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Multicenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis

Trial Profile

Multicenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 Oct 2023

At a glance

  • Drugs Ponesimod (Primary)
  • Indications Multiple sclerosis
  • Focus Therapeutic Use
  • Sponsors Actelion Pharmaceuticals
  • Most Recent Events

    • 16 Oct 2023 This trial has been completed in Netherlands, according to European Clinical Trials Database record.
    • 11 Oct 2023 Status changed from active, no longer recruiting to completed.
    • 25 Sep 2023 This trial has been completed in Hungary (End Date: 06 Sep 2023), according to European Clinical Trials Database record.

Trial Overview

Purpose

All objectives for this study are exploratory: - To investigate the long-term safety and tolerability of ponesimod. - To investigate the long-term efficacy of ponesimod. - To explore the dose response relationship of 10, 20 and 40 mg ponesimod on lymphocyte count, MRI endpoints, annualized relapse rate (ARR), and safety endpoints.

Primary Endpoints

Annualized confirmed relapse rate

safety_issue: No
description: IMPORTANT NOTE: Only exploratory analyses will be performed.
time_frame: 240 weeks

Time to first confirmed relapse

safety_issue: No
description: IMPORTANT NOTE: Only exploratory analyses will be performed.
time_frame: 240 weeks

Time to 3 month confirmed disability progression up to end of the study

safety_issue: No
description: IMPORTANT NOTE: Only exploratory analyses will be performed. Disability progression is defined as an increase of at least one full point in the Expanded Disability Status Scale (EDSS) score (or 1.5 points if the baseline EDSS was 0, or 0.5 points if the baseline EDSS was equal or greater than 5.5) with or without relapse, confirmed at the next scheduled EDSS assessment at least 12 weeks later (or if missing, at the next available scheduled EDSS assessment).
time_frame: Estimated period of time over which the event is assessed: 3 months. The time to event is defined as the time from initiation of study treatment until the first EDSS assessment meeting the criteria for disability progression.

Other Endpoints

(Serious) Adverse Events

time_frame: Up to 660 weeks (core plus extension) [1]

Diseases Treated

Indication Qualifiers Patient Segments
Multiple sclerosis treatment relapsing-remitting

Biomarker

NCT Number Biomarker Name Biomarker Function
NCT01093326 sphingosine-1-phosphate receptor 1 Official Title
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Subjects

  • Subject Type patients
  • Number

    Planned: 353

    Actual: 353

  • Sex male & female
  • Age Group 18-55 years; adult

Patient Inclusion Criteria

1. Patients who completed study treatment at their regular Week 24 (End of treatment) visit within the core study AC-058B201. 2. Signed informed consent for participating in the extension study.

Patient Exclusion Criteria

1. Any clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the patient at risk by participating in the extension study.

Trial Details

Identifiers

Identifier Owner
NCT01093326 ClinicalTrials.gov: US National Institutes of Health
EudraCT2009-011470-15 European Clinical Trials Database
AC058B202 -

Organisations

  • Sponsors Actelion Pharmaceuticals
  • Affiliations Actelion Pharmaceuticals; Janssen Research & Development; Janssen-Cilag; Johnson & Johnson; Johnson & Johnson Innovative Medicine

Trial Dates

  • Initiation Dates

    Actual : 12 May 2010

  • Primary Completion Dates

    Planned : 06 Sep 2023

    Actual : 06 Sep 2023

  • End Dates

    Planned : 06 Sep 2023

    Actual : 06 Sep 2023

Substudies/Extensions

SUB-STUDIES:

The trial protocol incorporates ancillary studies that are only implemented at selected sites:
- exploration of echocardiographic parameters;
- exploration of ophtalmological parameters by Optical Coherence Tomography (OCT).

