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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04788615 | Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS | PHASE3 | COMPLETED | 185 | — | — | Jul 23, 2021 | Nov 4, 2025 | Mar 3, 2026 | 41 | France, Germany +2 |
| NCT03560739 | A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients | PHASE2 | COMPLETED | 284 | — | — | Sep 11, 2018 | May 5, 2020 | Oct 8, 2021 | 41 | United States, Austria +7 |
NEDA-3 (yes/no) is defined as: 1. Absence of confirmed clinical relapse 2. Absence of new MRI activity (Gd+ T1 lesion or new/enlarged T2 lesion) with MRI re-baselined at Month 3 3. Absence of 3-month confirmed disability worsening
Bioequivalence of AUCtau ) will be measured over the time period of Week 8 to Week 12 dosing interval comparing the pre-filled syringe (PFS) and autoinjector (AI) devices both administered to the abdomen. Bioequivalence established if both measures meet the corresponding criterion specified by the reference-scaled average bioequivalence (RSABE) approach
Bioequivalence of Cmax will be measured over the time period of Week 8 to Week 12 dosing interval comparing the pre-filled syringe (PFS) and autoinjector (AI) devices both administered to the abdomen. Bioequivalence established if both measures meet the corresponding criterion specified by the reference-scaled average bioequivalence (RSABE) approach
| Arm | Type | Description |
|---|---|---|
| ofatumumab | EXPERIMENTAL | Oftatumumab 20mg auto injector syringes for subcutaneous injection on Day 1, Week 1 and 2, followed by subsequent monthly dosing, starting at Month 1. |
| First line DMT | ACTIVE_COMPARATOR | 1. Glatiramer acetate minimum dose 20mg or maximum dose 40mg twice a day or three times a week or 2. Interferon minimum dose 22µg or maximum dose of 0.25mg 3 times a week or once a week or Every second week depending on preparation or 3. Peg-Interferon beta-1a minimum dose of 63µg or maximum dose of 125µg every 2 weeks (14 days) or 4. Teriflunomide 14 mg once a day or 5. Dimethyl fumarate minimum dose of 120mg or maximum dose of 240mg twice a day 6. Diroximel fumarate minimum dose of 231mg or maximum dose of 462mg twice a day |
| OMB 20mg PFS abdomen | OTHER | ofatumumab 20 mg subcutaneous (sc.) injection with pre-filled syringes (PFS) administrated on abdomen |
| OMB 20mg AI abdomen | OTHER | ofatumumab 20 mg subcutaneous (sc.) injection with autoinjector (AI) administrated on abdomen |
| OMB 20mg PFS thigh | OTHER | ofatumumab 20 mg subcutaneous (sc.) injection with pre-filled syringes (PFS) administrated on thigh |
| OMB 20mg AI thigh | OTHER | ofatumumab 20 mg subcutaneous (sc.) injection with autoinjector (AI) administrated on thigh |
| Name | Type | Description |
|---|---|---|
| Ofatumumab | DRUG | 20mg Subcutaneous injection |
| First line DMT | DRUG | any one of these based on availability at country given as First line DMT Glatiramer acetate 20mg or 40mg or Interferon 22µg or 0.25mg or Peg-Interferon beta-1a 63µg or 125µg or Teriflunomide 14mg or Dimethyl fumarate 120mg or 240mg or Diroximel fumarate 231mg or 462mg |
| ofatumumab with PRF | COMBINATION_PRODUCT | ofatumumab 20 mg subcutanious injection administered with pre-filled syringe (PRF) |
| ofatumumab with AI | COMBINATION_PRODUCT | ofatumumab 20 mg subcutaneous injection administered with autoinjector (AI) |
Inclusion Criteria 1. Written informed consent obtained before any assessment 2. Male/female patients, 18 through 55 (inclusive) years of age. 3. Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018). 4. Relapsing MS: relapsing-course (RMS), as defined by Lublin et a...