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Also known as Empasiprubart IV, empasiprubart SC AI, empasiprubart AI
Empasiprubart · 8 trials · 15 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.
The Guillain-Barré Syndrome Disability Scale (GBS-DS) is a clinician-reported measure of global functional disability. It has 7 categories ranging from 0 (healthy) to 6 (death), with higher scores indicating greater disability. A GBS-DS score ≤2 indicates the participant is able to walk 10 meters or more without assistance.
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 |
| Empasiprubart + IVIg | EXPERIMENTAL | Participants receive empasiprubart by intravenous infusion and IVIg by intravenous infusion. |
| Placebo + IVIg | PLACEBO_COMPARATOR | Participants receive placebo by intravenous and IVIg by intravenous infusion. |
| 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 |
| Empasiprubart Placebo IV | OTHER | Intravenous infusion of Placebo |
| Intravenous immunoglobulin (IVIg) | 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 biologic developed by argenx SE for neurological autoimmune conditions. It is being studied in AChR-Ab seropositive generalized myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, dermatomyositis, Guillain-Barré syndrome, and multifocal motor neuropathy. It is in Phase 2 clinical development and is not yet approved.
Empasiprubart is being developed to treat several neurological autoimmune disorders, including AChR-Ab seropositive generalized myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, dermatomyositis, Guillain-Barré syndrome, and multifocal motor neuropathy. These are the indications under study in its clinical program.
Empasiprubart is developed by argenx SE, which trades under the ticker ARGX. The company is running the Phase 2 clinical program evaluating the drug across its neurological indications.
Empasiprubart is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. Its trials include a Phase 2 study in generalized myasthenia gravis and a Phase 2/Phase 3 study in adolescents with chronic inflammatory demyelinating polyradiculoneuropathy.
Empasiprubart trials include NCT07673627, a recruiting Phase 2 study of IV monotherapy in AChR-Ab seropositive generalized myasthenia gravis, and NCT07821762, a Phase 2 study as add-on therapy to IVIg in Guillain-Barré syndrome. NCT07638566 is a Phase 2/Phase 3 study in adolescent CIDP, and NCT07610564 is a Phase 1 nerve morphology study in multifocal motor neuropathy.
Yes. Empasiprubart IV, empasiprubart SC AI, empasiprubart AI, and empasiprubart IV all refer to the same investigational drug, empasiprubart. The suffixes describe the formulation or route studied, such as intravenous or subcutaneous administration, rather than a different molecule.