Other Details

  • Design double-blind; multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location Australia; Austria; Bulgaria; Canada; Czech Republic; England; Finland; France; Germany; Hungary; Israel; Italy; Netherlands; Poland; Romania; Russia; Serbia; Spain; Sweden; Switzerland; Ukraine; United Kingdom; USA
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
PonesimodPrimary Drug Oral Tablet

Ponesimod 10 mg

Ponesimod 10 mg oral use
Drug: Ponesimod 10 mg (Ponesimod 10 mg oral use)

Ponesimod 20 mg

Ponesimod 20 mg oral use
Drug: Ponesimod 20 mg (Ponesimod 20 mg oral use)

Ponesimod 40 mg

Ponesimod 40 mg oral use
Drug: Ponesimod 40 mg (Ponesimod 40 mg oral use)

Results

Therapeutic efficacy

Treatment with ponesimod 20 mg in patients with relapsing remitting multiple sclerosis (RRMS) in a phase II and its ongoing extension study demonstrated consistent low levels of disease activity across relevant clinical and MRI outcomes. Kaplan-Meier risks of 6-month confirmed disability accumulation (6 m-CDA) for confirmed relapses at Week 432 was 20.4% for ponesimod 20 mg (P20) arm. The annualised relapse rate (ARR) for confirmed relapses was observed to be 0.154 (0.111‒0.214) for P20 arm. Mean number of T1 gadolinium enhancing lesions per patient per scan was observed to be 0.448 (0.305‒0.657). Mean number of new or enlarging T2 lesions per year was noted to be 0.718 (0.523‒0.985). Pooled results from phase II and extension study showed that the Kaplan-Meier risks of 6-month confirmed disability accumulation (6 m-CDA) were 29.6% and 16.4% for ponesimod 10 mg (P10) arm and ponesimod 20 mg (P20) arm, respectively, corresponding to a 49% (95% confidence interval [CI]: 8-72%; p=0.024) relative reduction (RR) in the P20 arm compared to the P10 arm. The annualized relapse rate (ARR) for confirmed relapses was 0.227 and 0.153 with P10 and P20, respectively (RR for P20 arm: 32.5% [95% CI: -3.6-56.1%; p=0.07]). RR in the P20 arm was 33.5% (95% CI: 1.2-55.3%; p=0.043) for all confirmed and unconfirmed relapses. P10 and P20 arm showed the mean number of T1 gadolinium-enhancing lesions(T1 Gd+) per subject per scan of 1.371 and 0.768, respectively (RR in the P20 arm: 44% [95% CI: 14.7-63.2%; p=0.007]). P10 and P20 arm showed the mean number of new or enlarging T2 lesions per subject per 24 weeks of 0.884 and 0.293 (RR in the P20 arm: 66.9% [95% CI: 50.3-77.9%; p< 0.0001]). Pooled analysis compared efficacy and safety of P20 arm vs P10 arm [2] [3]

In this interim analysis, the annualised relapse rates (ARR; co-primary endpoint) in patients with relapsing-remitting multiple sclerosis who received continuous treatment with ponesimod 10, 20 and 40 mg/day were 0.22, 0.23 and 0.15, respectively. In patients who received placebo during the core study followed by ponesimod during the extension, the ARR was reduced from 0.52 at week 24 to 0.25 at week 48. [4]
In a pooled analysis of core (complete) and extension (interim) studies investigating patients with remitting relapsing multiple sclerosis, at week 115, ponesimode at doses of 10, 20 and 40 mg was associated with annualized relapse rate ([ARR] co-primary endpoint) of 0.24%, 0.21% and 0.14%, respectively. The ex-placebo groups (placebo/10, placebo/20 and placebo/40 mg) were associated with ARR of 0.33%, 0.25% and 0.33%, respectively. An apparent dose-relationship was observed in terms of time to first confirmed relapse in ponesimode recipients (co-primary endpoint). [5]

Adverse events

Treatment with ponesimod 10mg (P10) and ponesimod 20mg (P20) from a phase II trial and its ongoing extension study was well tolerated. The proportion (%) of ponesimod 10mg (P10) and ponesimod 20mg (P20) patients with all adverse events (AEs), serious AEs, and AEs leading to treatment discontinuation were observed to be 94.2 versus 91.0, 15.1 versus 13.8, and 12.2 versus 10.3, respectively. The most common treatment-emergent AEs were nasopharyngitis (30%), headache (24%) and upper respiratory tract infection (21%). Most SAEs were reported in a single patient, no SAE was reported at an incidence of >1%. Pooled analysis compared efficacy and safety of P20 arm vs P10 arm [2] [3] .

