International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

• Register: EUCTR
• Last refreshed on: 29 April 2020
• Main ID: EUCTR2012-000540-10-PT
• Date of registration: 21/08/2015
• Prospective Registration: Yes
• Primary sponsor: Actelion Pharmaceuticals Ltd
• Public title: International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis
• Scientific title: Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM
• Date of first enrolment: 23/10/2015
• Target sample size: 1100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000540-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Belarus, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, Finland, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: clinical trial disclosure desk
• Affiliation: Actelion Pharmaceuticals Ltd

• Name: clinical trial disclosure desk
• Affiliation: Actelion Pharmaceuticals Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
Male and female subjects aged 18 to 55 years with established diagnosis of MS McDonald 2010 with relapsing course from onset (i.e., RRMS and SPMS with superimposed relapses).
Subjects must have active disease evidenced by one or more MS attacks with onset within the period of 12 to 1 months prior to baseline EDSS assessment, or by two or more MS attacks with onset within the 24 to 1 months prior to baseline EDSS assessment, or with one or more gadolinium-enhancing (Gd+) lesion(s) of the brain on an MRI performed within 6 months prior to baseline EDSS assessment.
Enrolled subjects must be ambulatory (EDSS score of up to 5.5 inclusive) and may be treatment-naïve or previously treated with MS disease modifying therapy.
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 1100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic, ophthalmological, ocular) or lactating or pregnant women are not eligible to enter the study.
Subjects with contraindications to MRI or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study are not eligible to enter the 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 multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 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: Capsule
INN or Proposed INN: Ponesimod
Current Sponsor code: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
CAS Number: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Aubagio®
Product Name: Aubagio®
Pharmaceutical Form: Tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
CAS Number: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
CAS Number: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
CAS Number: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: m

Primary Outcome(s)

Primary end point(s): Annualized relapse rate defined as the number of confirmed relapses per subject-year.

Timepoint(s) of evaluation of this end point: All relapses up to EOS will be included in the analysis, irrespective of any treatment discontinuations prior to study completion.

Main Objective: - To determine whether ponesimod is more efficacious than teriflunomide in terms of reducing relapses in subjects with RMS.

Secondary Objective: - To assess the effect of ponesimod on disability accumulation and on other aspects of multiple sclerosis (MS) disease control
- To assess the safety and tolerability of ponesimod in subjects with RMS.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1: end of study
2, 4, 5: week 108
3: time to first confirmed relapse

Secondary end point(s): 1. Time to 12-week confirmed disability accumulation (CDA) from baseline to EOS;
2. Percent change in brain volume (PCBV) from baseline to Week 108;
3. Time to first confirmed relapse;
4. Cumulative number of combined unique active lesions (CUAL; defined as new Gd+ T1 lesions plus new or enlarging T2 lesions [without double-counting of lesions]) from baseline to Week 108;
5. Change from baseline to Week 108 in fatigue-related symptoms as measured by the symptoms domain of the Fatigue Symptoms and Impact Questionnaire – Relapsing Multiple Sclerosis (FSIQ–RMS);

Secondary ID(s)

AC-058B301

2012-000540-10-DE

Source(s) of Monetary Support

Actelion Pharmaceuticals Ltd

Ethics review

Status: Approved
Approval date: 23/10/2015
Contact: