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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 being studied for the treatment of active idiopathic inflammatory myopathy, a group of rare muscle diseases that includes myositis, dermatomyositis, polymyositis, immune-mediated necrotizing myopathy, and antisynthetase syndrome. It is administered subcutaneously and is currently in clinical development.
EFG PH20 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 efficacy and safety of this investigational therapy in patients with active idiopathic inflammatory myopathy.
EFG PH20 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with active idiopathic inflammatory myopathy.
EFG PH20 has one completed Phase 2 clinical trial, registered as NCT05523167. This randomized, double-blind, placebo-controlled study enrolled 265 adult participants with active idiopathic inflammatory myopathy and evaluated the efficacy and safety of the drug across multiple countries worldwide.
EFG PH20 is a monoclonal antibody designed to target and neutralize the activity of the neonatal Fc receptor, which plays a role in recycling immunoglobulin G antibodies. By blocking this receptor, the drug reduces levels of pathogenic IgG antibodies that contribute to the muscle inflammation seen in idiopathic inflammatory myopathy.
Yes, EFG PH20 is the same drug as efgartigimod PH20 SC. The clinical trial NCT05523167, which investigated the efficacy and safety of efgartigimod PH20 SC in adults with active idiopathic inflammatory myopathy, is the trial associated with EFG PH20.