Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Efgartigimod PH20 SC - prefilled syringe, Efgartigimod PH20 SC, Efgartigimod PH20, efgartigimod PH20 SC, efgartigimod PH20, Efgartigimod PH20 (ARGX-113) SC
Efgartigimod PH20- prefilled syringe · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment arm 1 | EXPERIMENTAL | Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) |
| Treatment arm 2 | EXPERIMENTAL | Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) up to week 24 followed by placebo PH20 SC on top of optimized standard background immunosuppression therapy from weeks 24 to 48 |
| Treatment arm 3 | PLACEBO_COMPARATOR | Participants receiving Placebo PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) |
| Name | Type | Description |
|---|---|---|
| Efgartigimod PH20 SC - prefilled syringe | COMBINATION_PRODUCT | Subcutaneous efgartigimod PH20 SC given by prefilled syringe |
| Placebo PH20 SC - prefilled syringe | OTHER | Subcutaneous placebo PH20 SC given by prefilled syringe |
Inclusion Criteria: * The participant is within the ages of 18 and 80 years old * The participant had a kidney transplant (living or deceased donor) at least 6 months before the study * The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detec...
Efgartigimod PH20 is an investigational monoclonal antibody being developed for multiple antibody-mediated autoimmune conditions, including primary immune thrombocytopenia, bullous pemphigoid, antibody-mediated rejection in kidney transplant recipients, and Graves' disease. It is also being studied for myasthenia gravis, pemphigus vulgaris, Sjogren's disease, and ocular myasthenia gravis.
Efgartigimod PH20 targets the neonatal Fc receptor (FcRn), a protein that helps recycle immunoglobulin G (IgG) antibodies. By blocking FcRn, Efgartigimod PH20 is designed to reduce levels of pathogenic IgG antibodies that drive autoimmune diseases. This mechanism is being evaluated across several indications in clinical trials.
Efgartigimod PH20 is being developed by argenx SE, a biopharmaceutical company traded on NASDAQ under the ticker ARGX. The company is conducting clinical trials for this drug across multiple autoimmune indications, including primary immune thrombocytopenia, bullous pemphigoid, antibody-mediated rejection, and Graves' disease.
Efgartigimod PH20 is in Phase 2 and Phase 3 clinical trials. It is an investigational drug, meaning it has not been approved by regulatory authorities. Ongoing trials include a Phase 3 study for primary immune thrombocytopenia and a Phase 3 study for Graves' disease, with Phase 2 studies for bullous pemphigoid and antibody-mediated rejection.
Efgartigimod PH20 is being studied in several trials. NCT04812925 is a Phase 3 study for primary immune thrombocytopenia. NCT05267600 is a Phase 2/3 study for bullous pemphigoid. NCT06503731 is a Phase 2 study for antibody-mediated rejection. NCT07596849 is a Phase 3 study for Graves' disease.
Yes, Efgartigimod PH20 is also known as Efgartigimod PH20 SC, Efgartigimod PH20 SC - prefilled syringe, and Efgartigimod PH20 (ARGX-113) SC. These names refer to the same drug product, which is administered subcutaneously using a prefilled syringe formulation.