Aslan Pharmaceuticals has announced the initiation of a Phase IIb trial evaluating its antibody, ASLAN004 (now known as eblasakimab), to treat moderate-to-severe atopic dermatitis (AD) in adult patients.
The first-in-class monoclonal antibody eblasakimab acts on the IL-13 receptor. Topline results from the trial are expected in the first half of 2023.
In the double-blind, placebo-controlled, randomised TREK-AD study, the company will evaluate the efficacy and safety of the antibody in nearly 300 adult patients.
Participants would be randomised in equal ratio to four active treatment arms and one placebo arm.
The 16-week, dose-ranging clinical trial will evaluate 300mg and 400mg doses of eblasakimab every two weeks, and 400mg and 600mg doses every four weeks.
After the 16-week treatment period, the subjects will be followed up for 12 weeks for safety.
Aslan Pharmaceuticals CEO Dr Carl Firth said: “Building upon the positive data we recently announced from the proof-of-concept study, the Phase IIb programme will enable us to evaluate its potential as a novel treatment option that could provide meaningful improvements over existing therapies.
“This is a key milestone for Aslan and moves us closer towards demonstrating the positive impact that eblasakimab could have on the burden of disease for atopic dermatitis and for other Type 2 driven allergic diseases.”
The study is expected to recruit subjects across 100 study centres in North America, Asia Pacific and Europe.
Percentage change in Eczema Area Severity Index (EASI) score from baseline to week 16 is the study’s primary efficacy goal.
The proportion of subjects attaining Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear), and a 75% or greater reduction in EASI (EASI-75) include the key secondary efficacy endpoints.
Other secondary goals include proportion of patients achieving EASI-50 and EASI-90, and variations in peak pruritus.