Ignite Creation Date:
2024-05-06 @ 9:07 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02907177
Status:
TERMINATED
Last Update Posted:
2021-05-18
First Post:
2016-08-25
Brief Title:
Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate Tecfidera
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Multicenter Randomized Double-blind Parallel-group add-on Superiority Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate Tecfidera
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sponsor decision due to low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POINT
Brief Summary:
This clinical study compares the efficacy safety and tolerability of therapy with ponesimod vs placebo in subjects with active RMS who are treated with DMF Tecfidera
Detailed Description:
The study will assess the efficacy safety and tolerability of add-on therapy with ponesimod 20 mg vs placebo in adult participants with active relapsing multiple sclerosis RMS who are treated with dimethyl fumarate DMF Approximately 600 participants who have been receiving DMF for at least 6 months will be randomized in a 11 ratio to ponesimod 20 mg or placebo The study consists of the following study periods Pre-randomization period Treatment period Post-treatment observation period The study includes one ponesimod treatment arm at the maintenance dose of 20 mg od corresponding to the optimal dose when used as monotherapy based on the Phase 2 dose-finding trial and its ongoing extension The study includes a placebo comparator arm but all patients will remain on DMF background therapy throughout the study Moreover participants who experience a confirmed relapse or an event of 24-week confirmed disability accumulation DMF while on study drug will have the option to switch to an alternative treatment The treatment period has a variable duration from a minimum of 60 weeks for the last subject randomized to a maximum of 156 weeks for the first subjects randomized in the trial and includes a gradual up-titration of ponesimod from a 2 mg starting dose to a 20 mg maintenance dose over a period of 14 days The total duration of the study will be approximately up to 167 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None