In this interim analysis, no new tolerability concerns were observed with ponesimod therapy in patients with relapsing-remitting multiple sclerosis. Ponesimod therapy was discontinued in 10% of patients. The adverse events reported in ≥15% of patients were headache, nasopharyngitis, dyspnoea and upper respiratory tract infections. [4]
In a pooled analysis of core (complete) and extension (interim) studies investigating patients with remitting relapsing multiple sclerosis, at week 115, the adverse events reported in more than or equal to 15% of patients receiving ponesimod (10, 20, and 40 mg) were nasopharyngitis, headache, dyspnea and upper respiratory tract infection. Cough, dizziness, fatigue, urinary tract infection and increase alanine aminotransferase were reported in ex-placebo patients. [5]

Publications

  1. Freedman MS, Pozzilli C, Havrdova EK, Coyle PK, Lemle A, Burcklen M, et al. Long-term Efficacy and Safety of Ponesimod, an oral S1P1 Receptor Modulator: Results from Randomized Phase II Core and Extension Studies in Relapsing-Remitting Multiple Sclerosis. AAN-2020 2020; abstr. N/A.

    Available from: URL: https://index.mirasmart.com/AAN2020/PDFfiles/AAN2020-001752.html
  2. E Havrdova, A Achiron, P Coyle, D D'Ambrosio, J-P Eralinna, B Hennessy, et al. Efficacy and safety of 2 doses of ponesimod (10 and 20 mg o.d.): interim analysis of a phase II extension trial in relapsing-remitting multiple sclerosis. ECTRIMS-ACTRIMS-2017 2017; abstr. P1151.

    Available from: URL: http://www.professionalabstracts.com/ectrims2017/iplanner/#/list
  3. Freedman M, Boster A, Fernandez O, Melanson M, Pozzilli C, D'Ambrosio D, et al. Long-Term Efficacy, Safety and Tolerability of Ponesimod in Patients with Relapsing-Remitting Multiple Sclerosis. 65th-AAN-2013 2013; abstr. P01.156.

    Available from: URL: http://www.abstracts2view.com/aan/view.php?nu=AAN13L%5fP01.156
  4. Pozzilli C, Fernandez O, Olsson T, Freedman MS, Melanson M, Boster A, et al. Maintenance of efficacy, safety and tolerability of ponesimod in patients with relapsing remitting multiple sclerosis: phase II extension study. ECTRIMS-2013 2013; abstr. P 995.

    Available from: URL: http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=178657&XNSPRACHE_ID=2&XNKONGRESS_ID=195&XNMASKEN_ID=900
  5. Rosas-Ballina M, Wooller A, Walter V, Ait-Tihyaty M, Vaclavkova A, Pozzilli C. Ponesimod in Relapsing Forms of Multiple Sclerosis - Long-Term Pooled Safety Results from the Clinical Development Program. ACTRIMS-2022 2022; abstr. P084..

    Available from: URL: https://www.abstractsonline.com/pp8#!/10495/presentation/138
  6. Wong J, Hertoghs N, Lemle A, Linscheid P, Raghavan N, Singh A, et al. COVID-19 Antibody Response by Vaccine Type and Lymphocyte Count in RMS Patients on Ponesimod: Results From Phase 2 Long-term Extension Study AC-058B202. AAN-2023 2023; abstr. P12.003.

    Available from: URL: https://index.mirasmart.com/aan2023/PDFfiles/AAN2023-002380.html
  7. Freedman MS, Pozzilli C, Havrdova EK, Lemle A, Burcklen M, Larbalestier A, et al. Long-term Treatment With Ponesimod in Relapsing-Remitting Multiple Sclerosis: Results from Randomized Phase 2b Core and Extension Studies. Neurology 2022;.

    PubMed | CrossRef Fulltext
  8. Freedman MS, Pozzilli C, Havrdova EK, Coyle PK, Lemle A, Burcklen M, et al. Reversibility of Clinical Abnormalities Associated with Ponesimod: Results from Randomised Phase II Core and Extension Studies in Relapsing Remitting Multiple Sclerosis. EAN-2020 2020; abstr. EPR1175.

