Approval Probability
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Adjusted LOA
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Also known as Empasiprubart IV, empasiprubart IV
empasiprubart · 7 trials · 14 indications
The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).
CL = Clearance; Vd = apparent volume of distribution.
C2 = complement component 2.
CSA : cross-sectional area
| Arm | Type | Description |
|---|---|---|
| Part A - Empasiprubart | EXPERIMENTAL | Participants receive empasiprubart during part A |
| Part A - Placebo | PLACEBO_COMPARATOR | Participants receive placebo during part A |
| Part B - Empasiprubart | EXPERIMENTAL | Participants receive empasiprubart during part B. Participants from the empasiprubart arm in part A will receive placebo once to maintain the blind of part A. |
| Part A - empasiprubart + IVIg-placebo | EXPERIMENTAL | During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm. |
| Part A - IVIg + empasiprubart-placebo | ACTIVE_COMPARATOR | During Part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm. |
| Empasiprubart IV | EXPERIMENTAL | Participants will receive empasiprubart IV |
| Placebo IV | PLACEBO_COMPARATOR | Participants receive placebo IV in the DBTP |
| Efgartigimod PH20 SC PFS | OTHER | Participants receive open-label efgartigimod PH20 SC PFS in the safety follow-up period |
| Empasiprubart | EXPERIMENTAL | Patients receiving Empasiprubart IV |
| Placebo | PLACEBO_COMPARATOR | Patients receiving Placebo IV |
| Name | Type | Description |
|---|---|---|
| Empasiprubart IV | BIOLOGICAL | Intravenous infusion of empasiprubart |
| Placebo IV | OTHER | Intravenous infusion of placebo |
| empasiprubart | BIOLOGICAL | Intravenous infusion of empasiprubart |
| IVIg | BIOLOGICAL | Intravenous infusion of IVIg |
| empasiprubart-placebo | OTHER | A placebo resembling the empasiprubart treatment |
| IVIg-placebo | OTHER | A placebo resembling the IVIg treatment |
| IVIG (Intravenous Immunoglobulin) | BIOLOGICAL | Intravenous infusion of IVIg |
| Efgartigimod PH20 SC PFS | COMBINATION_PRODUCT | Subcutaneous administration of efgartigimod PH20 via pre-filled syringe (PFS) |
Inclusion Criteria: * Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021) * Has either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or dista...
Empasiprubart is an investigational monoclonal antibody being developed for neurological conditions including Multifocal Motor Neuropathy (MMN), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Dermatomyositis, and AChR-Ab Seropositive Generalized Myasthenia Gravis. It is administered intravenously and is currently in Phase 2 clinical development.
Empasiprubart is being developed by argenx SE, a biopharmaceutical company traded on the NASDAQ under the ticker ARGX. The company is conducting clinical trials for this investigational monoclonal antibody in neurological indications.
Empasiprubart is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its efficacy and safety in conditions such as Multifocal Motor Neuropathy and Chronic Inflammatory Demyelinating Polyneuropathy.
Empasiprubart is being studied in several clinical trials. NCT06742190 compares it to IVIg in adults with Multifocal Motor Neuropathy. NCT06920004 and NCT07091630 assess it versus IVIg or alone in adults with CIDP. NCT07610564 evaluates its effect on nerve morphology by ultrasound in Multifocal Motor Neuropathy.
Yes, Empasiprubart and empasiprubart IV refer to the same drug. The intravenous formulation is the route of administration used in clinical trials for this investigational monoclonal antibody being developed by argenx SE.
Empasiprubart is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. It is being studied in clinical trials for neurological conditions, but it has not received regulatory approval for any use.