Incyte has treated the first patient in the Phase III TRuE-AD clinical trial programme to assess the safety and efficacy of ruxolitinib cream for the treatment of patients with atopic dermatitis (AD).
The trial programme features two Phase III studies and is designed to evaluate ruxolitinib as monotherapy for adolescent and adult patients with AD aged 12 years or over.
Each of the studies is expected to enrol around 600 patients who have been diagnosed with AD for at least two years.
Patients with an Investigator’s Global Assessment (IGA) score of two to three, a Body Surface Area (BSA) involvement (excluding scalp) of 3% to 20%, and who are candidates for topical therapy will be included in the TRuE-AD trial.
Incyte aims to randomise the patients in 2:2:1 ratio into one of three treatment arms as part of the trial.
The trial’s primary objective is the proportion of patients witnessing an Investigator’s Global Assessment Treatment Success (IGA-TS), measured as an IGA score of 0 (clear) or one (almost clear) with at least a two-point improvement from baseline at week 8.
Major secondary objectives of the trial comprise the proportion of patients achieving at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI) score, and the proportion of subjects with at least a four-point improvement in the itch numerical rating scale (NRS).
Both trials of the TRuE-AD programme are also expected to monitor the frequency, duration, and severity of adverse events related to the use of ruxolitinib cream.
Incyte chief medical officer Steven Stein said: “Atopic dermatitis can have a serious impact on patients’ overall health and quality of life and, unfortunately, the long-term use of prescription topical corticosteroids can lead to significant side effects, underscoring the medical need for new topical therapies to treat this chronic skin disease.
“With the initiation of the Phase III programme, for ruxolitinib cream, we are moving closer to our goal of providing a safe and effective alternative treatment for adolescent and adult patients living with this chronic, burdensome disease.”
Around 11 million people in the US are currently estimated to have diagnosed with and are being treated for AD, which is a chronic disease characterised by inflammation of the skin.