    Available from: URL: https://www.ean.org/paris2020/6th-Congress-of-the-European-Academy-of-Neurology-Paris-2020.3833.0.html

Authors

Author Total Publications First Author Last Author
A Achiron 1 - -
Ait-Tihyaty M 1 - -
B Hennessy 1 - -
Boster A 2 - -
Burcklen M 3 - -
C Pozzilli 1 - -
Coyle PK 2 - -
D D'Ambrosio 1 - -
D'Ambrosio D 2 - 1
E Havrdova 1 1 -
E Lindenstroem 1 - -
Fernandez O 2 - -
Freedman M 1 1 -
Freedman MS 4 3 -
G Izquierdo 1 - -
Havrdova EK 3 - -
Hennessy B 4 - -
Hertoghs N 1 - -
J Lycke 1 - -
J-P Eralinna 1 - -
Larbalestier A 3 - -
Lemle A 4 - -
Linscheid P 1 - -
M Freedman 1 - 1
Melanson M 2 - -
Olsson T 5 - 4
P Coyle 1 - -
Pozzilli C 6 1 1
Radue E-W 1 - -
Raghavan N 1 - -
Rames A 1 - -
Rosas-Ballina M 1 1 -
Scherz T 2 - -
Sidorenko T 3 - 1
Singh A 1 - -
Vaclavkova A 4 - -
Walter V 1 - -
Wong J 1 1 -
Wooller A 1 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
clinical trial disclosure desk
Gewerbestrasse 16
Allschwil
Postcode: 4123
Switzerland
clinical-trials-disclosure@actelion.com
show details
Actelion Pharmaceuticals Switzerland

Centres

Centre Name Location Trial Centre Country
Actelion
-
-
Actelion Pharmaceuticals
Gewerbestrasse 16
Allschwil
4123
Switzerland
medinfo@actelion.com
show details
Allschwil Switzerland
ACTELION Pharmaceuticals Ltd.
-
Switzerland
Clinical Investigative 1602 Turku Finland
Clinical Investigative 2501 Belgrade Serbia
Clinical Investigative Site # 1301 Sofia Bulgaria
Clinical Investigative Site # 1500 Praha Czech-Republic
Clinical Investigative Site # 1501 Poruba Czech-Republic
Clinical Investigative Site # 1502 Brno Czech-Republic
Clinical Investigative Site # 1503 Teplice Czech-Republic
Clinical Investigative Site # 1504 Olomouc Czech-Republic
Clinical Investigative Site # 1601 Hyvinkaa Finland
Clinical Investigative Site # 2001 Tel-Hashomer Israel
Clinical Investigative Site # 2103 Roma Italy
Clinical Investigative Site # 2302 Wroclaw Poland
Clinical Investigative Site # 2304 Warszawa Poland
Clinical Investigative Site # 2305 Katowice Poland
Clinical Investigative Site # 2501 Kragujevae Serbia
Clinical Investigative Site # 2800 Stockholm Sweden
Clinical Investigative Site # 2801 Umea Sweden
Clinical Investigative Site # 3129 Latham, New York USA
Clinical Investigative Site #2101 Gallarate Italy
Clinical Investigative Site #2303 Poznan Poland
Clinical Investigative Site #2701 Malaga Spain
Clinical Investigative Site #3129 Latham, New York USA
Clinical Investigative Site 1101 Vienna Austria
Clinical Investigative Site 1400 Ottawa, Ontario Canada
Clinical Investigative Site 1506 Jihlava Czech-Republic
Clinical Investigative Site 1600 Helsinki Finland
Clinical Investigative Site 1603 Tampere Finland
Clinical Investigative Site 1701 Montpellier France
Clinical Investigative Site 1802 Essen Germany
Clinical Investigative Site 1804 Ulm Germany
Clinical Investigative Site 1807 Berlin Germany
Clinical Investigative Site 1900 Esztergom Hungary
Clinical Investigative Site 1902 Gyor Hungary
Clinical Investigative Site 1904 Budapest Hungary
Clinical Investigative Site 1905 Budapest Hungary
Clinical Investigative Site 1908 Budapest Hungary
Clinical Investigative Site 2002 Zerifin Israel
Clinical Investigative Site 2102 Padova Italy
Clinical Investigative Site 2104 Genova Italy
Clinical Investigative Site 2105 Biacci Italy
Clinical Investigative Site 2106 Milano Italy
Clinical Investigative Site 2203 Breda Netherlands
Clinical Investigative Site 2401 Cluj-Napoca Romania
Clinical Investigative Site 2402 Timisoara Romania
Clinical Investigative Site 2502 Nis Serbia
Clinical Investigative Site 2700 Sevilla Spain
Clinical Investigative Site 2705 Madrid Spain
Clinical Investigative Site 2706 Barcelona Spain
Clinical Investigative Site 2802 Goteborg Sweden
Clinical Investigative Site 2901 Lugano Switzerland
Clinical Investigative Site 3002 London United-Kingdom
Clinical Investigative Site 3003 Bristol United-Kingdom
Clinical Investigative Site 3004 Plymouth United-Kingdom
Clinical Investigative Site 3100 Tucson, Arizona USA
Clinical Investigative Site 3101 Indianapolis, Indiana USA
Clinical Investigative Site 3102 Kirkland, Washington USA
Clinical Investigative Site 3105 Kansas City, Kansas USA
Clinical Investigative Site 3107 Lenexa, Kansas USA
Clinical Investigative Site 3112 Burlington, Vermont USA
Clinical Investigative Site 3113 Cincinnati, Ohio USA
Clinical Investigative Site 3115 Sacramento, California USA
Clinical Investigative Site 3116 Sarasota, Florida USA
Clinical Investigative Site 3117 Stanford, California USA
Clinical Investigative Site 3119 Raleigh, North Carolina USA
Clinical Investigative Site 3120 Stony Brook, New York USA
Clinical Investigative Site 3127 Schenectady, New York USA
Clinical Investigative Site 3130 Columbus, Ohio USA
Clinical Investigative Site 3132 Scottsdale, Arizona USA
Clinical Investigative Site 3200 St. Petersburg Russia
Clinical Investigative Site 3201 St. Petersburg Russia
Clinical Investigative Site 3202 Moscow Russia
Clinical Investigative Site 3203 Nizhniy Novgorod Russia
Clinical Investigative Site 3204 St. Petersburg Russia
Clinical Investigative Site 3205 Kazan Russia
Clinical Investigative Site 3206 Pyatigorsk Russia
Clinical Investigative Site 3207 Samara Russia
Clinical Investigative Site 3208 Ufa Russia
Clinical Investigative Site 3209 Saratov Russia
Clinical Investigative Site 3300 Kyiv Ukraine
Clinical Investigative Site 3302 Chernihiv Ukraine
Clinical Investigative Site 3303 Dnipropetrovsk Ukraine
Clinical Investigative Site 3304 Odesa Ukraine
Clinival Investigative Site # 1901 Miskolc Hungary

