A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.

Phase 1

• Conditions: Relapsing multiple sclerosis.; MedDRA version: 21.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-004719-10-FI
• Lead Sponsor: Actelion Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-12
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

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 < 0.02
mg/L and until at least 30 days after study treatment
discontinuation;
- must have been using reliable methods of contraception
uninterrupted since EOT in the core study and must agree to
continue using reliable methods of contraception throughout
the study until 6 weeks after the first of two consecutive tests
showing teriflunomide plasma level < 0.02 mg/L and until at
least 30 days after discontinuation of study treatment.

- Fertile male subjects participating in the study who are sexually active with
WOCBP must agree to use a condom until 6 weeks after the first of two
consecutive tests confirming plasma teriflunomide level <0.02 mg/L.
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 800
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any of the following cardiovascular conditions on Day 1
pre-dose:
a. Resting heart rate (HR) < 50 bpm as measured by the pre-dose
12-lead ECG;
b. Presence of second degree atrioventricular (AV) block or third
degree AV block or a QTcF interval > 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: < 0.2 x 10^9/L (<200/mm^3 blinded
results);
b. Neutrophil count <1.0 × 10^9/L(< 1000 cells/mm^3);
c. Platelet count < 50 × 10^9/L (< 50 000 cells/mm^3);
d. Creatinine clearance < 30 mL/min (Cockroft-Gault) Any
findings below
3. At Visit 14 of the core study (EOT) >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified