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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).
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.
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 + 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. |
| 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 |
| 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 monoclonal antibody developed by argenx SE for neurological conditions. It is being studied in Phase 2 clinical trials as a treatment for AChR-Ab seropositive generalized myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, dermatomyositis, Guillain-Barré syndrome, and multifocal motor neuropathy.
Empasiprubart is being developed for several neurological indications: AChR-Ab seropositive generalized myasthenia gravis, chronic inflammatory demyelinating polyneuropathy (CIDP), dermatomyositis, Guillain-Barré syndrome (GBS), and multifocal motor neuropathy (MMN). It remains investigational and is not established as a marketed therapy for any of these conditions.
Empasiprubart is developed by argenx SE, which trades under the ticker ARGX. The company is running the clinical program for the antibody across its neurological indications, including generalized myasthenia gravis, CIDP, Guillain-Barré syndrome, and multifocal motor neuropathy.
Empasiprubart is in Phase 2 clinical development. Its trials include Phase 2 studies in AChR-Ab seropositive generalized myasthenia gravis, Guillain-Barré syndrome, and adolescent CIDP, plus a Phase 1 study in multifocal motor neuropathy. It is investigational and has not been approved by the FDA.
Empasiprubart trials include NCT07673627 (ADAPT Forward 2, Phase 2 in AChR-Ab seropositive generalized myasthenia gravis, recruiting in the United States, Greece, and Spain), NCT07821762 (Phase 2 as add-on to IVIg in Guillain-Barré syndrome), NCT07638566 (Phase 2 in adolescents with CIDP), and NCT07610564 (Phase 1 in multifocal motor neuropathy).
Yes. Empasiprubart IV, empasiprubart SC AI, empasiprubart AI, and empasiprubart IV all refer to the same investigational antibody, empasiprubart, developed by argenx SE. The added terms describe formulation or administration routes studied in its clinical program rather than separate products.