Status:
COMPLETED
Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis
Lead Sponsor:
Actelion
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 stud...
Detailed Description
The AC-058B303 study (extension study) is the long-term extension for the AC-058B301 study (core study). The core study has been designed to investigate the efficacy, safety and tolerability of ponesi...
Eligibility Criteria
Inclusion
- Signed informed consent
- Subjects with MS having completed the double-blind treatment in the core study as scheduled
- Compliance with teriflunomide elimination procedure
- Women of childbearing potential (WOCBP) must have a negative pre-treatment urine pregnancy test, must agree to undertake 4-weekly urine pregnancy tests, and must have been using reliable methods of contraception. Fertile male subjects participating in the study must agree to use a condom.
Exclusion
- Any of the following cardiovascular conditions on Day 1 pre-dose:
- Resting heart rate (HR) \< 50 bpm;
- Presence of second degree atrioventricular (AV) block or third degree AV block or a QTcF interval \> 470 ms (females), \> 450 ms (males);
- 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:
- Lymphocyte count: \< 0.2 x 109/L;
- Neutrophil count \<1.0 × 109/L;
- Platelet count \< 50 × 109/L;
- Creatinine clearance \< 30 mL/min
- At Visit 14 of the core study (EOT) \>30% decrease from core study baseline FEV1 and/or FVC;
- Clinically significant, persistent respiratory AEs (e.g., dyspnea) not resolved prior to first dosing in the extension study.
- Macular edema at any time between Visit 1 (Screening) in the core study and Day 1 of the extension study.
- 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:
- Suspected opportunistic infection of the CNS or any other infection which, in the opinion of the investigator, contraindicates re-start of the study drug;
- Stevens-Johnson syndrome or toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms.
- Need for and intention to administer forbidden study treatment-concomitant therapy
- Women who are pregnant or lactating.
- Male subjects wishing to parent a child;
- Treatment with any MS Disease Modifying Therapies;
- 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;
- Subjects unlikely to comply with the extension study protocol based on investigator best judgment
Key Trial Info
Start Date :
July 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2024
Estimated Enrollment :
877 Patients enrolled
Trial Details
Trial ID
NCT03232073
Start Date
July 5 2017
End Date
January 16 2024
Last Update
June 22 2025
Active Locations (148)
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1
The Research Center of Southern California, LLC
Carlsbad, California, United States, 92011
2
The Neurology Group
Pomona, California, United States, 91767
3
Mountain View Clinical Research
Denver, Colorado, United States, 80209
4
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States, 32174