episode of one or more new symptoms or worsened symptoms of Multiple sclerosis (MS), not related with fever/infection and lasting 24 hours after 30 days stable period.

    Measured: Week 96

  3. Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

    An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

    Measured: Up to 147 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2016 (estimated)
  2. Study start30 Mar 2017
  3. Primary completion26 Mar 2020
  4. Study completion26 Mar 2020

Why it stopped: sponsor decision due to low recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02907177
Sponsor's protocol ID
AC-058B302
Acronym
POINT
Status last verified
Apr 2021
First submitted
25 Aug 2016
Last updated
18 May 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kappos L, Burcklen M, D'Ambrosio D, Fox RJ, Freedman MS, Havrdova EK, Hennessy B, Hohlfeld R, Larbalestier A, Lemle A, Lindenstrom E, Lublin F, Montalban X, Sidorenko T, Sprenger T, Vaclavkova A, Wuerfel J, Pozzilli C. Ponesimod as add-on treatment in patients with active relapsing multiple sclerosis under dimethyl fumarate (POINT): A phase 3, randomized, placebo-controlled clinical trial. Mult Scler Relat Disord. 2025 Oct;102:106616. doi: 10.1016/j.msard.2025.106616. Epub 2025 Jul 13.

    PubMed 40700861

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ponesimod in people with Multiple Sclerosis, run by Actelion at 119 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in United States, France, Germany, Italy, Poland and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized Confirmed Relapse Rate (ARR) (time frame: Through study completion, an average of 68 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02907177, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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