Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARGX-109 · 1 trial · 1 indication
AE: adverse event, SAE: serious adverse event
| Arm | Type | Description |
|---|---|---|
| ARGX-109 | EXPERIMENTAL | Participants receiving the experimental drug |
| Placebo | PLACEBO_COMPARATOR | Participants receiving placebo |
| Name | Type | Description |
|---|---|---|
| ARGX-109 | BIOLOGICAL | administrations of ARGX-109 |
| Placebo | OTHER | administrations of placebo comparator |
Inclusion Criteria: * is aged 18 to 65 years, inclusive, when signing the ICF * has a body weight between 50 and 100 kg and a BMI between 18.5 and 30.0 kg/m2, inclusive Exclusion Criteria: * Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's...
ARGX-109 is an investigational monoclonal antibody developed by argenx SE. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in Canada. No approved indication has been announced for ARGX-109, and it remains in early clinical development.
ARGX-109 targets interleukin-6, or IL-6, a cytokine. By binding IL-6, the antibody is designed to interfere with IL-6 mediated signaling. IL-6 is a signaling protein involved in inflammatory and immune processes, which is why it is a target of interest for antibody therapeutics.
ARGX-109 is developed by argenx SE, a biotechnology company listed on the Nasdaq under the ticker ARGX. Argenx is the sponsor of the clinical program for ARGX-109.
ARGX-109 is in Phase 1 development. It is investigational and has not been approved by the FDA. The Phase 1 program consists of one completed trial, and no active trials are currently listed for ARGX-109.
ARGX-109 has been evaluated in one clinical trial, NCT06799416, titled A Study to Assess the Safety of ARGX-109 in Healthy Volunteers. The Phase 1 trial was completed, enrolled 40 healthy adult participants in Canada, and used a randomized, double-blind, placebo-controlled design.