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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04130997 | An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis | PHASE3 | ACTIVE NOT_RECRUITING | 1,100 | — | — | Nov 18, 2019 | May 31, 2032 | May 29, 2026 | 86 | United States, Belarus +6 |
| NCT03277261 | Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 ) | PHASE3 | COMPLETED | 549 | — | — | Sep 19, 2017 | Nov 6, 2020 | Dec 6, 2021 | 14 | United States |
| NCT03277248 | Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) | PHASE3 | COMPLETED | 545 | — | — | Aug 25, 2017 | Nov 12, 2020 | Dec 6, 2021 | 13 | United States |
ARR is defined as the number of relapses per-participant year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years).
| Arm | Type | Description |
|---|---|---|
| Ublituximab Infusions | EXPERIMENTAL | RMS301/RMS302: All participants transferring from RMS301/RMS302 who sign consent for this study will receive an initial 4-hour infusion of 150 mg ublituximab on Week 1 (Day 1) followed by a 1-hour infusion of 450 mg ublituximab 14 days later Week 3 (Day 15). Subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 312. RMS201E: All participants transferring from RMS201E who sign consent for this study will receive a 1-hour infusion of 450 mg ublituximab on Week 1 (Day 1) and subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 312. For all participants (RMS301/RMS302/RMS201E), infusion treatment will continue for 312 weeks, or until physician or participant decision to withdraw from the study. |
| Ublituximab + Oral Placebo | EXPERIMENTAL | Participants were administered ublituximab 150 milligrams (mg), intravenous (IV) infusion over 4 hours (h) on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo once daily (QD) from Day 1 up to the last day of Week 95. |
| Teriflunomide + IV Placebo | ACTIVE_COMPARATOR | Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72). |
| Name | Type | Description |
|---|---|---|
| Ublituximab | BIOLOGICAL | Ublituximab (TG-1101) is a recombinant chimeric monoclonal antibody targeting CD20, available as a 25 mg/mL concentrate for intravenous use, supplied by TG Therapeutics, Inc. |
| Teriflunomide | DRUG | Film-coated tablets administered orally. |
| Oral Placebo | DRUG | Administered orally. |
| IV Placebo | DRUG | Administered as an IV infusion. |
Inclusion Criteria: Participants must meet the following criteria: 1. Complete the 96-week double-blind TG1101-RMS301 (NCT03277261) or TG1101-RMS302 (NCT03277248) study or complete the final Week 208 visit of the TG1101-RMS201E (NCT03381170) study 2. Investigator believes may benefit from treatmen...