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

Phase 1

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

Registration Number: EUCTR2012-000540-10-CZ

Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 1100

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;Primary end point(s): Annualized relapse rate defined as the number of confirmed relapses per subject-year.;Main Objective: - To determine whether ponesimod is more efficacious than teriflunomide in terms of reducing relapses in subjects with RMS.;<br> Secondary Objective: - To assess the effect of ponesimod on disability accumulation and on other aspects of multiple sclerosis (MS) disease control<br> - To assess the safety and tolerability of ponesimod in subjects with RMS.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1. Time to 12-week confirmed disability accumulation (CDA) from baseline to EOS;<br> 2. Percent change in brain volume (PCBV) from baseline to Week 108;<br> 3. Time to first confirmed relapse;<br> 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;<br> 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);<br> ;<br> Timepoint(s) of evaluation of this end point: 1: end of study<br> 2, 4, 5: week 108<br> 3: time to first confirmed relapse<br>

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