Table of Contents
- Trial overview
- Complement-mediated kidney disease study
- Geographic atrophy study
- What the trial endpoints mean
- Who is being studied
Trial overview
Two authorised Phase 2 studies are investigating ADX-038 in different diseases.[1][2] Both are interventional trials, which means researchers give a treatment and then measure what happens.[1][2]
The studies are planned for adults with either complement-mediated kidney disease or geographic atrophy secondary to age-related macular degeneration.[1][2] Planned enrollment is 45 people in the kidney study and 240 people in the eye study.[1][2]
Complement-mediated kidney disease study
NCT06989359 is a Phase 2 study of ADX-038 in complement-mediated kidney disease.[1] The study is authorised and plans to include 45 participants.[1]
The main goal is to evaluate the safety and tolerability of ADX-038.[1] Safety means whether the treatment causes health problems, and tolerability means how well people can take it during the study.[1]
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.[1]
Geographic atrophy study
NCT06990269 is a Phase 2 study in geographic atrophy secondary to age-related macular degeneration.[2] It is authorised and plans to enroll 240 adult participants.[2]
This trial is evaluating the effect of ADX-038 on GA lesion growth, meaning how the damaged area in the eye changes over time.[2] The study compares change from baseline to Month 12 in the study eye.[2]
The primary outcome is the slope of change in GA area, measured by fundus autofluorescence (FAF) and expressed in mm/year.[2] FAF is an imaging test that helps researchers see and measure retinal damage.[2]
What the trial endpoints mean
An endpoint is the main result researchers use to judge a trial.[1][2] In the kidney study, the endpoint is about side effects and how often they happen, and how serious they are.[1]
In the eye study, the endpoint is about whether the damaged area in the retina grows more slowly over 12 months.[2] This is measured in the study eye, which is the eye chosen for the trial’s main analysis.[2]
Who is being studied
The kidney trial is focused on people with complement-mediated kidney disease.[1] The eye trial is focused on adult participants with geographic atrophy secondary to AMD.[2]
These trials are not designed to study the same population, because they address different diseases.[1][2] Together, they show that ADX-038 is being tested in separate patient groups with different research goals.[1][2]
