Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03623243 | Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients | PHASE3 | COMPLETED | 185 | — | — | Feb 14, 2019 | Jul 6, 2022 | Jun 20, 2024 | 55 | United States, Puerto Rico |
An Adverse Event (AE) is any untoward medical occurrence in a participant that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as the AEs started after the first dose of siponimod to 30 days after the date of the last actual administration, or events present prior to start of treatment but which increased in severity. TEAEs suspected to be related to study drug are reported.
| Arm | Type | Description |
|---|---|---|
| Siponimod | EXPERIMENTAL | Participants will receive titrated doses of siponimod tablets, orally, once daily of 0.25 mg on Day 2, 0.5 mg on Day 3, 0.75 mg on Day 4, 1.25 mg on Day 5, and maintenance dose of siponimod 2.0 mg tablets, orally, once daily from Day 6 up to 6 months. As of protocol amendment 3, participants entering the trial converting from fingolimod will start directly with 2 mg dose of siponimod. |
| Name | Type | Description |
|---|---|---|
| Siponimod | DRUG | Siponimod 2mg tablets taken once daily |
Key Inclusion Criteria: 1. Signed informed consent. 2. Male or female aged 18 to 65 years (inclusive). 3. Patients with advancing RMS as defined by the principal investigator. 4. Prior history of relapsing MS (RMS), with or without progressive features, according to the 2010 Revised McDonald or Lub...