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Also known as efgartigimod PH20 SC in stage B
efgartigimod PH20 in stage B · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| efgartigimod PH20 SC | EXPERIMENTAL | patients receiving efgartigimod PH20 SC in both stage A as stage B |
| Placebo | PLACEBO_COMPARATOR | patients receiving efgartigimod PH20 SC during stage A and receiving placebo in stage B |
| Name | Type | Description |
|---|---|---|
| efgartigimod PH20 SC in stage B | BIOLOGICAL | Stage A: efgartigimod PH20 SC, Stage B: efgartigimod PH20 SC |
| placebo in stage B | OTHER | Stage A: N/A, stage B: placebo |
Inclusion Criteria: 1. Ability to understand the requirements of the trial, provide written informed consent (include consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits) 2....
Efgartigimod PH20 in stage B is an investigational monoclonal antibody developed by argenx SE for chronic inflammatory demyelinating polyneuropathy (CIDP), an autoimmune disorder affecting the peripheral nerves. The stage B designation refers to a subcutaneous formulation of efgartigimod studied in a Phase 2 clinical trial. It is also known as efgartigimod PH20 SC in stage B.
Efgartigimod PH20 in stage B is being studied for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), an autoimmune disorder that affects the peripheral nerves. The Phase 2 trial enrolled adults 18 years and older with CIDP across multiple countries. It is investigational and has not been approved for CIDP.
Efgartigimod PH20 in stage B targets FCGRT, the neonatal Fc receptor, and acts as an antagonist. By binding FCGRT, the antibody is designed to reduce recycling of immunoglobulin G, lowering circulating IgG levels, which is relevant in antibody-mediated autoimmune conditions such as CIDP. This mechanism is the basis for its study in the Phase 2 CIDP trial.
Efgartigimod PH20 in stage B is being developed by argenx SE, which trades under the ticker ARGX. Argenx is the sponsor of the Phase 2 subcutaneous efgartigimod study in chronic inflammatory demyelinating polyneuropathy (CIDP).
Efgartigimod PH20 in stage B is in Phase 2 development for chronic inflammatory demyelinating polyneuropathy (CIDP). The single Phase 2 trial, NCT04281472, is completed and enrolled 322 participants. The study was randomized, double blind, and placebo controlled. The drug remains investigational and is not approved for CIDP.
Efgartigimod PH20 in stage B was evaluated in one Phase 2 clinical trial, NCT04281472, titled a study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy. The trial is completed, enrolled 322 adults, and was conducted across the United States, Europe, Asia, and other regions.
Yes, efgartigimod PH20 in stage B is also known as efgartigimod PH20 SC in stage B. The SC refers to the subcutaneous formulation of efgartigimod studied in the Phase 2 CIDP trial. Both names refer to the same investigational monoclonal antibody developed by argenx SE.