Trial History

Event Date Event Type Comment
16 Oct 2023 Other trial event This trial has been completed in Netherlands, according to European Clinical Trials Database record. Updated 16 Oct 2023
16 Oct 2023 Other trial event Last checked against European Clinical Trials Database record. Updated 16 Oct 2023
16 Oct 2023 Other trial event Last checked against the ClinicalTrials.gov record. Updated 16 Oct 2023
11 Oct 2023 Status change - completed Status changed from active, no longer recruiting to completed. Updated 16 Oct 2023
25 Sep 2023 Other trial event This trial has been completed in Hungary (End Date: 06 Sep 2023), according to European Clinical Trials Database record. Updated 25 Sep 2023
29 Aug 2023 Other trial event This trial has been completed in Poland, according to European Clinical Trials Database. Updated 29 Aug 2023
16 Aug 2023 Other trial event This trial has been completed in Czechia . Updated 16 Aug 2023
07 Jul 2023 Other trial event This trial has been completed in Bulgaria. Updated 07 Jul 2023
27 Apr 2023 Results Results assessing the SARS-CoV-2 humoral response by vaccine type and pre-vaccination lymphocyte count in relapsing multiple sclerosis patients who have received coronavirus disease 2019 vaccination while on ponesimod treatment, presented at the 75th Annual Meeting of the American Academy of Neurology 2023. Updated 15 Jun 2023
13 Feb 2023 Other trial event This trial has been completed in Finland, according to European Clinical Trials Database record. Updated 13 Feb 2023
10 Jan 2023 Other trial event This trial has been completed in Austria, according to European Clinical Trials Database. Updated 10 Jan 2023
03 Jan 2023 Completion date Planned End Date changed from 19 Oct 2023 to 6 Sep 2023. Updated 05 Jan 2023
03 Jan 2023 Other trial event Planned primary completion date changed from 19 Oct 2023 to 6 Sep 2023. Updated 05 Jan 2023
23 Oct 2022 Other trial event This trial has been completed in Sweden, according to European Clinical Trials Database. Updated 25 Oct 2022
06 Jun 2022 Results Results from EudraCT2008-006786-92 and EudraCT2009-011470-15 evaluating the dose-response relationship of 10, 20 and 40-mg ponesimod and long-term efficacy and safety of ponesimod 20 mg , published in the Neurology Updated 09 Jun 2022
30 Mar 2022 Completion date Planned End Date changed from 15 Dec 2023 to 19 Oct 2023. Updated 12 Apr 2022
30 Mar 2022 Other trial event Planned primary completion date changed from 15 Dec 2023 to 19 Oct 2023. Updated 12 Apr 2022
26 Feb 2022 Results Results of a pooled analysis (AC-058B201 and AC-058B301/OPTIMUM & AC-058B202 and AC-058B303/OPTIMUM-LT studies data) from patients in the ponesimod 20mg assessed the long term safety arm presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2022 Updated 04 Apr 2022
26 Jan 2022 Other trial event This trial has been completed in Germany, according to European Clinical Trials Database record. Updated 27 Jan 2022
23 Nov 2021 Completion date Planned End Date changed from 1 Dec 2023 to 15 Dec 2023. Updated 08 Dec 2021
23 Nov 2021 Other trial event Planned primary completion date changed from 1 Dec 2023 to 15 Dec 2023. Updated 08 Dec 2021
11 Aug 2021 Biomarker Update Biomarkers information updated Updated 07 Nov 2021
13 Apr 2021 Completion date Planned End Date changed from 15 Dec 2023 to 1 Dec 2023. Updated 15 Apr 2021
