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Also known as EFG PH20 SC
EFG PH20 · 1 trial · 6 indications
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
| Arm | Type | Description |
|---|---|---|
| EFG PH20 SC | EXPERIMENTAL | participants receiving efgartigimod PH20 SC on top of background treatment |
| PBO PH20 SC | PLACEBO_COMPARATOR | participants receiving placebo PH20 SC on top of background treatment |
| Name | Type | Description |
|---|---|---|
| EFG PH20 SC | BIOLOGICAL | Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer |
| PBO | OTHER | Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer |
Inclusion Criteria: * Ability to consent in the jurisdiction in which the study is taking place and capable of giving signed informed consent. * A definite or probable clinical diagnosis of idiopathic inflammatory myopathy (IIM) * One of the following medical histories: Diagnosis of dermatomyositis...
EFG PH20 is an investigational monoclonal antibody developed by argenx SE for active idiopathic inflammatory myopathy, a group of rare autoimmune muscle disorders. It is also known as EFG PH20 SC, where SC refers to subcutaneous administration. It has been studied in a Phase 2 clinical trial and is not yet approved.
EFG PH20 is being developed to treat active idiopathic inflammatory myopathy, which includes myositis, dermatomyositis, polymyositis, immune-mediated necrotizing myopathy, and antisynthetase syndrome. The Phase 2 study enrolled adults 18 years and older with these active muscle conditions. It remains investigational and is not approved for any use.
EFG PH20 is developed by argenx SE, a biotechnology company whose shares trade under the ticker ARGX. Argenx sponsored the Phase 2 clinical trial evaluating the drug in active idiopathic inflammatory myopathy. The asset is also referred to as EFG PH20 SC.
EFG PH20 is in Phase 2 development. Its single clinical trial, NCT05523167, has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA or any other regulatory agency for active idiopathic inflammatory myopathy or any other indication.
EFG PH20 has been studied in one clinical trial, NCT05523167, titled A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy. The Phase 2 trial was randomized, double-blind, and placebo-controlled, enrolling 265 participants across 37 countries. It is now completed.
Yes, EFG PH20 SC is an alternative name for EFG PH20. The SC designation refers to the subcutaneous formulation of the monoclonal antibody. Both names refer to the same investigational asset developed by argenx SE for active idiopathic inflammatory myopathy, studied in the completed Phase 2 trial NCT05523167.