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
Conditions
Sponsors
Actelion Pharmaceuticals Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent, prior to initiation of any study-mandated procedure. 2. Subjects with MS having completed the double-blind treatment in the core study as scheduled (i.e., who completed the double-blind treatment period until Week 108). 3. Compliance with teriflunomide elimination procedure assessed as sufficient by the investigator at visit FU1 or abbreviated visit FU2 of the core study, whichever occurred last. 4. For subjects of reproductive potential: - Women of childbearing potential (WOCBP): - must have a negative pre-treatment urine pregnancy test on Day 1; - must agree to undertake 4-weekly urine pregnancy tests during the study and until 6 weeks after the first of two consecutive tests showing teriflunomide plasma level =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any of the following cardiovascular conditions on Day 1 pre-dose: a. Resting heart rate (HR) 470 ms (females), > 450 ms (males) on pre- dose 12-lead ECG; 2. Any of the following alerts from central laboratory at Visit 14 of the core study (EOT) which was confirmed as an alert at repeated testing or not repeated prior to FU1 of the core study: a. Lymphocyte count: 30% decrease from core study baseline FEV1 and/or FVC; 4. Clinically significant, persistent respiratory AEs (e.g., dyspnea) not resolved prior to first dosing in the extension study. 5. Macular edema at any time between Visit 1 (Screening) in the core study and Day 1 of the extension study. 6. Presence of the following at core study Visit 14 (EOT, Week 108), FU1, or abbreviated visit FU2, or on Day 1 of the extension study pre-dose: a. Suspected opportunistic infection of the CNS or any other infection which, in the opinion of the investigator, contraindicates re-start of the study drug; b. Stevens-Johnson syndrome or toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms. 7. Need for and intention to administer forbidden studytreatment-concomitant therapy 8. Women who are pregnant or lactating. 9. Male subjects wishing to parent a child any time before the 6 week period following the first of two consecutive tests confirming plasma teriflunomide level <0.02 mg/L; 10. Treatment with any MS Disease Modifying Therapies (DMTs) between core study EOT and first dosing in extension study; 11. Any other clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the subject at risk by participating in the study; 12. Subjects unlikely to comply with the extension study protocol based on investigator best judgment from the core study protocol , e.g., uncooperative attitude, inability to return for follow-up visits, or known likelihood of not completing the extension study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: NA;Timepoint(s) of evaluation of this end point: NA;Main Objective: Safety objectives: - To describe the long-term safety and tolerability of ponesimod 20 mg in subjects with RMS. - To describe the effects of re-initiation of ponesimod treatment after interruption in subjects with RMS. Efficacy objectives: - To describe the long term disease control in subjects with RMS receiving ponesimod 20 mg. - To describe the effect of a switch from teriflunomide to ponesimod 20 mg on disease control in subjects with RMS.;Primary end point(s): The main clinical and MRI-based endpoints are: - Annualized confirmed relapse rate (ARR; based on the number of confirmed relapses per subject-year); - Time from core study randomization to first confirmed relapse; - Time from core baseline to first 12-week confirmed disability accumulation (CDA); - Time from core baseline to first 24-week confirmed disability accumulation (CDA); - Percent change from baseline in brain volume (PCBV) at all assessments; - Cumulative number of combined unique active lesions (CUAL, defined as new Gd+ T1 lesions plus new or enlarging T2 lesions without double-counting the lesions) at all assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
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
Public Contactclinical trial disclosure desk
Actelion Pharmaceuticals Ltd.
Outcome results
None listed