13 Apr 2021 Other trial event Planned primary completion date changed from 15 Dec 2023 to 1 Dec 2023. Updated 15 Apr 2021
16 Feb 2021 Completion date Planned End Date changed from 1 Dec 2023 to 15 Dec 2023. Updated 18 Feb 2021
16 Feb 2021 Other trial event Planned primary completion date changed from 1 Dec 2023 to 15 Dec 2023. Updated 18 Feb 2021
22 Jan 2021 Completion date Planned End Date changed from 15 Dec 2023 to 1 Dec 2023. Updated 28 Jan 2021
22 Jan 2021 Other trial event Planned primary completion date changed from 15 Dec 2023 to 1 Dec 2023. Updated 28 Jan 2021
27 Oct 2020 Completion date Planned End Date changed from 15 Dec 2021 to 15 Dec 2023. Updated 30 Oct 2020
27 Oct 2020 Other trial event Planned primary completion date changed from 15 Dec 2021 to 15 Dec 2023. Updated 30 Oct 2020
26 May 2020 Results Results presented at the 6th Congress of the European Academy of Neurology Updated 04 Jul 2020
01 May 2020 Results Results of combined analyses of Core and Extension studies presented at the 72nd Annual Meeting of the American Academy of Neurology Updated 18 May 2020
18 Jan 2018 Completion date Planned End Date changed from 1 Jan 2022 to 15 Dec 2021. Updated 23 Jan 2018
18 Jan 2018 Other trial event Planned primary completion date changed from 1 Dec 2021 to 15 Dec 2021. Updated 23 Jan 2018
28 Oct 2017 Interim results Interim results of pooled data (data cut off; 1 Sep 2016 ) comparing efficacy and safety of Ponesimod 20 mg versus 10 mg, presented at the 7th Joint Congress of the European Committee for Treatment and Research in Multiple Sclerosis and Americas Committee for Treatment and Research in Multiple Sclerosis. Updated 22 Nov 2017
16 Mar 2015 Completion date Planned End Date changed from 1 Jul 2016 to 1 Jan 2022 as per ClinicalTrials.gov record. Updated 24 Mar 2015
16 Mar 2015 Other trial event Planned primary completion date changed from 1 Mar 2016 to 1 Dec 2021 as per ClinicalTrials.gov record. Updated 24 Mar 2015
05 Oct 2013 Results Results of pooled analysis of core study (complete) and extension study (interim) presented at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis. Updated 03 Mar 2015
23 Mar 2013 Interim results Interim results (after a mean total treatment duration of 92 weeks [core + extension]) presented at the 65th Annual Meeting of the American Academy of Neurology. Updated 12 Mar 2013
12 Mar 2013 New trial record New trial record Updated 12 Mar 2013
21 Apr 2012 Other trial event Planned patient number changed from 353 to 400 as reported by European Clinical Trials Database (Extension trial: EudraCT2009-011470-15). Updated 12 Mar 2013
18 Apr 2012 Status change - active, no longer recruiting Status of the extension trial (NCT01093326) changed from recruiting to active, no longer recruiting. Updated 12 Mar 2013
18 Apr 2012 Completion date Planned end date of the extension trial (NCT01093326) changed from 30 Mar 2014 to Jul 2016. Updated 12 Mar 2013
10 Mar 2012 Status change - recruiting Status for (extension trial: EudraCT2009-011470-15) is recruiting. Updated 12 Mar 2013
10 Mar 2012 Other trial event Planned patient number of (extension trial: EudraCT2009-011470-15) is 353. Updated 12 Mar 2013
10 Mar 2012 Other trial event Actual initiation date of (extension trial: EudraCT2009-011470-15) is 30 Mar 2010. Updated 12 Mar 2013
10 Mar 2012 Other trial event Planned end date of (extension trial: EudraCT2009-011470-15) is 30 Mar 2014. Updated 12 Mar 2013

