Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 AChR-Ab seropositive generalized myasthenia gravis, dermatomyositis, multifocal motor neuropathy (MMN), chronic inflammatory demyelinating polyneuropathy, and chronic inflammatory demyelinating polyradiculoneuropathy. It is administered intravenously and is currently in clinical trials.
Empasiprubart is being developed by argenx SE, a biopharmaceutical company traded on the NASDAQ under the ticker ARGX. The company is conducting clinical trials to evaluate the safety and efficacy of Empasiprubart for multiple 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 actively recruiting participants to study its effects in conditions such as multifocal motor neuropathy and generalized myasthenia gravis.
Empasiprubart is being studied in several trials, including NCT06742190, a Phase 3 study comparing Empasiprubart to IVIg in adults with multifocal motor neuropathy; NCT07610564, a Phase 1 study on nerve morphology; NCT07638566, a Phase 2 study in adolescents with CIDP; and NCT07673627, a Phase 2 study in AChR-Ab seropositive generalized myasthenia gravis.
Yes, Empasiprubart IV is another name for Empasiprubart. The drug is administered intravenously, and the 'IV' designation is sometimes used in clinical trial titles and descriptions to specify the route of administration.