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
Latest Information Update: 16 Oct 2023
At a glance
- Drugs Ponesimod (Primary)
- Indications Multiple sclerosis
- Focus Therapeutic Use
- Sponsors Actelion Pharmaceuticals
- 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.
Most Recent Events
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 |
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
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
clinical trial disclosure desk
Gewerbestrasse 16
show details
Allschwil Postcode: 4123 Switzerland clinical-trials-disclosure@actelion.com |
Actelion Pharmaceuticals | Switzerland |
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
Actelion |
-
|
-
|
Actelion Pharmaceuticals
Gewerbestrasse 16
show details
Allschwil 4123 Switzerland medinfo@actelion.com |
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 |
Table of Contents
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
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 -
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 -
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 -
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 -
European Clinical Trials Database. Trial-Reg 2023;.
Available from: URL: https://www.clinicaltrialsregister.eu -
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 -
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 -
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 -
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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