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.

    Available from: URL: http://clinicaltrials.gov
  2. Freedman MS, Pozzilli C, Havrdova EK, Coyle PK, Lemle A, Burcklen M, et al. Long-term Efficacy and Safety of Ponesimod, an oral S1P1 Receptor Modulator: Results from Randomized Phase II Core and Extension Studies in Relapsing-Remitting Multiple Sclerosis. AAN-2020 2020; abstr. N/A.

    Available from: URL: https://index.mirasmart.com/AAN2020/PDFfiles/AAN2020-001752.html
  3. E Havrdova, A Achiron, P Coyle, D D'Ambrosio, J-P Eralinna, B Hennessy, et al. Efficacy and safety of 2 doses of ponesimod (10 and 20 mg o.d.): interim analysis of a phase II extension trial in relapsing-remitting multiple sclerosis. ECTRIMS-ACTRIMS-2017 2017; abstr. P1151.

    Available from: URL: http://www.professionalabstracts.com/ectrims2017/iplanner/#/list
  4. Freedman M, Boster A, Fernandez O, Melanson M, Pozzilli C, D'Ambrosio D, et al. Long-Term Efficacy, Safety and Tolerability of Ponesimod in Patients with Relapsing-Remitting Multiple Sclerosis. 65th-AAN-2013 2013; abstr. P01.156.

    Available from: URL: http://www.abstracts2view.com/aan/view.php?nu=AAN13L%5fP01.156
  5. Pozzilli C, Fernandez O, Olsson T, Freedman MS, Melanson M, Boster A, et al. Maintenance of efficacy, safety and tolerability of ponesimod in patients with relapsing remitting multiple sclerosis: phase II extension study. ECTRIMS-2013 2013; abstr. P 995.

    Available from: URL: http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=178657&XNSPRACHE_ID=2&XNKONGRESS_ID=195&XNMASKEN_ID=900
  6. European Clinical Trials Database. Trial-Reg 2023;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  7. Rosas-Ballina M, Wooller A, Walter V, Ait-Tihyaty M, Vaclavkova A, Pozzilli C. Ponesimod in Relapsing Forms of Multiple Sclerosis - Long-Term Pooled Safety Results from the Clinical Development Program. ACTRIMS-2022 2022; abstr. P084..

    Available from: URL: https://www.abstractsonline.com/pp8#!/10495/presentation/138
  8. Wong J, Hertoghs N, Lemle A, Linscheid P, Raghavan N, Singh A, et al. COVID-19 Antibody Response by Vaccine Type and Lymphocyte Count in RMS Patients on Ponesimod: Results From Phase 2 Long-term Extension Study AC-058B202. AAN-2023 2023; abstr. P12.003.

    Available from: URL: https://index.mirasmart.com/aan2023/PDFfiles/AAN2023-002380.html
  9. Freedman MS, Pozzilli C, Havrdova EK, Lemle A, Burcklen M, Larbalestier A, et al. Long-term Treatment With Ponesimod in Relapsing-Remitting Multiple Sclerosis: Results from Randomized Phase 2b Core and Extension Studies. Neurology 2022;.

    PubMed | CrossRef Fulltext
  10. Freedman MS, Pozzilli C, Havrdova EK, Coyle PK, Lemle A, Burcklen M, et al. Reversibility of Clinical Abnormalities Associated with Ponesimod: Results from Randomised Phase II Core and Extension Studies in Relapsing Remitting Multiple Sclerosis. EAN-2020 2020; abstr. EPR1175.

    Available from: URL: https://www.ean.org/paris2020/6th-Congress-of-the-European-Academy-of-Neurology-Paris-2020.3833.0.html
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