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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04926818 | Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis | PHASE3 | ACTIVE NOT_RECRUITING | 129 | — | — | Oct 5, 2021 | Feb 28, 2031 | May 14, 2026 | 51 | United States, Argentina +23 |
Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25).
| Arm | Type | Description |
|---|---|---|
| ofatumumab - 20 mg injection/ placebo | EXPERIMENTAL | Ofatumumab as a solution for injection in an autoinjector containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content) for subcutaneous administration. A loading dose at Day1, Day 7 and Day 14 and then injections every 4 weeks/ 6 weeks (depending on patient's body weight). |
| siponimod - 0.5 mg, 1 mg or 2 mg/ placebo | EXPERIMENTAL | Siponimod tablet administered orally once daily. Titration period, Day 1 to Day 6, first dose is either 0.1 mg or 0.25 mg up to daily dose of either 0.5 mg, 1 mg or 2 mg (depending on CYP2C9 genotype and body weight). |
| fingolimod - 0.5 mg or 0.25 mg/ placebo | ACTIVE_COMPARATOR | Fingolimod capsule administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight). |
| Name | Type | Description |
|---|---|---|
| Fingolimod | DRUG | Fingolimod capsule administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight). |
| Ofatumumab | DRUG | Ofatumumab as a solution for injection in an autoinjector containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content) for subcutaneous administration. A loading dose at Day1, Day 7 and Day 14 and then injections every 4 weeks/ 6 weeks (depending on patient's body weight). |
| Siponimod | DRUG | Siponimod tablet administered orally once daily. Titration period, Day 1 to Day 6, first dose is either 0.1 mg or 0.25 mg up to daily dose of either 0.5 mg, 1 mg or 2 mg (depending on CYP2C9 genotype and body weight). |
| Fingolimod placebo | OTHER | Fingolimod matching placebo capsule |
| Siponimod placebo | OTHER | Siponimod matching placebo tablet |
| Ofatumumab placebo | OTHER | Ofatumumab matching placebo autoinjector |
Inclusion Criteria: 1. Between 10 to \<18 years of age (i.e., have not yet had their 18th birthday) at randomization 2. Diagnosis of multiple sclerosis 3. EDSS score of 0 to 5.5, inclusive 4. At least one MS relapse/attack during the previous year or two MS relapses in the previous two years prior ...