In short
Clinical trials are investigating ADX-038 in adults with complement-mediated kidney disease and geographic atrophy secondary to age-related macular degeneration. These studies are looking at safety, tolerability, and early signs of benefit. Both trials are in Phase 2 and are currently authorised.
Key points
- ADX-038 is being studied in two authorised Phase 2 clinical trials. One trial is for adults with complement-mediated kidney disease, and the other is for adults with geographic atrophy secondary to age-related macular degeneration. The kidney study focuses on safety and tolerability, including treatment-emergent adverse events. The eye study focuses on how geographic atrophy changes over 12 months in the study eye. Planned enrollment is 45 people in the kidney trial and 240 people in the eye trial.
Trial overview
Two authorised Phase 2 studies are investigating ADX-038 in different diseases. Both are interventional trials, which means researchers give a treatment and then measure what happens.
The studies are planned for adults with either complement-mediated kidney disease or geographic atrophy secondary to age-related macular degeneration. Planned enrollment is 45 people in the kidney study and 240 people in the eye study.
Complement-mediated kidney disease study
NCT06989359 is a Phase 2 study of ADX-038 in complement-mediated kidney disease. The study is authorised and plans to include 45 participants.
The main goal is to evaluate the safety and tolerability of ADX-038. Safety means whether the treatment causes health problems, and tolerability means how well people can take it during the study.
The primary outcome is the incidence and severity of treatment-emergent adverse events (TEAEs), which are side effects or health problems that begin after treatment starts.
Geographic atrophy study
NCT06990269 is a Phase 2 study in geographic atrophy secondary to age-related macular degeneration. It is authorised and plans to enroll 240 adult participants.
This trial is evaluating the effect of ADX-038 on GA lesion growth, meaning how the damaged area in the eye changes over time. The study compares change from baseline to Month 12 in the study eye.
The primary outcome is the slope of change in GA area, measured by fundus autofluorescence (FAF) and expressed in mm/year. FAF is an imaging test that helps researchers see and measure retinal damage.
What the trial endpoints mean
An endpoint is the main result researchers use to judge a trial. In the kidney study, the endpoint is about side effects and how often they happen, and how serious they are.
In the eye study, the endpoint is about whether the damaged area in the retina grows more slowly over 12 months. This is measured in the study eye, which is the eye chosen for the trial’s main analysis.
Who is being studied
The kidney trial is focused on people with complement-mediated kidney disease. The eye trial is focused on adult participants with geographic atrophy secondary to AMD.
These trials are not designed to study the same population, because they address different diseases. Together, they show that ADX-038 is being tested in separate patient groups with different research goals.