Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...