Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Efgartigimod Alfa · 1 trial · 1 indication
Number of enrolled participants per month
Proportion of randomized participants who receive both doses of assigned study intervention, attend all assigned study visits, and complete at least the high contrast visual acuity, low contrast visual acuity, and Pelli-Robson assessments at all visits
Difference in change in high-contrast visual acuity from baseline to 1 month between groups
Difference in change in low contrast visual acuity (LCVA) (# of letters seen at 2.5% illumination) from baseline to 1 month between groups
| Arm | Type | Description |
|---|---|---|
| Efgartigmod alfa | ACTIVE_COMPARATOR | 10 patients will receive efgartigimod alfa All participants will receive standard of care high dose corticosteroids for 3 days with a prednisone taper over 3 weeks. |
| Placebo | PLACEBO_COMPARATOR | 10 patients will receive placebo. All participants will receive standard of care high dose corticosteroids for 3 days with a prednisone taper over 3 weeks. |
| Name | Type | Description |
|---|---|---|
| Efgartigimod Alfa | DRUG | 2,016 mg will be administered subcutaneously by a healthcare provider on Day 0 and Day 3 of the trial. Rescue therapy with therapeutic plasma exchange will be given to any participant based on the results of Day 7 evaluation. |
| Placebo | DRUG | Subcutaneous injection of placebo will be administered by a healthcare provider on Day 0 and Day 3 of the trial. Rescue therapy with therapeutic plasma exchange will be given to any participant based on the results of Day 7 evaluation. |
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Adults aged 18 years or older 4. Diagnosed with a first episode of optic neuritis, based on clinical presentation (i...
Efgartigimod Alfa is being studied for the treatment of acute optic neuritis, a neurological condition involving inflammation of the optic nerve. It is currently in Phase 2 clinical development as an investigational therapy for this indication.
Efgartigimod Alfa targets the neonatal Fc receptor (FcRn), which plays a role in recycling IgG antibodies. By blocking FcRn, it reduces levels of pathogenic IgG antibodies, potentially mitigating the autoimmune attack on the optic nerve in optic neuritis.
Efgartigimod Alfa is being developed by argenx SE, a biopharmaceutical company listed on the NASDAQ under the ticker ARGX. The company is conducting a Phase 2 clinical trial for this drug in optic neuritis.
Efgartigimod Alfa is in Phase 2 clinical development for optic neuritis. It is an investigational drug and has not been approved by regulatory authorities for this indication. The ongoing trial is recruiting participants in the United States.
Efgartigimod Alfa is being evaluated in a Phase 2, randomized, double-blind, placebo-controlled trial (NCT06453694) for acute optic neuritis. The study, titled 'Efgartigimod for the Treatment of Acute Optic Neuritis,' is recruiting 20 participants aged 18 years and older in the United States.
Efgartigimod Alfa is the active ingredient in Vyvgart, a brand name for the drug. In the context of optic neuritis, it is being investigated under the name Efgartigimod Alfa in a Phase 2 clinical trial.