Asana BioSciences has commenced the RADIANT Phase llb trial to investigate the efficacy, safety, tolerability, and pharmacokinetics of ASN002 to treat patients with moderate-to-severe atopic dermatitis (AD).
The randomised, double-blind, placebo-controlled trial is expected to enrol around 220 adult patients diagnosed with chronic atopic dermatitis for at least six months with an eczema area and severity index (EASI) score of 16 or more.
The patients will also be required to have an investigator’s global assessment (IGA) score of three or greater, and a body surface area involving at least 10% at baseline.
As part of the trial, the enrolled patients will be randomly assigned to receive a 40mg, 60mg or 80mg once-daily dose of ASN002 or placebo for 12 weeks.
The trial’s primary outcome measure is the change in EASI score from baseline to week 12.
Its secondary endpoints are IGA, pruritus scores (NRS), patient-oriented eczema measure (POEM) and dermatology life quality index (DLQI).
The trial is set to be carried out at various sites in the US, Canada and Germany.
Asana BioSciences founder and CEO Dr Sandeep Gupta said: “We believe ASN002 is the first JAK inhibitor to report parallel improvements in clinical, histological and molecular parameters in AD skin lesions.
“These compelling data indicate the potential of ASN002 as an important treatment option for patients with moderate-to-severe atopic dermatitis, as well as its potential applications for other dermatologic and auto-immune diseases.”
AD is a common inflammatory skin disease that affects both children and adults.
The disease is characterised by pruritus (itch), a chronically relapsing course, and often affects a personal or family history of atopic diseases.