An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.

• Register: EUCTR
• Last refreshed on: 29 June 2020
• Main ID: EUCTR2009-011470-15-GB
• Date of registration: 29/03/2010
• Prospective Registration: Yes
• Primary sponsor: ACTELION Pharmaceuticals Ltd
• Public title: An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.
• Scientific title: Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis
• Date of first enrolment: 22/06/2010
• Target sample size: 353
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011470-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: TP1 + TP2: double-blind; TP3: open-label; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Registry group
• Affiliation: Janssen-Cilag International NV

• Name: Clinical Registry group
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients who completed study treatment at their regular Week 24 (EOT) visit within the core study (AC-058B201).

2. Signed informed consent for participating in the extension study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 353
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Patients meeting any of the study-specific criteria for permanent discontinuation of study drug, or patients receiving any of the prohibited concomitant medication.

2. Any other 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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

relapsing-remitting multiple sclerosis
MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Product Name: ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PONESIMOD
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PONESIMOD
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-

Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PONESIMOD
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-

Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PONESIMOD
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PONESIMOD
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-

Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PONESIMOD
Current Sponsor code: ACT-128800
Concentration unit:

Primary Outcome(s)

Primary end point(s): Only exploratory efficacy endpoints will be investigated.

The following exploratory endpoints will be analyzed:
1. Annualized confirmed relapse rate.
2. Time to first confirmed relapse
3. Time to 24-week confirmed disability progression up to end of the study.

Additional endpoints/parameters based on MRI scans, relapses as well as endpoints related to safety and tolerability will be investigated.

Timepoint(s) of evaluation of this end point: Not applicable

Secondary Objective: Not applicable

Main Objective: 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.

Secondary Outcome(s)

Secondary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary ID(s)

AC-058B202

2009-011470-15-FI

Source(s) of Monetary Support

Actelion Pharmaceuticals Ltd

Ethics review

Status: Approved
Approval date: 22/06/2010
Contact: