Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ofatumumab, Ofatumumab new dose
ofatumumab with PRF · 2 trials · 1 indication
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...
Ofatumumab is used for relapsing multiple sclerosis, leukaemia, diffuse large B-cell lymphoma, cancer, lymphoma, and non-Hodgkin lymphoma. It is being studied in clinical trials for these conditions, including relapsing multiple sclerosis and various blood cancers.
Ofatumumab is a monoclonal antibody, indicated by the -mab suffix in its target class. It is being investigated for conditions such as relapsing multiple sclerosis and B-cell malignancies, where it acts on CD20-positive B cells.
Ofatumumab is developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical trials to evaluate the drug for multiple indications, including relapsing multiple sclerosis and lymphoma.
Ofatumumab is in Phase 2 and Phase 3 clinical trials. It is an investigational drug, not yet approved, and is being studied for conditions such as relapsing multiple sclerosis, leukaemia, and diffuse large B-cell lymphoma.
Ofatumumab has been studied in several clinical trials, including NCT02792231, a Phase 3 trial comparing it to teriflunomide in relapsing multiple sclerosis, and NCT01313689, a Phase 3 trial in chronic lymphocytic leukemia. Other trials include NCT01294579 and NCT01626352 for non-Hodgkin lymphoma.
Yes, Ofatumumab is also known as Ofatumumab new dose. This alternative name is used in some contexts, but both refer to the same drug developed by Novartis AG.